chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patients were administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patients were administered an expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patients were administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patients were administered an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. The vial was initially stored in the refrigerator was on 04-Nov-2021. Dates of administration of vaccine was 05-Nov-2021 and 12-Nov-2021. The vial didn't undergo any temperature excursions. In total 60 doses were administered.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered from an expired vaccine) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 04-Nov-2021. The vial did not undergo any temperature excursions. It was reported that the patient had no adverse event (AE) and was monitored. Some of the vaccines were administered on 05-Nov-2021 and some on 12-Nov-2021.  No concomitant medications were reported.  No treatment information was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received booster dose. No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Nov-2021. Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021. The vial did not undergone any temperature excursions. HCP stated, no adverse event occurred as a result of this misadministration, patients were monitored. No treatment medications were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that on 04-Nov-2021, the vaccine was initially stored in the refrigerator. Date of administration of vaccine to the patients was on 05-Nov-2021 and 12-Nov-2021. And also stated that the vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered from an expired vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient administered expired vaccine which was initially stored on 04-Nov-2021 patients were administered with dose in which some vaccinated on 05-Nov-2021 and 12-Nov-2021. The vial did not undergo any temperature excursions.  No Treatment medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04 Nov 2021. Dates of administration of vaccine was some were on 05 Nov 2021 and the other doses on 12 Nov 2021. The vial did not undergone any temperature excursions. HCP stated, no adverse event occurred as a result of this misadministration, patients were monitored.  No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 04-Nov-2021 and the vial did not undergo any temperature excursions. It was reported that, some patients took dose on 05-Nov-2021 and the other patients took dose on 12-Nov-2021.  The patient did not experience any events, because of this misadministration.  No treatment information was provided by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2 vials from same lot number 1st vial Lot number: 050E21A , Administered on 05Nov2021 2nd vial Lot number: 050E21A, Administered on 12Nov2021. No concomitant medication was provided by the reporter. 34 patients were administered from an expired vaccine. 16 staff members were administered from the expired vaccine. 2 patients have passed  away. No treatment was provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received booster dose. No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Nov-2021. Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021. The vial did not undergone any temperature excursions. HCP stated, no adverse event occurred as a result of this misadministration, patients were monitored. No treatment medications were reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient  received  dose of Moderna vaccine beyond  30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient  received  dose of Moderna vaccine beyond  30-day use by date) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient  received  dose of Moderna vaccine beyond  30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient  received  dose of Moderna vaccine beyond  30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  HCP reports vial was brought to clinic and placed in refrigerator of January 05, 2022.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Follow up contains No New Information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: After each shot she started having palpitations; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (After each shot she started having palpitations) and DYSPNOEA (Shortness of breath) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ014) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to morphine), Shellfish allergy, Iodine allergy and Cardiomyopathy (Cardiomyopathy from a virus Start Date: A year before the COVID pandemic.  Stop Date: With exercise she only had palpitations when she is tired.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (After each shot she started having palpitations) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (After each shot she started having palpitations) and DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) she had a EKG but it showed normal sinus with multiple contractions..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant product use was reported.  The patient received 1st dose on 15-Jan-2021, Lot number: 011LZ014 unsure if it was an H or an A. The patient reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient reported that after each shot the patient started having palpitations, shortness of breath so the patient went to the Cardiologist, but they were not convinced it was the shot, the patient had an EKG, but it showed normal sinus with multiple contractions.  No treatment information was provided.   This case was linked to MOD-2022-503124, MOD-2022-503135 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received dose of Moderna vaccine beyond 30-day use by date; Received  dose of Moderna vaccine beyond  30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Received dose of Moderna vaccine beyond 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received  dose of Moderna vaccine beyond  30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received dose of Moderna vaccine beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Received dose of Moderna vaccine beyond 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vials were placed in refrigerator on 05-Jan-2022.