chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Skin reaction
Clinical narrative: BAD SKIN REACTION; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a consumer via a company representative concerned a 14 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: Unk) dose was not reported, administered on 16-OCT-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 16-OCT-2021, the patient experienced product administered to patient of inappropriate age. On 16-OCT-2021, the patient experienced off label use. On an unspecified date, the patient experienced bad skin reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad skin reaction, and the outcome of product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Thrombosis
Clinical narrative: BLOOD CLOT IN THE ARM; SEVERE REACTION; This spontaneous potential legal report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction and blood clot in the arm, and was hospitalized (date unspecified) for a while. Number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the arm and severe reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211145419- covid-19 vaccine ad26.cov2.s  blood clot in arm and  severe reaction. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Nausea, Throat irritation, Vomiting
Clinical narrative: A couple days later child began with throat irritation on day 2, nausea on day 3, 4, 5, 6.  It is now day 7 and pt. still complains of nausea sensation although it may be subsiding.   On day 3, we took a flight for our family vacation and pt. had a couple of instances of light committing.  I SUSPECT PT. WAS GIVEN 20 MICROGRAMS RATHER THAN 10 MICROGRAMS.  I WILL NEED TO DOUBLE CHECK THE PAPERS WE WERE GIVEN AFTER ADMINISTRATION OF DOSE.  We are currently out of the country on vacation.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ear disorder, Herpes zoster
Clinical narrative: Activated shingles at only 42 years old. Needed two rounds of acyclovir. Damaged ear. Have had ear infection taking antibiotics for nearly 3 month straight.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen/sore left armpit. Lasted for the next 3 days. Wasn?t extreme, could still use arms but was uncomfortable and slightly painful.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Vaccination complication
Clinical narrative: "I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter; Bed rest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter) and BED REST (Bed rest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter) and BED REST (Bed rest). At the time of the report, VACCINATION COMPLICATION ("I have a daughter who experience this same thing and, she is been out of commission for a day and a half that I was"/Similar side effects to those of reporter) and BED REST (Bed rest) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Added patient's demographic information.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue
Clinical narrative: Feeling dizzy; Broke out on a cold sweat; Started to feel really really tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), COLD SWEAT (Broke out on a cold sweat) and FATIGUE (Started to feel really really tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031L20A and 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Started to feel really really tired). On 13-Nov-2021, the patient experienced DIZZINESS (Feeling dizzy) and COLD SWEAT (Broke out on a cold sweat). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy), COLD SWEAT (Broke out on a cold sweat) and FATIGUE (Started to feel really really tired) outcome was unknown. No concomitant medications were provided. The patient took Lorazepam because she was really scared and anxious about the symptoms she have. This case was linked to MOD-2021-385992 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: the pain came back in 2-3 weeks; pain when the needle was injected, but it was only briefly and was fine afterwards; in a day or two the pain came back. Then the pain was gone after about four days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (in a day or two the pain came back. Then the pain was gone after about four days), PAIN (the pain came back in 2-3 weeks) and VACCINATION SITE PAIN (pain when the needle was injected, but it was only briefly and was fine afterwards) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Osteoarthritis. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN (in a day or two the pain came back. Then the pain was gone after about four days). On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain when the needle was injected, but it was only briefly and was fine afterwards). On an unknown date, the patient experienced PAIN (the pain came back in 2-3 weeks). At the time of the report, PAIN (in a day or two the pain came back. Then the pain was gone after about four days) and VACCINATION SITE PAIN (pain when the needle was injected, but it was only briefly and was fine afterwards) had resolved and PAIN (the pain came back in 2-3 weeks) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were reported.Treatment medications were not provided by the reporter. This case was linked to MOD-2021-213459 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (11 patients were given 0.5mL doses as booster doses instead of 0.25 ml) 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 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (11 patients were given 0.5mL doses as booster doses instead of 0.25 ml). On 15-Nov-2021, ACCIDENTAL OVERDOSE (11 patients were given 0.5mL doses as booster doses instead of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medications were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Positive Covid19 after Moderna vaccine; Off label : Doses administered 14 days apart; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid19 after Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Off label : Doses administered 14 days apart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Off label : Doses administered 14 days apart). On 15-Nov-2021, the patient experienced COVID-19 (Positive Covid19 after Moderna vaccine). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Off label : Doses administered 14 days apart) had resolved. At the time of the report, COVID-19 (Positive Covid19 after Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, SARS-CoV-2 test: positive covid-19 (Positive) Positive COVID-19.         No concomitant medication information was reported. No treatment medication information was reported.  On 11NOV2021 Thursday patient was having the sniffles, headache and cold like symptoms of COVID-19.  