chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 18 month old patient received a dose of Kinrix; received a dose of Kinrix instead of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Kinrix in left thigh. The practice administrator reported that, an 18 month old patient received a dose of Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was linked with case US2022006655, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006655:same reporter
Age: 55.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 55-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. Concurrent medical conditions included distal pancreatectomy and splenectomy. On 1st September 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was the patient. The patient had preoperative care after a distal pancreatectomy and splenectomy in October 2021. The patient received 1st dose Bexsero at the age of 55 years old, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA5788, expiry date 30th September 2021) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 14th January 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter reported that a patient was inadvertently administered an expired dose of Bexsero on the date of reporting, which led to expired vaccine used. No further events were reported. The reporter agreed to be contacted for follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysgeusia, Eructation, Flatulence, Gastrointestinal disorder
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had administered diet coke. The patient experienced adverse reaction when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on OCT-2021 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 funny taste in mouth, (gastrointestinal) upset, sick ever since, like a weird gas pain, burping (seventy percent burp out), (gastrointestinal) complaints, and vomiting. The action taken with covid-19 vaccine was not applicable. The outcome of the vomiting, funny taste in mouth, (gastrointestinal) upset, sick ever since, like a weird gas pain, burping (seventy percent burp out) and (gastrointestinal) complaints was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211630.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had administered diet coke. The patient experienced adverse reaction when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on OCT-2021 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 funny taste in mouth, (gastrointestinal) upset, sick ever since, like a weird gas pain, burping (seventy percent burp out), (gastrointestinal) complaints, and vomiting. The action taken with covid-19 vaccine was not applicable. The outcome of the vomiting, funny taste in mouth, (gastrointestinal) upset, sick ever since, like a weird gas pain, burping (seventy percent burp out) and (gastrointestinal) complaints was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211630.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: VERY ACHY AS THE DAY WENT GOT WORSE; CHILLS AS THE DAY WENT GOT WORSE (CURRENTLY COVERED WITH BLANKETS); HEADACHES AS THE DAY WENT GOT WORSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, administered on 12-JAN-2022 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-JAN-2022, the patient experienced very achy as the day went got worse, chills as the day went got worse (currently covered with blankets), and headaches as the day went got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very achy as the day went got worse, chills as the day went got worse (currently covered with blankets), and headaches as the day went got worse. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Nephropathy
Clinical narrative: This spontaneous report received from a consumer concerned a female of unspecified age, race, and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, about a week later after vaccination, the patient went to her doctor, and she had a blood test and was diagnosed with stage 3 kidney disease. Laboratory data (dates unspecified) included: Blood test (NR: not provided) stage 3 kidney disease. The action taken with covid-19 vaccine was not applicable. The outcome of stage 3 kidney disease was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220100154 and 20220104344.; Sender's Comments: V0: 20220124695 -COVID-19 VACCINE Stage 3 kidney disease. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Just the pain in the arm) 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, 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 PAIN IN EXTREMITY (Just the pain in the arm). At the time of the report, PAIN IN EXTREMITY (Just the pain in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided. No treatment medication was provided. In any of the shots patient had just pain in the arm.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: covid infection; Missed Second Dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (covid infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed Second Dose) 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 COVID-19 (covid infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed Second Dose). At the time of the report, COVID-19 (covid infection) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed Second Dose) 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.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.  Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the adverse event of special interest COVID-19. The event occurred an unknown time after the first dose of mRNA-1273. AT the time of the report the patient had not received the second dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the adverse event of special interest COVID-19. The event occurred an unknown time after the first dose of mRNA-1273. AT the time of the report the patient had not received the second dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        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. It was reported that there was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped. The original was kept -15 to -25 and then shipped and kept refrigerate. This lot was shipped on 06-Dec-2021,The error was caught on 11-Jan-2022 when a new shipment was received.   This case was linked to MOD-2022-449524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Significant Follow up received included , reporter details and suspect expiration date was updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Recovering from .... after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Recovering from .... after vaccination) 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 VACCINATION COMPLICATION (Recovering from .... after vaccination). At the time of the report, VACCINATION COMPLICATION (Recovering from .. after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Heart rate, Heart rate increased
