chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 48.0
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 a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.      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. Treatment details was not reported by the reporter. The vial was initially stored in the refrigerator- 01-DEC-2021. No temperature excursions.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccinations past the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccinations past the expiration date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (Administered vaccinations past the expiration date). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered vaccinations past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took Booster dose. It was reported that that some patients who received the expired vaccine had reported flu-like symptoms after receiving the vaccination but reporter did not have details on that.  The date  when the vial was initially stored in the refrigerator 01-DEC-2021 and was reported that the vial did not undergo any temperature excursions.  No concomitant medication details was provided. No treatment medication details was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness
Clinical narrative: Flu-like symptoms; expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired dose administered to patients). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Flu-like symptoms after receiving the vaccination was reported. Concomitant medications were not reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (Expired vaccine was administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. It was reported that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that. Date the vial was initially stored in the refrigerator on 01 Dec 2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired dose administered to patients) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031H21A) for COVID-19 immunization. No medical history reported. On Jan 6, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 6, 2022, patient experienced administered expired product (expired dose administered to patients). On Jan 6, 2022, administered expired product (expired dose administered to patients): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) 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.   Date the vial was initially stored in the refrigerator was on 01-Dec-2021 and the vial did not undergo any temperature excursions.  It was reported by the reporter that, some patients had reported flu-like symptoms after receiving the vaccination, but she did not have details on that.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) 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.   Number of doses/vials were 63 doses, 3-4 vials; date the vial was initially stored in the refrigerator was on 01-Dec-2021 and the vial did not undergo any temperature excursions.  It was reported by the reporter that, some patients had reported flu-like symptoms after receiving the vaccination, but she did not have details on that.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (Expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) had resolved.        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. Some patients had reported flu-like symptoms after receiving the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives that are spontaneously appearing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (Hives that are spontaneously appearing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives that are spontaneously appearing). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of daily. At the time of the report, URTICARIA (Hives that are spontaneously appearing) had not resolved.            No concomitant medications were reported.  The patient got his booster and approximately 10 days later is having the same concern with hives that are spontaneously appearing only to be controlled by daily Zyrtec. If not taken, they continue to reappear to this day.   This case was linked to MOD-2022-437335 (Patient Link).
Age: 49.0
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 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (Expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. HCP states that some patients had reported flu-like symptoms after receiving the vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itchy). The patient was treated with COLECALCIFEROL (D3 5000) for Adverse event, at a dose of 5000 IU once a day; ASCORBIC ACID (VIT C) for Adverse event, at a dose of 1000 mg once a day; ASCORBIC ACID, QUERCETIN (QUERCITIN) for Adverse event, at an unspecified dose and frequency; ZINC for Adverse event, at an unspecified dose and frequency; RUPATADINE for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of 10 mg twice a day. At the time of the report, PRURITUS (Itchy) had not resolved.            No concomitant information was reported.  Reporter reports the case from the Chronic Spontaneous Urticaria After COVID-19 Vaccine Support Group from Social Media.  Patient stated that he tried low histamine diet, cut alcohol and intermittent fasting and was taking lots of supplements but nothing worked like Zyrtec. He said that the maximum days without taking Zyrtec was 4 but even then, he was taking steroids. So maximum days without taking antihistamines was 3 days. Patient reported that his condition started on 01-Nov-2021, 10 days after receiving his Moderna Booster and he has visited an allergist on 02 Nov, and since then he has tried all the antihistamines, Rupatadine, Xyzal, Zyrtec and 12 days of Medrol (same as Prednisone).   He stated that he keeps a healthy lifestyle and exercises regularly, no prior allergies (only to Penicillin, but it was very common). He said that his condition was getting better than in the first weeks, but now he was being very careful with his food, he does not eat sugar, bread, no alcohol and no junk food. He said that he tried not to take any meds (no Ibuprofen or other NSAID drugs) and was trying not to be stressed. Unfortunately, he needed Zyrtec 2 times per week when the itching was back.   Patient stated that he had an appointment with an allergist, and she told him that it was not a good idea to take medication only when needed and thus she doubled his Zyrtec dose (10 mg in the morning and 10 mg in the evening) for 1 month and asked him to visit again after one month. She told him that it was an immune reaction, and the body needs antihistamines to regulate itself. Otherwise, this condition may become chronic.   This case was linked to MOD-2022-437335 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired dose administered to patient). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Some patients had reported of experiencing flu-like symptoms after receiving the vaccine but the reporter did not have details on that.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (Expired dose administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided   This case was linked to MOD-2022-449303 (Patient Link).
Age: 57.0
Sex: U
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 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was stored in refrigerator on 01-Dec-2021 and it did not undergo temperature excursions.  No concomitant medications were reported.  No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight injection site pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 017C21A and 014J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (flu shot given 2.5 weeks before the vaccination. Patient had side effects) in 2021. Past adverse reactions to the above products included Adverse reaction with Flu shot. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to the drug Mucinex), SLE (Patient is in remission, mild and not on immuno suppressant drugs for years), Gout (Pseudo gout), GERD and High cholesterol. Concomitant products included OMEPRAZOLE for GERD, ATORVASTATIN for High cholesterol, MAGNESIUM and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slight injection site pain). At the time of the report, VACCINATION SITE PAIN (slight injection site pain) 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.   Patient was never tested positive for COVID-19.  Patient had no acute illnesses at the time of injections.   This case was linked to MOD-2022-438826, MOD-2022-437114 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. On 01-Dec-2021 the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions. Some patients had reported flu-like symptoms after receiving the vaccination but the reporter did not have details on that.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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) 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. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. some patients had reported flu-like symptoms after receiving the vaccination but the reporter did not have details on that. The treatment information was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expired vaccine was administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expired vaccine was administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Rash vesicular, Urticaria
Clinical narrative: rash with hives and blistering; rash with hives and blistering; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash with hives and blistering) and RASH VESICULAR (rash with hives and blistering) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash with hives and blistering) and RASH VESICULAR (rash with hives and blistering). At the time of the report, URTICARIA (rash with hives and blistering) and RASH VESICULAR (rash with hives and blistering) had not resolved.            No concomitant medication was reported. No treatment medication was reported. It was reported that patient had the booster on the 13th and on the 24th developed a rash with hives and blistering. They also wanted to know if there was a cure for 'moderna skin'.   This case was linked to MOD-2022-449904, MOD-2022-449887, MOD-2022-449904 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took Booster dose flu-like symptoms was reported by some patients.  Date the vial was initially stored in the refrigerator 01-DEC-2021 The vial did not undergo any temperature excursions.  No concomitant medication details was provided. No treatment medication details was provided.