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received: no new information was added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date; Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) and PRODUCT STORAGE ERROR (Six patient(s) received  dose of Moderna vaccine beyond  30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  The nurses gave vaccines after the beyond use date.It was reported that the vial was brought to clinic and placed in refrigerator on 05 Jan 2022.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up information included no new information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, Hypertension, Pyrexia
Clinical narrative: Trouble breathing; BP shot way up; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), HYPERTENSION (BP shot way up) and PYREXIA (103 fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Asthma, Hypothyroidism, Shellfish allergy (Shrimp allergy anaphylaxis), Seasonal allergy and Allergy (Tysabri allergy). Concomitant products included OCRELIZUMAB (OCREVUS), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), EPINEPHRINE (EPIPEN), ALBUTEROL [SALBUTAMOL] and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced DYSPNOEA (Trouble breathing), HYPERTENSION (BP shot way up) and PYREXIA (103 fever). At the time of the report, DYSPNOEA (Trouble breathing), HYPERTENSION (BP shot way up) and PYREXIA (103 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: increased (High) BP shot way up. In October 2021, Body temperature: 103 103 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Six patient(s) received  dose of Moderna vaccine beyond 30-day use by date; Received  dose of Moderna vaccine beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patient(s) received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Six patient(s) received dose of Moderna vaccine beyond 30-day use by date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.   No Medical History information was reported.   On 02-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced PRODUCT STORAGE ERROR (Six patient(s) received dose of Moderna vaccine beyond 30-day use by date). On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patient(s) received dose of Moderna vaccine beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Six patient(s) received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Six patient(s) received dose of Moderna vaccine beyond 30-day use by date) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. HCP reports vial was brought to clinic and placed in refrigerator on 05-Jan-2022. No treatment medication information was provided.  Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: No new follow-up information received.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:15 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine was administered (punctured for more than 12 hours)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. No treatment were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Six patients received dose of Moderna vaccine beyond 30-day use by date; Six patients received dose of Moderna vaccine beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Six patients received dose of Moderna vaccine beyond 30-day use by date) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received dose of Moderna vaccine beyond 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Six patients received dose of Moderna vaccine beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Six patients received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Six patients received dose of Moderna vaccine beyond 30-day use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported.  It was reported that vial was brought to clinic and placed in refrigerator on January 05 2022.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up received contains no new information.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Polymerase chain reaction
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021 at 8:47 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2020, Polymerase chain reaction: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that the acute illnesses at the time of vaccination and up to one month before was unknown.    The treatment information was unknown.   This case was linked to MOD-2022-498946 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  It was unknown when the patient received the first and second dose of vaccination.  No Treatment medication reported.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Rash, SARS-CoV-2 test
Clinical narrative: Rash spreading to legs, knees and upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spreading to legs, knees and upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Knee Replacement Surgery). Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Immunocompromised, Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism (Syndrome) and Migraine. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, PILOCARPINE for Dry mouth, METFORMIN for Dyspepsia, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash spreading to legs, knees and upper arm). The patient was treated with MUPIROCIN ongoing since an unknown date for Rash, at a dose of 1 dosage form three times a day; PIMECROLIMUS (topical) ongoing since an unknown date for Rash, at a dose of 1 % percent twice a day and TRIAMCINOLONE (topical) ongoing since an unknown date for Rash, at a dose of .1 % percent twice a day. At the time of the report, RASH (Rash spreading to legs, knees and upper arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect The patient dermatologist took a biopsy, and, in the results, they could not detect what it was. On an unknown date, SARS-CoV-2 test: not tested positive (Negative) Had not tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had chronic illnesses not improved or worsened after the vaccination. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had vaccine in her deltoid muscle and had not the vaccination card to provide lot number, expiration date and dose quantity administered. Patient had concomitant policarpine 5 mg 3/4 times a day. Treatment medications information included patient had phototherapy, mupirocin 3 times a day for 5 days, pimecrolimus 1% topical cream twice a day, triamcinolone 0.1 % topical cream twice a day (none of them worked).   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Biopsy, Headache, Influenza like illness, Mobility decreased
