chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Coeliac disease, Dizziness
Clinical narrative: Celiac Disease; Dizziness occurred within a minute of getting the vaccine and lasted for an hour; This case was reported by a nurse via call center representative and described the occurrence of celiac disease in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number T29Y2, expiry date 8th April 2023) for prophylaxis.   On 8th December 2021, the patient received the 1st dose of Shingrix. On 8th December 2021, between 2 and 4 months after receiving Shingrix, the patient experienced dizziness. In March 2022, the patient experienced celiac disease (serious criteria GSK medically significant). On an unknown date, the outcome of the celiac disease was unknown and the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the celiac disease and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: The nurse practitioner (NP) stated that a patient was there for her 2nd dose of Shingrix and had dizziness after the first dose. The dizziness occurred within a minute of getting the vaccine and lasted for an hour. She was diagnosed with celiac disease in March 2022. The reporter consented to follow up via postal.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022, the patient received the 2nd dose of Shingrix. On 1st June 2022, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comments: The reporter was the patient's wife who reported an AE (adverse event) on behalf of her husband. The patient received second dose of Shingrix vaccine and this morning (on day of reporting), the patient developed a fever which was not resolved. The reporter provided medical advice disclaimer and referred to HCP (Health care professional). The reporter consented to follow up.
Age: 100.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Peripheral swelling
Clinical narrative: swelling on her arm; administrated with a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 100-year-old female patient who received Herpes zoster (Shingrix) (batch number xm22g, expiry date 31st August 2023) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, patient received first does of Shingrix) and Shingrix (On an unknown date, patient received second does of Shingrix).   On 1st June 2022, the patient received the 3rd dose of Shingrix. On 1st June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On 2nd June 2022, the patient experienced swelling arm. On 2nd June 2022, the outcome of the swelling arm was not recovered/not resolved. On an unknown date, the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: The patient received a dose of Shingrix and experienced swelling in arm and extra dose administered. On 2nd June 2022, 1 day after receiving Shingrix, the patient experienced swelling arm. The reporter consented to follow up. Additional Supportive Information: The patient received third dose of Shingrix which led to extra dose administered. The information of first and second dose was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3 or 4 years ago, second dose was not administered yet; This case was reported by a pharmacist 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 (1st dose received on an unknown date 3 or 4 years before date of reporting).   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 Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: Pharmacist reported second dose was not administered at the time of reporting. HCP had no information regarding patient´s demographics or the exact vaccination date. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash on one side of her body; This case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced shingles and generalized rash. On an unknown date, the outcome of the shingles and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments: Reporter was a GSK (GlaxoSmithKline) representative who called on behalf of an HCP (Health care professional). The reporter stated that the physician spoke to one of his patients who received first dose of Shingrix last week from the date of reporting. The patient reported that a rash on one side of body and suspected that it was shingles.  Till the time of reporting shingles was not confirmed by the physician since she was going to send him a picture later on the day of reporting. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient was administered a pediatric dose of Havrix; adult patient was administered a pediatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received HAV (Havrix pediatric) for prophylaxis.   On 2nd June 2022, the patient received Havrix pediatric. On 2nd June 2022, unknown after receiving Havrix pediatric, 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.   Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: Healthcare provider reported an adult patient was administered a pediatric dose of Havrix. The event occurred at a different facility and reporter did not have any of the patient details, or lot number or expiration date of the dose administered. The reporter believed the patient was male. The reporter consented to follow up. Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix on 2nd June 2022, which led to underdose and adult use of a child product
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: rash five days; This case was reported by a other health professional via sales rep and described the occurrence of rash in a patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 5 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Bexsero and Bexsero 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 Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments:  The reporter reported that the patient received first dose of Bexsero and five days post vaccination the patient experienced rash. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: came to get Menveo, administered Bexsero; administered Bexsero, already received 2 doses; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31st March 2023) 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.   Previously administered products included bexsero (2 doses received on an unknown date).   