This is a spontaneous case of Inappropriate schedule of product administration for this 65-year-old female patient, with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19. The event occurred 7 months 15 days after the first dose of mRNA-1273 vaccine and 7 months after the second dose of mRNA-1273 vaccine. It was reported that patient experienced sniffles, headache and cold like symptoms and was confirmed Covid 19 positive. Vaccine doses were administered 14 days apart. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: No new information was received.; Sender's Comments: This is a spontaneous case of Inappropriate schedule of product administration for this 65-year-old female patient, with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19. The event occurred 7 months 15 days after the first dose of mRNA-1273 vaccine and 7 months after the second dose of mRNA-1273 vaccine. It was reported that patient experienced sniffles, headache and cold like symptoms and was confirmed Covid 19 positive. Vaccine doses were administered 14 days apart. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: A little sore arm after second shot; first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore arm after second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm after second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021). On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021) had resolved. On 23-Mar-2021, PAIN IN EXTREMITY (A little sore arm after second shot) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-386675, MOD-2021-386715 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Both my wife and I after slight symtoms from the booster as described; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Both my wife and I after slight symtoms from the booster as described) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 (Both my wife and I after slight symtoms from the booster as described). At the time of the report, VACCINATION COMPLICATION (Both my wife and I after slight symtoms from the booster as described) had resolved. Not Provided          No concomitant medications reported by reporter.  The next day after booster dose, patient received high dose flu shot.   This case was linked to MOD-2021-363423, MOD-2021-363442 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Migraine, Palpitations
Clinical narrative: Bad migraine; Felt sick; Headache; Low grade fever; Heart was pounding for what it seemed like hours; Really thirsty; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was pounding for what it seemed like hours), THIRST (Really thirsty), MIGRAINE (Bad migraine), MALAISE (Felt sick) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A, 053C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder (Heart palpatations) on 01-Jan-2000. Concurrent medical conditions included Migraine (Migraines) since 09-Jan-1987.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PALPITATIONS (Heart was pounding for what it seemed like hours), THIRST (Really thirsty), HEADACHE (Headache) and PYREXIA (Low grade fever). On 10-Nov-2021, the patient experienced MIGRAINE (Bad migraine) and MALAISE (Felt sick). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 10-Nov-2021, PALPITATIONS (Heart was pounding for what it seemed like hours), THIRST (Really thirsty), HEADACHE (Headache) and PYREXIA (Low grade fever) had resolved. At the time of the report, MIGRAINE (Bad migraine) and MALAISE (Felt sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: low (Low) low grade fever.         No relevant concomitant medications were reported.   This case was linked to MOD-2021-388787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received added patient demographics, added medical history. added 2nd dose details, added vaccine facility information. added events. On 16-Nov-2021: Follow up received contains non significant information. On 16-Nov-2021: Follow up received contains non significant information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Bad migraine; Felt sick; Headache; Low grade fever; Heart was pounding for what it seemed like hours; Really thirsty; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was pounding for what it seemed like hours), THIRST (Really thirsty), MIGRAINE (Bad migraine), MALAISE (Felt sick) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A, 053C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder (Heart palpatations) on 01-Jan-2000. Concurrent medical conditions included Migraine (Migraines) since 09-Jan-1987.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PALPITATIONS (Heart was pounding for what it seemed like hours), THIRST (Really thirsty), HEADACHE (Headache) and PYREXIA (Low grade fever). On 10-Nov-2021, the patient experienced MIGRAINE (Bad migraine) and MALAISE (Felt sick). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 10-Nov-2021, PALPITATIONS (Heart was pounding for what it seemed like hours), THIRST (Really thirsty), HEADACHE (Headache) and PYREXIA (Low grade fever) had resolved. At the time of the report, MIGRAINE (Bad migraine) and MALAISE (Felt sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: low (Low) low grade fever.         No relevant concomitant medications were reported.   This case was linked to MOD-2021-388787 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received added patient demographics, added medical history. added 2nd dose details, added vaccine facility information. added events. On 16-Nov-2021: Follow up received contains non significant information. On 16-Nov-2021: Follow up received contains non significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Joint swelling, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird), JOINT SWELLING (knee swell up), SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 439905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, CARVEDILOL and ENALAPRIL for Prophylaxis and Hypertension, ATORVASTATIN CALCIUM (LIPITOR) and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Nov-2021, the patient experienced SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up). On an unknown date, the patient experienced JOINT SWELLING (knee swell up). At the time of the report, PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird), JOINT SWELLING (knee swell up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter.   