chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 8th August 2022, the patient received Havrix. On 8th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-Aug-2022 Reporter's comment: The pharmacist reported that a patient received an expired dose of Havrix. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Twinrix 1st dose on 19-Jan-2022, came to get 2nd dose today (11-Aug-2022) not get yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 19 January 2022 from lot number X239D and expiry date 7th August 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received 1st dose of Twinrix Vaccine. The reporter stated that the patient was back for the second dose today (on the day of reporting). The reporter stated that the patient did not received the 2nd dose on 11th August 2022. The reporter asked the if patient should receive second dose or restart the series. The reporter consented to follow up.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 0.5
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: less than a year old patient received Havrix adult dose; less than a year old patient received Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old female patient who received HAV (Havrix adult) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 Information: GSK Receipt Date: 11-Aug-2022. Reporter's Comments: The nurse reported that a patient who was less than a year old received an adult dose of Havrix. The reporter consented to follow up via email.  Additional Supportive Information: The patient who was less than a year old received an adult dose of Havrix, which led to overdose and adult product administered to child.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero admnistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The clinic manager stated that Bexsero was administered to a patient 1 day after the expiration date. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Besero, which led to expired vaccine used. The case was linked with case US2022118576, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022118576:Same reporter
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered 3 days after expiration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The clinic manager stated that Bexsero was administered to a patient 3 days after the expiration date. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used. The case was linked with case US2022118576, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022118575:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 12th August 2022, the patient received Havrix. On 12th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: A clinic manager reported that a patient received an expired dose of Havrix on 12th August 2022. The Havrix expired on 09th August 2022. The clinic manager did not have any patient details at the time of report but consented to follow-up via email. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot #1 on 05-Nov-2021, yet to receive second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on 5th November 2021).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The patient had not yet to receive the second dose and was beyond the 6 month window. The patient did not had the lot number of the vaccine which was administered. No further questions asked (due to difficulty understanding each other).  The reporter was failed to asked for his date of birth. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-222 Reporter's comment: The registered pharmacist called to inquired that the patient should need to revaccinated. The reporter reported that an expired Bexsero was administered to a patient. No additional details were provided. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose in 2020, second dose on 5/3/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number DC434, expiry date 3rd June 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2020 from another pharmacy.).   On 3rd May 2022, the patient received the 2nd dose of Shingrix. On 3rd May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comment: The reporter was a pharmacist. The reporter stated that the patient received Shingrix Vaccine. The patient received 1st dose in 2020 at another pharmacy and then received 2nd dose on 03-May-2022 at reporter pharmacy. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Received dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA570A, expiry date 30th June 2022) for prophylaxis.   On 12th August 2022, the patient received Menveo. On 12th August 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The pharmacist reported that the patient received Menveo that had expired on 30th June 2022.  The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. HCP (Health care professional) requested follow up but only provided address. Additional Supportive Information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: received a dose Intramuscularly; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number YH345, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 12th August 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 12th August 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's Comments: The physician reported that a 4-month-old patient received a dose of Rotarix Intramuscularly. The reporter gave consent to follow up. Additional Supportive Information: The patient received a dose of Rotarix Intramuscularly, which led inappropriate route of vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fracture, Nerve injury, Pulmonary embolism, Thrombosis
Clinical narrative: BLOOD CLOT; PULMONARY EMBOLISM; FELL; BROKE A BONE; SEVERED A NERVE; LOST A 100 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, thoracic aortic aneurysm, sulfa antibiotics allergy (hives), abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was no longer on blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202S21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 61 years old. Concomitant medications included diltiazem (Cardizem). On an unspecified date in JUN-2021 (After about 2 months later), the patient started having trouble in breathing and her doctor encouraged her to go to the ER (emergency room) because she told her that she got the JNJ COVID-19 vaccine. The lung clinic doctor sent patient to the emergency room when she was having trouble breathing. On JUN-2021, the patient experienced blood clot, pulmonary embolism and was hospitalized (date unspecified). She was admitted to the hospital for 7 to 10 days and she was put on the Eliquis (apixaban) for blood clots and pulmonary embolism. On an unspecified date, the patient fell, and had broke a bone, severed a nerve and I have lost a 100 pounds and also need knee surgery. The patient wish that she had never got the COVID vaccine and had just taken her chances with COVID. The patient visited the emergency room and physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and pulmonary embolism, and the outcome of fell, broke a bone, lost a 100 pounds and severed a nerve was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220822212-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related. 20220822212-covid-19 vaccine ad26.cov2.s-pulmonary embolism. This event(s) is labeled per Agency and is therefore considered potentially related. 20220822212-covid-19 vaccine ad26.cov2.s-fell. