chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-448109 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of accidental underdose (half dose given for 3rd dose by accident) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced accidental underdose (half dose given for 3rd dose by accident). At the time of the report, accidental underdose (half dose given for 3rd dose by accident): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06-Dec-2021,Lot 012H21B vials were placed in refrigerator.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-448109 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On December 6, 2021, Lot 012H21B vials were placed  in refrigerator. No concomitant medication were provided. No treatment information were given.   This case was linked to MOD-2022-448109 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Woke up in the middle of the night sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Woke up in the middle of the night sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Woke up in the middle of the night sick). At the time of the report, ILLNESS (Woke up in the middle of the night sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant use were reported. No Treatment were reported.   This case was linked to MOD-2022-449904, MOD-2022-449915 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose: 21 day after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose: 21 day after first dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose: 21 day after first dose). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose: 21 day after first dose) had resolved.            No concomitant medication were reported  No treatment information was reported   This case was linked to MOD-2022-448146, MOD-2022-447768 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031H21A) for COVID-19 immunization. No medical history reported. On Jan 11, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 11, 2022, patient experienced administered expired product (expired vaccine used). On Jan 11, 2022, administered expired product (expired vaccine used): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated her clinic administered vaccinations past the expiration date for the Moderna COVID-19 vaccine. HCP stated some patients reported flu-like symptoms after receiving the vaccination but she did not have those details.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 21 day after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 21 day after first dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 21 day after first dose). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 21 day after first dose) had resolved.            No Concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-448146, MOD-2022-447768 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Apainful bump in my armpit that lasted about 10 days after the third dose of the vaccine. Today, even though it doesn't hurt anymore, it's still a bit swollen. I didn't receive any medical treatment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urine analysis
Clinical narrative: body aches
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bacterial test positive, Bilirubin urine, Blood albumin normal
Clinical narrative: Extreme malaise, body soreness, and fatigue started around 24 hour after 11/22/21 vaccination. In the following 12-24  hours, patient developed alarming gross hematuria, resulting in a 11/24/21 ER assessment and treatment that seemingly resolved gross hematuria. Follow up appointments with family medicine and nephrology showed no apparent, physical issues with kidneys, but microscopic levels of hematuria and proteinuria had not yet resolved in the 4 weeks following vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin normal, Blood urine, Fatigue, Globulins increased, Glomerular filtration rate normal
Clinical narrative: Extreme malaise, body soreness, and fatigue started around 24 hour after 11/22/21 vaccination. In the following 12-24  hours, patient developed alarming gross hematuria, resulting in a 11/24/21 ER assessment and treatment that seemingly resolved gross hematuria. Follow up appointments with family medicine and nephrology showed no apparent, physical issues with kidneys, but microscopic levels of hematuria and proteinuria had not yet resolved in the 4 weeks following vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Malaise, Metabolic function test, Pain, Protein urine present
Clinical narrative: Extreme malaise, body soreness, and fatigue started around 24 hour after 11/22/21 vaccination. In the following 12-24  hours, patient developed alarming gross hematuria, resulting in a 11/24/21 ER assessment and treatment that seemingly resolved gross hematuria. Follow up appointments with family medicine and nephrology showed no apparent, physical issues with kidneys, but microscopic levels of hematuria and proteinuria had not yet resolved in the 4 weeks following vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Proteinuria, Red blood cells urine positive, Ultrasound scan normal, Urinary sediment present, Urine analysis
Clinical narrative: Extreme malaise, body soreness, and fatigue started around 24 hour after 11/22/21 vaccination. In the following 12-24  hours, patient developed alarming gross hematuria, resulting in a 11/24/21 ER assessment and treatment that seemingly resolved gross hematuria. Follow up appointments with family medicine and nephrology showed no apparent, physical issues with kidneys, but microscopic levels of hematuria and proteinuria had not yet resolved in the 4 weeks following vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: Extreme malaise, body soreness, and fatigue started around 24 hour after 11/22/21 vaccination. In the following 12-24  hours, patient developed alarming gross hematuria, resulting in a 11/24/21 ER assessment and treatment that seemingly resolved gross hematuria. Follow up appointments with family medicine and nephrology showed no apparent, physical issues with kidneys, but microscopic levels of hematuria and proteinuria had not yet resolved in the 4 weeks following vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dizziness, Electrocardiogram, Headache
Clinical narrative: After the shot I began experiencing fever, chills, and an extreme headache.  Two days after I was experiencing neurology issues on my right side.  I have also having waves of dizziness that accompanied the speech, hand, and movement impairment.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Nervous system disorder, Pyrexia, Speech disorder, X-ray