This case was linked to MOD-2021-387092 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird), JOINT SWELLING (knee swell up), SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 439905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, CARVEDILOL and ENALAPRIL for Prophylaxis and Hypertension, ATORVASTATIN CALCIUM (LIPITOR) and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Nov-2021, the patient experienced SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up). On an unknown date, the patient experienced JOINT SWELLING (knee swell up). At the time of the report, PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird), JOINT SWELLING (knee swell up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter.   This case was linked to MOD-2021-387092 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient/multiple patients received expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/multiple patients received expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/multiple patients received expired vaccine). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/multiple patients received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient experienced no symptoms.  Reporter declined to share concomitant medication.   No treatment information was provided  It was reported that patient's first 2 doses were Pfizer.   HCP said multiple other patients from the clinic also received this expired vaccine.    Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up information received on 16 Nov 2021 includes patient gender
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; 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 VERTIGO (vertigo) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: like burning ice; 2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.; sort of itchiness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (like burning ice), HERPES ZOSTER (2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.) and PRURITUS (sort of itchiness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F211A, 047A21A and 036521A) for COVID-19 vaccination.     Previously administered products included for Prophylaxis: Flu Vaccine.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 09-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 BURNING SENSATION (like burning ice), HERPES ZOSTER (2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.) and PRURITUS (sort of itchiness). At the time of the report, BURNING SENSATION (like burning ice), HERPES ZOSTER (2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.) and PRURITUS (sort of itchiness) outcome was unknown.     No concomitant information was reported. The patient reported that after the first 2 doses but before the last booster dose, she had a flu vaccine, and she really felt her arm was very sore. She does not had any known allergies.She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles. Caller stated she doesn't want to get more injections because that had gotten worse, and that was supposed to be half a dose.   This case was linked to MOD-2021-386895, MOD-2021-386572 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Lip swelling, Pyrexia
Clinical narrative: Swelling on her lips; Difficulty swallowing; Fever 101 F after booster; Felt very tired immediately after booster; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (Swelling on her lips), DYSPHAGIA (Difficulty swallowing), PYREXIA (Fever 101 F after booster) and FATIGUE (Felt very tired immediately after booster) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease and Blood pressure high. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VALSARTAN for an unknown indication.    On 14-Nov-2021 at 1:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2021, the patient experienced FATIGUE (Felt very tired immediately after booster). On 15-Nov-2021, the patient experienced LIP SWELLING (Swelling on her lips) and DYSPHAGIA (Difficulty swallowing). 15-Nov-2021, the patient experienced PYREXIA (Fever 101 F after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling on her lips), DYSPHAGIA (Difficulty swallowing), PYREXIA (Fever 101 F after booster) and FATIGUE (Felt very tired immediately after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the first dose of Moderna COVID-19 vaccine on 27-Dec-2020 (Lot# 039L20A & Exp. Date: Unknown). She received the 2nd dose of Moderna COVID-19 vaccine  on 25-Jan-2021  Lot#  013L20A & Exp. Date: Unknown). Year of birth is provided 1965. Patient spoke to one of the ER doctor's from her job and he told her to go to the ER if the lip swelling gets worst.   This case was linked to MOD-2021-019819 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fall, Head injury, Illness
Clinical narrative: Arm swelled up; Inflamed, enlarged; Arm swelled up and it hurt; Really bad reaction; Got ill; On the floor for two hours/fell in the bathroom; Couldn't get up; Felt weak , knocked her out; Hit her head on the shower; This spontaneous case was reported by a consumer and describes the occurrence of FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out), HEAD INJURY (Hit her head on the shower) and PERIPHERAL SWELLING (Arm swelled up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004FZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson & Johnson Covid-19 Vaccine on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson Covid-19 Vaccine.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out) and HEAD INJURY (Hit her head on the shower). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelled up), INFLAMMATION (Inflamed, enlarged), PAIN IN EXTREMITY (Arm swelled up and it hurt), VACCINATION COMPLICATION (Really bad reaction) and ILLNESS (Got ill). At the time of the report, FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out), HEAD INJURY (Hit her head on the shower), PERIPHERAL SWELLING (Arm swelled up), INFLAMMATION (Inflamed, enlarged), PAIN IN EXTREMITY (Arm swelled up and it hurt), VACCINATION COMPLICATION (Really bad reaction) and ILLNESS (Got ill) outcome was unknown.            The patient states she has other underlying health conditions.  No concomitant medications were provided.   No treatment medications were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: Arm swelled up; Inflamed, enlarged; Arm swelled up and it hurt; Really bad reaction; Got ill; On the floor for two hours/fell in the bathroom; Couldn't get up; Felt weak , knocked her out; Hit her head on the shower; This spontaneous case was reported by a consumer and describes the occurrence of FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out), HEAD INJURY (Hit her head on the shower) and PERIPHERAL SWELLING (Arm swelled up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004FZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson & Johnson Covid-19 Vaccine on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson Covid-19 Vaccine.