chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Unbelievable pain, in her ribs, thighs, calves, and arms; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Unbelievable pain, in her ribs, thighs, calves, and arms) and PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 013L20A and FE3502) for COVID-19 vaccination.     Concurrent medical conditions included GERD and Arthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Unbelievable pain, in her ribs, thighs, calves, and arms). The patient was treated with PARACETAMOL (TYLENOL) for General body pain, at an unspecified dose and frequency. At the time of the report, PAIN (Unbelievable pain, in her ribs, thighs, calves, and arms) was resolving and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given.  With all doses of the vaccine it was a very smooth administration and patient had a little bit of sore arm.   Yesterday on 28-Apr-2022, patient started to experience unbelievable pain throughout body, in ribs, thighs, calves and arms. This was a fairly constant pain, but moved to these different body parts feeling some with more intensity than others. This has continued today on 29-Apr-2022, but was remarkably milder. Patient took Tylenol and used heat for symptoms which seemed to provide some improvement. This pain was different than past arthritis and the GERD limiting patient from taking many other medications. Patient had not taken any additional medications or treatments. Patient did not had a previous diagnosis of COVID-19.   This case was linked to MOD-2022-554727, MOD-2022-554795, MOD-2022-554797 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.; Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) and PRODUCT STORAGE ERROR (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056m21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022 at 10:57 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Apr-2022 at 10:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) and PRODUCT STORAGE ERROR (Patient Administered vaccine on 27-APR at 10:57am, post 24Hr duration of 26-Apr at 10:46am.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. Moderna vaccine was administered past the allowed 24 hours of room temperature allowance and past the allowed 12 hours after puncture. The vial was moved from the freezer to the fridge and believes on 15-April. Vial was moved to room temperature for initial use at 10:46 am on 26-April and punctured at that time. The last dose was administered on 27-April at 10:57 am.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Significant Live FU received, Lot no. updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: severe neuralgia, chest and back numbness in toes
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Fever and chills Fatigue Muscle and body aches Headache Diarrhea
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and chills Fatigue Muscle and body aches Headache Diarrhea
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Disorientation, Feeling abnormal, Malaise
Clinical narrative: Same symptoms I had when I had covid
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anticoagulant therapy, Bedridden, Flank pain, Headache
Clinical narrative: After the vaccine, I felt like I was feeling the effects of COVID-19. I got a sore throat, headache, no tastes, and congestion. I was bedridden for 8 days. I took a COVID-19 test and it came back negative. I slowly started to get better, but I still didn't feel like I was at 100%. Three months later on 1/2/2022, I got a strong pain in my side, by the next day it had worsened so I went to the ER and was admitted. They ran tests and found a Pulmonary Embolism in my left lung. I stayed in the hospital for 3 ½ days then put on a blood thinner and told to use an Berodual Inhaler. As of 5/4/2022 I feel about 95% better.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Malaise, Oropharyngeal pain, Pulmonary embolism, Respiratory tract congestion
Clinical narrative: After the vaccine, I felt like I was feeling the effects of COVID-19. I got a sore throat, headache, no tastes, and congestion. I was bedridden for 8 days. I took a COVID-19 test and it came back negative. I slowly started to get better, but I still didn't feel like I was at 100%. Three months later on 1/2/2022, I got a strong pain in my side, by the next day it had worsened so I went to the ER and was admitted. They ran tests and found a Pulmonary Embolism in my left lung. I stayed in the hospital for 3 ½ days then put on a blood thinner and told to use an Berodual Inhaler. As of 5/4/2022 I feel about 95% better.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: After the vaccine, I felt like I was feeling the effects of COVID-19. I got a sore throat, headache, no tastes, and congestion. I was bedridden for 8 days. I took a COVID-19 test and it came back negative. I slowly started to get better, but I still didn't feel like I was at 100%. Three months later on 1/2/2022, I got a strong pain in my side, by the next day it had worsened so I went to the ER and was admitted. They ran tests and found a Pulmonary Embolism in my left lung. I stayed in the hospital for 3 ½ days then put on a blood thinner and told to use an Berodual Inhaler. As of 5/4/2022 I feel about 95% better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Pruritus, Swelling face