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220822212-covid-19 vaccine ad26.cov2.s- broke a bone and severed a nerve. The case causality is considered NOT RELATED. Rationale: recent event of fall provides more plausible explanation.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: BLOOD CLOT; PULMONARY EMBOLISM; FELL; BROKE A BONE; SEVERED A NERVE; LOST A 100 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, thoracic aortic aneurysm, sulfa antibiotics allergy (hives), abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was no longer on blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202S21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 61 years old. Concomitant medications included diltiazem (Cardizem). On an unspecified date in JUN-2021 (After about 2 months later), the patient started having trouble in breathing and her doctor encouraged her to go to the ER (emergency room) because she told her that she got the JNJ COVID-19 vaccine. The lung clinic doctor sent patient to the emergency room when she was having trouble breathing. On JUN-2021, the patient experienced blood clot, pulmonary embolism and was hospitalized (date unspecified). She was admitted to the hospital for 7 to 10 days and she was put on the Eliquis (apixaban) for blood clots and pulmonary embolism. On an unspecified date, the patient fell, and had broke a bone, severed a nerve and I have lost a 100 pounds and also need knee surgery. The patient wish that she had never got the COVID vaccine and had just taken her chances with COVID. The patient visited the emergency room and physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and pulmonary embolism, and the outcome of fell, broke a bone, lost a 100 pounds and severed a nerve was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220822212-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related. 20220822212-covid-19 vaccine ad26.cov2.s-pulmonary embolism. This event(s) is labeled per Agency and is therefore considered potentially related. 20220822212-covid-19 vaccine ad26.cov2.s-fell. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220822212-covid-19 vaccine ad26.cov2.s- broke a bone and severed a nerve. The case causality is considered NOT RELATED. Rationale: recent event of fall provides more plausible explanation.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: SHE KNOWS THAT THE J AND J/JANSSEN COVID 19 VACCINE IS ASSOCIATED WITH BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total for COVID-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the multiple patient's (that consumer knows) experienced blood clots which were associated with J and J/janssen covid 19 vaccine. The consumer also questioned about how many were caused by a COVID infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of she knows that the j and j/janssen covid 19 vaccine is associated with blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220824464-covid-19 vaccine ad26.cov2.s-  She knows that the j and j/janssen covid 19 vaccine is associated with blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Decreased immune responsiveness
Clinical narrative: ABSOLUTELY NO IMMUNITY; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on APR-2022 for covid-19 prophylaxis. No concomitant medications were reported.  On 2022, the patient experienced absolutely no immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of absolutely no immunity was not reported. This report was non-serious.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that had undergone temperature excursion.; No adverse event; Patient was administered with vaccine that had undergone temperature excursion. This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.). Concomitant medications were not provided by the reporter. It was reported that, the duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were still frozen after the excursion.  No symptoms were reported after the administration of the vaccines. Vials were unpunctured at the time of excursion.  Lot numbers affected were  AS1412B and AR5186C with expiry date of 10-Feb-2023 and 17-Nov-2022. It was determined even though there was a temperature excursion one time that the vaccines were still viable and can be used until the end of the day on 17-Aug-2022. Treatment information was not provided. This case was linked to MODERNATX, INC.-MOD-2022-628685 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2022: Significant follow up received included patient information, dosage information and narrative updated. Sender's Comments:  MODERNATX, INC.-MOD-2022-628685:Master case.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, Arthropathy, Chills, Depressed mood, Incorrect route of product administration
Clinical narrative: FEEL DEPRESSED; SWELLING IN FACE; Neck swelling; FLARE UP/KNEES WORSE; SORE ARM/HEEL PAIN; CHILLS; Wrist pain; Vaccination site pain; Vaccine was administered through subcutaneous route of administration; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE) and PAIN IN EXTREMITY (SORE ARM/HEEL PAIN) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Rheumatoid arthritis and PREDNISONE for an unknown indication. Concurrent medical conditions included Ankylosing spondylitis and Rheumatoid arthritis aggravated. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 19-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient started PREDNISONE (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered through subcutaneous route of administration). On an unknown date, the patient experienced DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE), PAIN IN EXTREMITY (SORE ARM/HEEL PAIN), CHILLS (CHILLS), ARTHRALGIA (Wrist pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE) and ARTHRALGIA (Wrist pain) had not resolved and PAIN IN EXTREMITY (SORE ARM/HEEL PAIN), CHILLS (CHILLS), VACCINATION SITE PAIN (Vaccination site pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered through subcutaneous route of administration) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged. The reporter's causality for the event of sore arm and chills was no reasonable possibility. No concomitant medications were reported. The reporter's causality for the event makes feel depressed from swelling in face and neck, flare up/knees worse and Humira had not helped with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the events of wrist pain and heel pain was not provided. No treatment medications were reported. Reporter did not allow further contact.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity, Swelling, Swelling face, Vaccination site pain