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out) and HEAD INJURY (Hit her head on the shower). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swelled up), INFLAMMATION (Inflamed, enlarged), PAIN IN EXTREMITY (Arm swelled up and it hurt), VACCINATION COMPLICATION (Really bad reaction) and ILLNESS (Got ill). At the time of the report, FALL (On the floor for two hours/fell in the bathroom), DYSSTASIA (Couldn't get up), ASTHENIA (Felt weak , knocked her out), HEAD INJURY (Hit her head on the shower), PERIPHERAL SWELLING (Arm swelled up), INFLAMMATION (Inflamed, enlarged), PAIN IN EXTREMITY (Arm swelled up and it hurt), VACCINATION COMPLICATION (Really bad reaction) and ILLNESS (Got ill) outcome was unknown.            The patient states she has other underlying health conditions.  No concomitant medications were provided.   No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered this lot to their patients after the lot expired on of 10-9-2021; 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 (Administered this lot to their patients after the lot expired on of 10-9-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered this lot to their patients after the lot expired on of 10-9-2021). In 2021, EXPIRED PRODUCT ADMINISTERED (Administered this lot to their patients after the lot expired on of 10-9-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   As reported they administered mentioned Lot to their patients after the lot expired on of 09 Oct 2021.  The vaccine administration date for each patient range from  11 Oct 2021 to 14 Nov 2021.  No concomitant medications were mentioned. No treatment details were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 1 cc and a half [dose]; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (1 cc and a half [dose]) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1.5 ml. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (1 cc and a half [dose]). At the time of the report, ACCIDENTAL OVERDOSE (1 cc and a half [dose]) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Medical history and age was added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 21 days between 1st and 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (21 days between 1st and 2nd dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (21 days between 1st and 2nd dose). On 12-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (21 days between 1st and 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Concomitant medications were not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site discomfort, Vaccination site pain, Vaccination site warmth
Clinical narrative: It was warm; Discomfort at the injection site; Pain and discomfort at the injection site; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the injection site), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PAIN (Pain and discomfort at the injection site) and CHILLS (Severe chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 015M20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the injection site), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PAIN (Pain and discomfort at the injection site) and CHILLS (Severe chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 14-Nov-2021, CHILLS (Severe chills) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the injection site), VACCINATION SITE WARMTH (It was warm) and VACCINATION SITE PAIN (Pain and discomfort at the injection site) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-047836, MOD-2021-047860 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 expired doses were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses were administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Med Info Agent: Client**CROSSLINKED TO MOD21-164106** HCP calling to provide missing information about an incident where 4 patients received an expired vaccine. HCP confirmed there were only 4 Patients involved, all females, and that they all received booster doses. No more demographics were given.HCP said the Hospital received the shipment one week ago, and that vials were transported in a cold container and remained cold the entire time while being transported. HCP could not confirm the exact date the shipment was received, he said "about a week ago" but confirmed vials were immediately placed in the refrigerator. HCP also confirmed vials expired on November 13th. The following data was copied from CASE MOD21-164106: "We were administering the COVID booster vaccine and one of the lots ( 054C21A ) expired on the 13Nov2021 and 5 (five) patients received it earlier today 15Nov2021. I was wondering if there was any data on people receiving the vaccine that expired? Anything we need to monitor or effectiveness? o *Lot number(s) - 054C21A o Number of doses/vials - 5 patients o *Date the vial was initially stored in the refrigerator - Not sure, pharmacy manager in a meeting. o *Date(s) of administration of vaccine  15Nov2021 o Did the vial undergo any temperature excursions? No, once it's delivered it goes into the fridge into the vault."  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-386799, MOD-2021-387483, MOD-2021-387484 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unauthorized age to receive the Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age to receive the Moderna booster) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Pfizer vaccine for her primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age to receive the Moderna booster). On 12-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized age to receive the Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: fever blisters on the lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blisters on the lips) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included DOLUTEGRAVIR SODIUM, RILPIVIRINE HYDROCHLORIDE (JULUCA) and NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced ORAL HERPES (fever blisters on the lips). The patient was treated with DOCOSANOL (ABREVA) for Fever blister, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (fever blisters on the lips) was resolving.            concomitant medications include high blood pressure medication. No known food allergies reported, After the third dose, the caller stated 8-9 days later he had an adverse event similar to the reaction after the second dose.   This case was linked to MOD-2021-022476 (Patient Link).