Clinical narrative: Itching on the face after after first booster and facial filler; Swelled up Face after first booster and facial filler; Delayed reaction after first booster and facial filler; second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on the face after after first booster and facial filler), SWELLING FACE (Swelled up Face after first booster and facial filler), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021) and HYPERSENSITIVITY (Delayed reaction after first booster and facial filler) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A, 044B21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021). On 28-Feb-2022, the patient experienced PRURITUS (Itching on the face after after first booster and facial filler), SWELLING FACE (Swelled up Face after first booster and facial filler) and HYPERSENSITIVITY (Delayed reaction after first booster and facial filler). On 21-Mar-2022, PRURITUS (Itching on the face after after first booster and facial filler), SWELLING FACE (Swelled up Face after first booster and facial filler) and HYPERSENSITIVITY (Delayed reaction after first booster and facial filler) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of primary series administered on 19-Apr-2021 and 1st booster was administered on 19-Aug-2021) outcome was unknown.            No concomitant medication was reported by the reporter.  Patient received Juviderm and Sculctra Facial Fillers in the face on DEC2021  No treatment medication was reported by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: terrible joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (terrible joint aches) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (terrible joint aches). At the time of the report, ARTHRALGIA (terrible joint aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-554862, MOD-2022-554863, MOD-2022-554864 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.) 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 an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.). At the time of the report, IMMUNISATION REACTION (Patient stated that I've never been diagnosed with this issue in my life that I can remember. It is a very embarrassing issue.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant drugs were not reported.  Treatment details were not given.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine(0.25 mL); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine(0.25 mL)) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     It was unknown regarding allergies (medications, food, and other products). Reported unknown if patient ever had COVID positive test or diagnosis and stated unknown history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Unknown if patient received other vaccines given within 1 month prior to Moderna COVID-19.  .     On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine(0.25 mL)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine(0.25 mL)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  The vial was initially stored in the refrigerator on 30Mar2022. Patient received 2nd booster dose on 29Apr2022.  It was reported unknown that the adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized): Unknown the patient has experienced a similar event in the past.  The vial did not undergo any temperature excursion.   No treatment medications was provided by the reporter.   This case was linked to MOD-2022-555070 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: Extreme cutaneous vasculitis on my lower limbs; This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (Extreme cutaneous vasculitis on my lower limbs) 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 19-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CUTANEOUS VASCULITIS (Extreme cutaneous vasculitis on my lower limbs) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Extreme cutaneous vasculitis on my lower limbs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.  Patient experienced extreme cutaneous vasculitis on lower limb and received 5 dose treatment of steroids and antibiotics over 6 months period without any improvement success.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced serious (medically significant) unexpected event of Cutaneous vasculitis (reported as Extreme cutaneous vasculitis on my lower limbs), approximately 5 months after receiving second dose of mRNA-1273 vaccine. The patient received 5 dose treatment of steroids and antibiotics (both unspecified) over 6 months period without any improvement success. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced serious (medically significant) unexpected event of Cutaneous vasculitis (reported as Extreme cutaneous vasculitis on my lower limbs), approximately 5 months after receiving second dose of mRNA-1273 vaccine. The patient received 5 dose treatment of steroids and antibiotics (both unspecified) over 6 months period without any improvement success. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022; Received vaccine expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     It was unknown if the patient ever had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy and Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVASC) and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for Blood pressure high.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in the refrigerator on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care, and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 at 06:44 PM. The vial did not undergo any temperature excursion. No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     It was unknown if the patient ever had COVID + test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (codeine) and Hypertension (Recent change in status such as improvement or worsening: none). Concomitant products included TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for an unknown indication.