Clinical narrative: Pulse of 100, high pulse; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Pulse of 100, high pulse) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 060H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure management.   On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced HEART RATE INCREASED (Pulse of 100, high pulse) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Pulse of 100, high pulse) outcome was unknown and CHILLS (Chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: 85/75 (Low) Patient  blood pressure was 85/75. In January 2022, Heart rate: 100 (High) Reported that it is not normal , patient has high pulse.         Patient reported chills, and she is kind of out of it.   This case was linked to MOD-2022-452229 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: where i can get of side effects if a patient revcive 0.5ml on his booster vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (where i can get of side effects if a patient revcive 0.5ml on his booster 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 ACCIDENTAL OVERDOSE (where i can get of side effects if a patient revcive 0.5ml on his booster vaccine). At the time of the report, ACCIDENTAL OVERDOSE (where i can get of side effects if a patient revcive 0.5ml on his booster vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Tremor
Clinical narrative: today he woke up very cold; shaking; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING COLD (today he woke up very cold) and TREMOR (shaking) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEELING COLD (today he woke up very cold) and TREMOR (shaking). At the time of the report, FEELING COLD (today he woke up very cold) and TREMOR (shaking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cough, Malaise, Pyrexia
Clinical narrative: I am not feeling well; Caller coughed at the end of the call; I have a temperature of a 102; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I am not feeling well), COUGH (Caller coughed at the end of the call) and PYREXIA (I have a temperature of a 102) 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 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MALAISE (I am not feeling well), COUGH (Caller coughed at the end of the call) and PYREXIA (I have a temperature of a 102). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (I am not feeling well), COUGH (Caller coughed at the end of the call) and PYREXIA (I have a temperature of a 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (abnormal) temperature of a 102.         No concomitant drug details were reported. No treatment details were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: covid arm; warm; itchy; red circle about 4-5 inches in diameter; not very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and MYALGIA (not very sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, ENALAPRIL, GABAPENTIN, HYDROCHLOROTHIAZIDE, PROPRANOLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and MYALGIA (not very sore). On 21-May-2021, VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and MYALGIA (not very sore) had resolved.            Treatment medications were not reported.   This case was linked to MOD-2022-451928, MOD-2022-451878, MOD-2022-451928 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: The rash on my leg/I developed a rash; bad side effect of the Moderna Shot afterwards; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (bad side effect of the Moderna Shot afterwards) and RASH (The rash on my leg/I developed a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Edema and Overweight. Concurrent medical conditions included Allergy (allergic to lysol laundry additive).    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (bad side effect of the Moderna Shot afterwards). In August 2021, the patient experienced RASH (The rash on my leg/I developed a rash). At the time of the report, VACCINATION COMPLICATION (bad side effect of the Moderna Shot afterwards) outcome was unknown and RASH (The rash on my leg/I developed a rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  It was reported that patient was overweight, had edema and lost 75 pounds. Patient was allergic to things and got this rash and it will not go away. She was about 95 percent better though with the rash.  It was also reported that  she does not take other medications and  reported no further lifestyle changes or medical history.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: The lymph nodes in my arm pit are still sore; And slightly swollen/ lymph nodes in my arm pit; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPH NODE PAIN (The lymph nodes in my arm pit are still sore) and LYMPHADENOPATHY (And slightly swollen/ lymph nodes in my arm pit) 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 13-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (The lymph nodes in my arm pit are still sore) and LYMPHADENOPATHY (And slightly swollen/ lymph nodes in my arm pit). At the time of the report, LYMPH NODE PAIN (The lymph nodes in my arm pit are still sore) and LYMPHADENOPATHY (And slightly swollen/ lymph nodes in my arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: inbitially 0.125  and later recieived correct dose 0.25; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (inbitially 0.125  and later recieived correct dose 0.25) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04D21A) for COVID-19 vaccination.     Concurrent medical conditions included Borderline diabetes. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) from 10-Dec-2021 to an unknown date for an unknown indication.    On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced OVERDOSE (inbitially 0.125  and later recieived correct dose 0.25). On 19-Dec-2021, OVERDOSE (inbitially 0.125  and later recieived correct dose 0.25) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: herpes that come up on my chest; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES VIRUS INFECTION (herpes that come up on my chest) 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 HERPES VIRUS INFECTION (herpes that come up on my chest). At the time of the report, HERPES VIRUS INFECTION (herpes that come up on my chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been prescribed with an antiviral drug for herpes. No concomitant medications were provided by the reporter. Patient wanted to get the booster on the day of reporting.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site, of about an inch and a half diameter) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 13-Jan-2022, 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site, of about an inch and a half diameter). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site, of about an inch and a half diameter) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medications included vitamins. No treatment medications were reported. This case was linked to MOD-2022-452074, MOD-2022-452101 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Initially 0.125ml  and later recieived correct dose 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Initially 0.125ml  and later recieived correct dose 0.25ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to morphine derivaties), Penicillin allergy, Drug allergy (Allergic to Tetracycline and related), Hypertension and Respiratory system disorder. Concomitant products included BENZONATATE for Cough, ONDANSETRON and PROCHLORPERAZINE for Nausea, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) and TRAMADOL for Pain, SALBUTAMOL (ALBUTEROL HFA) for Wheezing, AMLODIPINE BESYLATE, AZITHROMYCIN, CEFUROXIME, DEXAMETHASONE, DOXYCYCLINE HYCLATE, GABAPENTIN, GUAIFENESIN, HYDROCHLOROTHIAZIDE, LIDOCAINE, PRILOCAINE (LIDOCAINE/PRILOCAINE), LORAZEPAM, NITROFURANTOIN (NITROFURANTOIN MONO/MAC), OLANZAPINE, POTASSIUM CHLORIDE and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETH/TRIMETH) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .375 milliliter. On an unknown date, the patient experienced OVERDOSE (Initially 0.125ml  and later recieived correct dose 0.25ml). At the time of the report, OVERDOSE (Initially 0.125ml  and later recieived correct dose 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Patient was initially administered with 0.125ml as booster and she came back and received the correct 0.25ml.