Age: 37.0
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 a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial was stored in refrigerator on 01 December 2021 and it did not undergo any temperature excursions. Vaccine expiry date was on 02 January 2022.  The reporter stated that some patients had reported flu like symptoms after receiving the vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported. On 11-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. HCP stated that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 41.0
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 a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Flu-like symptoms after receiving the vaccination were reported. Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adrenal adenoma, Computerised tomogram, Magnetic resonance imaging, Renal cyst
Clinical narrative: two kidney cysts exactly the same size, one on each kidneys; an adenoma on my rt adrenal gland; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CYST (two kidney cysts exactly the same size, one on each kidneys) and ADRENAL ADENOMA (an adenoma on my rt adrenal gland) 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.    In March 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL CYST (two kidney cysts exactly the same size, one on each kidneys) and ADRENAL ADENOMA (an adenoma on my rt adrenal gland). At the time of the report, RENAL CYST (two kidney cysts exactly the same size, one on each kidneys) and ADRENAL ADENOMA (an adenoma on my rt adrenal gland) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) CT and MRI showed two kidney cysts exactly the same size, one on each kidneys and an adenoma on the right adrenal gland.. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) CT and MRI showed two kidney cysts exactly the same size, one on each kidneys and an adenoma on the right adrenal gland..         No concomitant medication and treatment information was reported.
Age: 31.0
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 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that flu-like symptoms after receiving the vaccination. No concomitant medications were provided. No treatment medications were provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided HCP stated that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that
Age: 32.0
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 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. it was reported that some patients experienced Flu like symptoms.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. Patient took the booster dose as an expired vaccine. The expired vaccine was administered on 3 different dates, 4JAN2022 (20 patients), 6JAN2022 (29 patients), and 11JAN2022 (14 patients).  HCP stated that some patients had reported flu-like symptoms after receiving the vaccination. The number of doses/vials-63 doses, 3-4 vials. Date the vial was initially stored in the refrigerator-01-Dec-2021.
Age: 51.0
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 a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. The expired vaccine was administered on 3 different dates, 4JAN2022 (20 patients), 6JAN2022 (29 patients), and 11JAN2022 (14 patients).  HCP stated that some patients had reported flu-like symptoms after receiving the vaccination. The number of doses/vials-63 doses, 3-4 vials. Date the vial was initially stored in the refrigerator-01-Dec-2021. The vial doesn't undergo any temperature excursions.
Age: 74.0
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 a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) 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 (Expired vaccine used). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        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.  It was reported that that some patients who received the expired vaccine had reported flu-like symptoms after receiving the vaccination but she did not have details on that.   This case was linked to MOD-2022-449812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Report type changed from invalid to spontaneous. Added patient details and dose details.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Maternal exposure during pregnancy
Clinical narrative: Emergency C-section; received Moderna vaccine while pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of CAESAREAN SECTION (Emergency C-section) and MATERNAL EXPOSURE DURING PREGNANCY (received Moderna vaccine while pregnant) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna vaccine while pregnant). On 08-May-2021, the patient experienced CAESAREAN SECTION (Emergency C-section). The cesarean delivery occurred on 08-May-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. On 08-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna vaccine while pregnant) had resolved. At the time of the report, CAESAREAN SECTION (Emergency C-section) outcome was unknown.      No treatment and concomitant medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: drug use in unapproved population; Fever and sore arm where vaccine was taken; Fever and sore arm where vaccine was taken; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA6780) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset Aug2021, outcome "unknown", described as "drug use in unapproved population"; VACCINATION SITE PAIN (non-serious), PYREXIA (non-serious) all with onset Aug2021, outcome "recovering" and all described as "Fever and sore arm where vaccine was taken". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of product use issue, vaccination site pain, pyrexia.  Additional information: Patient did not receive other vaccine in four weeks or other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Neck pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. A female patient received BNT162B2 (COMIRNATY, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "liver and kidney failure" (unspecified if ongoing); "Kidney failure" (unspecified if ongoing); "No immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "soreness in her shoulder"; NECK PAIN (non-serious), BONE PAIN (non-serious), outcome "unknown" and all described as "soreness in her shoulder and neck bone". The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased
Clinical narrative: creatinine level jumped 20-25%; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient.  A male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "kidney issues" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: BLOOD CREATININE INCREASED (non-serious), outcome "recovered", described as "creatinine level jumped 20-25% ". The event "creatinine level jumped 20-25%" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's creatinine level jumped 20-25% and took 4, 5, 6 weeks to go back to normal. He didn't want to panic with seeing an elevated number as he is under medical care. He also reported that he was almost sent for dialysis by his provider due to elevated numbers but he got better 20%.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.