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 06:44PM. The vial did not undergo any temperature excursion. Treatment medications were not reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after expiry) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. Patient did not had any allergies to medications, food and other products. It was unknown patient neither diagnosed with COVID-19 nor tested positive. On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. It was reported patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 06:44PM. The vial did not undergo any temperature excursion. Treatment medications were not reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022; Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     Patient did not had any allergies to medications, food and other products. It was unknown patient neither diagnosed with COVID-19 nor tested positive.  Concomitant products included ZOLPIDEM, MELOXICAM, ZOLPIDEM, FLECAINIDE, DILTIAZEM and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 23-APR-2022, which was expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 23-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek for medical care and it was unknown whether patient experienced a similar event in the past. It was reported that the vial was initially stored in the refrigerator on 20-Apr-2022 06:44PM. The vial did not undergo any temperature excursion.  Patient had taken primary series (dose 1 and 2) of vaccination from unknown manufacturer on unknown date The vials had not undergone temperature excursion.  Treatment medications were not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022; patients were administered the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered the expired vaccine) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered the expired vaccine) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 20-Apr-2022 and administered on 26-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not receiving any concomitant medication. It was unknown whether patient ever had COVID positive  test or diagnosis. It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The pharmacist reported that 4 of their Moderna vials expired on 01 Apr 2022 and on 21 Apr 2022 through 26 Apr 2022, 5 patients were administered the expired vaccine. The vial was initially stored in the refrigerator on 20 Apr 2022 at 6:44PM. The vial did not undergo any temperature excursions. The patient received first and second dose of vaccination from unknown manufacturer. On 26 Apr 2022 patient received booster dose. The event did not cause patient to seek medical care. The patient had no allergies. No acute and chronic medical illnesses at the time of vaccination. No treatment drug was reported.   This case was linked to MOD-2022-555058, MOD-2022-555063, MOD-2022-555064, MOD-2022-555065 (Patient Link).
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 of my patients received expired Moderna Covid-19 vaccine. Both were booster doses (0.25mL).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose.   No concomitant medications was provided by the reporter. It was unknown if patient  had any Allergies to medications, food and other products or patient was diagnosed or tested positive for COVID-19. It was unknown if the patient had chronic or long-standing health condition and if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.  The Vial was initially stored in refrigerator 30-MAr-2022 and Dose administered after 30-day Use By Date or after manufacturer date of expiry Vial did not undergo any temperature excursions. Expired Vaccine was administered on 23-Apr-2022.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-555023 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: First Dose on 17-Jan-2021 and 2nd Dose on 27-Feb-2021; a little soreness in the arm; fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness in the arm), FATIGUE (fatigue), MYALGIA (Body aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 17-Jan-2021 and 2nd Dose on 27-Feb-2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 17-Jan-2021 and 2nd Dose on 27-Feb-2021). On an unknown date, the patient experienced PAIN IN EXTREMITY (a little soreness in the arm), FATIGUE (fatigue) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (a little soreness in the arm), FATIGUE (fatigue) and MYALGIA (Body aches) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 17-Jan-2021 and 2nd Dose on 27-Feb-2021) outcome was unknown.            No Concomitant product use was reported.  The patient had no side effects after the first shot and following the second shot the patient had a little soreness in the arm, fatigue, and body aches for about 24 hours.  No treatment information was reported.   This case was linked to MOD-2022-555093 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022; Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 08-Apr-2022, which was Expired vaccine on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vails that were expired on 01-Apr-2022, was stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 12-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 12-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 12-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reporter. Pharmacist called to verify an expiration date for lot number 026L21B. The pharmacist mentioned that they thought the vaccine was expired in Jun-2022. However the vaccine expired on 01-Apr-2022. Caller stated that 155 patients were vaccinated with expired doses from  02-Apr-2022 to 19-Apr-2022. The date in which the vial was initially stored in refrigerator was 04-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were reporter.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-Apr-2022.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Joint arthroplasty