On 2nd June 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered 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: 2-Jun-2022 Reporter's Comments: The patient came to get Menveo and was inadvertently administered Bexsero.  The reporter consented to follow up via postal. The patient had already received 2 doses of the Bexsero. Additional Supportive Information: The patient came to get Menveo and was inadvertently administered Bexsero, which led to wrong vaccine administered and extra dose administered.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix administered 06/02/2022, expiration date 05/26/2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received HAV (Havrix) (batch number J9587, expiry date 26th May 2022) for prophylaxis.   On 2nd June 2022, the patient received Havrix. On 2nd June 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: 2-Jun-2022 Reporter's Comments: The dose of Havrix was administered to the patient on 2nd June 2022 with an expiration date of 26th May 2022. Adverse event report contained all reported information by HCP (health care professional). Health care professional gave consent for safety to follow up. Additional Supportive Information: The patient received Havrix, which was already expired on 26th June 2022, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 11/12/2020. Second not yet administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 12th November 2020, batch number was 047FY or 047F4 and expiry date 16th September 2022.).   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: 2-JUN-2022 Reporter's Comments: Pharmacist reporting Shingrix first dose administered on 12th November 2020. Healthcare professional was unsure if first Shingrix dose lot number was 047FY or 047F4.  Second dose not yet administered. Adverse event report contained all reported information by healthcare professional.  Healthcare professional gave consent for safety team follow up. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 26Mar2021, has not received dose two.; This case was reported by a pharmacist 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 (1st dose received on 26th March 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: 2-Jun-2022 Reporter's Comments: Pharmacist reported that the patient received the first dose of Shingrix and had not received dose two. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Skin papilloma, Urinary tract infection
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Recurrent UTI / REOCCURING URINARY TRACT INFECTION) and SKIN PAPILLOMA (WARTS / WARTS on face / hands / feet) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid arthritis). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced URINARY TRACT INFECTION (Recurrent UTI / REOCCURING URINARY TRACT INFECTION) and SKIN PAPILLOMA (WARTS / WARTS on face / hands / feet). At the time of the report, URINARY TRACT INFECTION (Recurrent UTI / REOCCURING URINARY TRACT INFECTION) and SKIN PAPILLOMA (WARTS / WARTS on face / hands / feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The daily dose of Moderna was reported as 1 in 1 once.  It was reported that Patient developed warts she suspected it could be from Rinvoq. She desired to reduce rinvoq to once a week. She wanted to see how her blood work was without Rinvoq. She had warts on face, hands and feet. No remedy to help. It was unknown. It was unknown if patient was enrolled in COVID-19 vaccine trial. Treatment medication was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Significant live follow up was received. Concomitant drug information, case narrative updated. On 03-Jun-2022: Significant live follow up was received. Event information was updated ( The event of WARTS was amended to WARTS ON FACE/HANDS/FEET ).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No drug name was reported.).   On 21-Jan-2021 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021 at 10:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022 at 11:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Still testing positive after 15 days..         No concomitant medications were reported. It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received COVID-19 vaccine. The event reported was Four days after completing Paxlovid COVID symptoms of fever, headache, congestion, muscle aches, chest pressure with cough and exhaustion returned and lasted for another 6 days. Still testing positive after 15 days. The  Device Date was reported as 29-May-2022  Company comment- This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected COVID-19 after four doses of mRNA-1273 vaccine were administered. It was reported that four days after completing Paxlovid COVID symptoms of fever, headache, congestion, muscle aches, chest pressure with cough and exhaustion returned and lasted for another 6 days. Patient is still testing positive after 15 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected COVID-19 after four doses of mRNA-1273 vaccine were administered. It was reported that four days after completing Paxlovid COVID symptoms of fever, headache, congestion, muscle aches, chest pressure with cough and exhaustion returned and lasted for another 6 days. Patient is still testing positive after 15 days. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: Unknown.) in November 2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech. Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy).   In March 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. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Concomitant products were not provided.  It was reported that patient previously received COVID-19 vaccine and it was unknown whether patient took any medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with history of interchange of vaccine products, who experienced the unexpected non-serious AESI of Covid-19, approximately 13 months after receiving the second dose of mRNA-1273 vaccine and 6 months after a dose of Pfizer / BioNTech Covid-19 vaccine. Additionally, interchange of vaccine products was also reported. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports and further treatment details were not provided. Pfizer / BioNTech Covid-19 vaccine could be a confounder. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with history of interchange of vaccine products, who experienced the unexpected non-serious AESI of Covid-19, approximately 13 months after receiving the second dose of mRNA-1273 vaccine and 6 months after a dose of Pfizer / BioNTech Covid-19 vaccine. Additionally, interchange of vaccine products was also reported. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports and further treatment details were not provided. Pfizer / BioNTech Covid-19 vaccine could be a confounder. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Redeveloped symptoms of Covid-19 five days after completion of course of Paxlovid) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 93990S, 032L204 and 0ilh2uA) for COVID-19 vaccination. The patient had no drug allergy. The patient had previously received a COVID-19 vaccine. Concomitant products included ROSUVASTATIN from October 2021 to 13-May-2022 and ESTRADIOL from January 2022 to an unknown date for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Redeveloped symptoms of Covid-19 five days after completion of course of Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Redeveloped symptoms of Covid-19 five days after completion of course of Paxlovid) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device date was reported as 26-May-2022. Company Comment: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on May 23, 2022 day after the third dose of mRNA-1273 COVID-19 Vaccine which was administered on November 1, 2021. Patient was treated with nirmatrelvir and ritonavir at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 five days after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: Company Comment: This is a spontaneous case concerning a 71-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on May 23, 2022 day after the third dose of mRNA-1273 COVID-19 Vaccine which was administered on November 1, 2021. Patient was treated with nirmatrelvir and ritonavir at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 five days after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID-19 Vaccine, is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 and still is testing positive..         No concomitant medication were reported.  It was reported that, two weeks ago patient started taking Paxlovid and had a reaction to that one. He doesn't think its from Moderna. and the issue happened with Paxlovid on 21 May 2022.   He tested positive for COVID-19 and still is testing positive.  No treatment medication were reported.  Company Comment: This spontaneous case reported by a patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI Covid-19, around 1 year and 2 months after receiving a second dose of mRNA-1273.  He was started on Nirmatrelvir/Ritonavir (Paxlovid).  He tested positive for Covid-19 and is still testing positive.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI Covid-19, around 1 year and 2 months after receiving a second dose of mRNA-1273.  He was started on Nirmatrelvir/Ritonavir (Paxlovid).  He tested positive for Covid-19 and is still testing positive.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Generalized anxiety disorder and Allergy (Allergy of unspecified drug.).   On 24-Nov-2021 at 6:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            No Concomitant medication reported.  It was unknown if the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.   It had been reported that Took Paxlovid starting 20-May-2022 for full 5 day course. Symptoms resolved (except on-and off fatigue), then bad symptoms came back 14 days after initial symptoms appeared on the 19 -may-2022 , on 01-Jun-2022. Relapse of disease.  The patient had no drug allergy.  Company comment: This spontaneous case concerns a 41-year-old female patient with no relevant medical history, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the second dose of mRNA-1273 vaccine. She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports were not provided. Details of first dose were not provided. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no relevant medical history, who experienced the unexpected non-serious of Covid-19, 6 months after receiving the second dose of mRNA-1273 vaccine. She was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. The outcome of Covid-19 was reported as not resolved. Details of symptoms, clinical course, investigation reports were not provided. Details of first dose were not provided. The current pandemic situation of Covid-19 could be a confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 17:00 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 at 17:00 as dose 2, single (Lot number: EW0151), in left arm and on 19Aug2021 at 17:00 as dose 3 (booster), single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Jan2022 at 17:00 as dose 4 (booster), single (Lot number: 022J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). Concomitant medication(s) included: DEXLANSOPRAZOLE; INFLECTRA [INFLIXIMAB DYYB], start date: Jan2021. Past drug history included: Flagyl, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101.0 Fahrenheit; SARS-CoV-2 test: (19May2022) Positive, notes: Had a positive test on 19May, took the five day course of paxlovid starting that date; (24May2022) Negative, notes: As of 24May, I was testing negative again; (31May2022) Negative, notes: However as of 31May started to feel unwell, and mildly feverish with a cough (99) but tested negative; (01Jun2022) Positive, notes: As of this morning, I now have a proper 101.0 fever, loud cough, big headache and body aches and testing very positive, very quickly. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had a paxlovid / COVID rebound. Had a positive test on 5/19, took the five day course of paxlovid starting that date. As of 24May, I was testing negative again and feeling asymptomatic. However as of 31May I started to feel unwell, and mildly feverish with a cough (99) but tested negative. As of this morning, I now have a proper 101.0 fever, loud cough, big headache and body aches and testing very positive, very quickly. The patient received other medication in 2 weeks, which included Dexlansoprazole (Dexlansoprazole) and Inflextra (start date: Jan/2021).