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: felt tired/achy; felt tired/achy all day; didn't spike a fever until Friday night.; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (felt tired/achy), FATIGUE (felt tired/achy all day) and PYREXIA (didn't spike a fever until Friday night.) 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 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced PAIN (felt tired/achy), FATIGUE (felt tired/achy all day) and PYREXIA (didn't spike a fever until Friday night.). At the time of the report, PAIN (felt tired/achy), FATIGUE (felt tired/achy all day) and PYREXIA (didn't spike a fever until Friday night.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received their Moderna booster on Thursday and felt tired/achy all day Friday but didn't spike a fever until Friday night. The patient was trying to determine if that was still a result.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them). At the time of the report, VACCINATION COMPLICATION (Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them) had not 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.   Patient was wanting to know the side effects of the first Dose of Moderna. Concomitant and treatment medication was not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia oral, Urticaria
Clinical narrative: Hives/Six days later, the patient ended up with hives all over the body/Severe hives; Tingling in the tongue; Onset of feeling dizzy/Feeling woozy; This spontaneous case was reported by a dietician and describes the occurrence of URTICARIA (Hives/Six days later, the patient ended up with hives all over the body/Severe hives), PARAESTHESIA ORAL (Tingling in the tongue) and DIZZINESS (Onset of feeling dizzy/Feeling woozy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) from 06-Jan-2022 to an unknown date for an unknown indication.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced URTICARIA (Hives/Six days later, the patient ended up with hives all over the body/Severe hives), PARAESTHESIA ORAL (Tingling in the tongue) and DIZZINESS (Onset of feeling dizzy/Feeling woozy). The patient was treated with PREDNISONE for Adverse event, at a dose of 40 mg. At the time of the report, URTICARIA (Hives/Six days later, the patient ended up with hives all over the body/Severe hives), PARAESTHESIA ORAL (Tingling in the tongue) and DIZZINESS (Onset of feeling dizzy/Feeling woozy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was pre medicated with Zyrtec right before the vaccine. The patient stated that next day, she had onset of feeling dizzy and woozy, tingling in the tongue and had other things 3 days later.   This case was linked to MOD-2021-027034 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was a little sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was a little sore). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   This case was linked to MOD-2022-451573 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Vaccination complication
Clinical narrative: Burning sensation from tummy to toes / Still gets burning sensation today; Similar side effects as the first shot, after booster; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation from tummy to toes / Still gets burning sensation today) and VACCINATION COMPLICATION (Similar side effects as the first shot, after booster) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced BURNING SENSATION (Burning sensation from tummy to toes / Still gets burning sensation today) and VACCINATION COMPLICATION (Similar side effects as the first shot, after booster). At the time of the report, BURNING SENSATION (Burning sensation from tummy to toes / Still gets burning sensation today) had not resolved and VACCINATION COMPLICATION (Similar side effects as the first shot, after booster) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided. She still got burning sensation on 14JAN2021.   This case was linked to MOD-2021-106680, MOD-2021-246781 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had Moderna booster and disease symptoms came back) in a 64-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 an unknown date, the patient experienced VACCINATION COMPLICATION (had Moderna booster and disease symptoms came back). At the time of the report, VACCINATION COMPLICATION (had Moderna booster and disease symptoms came back) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The lot was shipped 06-Dec-2021 and the new expiration date should have been 05-Jan-2022 due to the refrigeration of the vaccine.  The error was caught when a new shipment was received.  No concomitant medications were reported.  No treatment information was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  There was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped. The original was kept -15 to -25 and then shipped and kept refrigerate. This lot was shipped on 06-Dec-2021 and the new expiration date should have been 05-Jan-2022 due to the refrigeration of the vaccine. The error was caught on 11-Jan-2022 when a new shipment was received. Immediately the vaccine given was stopped and 69 patients had received expired vaccine since 06-Jan-2022.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient had received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had received expired vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had received expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient had received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that there was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped. The original was kept -15 to -25 and then shipped and kept refrigerated. The lot was shipped on 06-Dec-2021 and the new expiration date should have been 05-Jan-2022 due to the refrigeration of the vaccine. The error was caught on 11-Jan-2022 when a new shipment was received and immediately stopped giving the vaccine and looked back.   This case was linked to MOD-2022-448109 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved 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 provided by the reporter. No treatment information was provided by the reporter.  There was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped to APD.  The original was kept -15 to -25 and then shipped and kept refrigerate.  This lot was shipped 6-Dec-2021 . The error was caught on 11-Jan-2022 when a new shipment was received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients had recieved expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients had recieved expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patients had recieved expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information provided.  There was a failure to change the expiration date of Moderna Lot 012H21B when it was shipped.  The original was kept -15 to -25 and then shipped and kept refrigerate.  This lot was shipped 6 Dec 2021  and the new expiration date should have been 5 Jan 2022 due to the refrigeration of the vaccine.  The error was caught on 11 Jan 2022 when a new shipment was received, immediately stopped giving the vaccine and looked back and 69 patients had received expired vaccine since 6 Jan 2022.   This case was linked to MOD-2022-448109 (Patient Link).