Clinical narrative: After the shot I began experiencing fever, chills, and an extreme headache.  Two days after I was experiencing neurology issues on my right side.  I have also having waves of dizziness that accompanied the speech, hand, and movement impairment.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: pretty zonked out, fatigued; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was pretty zonked out with the 1st dose of the Shingles vaccine and stated nothing really major just fatigued. The patient's second dose was coming up in couple months. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: felt like the flu; aching joints; aching muscles; headache; chills; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and had side effects included it felt like the flu, aching joints and muscles, headache, chills, nausea for two days. The patient thought he/she had caught Covid. The patient stated that nonetheless, still better than getting shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: felt like the flu; aching joints; aching muscles; headache; chills; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, headache, chills and nausea to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and had side effects included it felt like the flu, aching joints and muscles, headache, chills, nausea for two days. The patient thought he/she had caught Covid. The patient stated that nonetheless, still better than getting shingles. The follow-up would not possible as no contact details were available.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination, Influenza like illness, Nausea, Vomiting
Clinical narrative: dose 1 of SHINGRIX on May 30, 2021 /  it is now 7 months /she has not received the second dose yet; Vomiting; Nausea; she experienced fluish like symptoms/felt like she had the flu; Stated was really sick; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced incomplete course of vaccination, vomiting, nausea, influenza-like symptoms and sickness. On an unknown date, the outcome of the incomplete course of vaccination, vomiting, nausea, influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the vomiting, nausea, influenza-like symptoms and sickness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022002071  Additional details were reported as follows: The reporter was a nurse and patient herself. Nurse Practitioner stated she had not received the second dose yet, which led to incomplete course of vaccination.  She stated she just remembered it was supposed to be given at 6 months and it was now 7 months. Nurse Practitioner stated she experienced fluish like symptoms. Stated was really sick, which felt like she had the flu with nausea and vomiting for 2 to 3 days. NP unable to provide the vaccine details of Lot and expiration date. She mentioned she would get the second dose as soon as possible. Information provided per content. The patient was referred to health care professional and medical information phone number provided. Consent to follow up was denied. The present case was found to be duplicate of the case US2022002071. All the future information corresponding to the case would be submitted in the present case as case of record.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002071:same reporter
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Periorbital swelling
Clinical narrative: Eye swelling; Swelling around his right eye; This case was reported by a physician via call center representative and described the occurrence of eye swelling in a 2-year-old male patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2021-2022 season) (batch number 2579B, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included FluLaval Quadrivalent (received 1st dose on an unknown date) and FluLaval Quadrivalent (received 2nd dose on an unknown date). Concurrent medical conditions included ear infection (the patient had a ear infection prior to and at the time of the vaccine).   On 3rd January 2022, the patient received the 3rd dose of FluLaval Quadrivalent 2021-2022 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 3rd January 2022, 5 hrs after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced eye swelling and periocular swelling. In January 2022, the outcome of the eye swelling was recovered/resolved. On an unknown date, the outcome of the periocular swelling was unknown.   It was unknown if the reporter considered the eye swelling and periocular swelling to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by pediatrician. The patient received the Flulaval in his right thigh.  The reporter reported that the patient received 3rd flu vaccine given over the past 3 flu seasons.  The reporter reported that after receiving Flulaval, the patient developed swelling around his right eye.  The reporter reported that the patient also had an ear infection prior to and at the time of the vaccine that might had caused the eye swelling.  The reporter did not consent to follow up. This case had been linked to the case US2022002796, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002796:same reporter
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose given to adult (56 yrs old); Engerix-B pediatric 10 mcg dose given to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 56-year-old female patient who received HBV (Engerix B) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included engerix b (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Reported stated that Engerix-B pediatric 10 mcg dose given to patient which led to underdose and Adult use of a child product. Reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose over 1 year ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first dose of Shingrix a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not applicable for this report. The patient received a dose of Shingrix a year before reporting and have not received any dose since then. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. Consent to follow up was granted.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Migraine, Rheumatoid arthritis, Therapeutic response shortened
Clinical narrative: This spontaneous report received from a patient concerned an adult male of unknown race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) does not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  The patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced rheumatoid arthritis aggravated, migraine aggravated, and wearing off effect. The action taken with covid-19 vaccine was not applicable; and action taken with adalimumab was not reported. The patient was recovering from rheumatoid arthritis aggravated, and the outcome of migraine aggravated and wearing off effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220120812-Covid 19 Vaccine-Rheumatoid arthritis aggravated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Loose tooth, Ocular hyperaemia, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 57-year-old Hispanic or Latino female of unspecified race. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient had no known drug allergies, no known previous medical conditions, and no previous medication usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total, administered on 14-SEP-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. The patient stated that she traveled to her sisters for Christmas on 25-DEC-2021 where COVID-19 was rampant, and she wanted to test herself to see if she had contracted covid-19. On 30-DEC-2021 she tested herself with rapid antigen test and was negative. On 01-JAN-2022, she tested herself again with a rapid antigen test at home and the test result was positive (suspected covid-19 infection, and suspected clinical vaccination failure). She stated that she developed symptoms including rash, blood shot eyes, muscle aches all over body, fever, cough, sore throat, runny nose, and felt like she was going to lose all her teeth. She stated that her doctor had called her in a prescription for Azithromycin 500mg 1 daily for ten days, ibuprofen, and dexamethasone 6mg. She was also given a prescription for tobramycin eye drops for her blood shot eyes. She stated that on 12-Jan-2022, she finally tested negative based upon an at home rapid antigen test and that her symptoms are much better compared to 5 to 6 days ago. The action taken with covid-19 vaccine was not applicable. The patient was recovering from suspected covid-19 infection, felt like going to lose all teeth, and blood shot eyes, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000211462.; Sender's Comments: V0. 20220121251-covid-19 vaccine suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 06-Dec-2021, they placed a LOT 012H2B1A vials in the refrigerator upon receiving.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not reported. On 06-Dec-2021, they placed LOT 012H21B vials in the refrigerator, upon receiving.  Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of LOT 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose.   This case was linked to MOD-2022-448109 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: arm became an infection; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (arm became an infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (arm became an infection). At the time of the report, LOCALISED INFECTION (arm became an infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details included antibiotics for the infected arm. It was reported that the arm was much better.   This case was linked to MOD-2022-445073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2022: Follow up received contains non significant information. On 13-Jan-2022: Significant follow up received included Event outcome updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Vaccination site pain
Clinical narrative: mild icky feeling; felt achy; injection site left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (mild icky feeling), PAIN (felt achy) and VACCINATION SITE PAIN (injection site left arm was sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Palpitations.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced FEELING ABNORMAL (mild icky feeling), PAIN (felt achy) and VACCINATION SITE PAIN (injection site left arm was sore). On 23-Feb-2021, FEELING ABNORMAL (mild icky feeling) and PAIN (felt achy) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site left arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2022-447964, MOD-2022-447985 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: have a weak resistive system to disease due to a weak heart. I got a full moderna booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (have a weak resistive system to disease due to a weak heart. I got a full moderna booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency and Heart disorder.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced UNDERDOSE (have a weak resistive system to disease due to a weak heart. I got a full moderna booster shot). On 26-Aug-2021, UNDERDOSE (have a weak resistive system to disease due to a weak heart. I got a full moderna booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Patient got a full Moderna booster shot.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 6 December 2021,  Lot 012H21B vials was placed in refrigerator. No concomitant medications information were reported. No treatment medications information were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.  Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of Lot 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. On 06-Dec-2021, they placed LOT 012H21B vials in the refrigerator, upon receiving.   This case was linked to MOD-2022-448109, MOD-2022-449351, MOD-2022-449369, MOD-2022-449379, MOD-2022-449382, MOD-2022-449386, MOD-2022-449392, MOD-2022-449397, MOD-2022-449407, MOD-2022-449412, MOD-2022-449425, MOD-2022-449432, MOD-2022-449436, MOD-2022-449442, MOD-2022-449446, MOD-2022-449452, MOD-2022-449456, MOD-2022-449462, MOD-2022-449464, MOD-2022-449470, MOD-2022-449476, MOD-2022-449479, MOD-2022-449484, MOD-2022-449491, MOD-2022-449496, MOD-2022-449500, MOD-2022-449509, MOD-2022-449514, MOD-2022-449515, MOD-2022-449517, MOD-2022-449520, MOD-2022-449524, MOD-2022-449527, MOD-2022-449529, MOD-2022-449531, MOD-2022-449537, MOD-2022-449541, MOD-2022-449544, MOD-2022-449546, MOD-2022-449548, MOD-2022-449555, MOD-2022-449558, MOD-2022-449562, MOD-2022-449565, MOD-2022-449573, MOD-2022-449581, MOD-2022-449597, MOD-2022-449610, MOD-2022-449621, MOD-2022-449634, MOD-2022-449651, MOD-2022-449660, MOD-2022-449684, MOD-2022-449697, MOD-2022-449706, MOD-2022-449713, MOD-2022-449719, MOD-2022-449729, MOD-2022-449733, MOD-2022-449740, MOD-2022-449524 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. On 06 Dec 2021,placed Lot 012H21B vials in our refrigerator.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  On 06-Dec-2021, the vials were placed in refrigerator.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain, Vertigo, Vomiting
Clinical narrative: vertigo; arm pain at  injection site continued for the day; chills; vomiting; extreme body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme body pain), VERTIGO (vertigo), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (arm pain at  injection site continued for the day) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced PAIN (extreme body pain) and VOMITING (vomiting). On 06-Jan-2022 at 8:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 07-Jan-2022, the patient experienced VERTIGO (vertigo) and VACCINATION SITE PAIN (arm pain at  injection site continued for the day). The patient was treated with DIMENHYDRINATE (DRAMAMINE) on 07-Jan-2022 for Vertigo, at an unspecified dose and frequency. On 08-Jan-2022, PAIN (extreme body pain), VERTIGO (vertigo), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (arm pain at  injection site continued for the day) had resolved.            Concomitant medications were not provided by reporter.  The patient received Moderna booster on , thursday at about 11:30 AM. on the same day patient began to have chills around 8:00 PM; shortly thereafter vomiting followed by extreme body pain and in the AM woke up with vertigo and patient received OTC (Dramamine) to address verti go successfully, arm pain at  injection site continued for the day. By Saturday , patient back to normal.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.  On 06-Dec-2021, Lot 012H21B vials were placed in refrigerator, upon receiving.  Patient received one of these expired booster vaccine.   This case was linked to MOD-2022-448109, MOD-2022-449524.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  The vials were placed in refrigerator on 06 Dec 2021.   This case was linked to MOD-2022-449524 (Patient Link).