Clinical narrative: Rash spreading to legs, knees and upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spreading to legs, knees and upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Knee Replacement Surgery). Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Immunocompromised, Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism (Syndrome) and Migraine. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, PILOCARPINE for Dry mouth, METFORMIN for Dyspepsia, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash spreading to legs, knees and upper arm). The patient was treated with MUPIROCIN ongoing since an unknown date for Rash, at a dose of 1 dosage form three times a day; PIMECROLIMUS (topical) ongoing since an unknown date for Rash, at a dose of 1 % percent twice a day and TRIAMCINOLONE (topical) ongoing since an unknown date for Rash, at a dose of .1 % percent twice a day. At the time of the report, RASH (Rash spreading to legs, knees and upper arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect The patient dermatologist took a biopsy, and, in the results, they could not detect what it was. On an unknown date, SARS-CoV-2 test: not tested positive (Negative) Had not tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had chronic illnesses not improved or worsened after the vaccination. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had vaccine in her deltoid muscle and had not the vaccination card to provide lot number, expiration date and dose quantity administered. Patient had concomitant policarpine 5 mg 3/4 times a day. Treatment medications information included patient had phototherapy, mupirocin 3 times a day for 5 days, pimecrolimus 1% topical cream twice a day, triamcinolone 0.1 % topical cream twice a day (none of them worked).   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Peripheral swelling, Rash
Clinical narrative: Rash spreading to legs, knees and upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spreading to legs, knees and upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Knee Replacement Surgery). Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Immunocompromised, Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism (Syndrome) and Migraine. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, PILOCARPINE for Dry mouth, METFORMIN for Dyspepsia, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash spreading to legs, knees and upper arm). The patient was treated with MUPIROCIN ongoing since an unknown date for Rash, at a dose of 1 dosage form three times a day; PIMECROLIMUS (topical) ongoing since an unknown date for Rash, at a dose of 1 % percent twice a day and TRIAMCINOLONE (topical) ongoing since an unknown date for Rash, at a dose of .1 % percent twice a day. At the time of the report, RASH (Rash spreading to legs, knees and upper arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect The patient dermatologist took a biopsy, and, in the results, they could not detect what it was. On an unknown date, SARS-CoV-2 test: not tested positive (Negative) Had not tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had chronic illnesses not improved or worsened after the vaccination. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had vaccine in her deltoid muscle and had not the vaccination card to provide lot number, expiration date and dose quantity administered. Patient had concomitant policarpine 5 mg 3/4 times a day. Treatment medications information included patient had phototherapy, mupirocin 3 times a day for 5 days, pimecrolimus 1% topical cream twice a day, triamcinolone 0.1 % topical cream twice a day (none of them worked).   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Extra dose administered, Rash
Clinical narrative: Rash spreading to legs, knees and upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash spreading to legs, knees and upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Knee Replacement Surgery). Concurrent medical conditions included Drug allergy (Promethazine, Betadine and Lovenox), Immunocompromised, Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism (Syndrome) and Migraine. Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, PILOCARPINE for Dry mouth, METFORMIN for Dyspepsia, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash spreading to legs, knees and upper arm). The patient was treated with MUPIROCIN ongoing since an unknown date for Rash, at a dose of 1 dosage form three times a day; PIMECROLIMUS (topical) ongoing since an unknown date for Rash, at a dose of 1 % percent twice a day and TRIAMCINOLONE (topical) ongoing since an unknown date for Rash, at a dose of .1 % percent twice a day. At the time of the report, RASH (Rash spreading to legs, knees and upper arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect The patient dermatologist took a biopsy, and, in the results, they could not detect what it was. On an unknown date, SARS-CoV-2 test: not tested positive (Negative) Had not tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had chronic illnesses not improved or worsened after the vaccination. The patient had not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had vaccine in her deltoid muscle and had not the vaccination card to provide lot number, expiration date and dose quantity administered. Patient had concomitant policarpine 5 mg 3/4 times a day. Treatment medications information included patient had phototherapy, mupirocin 3 times a day for 5 days, pimecrolimus 1% topical cream twice a day, triamcinolone 0.1 % topical cream twice a day (none of them worked).   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Rash, SARS-CoV-2 test
