chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Headache, Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: Headache; All joints hurting; Legs feel heavy; Arm was hot to touch and sore; Arm was hot to touch and sore; BNT162B2 was administered before 19 days of primary dose.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Sep2021 at 18:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and unspecified medication (reported as well uterine) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Sep2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 18:15, the patient experienced headache, all joints hurting, legs feel heavy, arm was hot to touch and sore. The events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, all joints hurting, legs feel heavy, arm was hot to touch and sore was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; All joints hurting; Legs feel heavy; Arm was hot to touch and sore; Arm was hot to touch and sore; BNT162B2 was administered before 19 days of primary dose.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Sep2021 at 18:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and unspecified medication (reported as well uterine) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Sep2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 18:15, the patient experienced headache, all joints hurting, legs feel heavy, arm was hot to touch and sore. The events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, all joints hurting, legs feel heavy, arm was hot to touch and sore was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Migraine
Clinical narrative: Migraine headaches; Headaches; Elevated blood pressure for 3 weeks; This is a spontaneous report from a non-contactable nurse, the patient. A 52-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Aug2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Jul2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, the patient experienced migraine headaches/ headaches every day since the second dose as well as elevated blood pressure for 3 weeks. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event elevated blood pressure was resolved on an unknown date in 2021; while that of migraine headaches/ headaches was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever; arm soreness; swelling andpain at injection site; swelling andpain at injection site; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old patient of an unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Sep2021 at 15:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, irritable bowel syndrome (IBS) and severe allergies. The patient had a history of allergic to kiwi and to all furry animals. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 23Sep2021 at 18:00, the patient experienced fever, arm soreness, swelling and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, arm soreness, swelling and pain at injection site was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Endoscopy, Herpes zoster, Platelet count
Clinical narrative: She recently developed a new allergy to apples and has an epi-pen; She also previously had shingles on her arm; This is a spontaneous report from a contactable consumer or other non HCP.    A 54-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Patient stated she had a crazy several months. She had been to the ER several times with severe oesophageal reflux and GERD. She is currently taking a break from Ibrance until October. She had been off for a couple of months. She had an endoscopy completed. Being off of Ibrance is not helping her issue as far as she can tell. She is on GERD medication and is still having breakthrough issues. She is so nauseated some days she cannot get out of bed. This could be connected to her autoimmune disease, but she does not think it is related to Ibrance. She has lost some weight which is good since she has struggled with weight gain. She has no energy to work out. She recently fell off a ladder. She is trying to better manage her stress. She was previously so sick that she had to keep getting fluids. When she is on Ibrance her platelets and counts go down. She has had her COVID vaccine and flu vaccine. She recently developed a new allergy to apples and has an epi-pen. She ate one and her throat got itchy, and her lips were numb and tingly. She also previously had shingles on her arm. The outcome of the event new allergy to apples and has an epi-pen, she also previously had shingles on her arm on an unspecified date with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  Follow-up (27Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Radiates down to my foot; Aching pain in my right leg; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Sep2021 at 16:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 18Sep2021 at 13:00, two weeks after the second dose the patient experienced aching pain in her right leg that radiated down to her foot. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 09Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event aching pain in right leg that radiated down to her foot was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: bodyache; Headaches; diarrhea; nausea; fever; chill; This is a spontaneous report from a contactable other health care professional (patient). A 64-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: 30130, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 21Sep2021 at 03:30 PM (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cancer survivors, had covid last May. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 31Sep2021 at 02:30 PM (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No other medications received in two weeks. No known allergies reported. On 22Sep2021 at 03:00 AM, the patient experienced body ache, headaches, diarrhea, nausea, fever, chill. No seriousness criteria were reported. Therapeutic measures were taken for events with Motrin, plenty of hot tea. The outcomes of events were recovering.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bodyache; Headaches; diarrhea; nausea; fever; chill; This is a spontaneous report from a contactable other health care professional (patient). A 64-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: 30130, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 21Sep2021 at 03:30 PM (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cancer survivors, had covid last May. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number not reported, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 31Sep2021 at 02:30 PM (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No other medications received in two weeks. No known allergies reported. On 22Sep2021 at 03:00 AM, the patient experienced body ache, headaches, diarrhea, nausea, fever, chill. No seriousness criteria were reported. Therapeutic measures were taken for events with Motrin, plenty of hot tea. The outcomes of events were recovering.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old unknown gender patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the upper right arm on 23Mar2021 at 14:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history reported as "do not do that" and had known allergies to opiates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the upper left arm on an unknown date as a single dose for COVID-19 immunisation. On 23Sep2021 at 14:30, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Sep2021, the patient underwent hearing test and the result was unknown. Therapeutic measures were taken as a result of the event which included treatment with hearing test and would get hearing aid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Didn't have any immediate reaction to the vaccine, however the next day I awakened to a swollen top lip.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Sep2021 at 16:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included proteinuria. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient did not have any immediate reaction to the vaccine. However, the next day on 25Sep2021 at 07:00, the patient awakened to a swollen top lip. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen top lip was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Mammogram, Pain in extremity, Ultrasound scan