Clinical narrative: Major joint replacement surgery; This spontaneous case was reported by a consumer and describes the occurrence of JOINT ARTHROPLASTY (Major joint replacement surgery) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT ARTHROPLASTY (Major joint replacement surgery). At the time of the report, JOINT ARTHROPLASTY (Major joint replacement surgery) outcome was unknown.            No concomitant medications were reported. It was reported that Patient just had major joint replacement surgery and wanted to know if it was okay to get her second booster. No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Return of olfactory sensation, return of flavor sensation; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Return of olfactory sensation, return of flavor sensation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anosmia (diagnosed with anosmia over a decade ago and had not smelled aromas or enjoyed flavors this intensely since the patient was first inflicted many years back. ).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Return of olfactory sensation, return of flavor sensation). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Return of olfactory sensation, return of flavor sensation) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient was diagnosed with anosmia over a decade ago and had not smelled aromas or enjoyed flavors this intensely since the patient was first inflicted many years back. The patient experienced a return of olfactory and flavor sensations after the second booster shot. The patient was never been diagnosed with COVID-19, and did not believe that the patient ever got it. The patient mentioned that this reaction might be coincidental, but it was certainly welcome. It had only been 48 hours, and the patient was hoping it might be permanent.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: like I need to lie down; little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (like I need to lie down) and NAUSEA (little nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 025021A, 007B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced FEELING ABNORMAL (like I need to lie down) and NAUSEA (little nauseous). At the time of the report, FEELING ABNORMAL (like I need to lie down) and NAUSEA (little nauseous) outcome was unknown.            No concomitant medications were reported. About 1 hour after receiving the shot she started to feel a little nauseous, and like she needed to lie down. Patient stated that she had not taken any medications or treatments to try and help with this feeling.  No treatment medications were reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products. The patient did not have COVID positive test or diagnosis. The patient no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The event did not cause patient to seek medical care.  No treatment details were reported.   This case was linked to MOD-2022-556239, MOD-2022-556237, MOD-2022-556238 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Illness, Nausea, Rash
Clinical narrative: Diarrhea; Rash on her arm; Nausea; Vomiting; Dehydration; She was very sick for a week; This spontaneous case was reported by a nurse and describes the occurrence of DEHYDRATION (Dehydration), ILLNESS (She was very sick for a week), DIARRHOEA (Diarrhea), RASH (Rash on her arm) and NAUSEA (Nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydration), ILLNESS (She was very sick for a week), DIARRHOEA (Diarrhea), RASH (Rash on her arm), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DEHYDRATION (Dehydration), DIARRHOEA (Diarrhea), RASH (Rash on her arm), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and ILLNESS (She was very sick for a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient reported after receiving  dose of the Moderna COVID-19 vaccine she experienced a rash on her arm, nausea, vomiting, and diarrhea. She also went to the ER and was treated for dehydration. She was very sick for a week. Patient had only received 1st dose of moderna vaccine.   Treatment information was not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Rash on her arm; Nausea; Vomiting; Dehydration; She was very sick for a week; This spontaneous case was reported by a nurse and describes the occurrence of DEHYDRATION (Dehydration), ILLNESS (She was very sick for a week), DIARRHOEA (Diarrhea), RASH (Rash on her arm) and NAUSEA (Nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydration), ILLNESS (She was very sick for a week), DIARRHOEA (Diarrhea), RASH (Rash on her arm), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DEHYDRATION (Dehydration), DIARRHOEA (Diarrhea), RASH (Rash on her arm), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and ILLNESS (She was very sick for a week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient reported after receiving  dose of the Moderna COVID-19 vaccine she experienced a rash on her arm, nausea, vomiting, and diarrhea. She also went to the ER and was treated for dehydration. She was very sick for a week. Patient had only received 1st dose of moderna vaccine.   Treatment information was not reported.