Clinical narrative: After the second dose the rash spread more; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After the Second dose the rash spread more) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism, Migraine, Dry mouth, Digestion impaired, Gastrointestinal disorder NOS, Anxiety, Hyperlipidemia and Immunocompromised. Concomitant products included BUPROPION for Anxiety, clozanpam for Burning mouth syndrome, metformin for Digestion impaired, pilocarpine for Dry mouth, OMEPRAZOLE for Gastrointestinal symptom NOS, ATORVASTATIN for Hyperlipidemia, topiramate for Migraine, levothyroxine for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH (After the Second dose the rash spread more). The patient was treated with MUPIROCIN for Adverse event, at a dose of UNK, tid for 5 days; PIMECROLIMUS (topical) for Adverse event, at a dose of 1 percent topical cream , bid and TRIAMCINOLONE (topical) for Adverse event, at a dose of 0.1 percent topical cream twice a day. At the time of the report, RASH (After the Second dose the rash spread more) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was Her Dermatologist take a biopsy and in the results, they couldn't detect what it was. On an unknown date, SARS-CoV-2 test: negative (Negative) She did not tested positive for COVID-19.         At the time of the vaccination, she had a knee replacement Surgery.  Patient took the vaccine in deltoid muscle.  Patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine. All chronic illnesses did not improve but worsened after the vaccination, She reported she was a swimmer and that she was embarrassed to go the the pool to swim.   Additionally was treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503094, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Biopsy, Headache, Influenza like illness, Mobility decreased
Clinical narrative: After the second dose the rash spread more; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After the Second dose the rash spread more) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism, Migraine, Dry mouth, Digestion impaired, Gastrointestinal disorder NOS, Anxiety, Hyperlipidemia and Immunocompromised. Concomitant products included BUPROPION for Anxiety, clozanpam for Burning mouth syndrome, metformin for Digestion impaired, pilocarpine for Dry mouth, OMEPRAZOLE for Gastrointestinal symptom NOS, ATORVASTATIN for Hyperlipidemia, topiramate for Migraine, levothyroxine for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH (After the Second dose the rash spread more). The patient was treated with MUPIROCIN for Adverse event, at a dose of UNK, tid for 5 days; PIMECROLIMUS (topical) for Adverse event, at a dose of 1 percent topical cream , bid and TRIAMCINOLONE (topical) for Adverse event, at a dose of 0.1 percent topical cream twice a day. At the time of the report, RASH (After the Second dose the rash spread more) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was Her Dermatologist take a biopsy and in the results, they couldn't detect what it was. On an unknown date, SARS-CoV-2 test: negative (Negative) She did not tested positive for COVID-19.         At the time of the vaccination, she had a knee replacement Surgery.  Patient took the vaccine in deltoid muscle.  Patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine. All chronic illnesses did not improve but worsened after the vaccination, She reported she was a swimmer and that she was embarrassed to go the the pool to swim.   Additionally was treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503094, MOD-2022-503107, MOD-2022-503108 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Peripheral swelling, Rash
Clinical narrative: After the second dose the rash spread more; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After the Second dose the rash spread more) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome, Burning mouth syndrome, Hypothyroidism, Migraine, Dry mouth, Digestion impaired, Gastrointestinal disorder NOS, Anxiety, Hyperlipidemia and Immunocompromised. Concomitant products included BUPROPION for Anxiety, clozanpam for Burning mouth syndrome, metformin for Digestion impaired, pilocarpine for Dry mouth, OMEPRAZOLE for Gastrointestinal symptom NOS, ATORVASTATIN for Hyperlipidemia, topiramate for Migraine, levothyroxine for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH (After the Second dose the rash spread more). The patient was treated with MUPIROCIN for Adverse event, at a dose of UNK, tid for 5 days; PIMECROLIMUS (topical) for Adverse event, at a dose of 1 percent topical cream , bid and TRIAMCINOLONE (topical) for Adverse event, at a dose of 0.1 percent topical cream twice a day. At the time of the report, RASH (After the Second dose the rash spread more) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was Her Dermatologist take a biopsy and in the results, they couldn't detect what it was. On an unknown date, SARS-CoV-2 test: negative (Negative) She did not tested positive for COVID-19.         At the time of the vaccination, she had a knee replacement Surgery.  Patient took the vaccine in deltoid muscle.  Patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine. All chronic illnesses did not improve but worsened after the vaccination, She reported she was a swimmer and that she was embarrassed to go the the pool to swim.   Additionally was treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503094, MOD-2022-503107, MOD-2022-503108 (Patient Link).