Clinical narrative: she had first vaccine in Mar2021 with no issues other than her arm was sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date Mar2021 as dose 1, single for COVID-19 immunization. Medical history included non-tobacco user (don't smoke). Concomitant medication included multivitamin [vitamins NOS]. On an unspecified date Mar2021, the patient experienced she had first vaccine in mar2021 with no issues other than her arm was sore. The patient underwent lab tests and procedures which included mammogram: negative on Dec2020, ultrasound scan: negative on Dec2020, mammogram: unknown results on 21Jun2021 She ended up mammogram had papilloma 2cm enlarger clogged duct, biopsy: negative on an unspecified date the cyst collapsed, and biopsy: papilloma on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: Severe lymphadenopathy bilateral axillary; Bilateral arms swelling; Chest swelling; This is a spontaneous report from a contactable nurse. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm  on 04Jan2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 16Jan2021 at 7:00, the patient experienced severe lymphadenopathy bilateral axillary, bilateral arms swelling and chest swelling. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe lymphadenopathy bilateral axillary, bilateral arms swelling and chest swelling was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 12Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date  in 2021, the patient experienced headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were taken as a result of the event and included treatment with paracetamol (TYLENOL) 2 times. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event headache was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. NO further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: patient had bp at 189/89 but forgot to take her blood pressure medication in the morning; This is a spontaneous report from a non-contactable pharmacist. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in arm left on 20May2021 (at the age of 65 years old, Lot Number: ew0151) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had bp at 189/89 but forgot to take her blood pressure medication in the morning on 20May2021 with outcome of unknown. The patient was not pregnant. No other vaccine in four weeks. The event did not result in death, hospitalized, disability. No treatment received.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness that lasted 20 minutes; This is a spontaneous report from a non-contactable pharmacist. A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 12Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history AND concomitant medications were not reported. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced dizziness that lasted for 20 minutes. Since the vaccination, it was unknown if the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event dizziness was resolved on 12Mar2021, after the duration of 20 minutes.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Viral infection.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) had resolved.            Patient reported that he might had history of COVID 19 (Several tests yielded negative results).  No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-362956, MOD-2021-363022 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up information included no new information. On 27-Oct-2021: upon follow up receipt: Event outcome was updated(unknown-recovered) and narrative was generated accordingly.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, 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 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 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to-MODERNATX, INC.-MOD-2021-363460 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-363460:Cross linked case/ Master case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination complication
Clinical narrative: problems with pain in her joints; not felt right; pain in the joints and muscles; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRALGIA (problems with pain in her joints), VACCINATION COMPLICATION (not felt right) and MYALGIA (pain in the joints and muscles) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis and Irritable bowel syndrome.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (problems with pain in her joints), VACCINATION COMPLICATION (not felt right) and MYALGIA (pain in the joints and muscles). The patient was treated with IBUPROFEN ongoing since an unknown date for Diverticulitis, at an unspecified dose and frequency; HYDROCODONE ongoing since an unknown date for Diverticulitis, at an unspecified dose and frequency and MELATONIN ongoing since an unknown date for Sleeplessness, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (problems with pain in her joints), VACCINATION COMPLICATION (not felt right) and MYALGIA (pain in the joints and muscles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include blue pill and cream for her stomach diverticulitis.   This case was linked to MOD-2021-363450, MOD-2021-363553 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date of refrigeration of vaccine was 06-AUG-2021  No treatment information was reported.   This case was linked to MOD-2021-363775 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received dose from vials beyond 30-day use by date; received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (received dose from vials beyond 30-day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-may-2021 No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-364262 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.). On 16-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) had resolved. On 16-Oct-2021, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      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 reported. Vaccine was refrigerated on 07 May 2021.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Date of refrigeration of vial is 19-AUG-2021.   This case was linked to MOD-2021-364610 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) had resolved. At the time of the report, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  The refrigeration date was 07-May-2021.   This case was linked to MOD-2021-364649 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.      Medical history was not provided. .     On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 11-Jun-2021, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Date of refrigeration is 7 May 2021 No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      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 of refrigeration: 07-May-2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. Date of refrigeration was given as 07-MAY-2021
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose from vial beyond 30 day use by date; he patient received dose from vial beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30 day use by date) and PRODUCT STORAGE ERROR (he patient received dose from vial beyond 30 day use by date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30 day use by date) and PRODUCT STORAGE ERROR (he patient received dose from vial beyond 30 day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30 day use by date) and PRODUCT STORAGE ERROR (he patient received dose from vial beyond 30 day use by date) 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 use was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received dose from vials beyond 30-day use by date; Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was refrigerated on 07-May-2021.  No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-363032 (Patient Link).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received dose from vials beyond 30-day use by date; Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      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.  Date of refrigeration was 7 May 2021.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Immune system disorder, Skin fissures
Clinical narrative: immune system is completely out of control; hands are cracking and splitting so bad; major head to toe allergic reaction from the vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNE SYSTEM DISORDER (immune system is completely out of control), SKIN FISSURES (hands are cracking and splitting so bad) and ALLERGY TO VACCINE (major head to toe allergic reaction from the vaccine) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced IMMUNE SYSTEM DISORDER (immune system is completely out of control), SKIN FISSURES (hands are cracking and splitting so bad) and ALLERGY TO VACCINE (major head to toe allergic reaction from the vaccine). At the time of the report, IMMUNE SYSTEM DISORDER (immune system is completely out of control), SKIN FISSURES (hands are cracking and splitting so bad) and ALLERGY TO VACCINE (major head to toe allergic reaction from the vaccine) had not resolved.            Patient reported that his body is producing over 2800 uh vaccines in blood count which is 4 times the level.  No concomitant medication was reported No treatment medication was reported