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 17:00 as dose 1, single (Lot number: EP6955), in left arm, on 09Apr2021 at 17:00 as dose 2, single (Lot number: EW0151), in left arm and on 19Aug2021 at 17:00 as dose 3 (booster), single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Jan2022 at 17:00 as dose 4 (booster), single (Lot number: 022J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing). Concomitant medication(s) included: DEXLANSOPRAZOLE; INFLECTRA [INFLIXIMAB DYYB], start date: Jan2021. Past drug history included: Flagyl, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101.0 Fahrenheit; SARS-CoV-2 test: (19May2022) Positive, notes: Had a positive test on 19May, took the five day course of paxlovid starting that date; (24May2022) Negative, notes: As of 24May, I was testing negative again; (31May2022) Negative, notes: However as of 31May started to feel unwell, and mildly feverish with a cough (99) but tested negative; (01Jun2022) Positive, notes: As of this morning, I now have a proper 101.0 fever, loud cough, big headache and body aches and testing very positive, very quickly. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had a paxlovid / COVID rebound. Had a positive test on 5/19, took the five day course of paxlovid starting that date. As of 24May, I was testing negative again and feeling asymptomatic. However as of 31May I started to feel unwell, and mildly feverish with a cough (99) but tested negative. As of this morning, I now have a proper 101.0 fever, loud cough, big headache and body aches and testing very positive, very quickly. The patient received other medication in 2 weeks, which included Dexlansoprazole (Dexlansoprazole) and Inflextra (start date: Jan/2021).
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Immunocompromised patient received 4 full 0.5mL doses; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Immunocompromised patient received 4 full 0.5mL doses) 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 Immunocompromised.    In August 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In August 2021, the patient experienced OVERDOSE (Immunocompromised patient received 4 full 0.5mL doses). At the time of the report, OVERDOSE (Immunocompromised patient received 4 full 0.5mL doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 75.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Sore arm; Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021; This case was received via another Manufacturer (Reference number: 22K-163-4417969-00) on 02-Jun-2022 and was forwarded to Moderna on 02-Jun-2022.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis). Concomitant products included FOLIC ACID and METHOTREXATE for an unknown indication.   On 28-Mar-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021) outcome was unknown.            No treatment drugs were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality of event sore arm with Humira was reported as reasonable possibility/probable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound COVID after taking Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound COVID after taking Paxlovid) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced COVID-19 (Rebound COVID after taking Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID after taking Paxlovid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported.  The patient reported rebound of COVID-19 after taking Paxlovid.  Company comment: This spontaneous case concerns a 43-years-old female patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound COVID after taking Paxlovid) which occurred 6 months 23 days after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment. SARS-CoV-2 test was positive as on 31-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 43-years-old female patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound COVID after taking Paxlovid) which occurred 6 months 23 days after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment. SARS-CoV-2 test was positive as on 31-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Having rebound after taking paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Having rebound after taking paxlovid) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Having rebound after taking paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Having rebound after taking paxlovid) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the co-suspect Pfizer drug was taken for the treatment of COVID-19 from 19 May 2022 to 23 May 2022.Patient had experienced having rebound after taking paxlovidon 28 May 2022, and had not recovered.  Device Date was reported as 01Jun2022  Company comment: This spontaneous case concerns a 50-years-old male patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Having rebound after taking paxlovid) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment. Patient had experienced having rebound after taking paxlovidon 28 May 2022 and had not recovered. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 50-years-old male patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Having rebound after taking paxlovid) which occurred on unspecified day after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment. Patient had experienced having rebound after taking paxlovidon 28 May 2022 and had not recovered. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Rhinitis
Clinical narrative: nasal infection; The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.; This spontaneous case was reported by a patient and describes the occurrence of RHINITIS (nasal infection) and EXTRA DOSE ADMINISTERED (The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Extreme arthritis). Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Arthritis.    On 02-Jun-2022 at 11:00 AM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXTRA DOSE ADMINISTERED (The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.). On an unknown date, the patient experienced RHINITIS (nasal infection). At the time of the report, RHINITIS (nasal infection) and EXTRA DOSE ADMINISTERED (The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose.) outcome was unknown.            The patient stated that he had his fifth dose of Moderna on 02 Jun 2022. He had three doses and a first half dose. He stated that taking Tylenol and Advil could affect the shot. He did not know until today 02 Jun 2022. He took those on a regular basis because he had extreme arthritis. He took Tylenol at 5 in morning and ibuprofen with it. He received the vaccine at 11 in morning. He found that taking Tylenol and Advil will reduce the efficacy of the vaccine because the immune response to the vaccine might not be as effective. He stated that he read that on the internet, so he did not know if that was right. The patient wanted to know if it was okay for him to take Tylenol and Advil prior to getting the Moderna booster. He also had a bit of a nasal infection, so his doctor prescribed him Bactrim. His nurse was not able to tell him information and told him to ask Moderna. He stated he had not taken Bactrim yet. He wants to know how many days he should wait. He stated that his doctor and the pharmacist did not know how the vaccine works because they were not scientists and virologists. The patient stated he wanted to speak to a supervisor. He stated that he already talked to three doctors and pharmacists.