Clinical narrative: FEEL DEPRESSED; SWELLING IN FACE; Neck swelling; FLARE UP/KNEES WORSE; SORE ARM/HEEL PAIN; CHILLS; Wrist pain; Vaccination site pain; Vaccine was administered through subcutaneous route of administration; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE) and PAIN IN EXTREMITY (SORE ARM/HEEL PAIN) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Rheumatoid arthritis and PREDNISONE for an unknown indication. Concurrent medical conditions included Ankylosing spondylitis and Rheumatoid arthritis aggravated. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 19-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient started PREDNISONE (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered through subcutaneous route of administration). On an unknown date, the patient experienced DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE), PAIN IN EXTREMITY (SORE ARM/HEEL PAIN), CHILLS (CHILLS), ARTHRALGIA (Wrist pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE) and ARTHRALGIA (Wrist pain) had not resolved and PAIN IN EXTREMITY (SORE ARM/HEEL PAIN), CHILLS (CHILLS), VACCINATION SITE PAIN (Vaccination site pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered through subcutaneous route of administration) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged. The reporter's causality for the event of sore arm and chills was no reasonable possibility. No concomitant medications were reported. The reporter's causality for the event makes feel depressed from swelling in face and neck, flare up/knees worse and Humira had not helped with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the events of wrist pain and heel pain was not provided. No treatment medications were reported. Reporter did not allow further contact.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Ear disorder, Eye irritation, Nasopharyngitis
Clinical narrative: Ear disorder; Eye irritation; Cold; COVID-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (Ear disorder), EYE IRRITATION (Eye irritation), NASOPHARYNGITIS (Cold), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    There was no reported medical history.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced EAR DISORDER (Ear disorder), EYE IRRITATION (Eye irritation), NASOPHARYNGITIS (Cold), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, EAR DISORDER (Ear disorder) and NASOPHARYNGITIS (Cold) was resolving and EYE IRRITATION (Eye irritation), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient was sick at the time when patient was due flu shot. Patient had a cold and was just getting over it when it was time to do the COVID booster. Also patient was just getting her second Skyrizi shot. Patient had COVID, trouble with one of ears, felt cotton like was something stuck in eye and cold. Primary reporter did not have the lot number information, because the packaging was discarded.  Treatment medications were not reported.  Company comment- This spontaneous concerns a female patient of unknown age with no relevant medical history, who experienced unexpected, non-serious Covid-19 which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. The interval between the first and second doses of mRNA was noted to be 29 days, hence Drug ineffective was noted. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous concerns a female patient of unknown age with no relevant medical history, who experienced unexpected, non-serious  Covid-19 which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. The interval between the first and second doses of mRNA was noted to be 29 days, hence Drug ineffective was noted. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: A doctor got COVID after receiving a COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (A doctor got COVID after receiving a COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (A doctor got COVID after receiving a COVID-19 Vaccine). At the time of the report, COVID-19 (A doctor got COVID after receiving a COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported states that a doctor got Covid after receiving a Covid-19 Vaccine of unknown manufacturer.  No treatment medications were reported.  On 13-Aug-2022, the case MOD-2022-627368 became invalid as the suspect drug manufacturer was not known.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Upon internal review on 16-Aug-2022, significant correction was performed. Validity of the case has been upgraded from invalid to valid hence report type and classification was updated. Suspect product coding was updated from Moderna Covid-19 vaccine to Spikevax. Corresponding field and narrative updated accordingly.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Insomnia, Myalgia
Clinical narrative: Insomnia; Dizziness; Joint pain; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Concurrent medical conditions included Hypothyroidism, Hypertension, Chronic lymphocytic leukemia, Diabetes and Chronic kidney disease. Concomitant products included INSULIN for an unknown indication.   On 01-Nov-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue). At the time of the report, INSOMNIA (Insomnia), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had not resolved.            Patient's concomitant medications included thyroid and blood pressure medication.  The patient received booster dose.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypoaesthesia
Clinical narrative: Partial numbness in lower right quadrant of face after covid booster; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Partial numbness in lower right quadrant of face after covid booster) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced HYPOAESTHESIA (Partial numbness in lower right quadrant of face after covid booster). In 2022, HYPOAESTHESIA (Partial numbness in lower right quadrant of face after covid booster) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were provided by the reporter. Patient had taken Humira drug in the form of Solution for injection in pre filled pen. No treatment information were provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: It was reported the patient had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (It was reported the patient had COVID) in an 8-decade-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (It was reported the patient had COVID). At the time of the report, COVID-19 (It was reported the patient had COVID) outcome was unknown. Not Provided          No concomitant medication information was provided. It was reported that a patient received 2 shots of an mRNA, either the MODERNA or PFIZER. Treatment information was not provided.  Company Comment: This spontaneous case concerns an  8 decade old  patient  of an unknown gender with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred on an unknown date with vaccination with reported two doses of mRNA-1273 vaccine ( dose numbers and date of vaccination not reported ) . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns an  8 decade old  patient  of an unknown gender with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred on an unknown date with vaccination with reported two doses of mRNA-1273 vaccine ( dose numbers and date of vaccination not reported ) . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; No adverse event; Vaccine administered after an excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after an excursion) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after an excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after an excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after an excursion).    No concomitant medications were reported. Reporter stated that the duration of the excursions was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials was still frozen after the excursion.  It was reported that there were no adverse reactions to the Covid vaccines given and it was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the day on 17-Aug-2022. No treatment medications were reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    Patient age was reported as 10 years, 10 months.  No concomitant product use was reported.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  No treatment information was provided.