chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after the first and second Moderna Covid-19 vaccines in the primary series; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the primary series) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the primary series). At the time of the report, FATIGUE (Fatigue after the first and second Moderna Covid-19 vaccines in the primary series) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported.  The reporter stated no other adverse reactions for her Son in law.  No treatment information was provided.   This case was linked to MOD-2022-580291, MOD-2022-580295 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Mild fatigue after booster dose; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Mild fatigue after booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Mild fatigue after booster dose). At the time of the report, FATIGUE (Mild fatigue after booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date, patient received booster dose. The reporter reported no other adverse reactions for her Son In Law. No concomitant medication reported. No treatment medication details reported.   This case was linked to MOD-2022-580291, MOD-2022-580294 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Sulfa allergy) and Penicillin allergy.  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 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) had not resolved. Not Provided.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  No concomitant medications were reported. The patient did not received any medications/products within 2 weeks of starting COVID-19 treatment. The patient reported rebound symptoms on 27-May-2022 and was not recovered at that time. The device date was 29-May-2022.  Company comment-This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving a dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18th to 22nd May2022. She had a rebound symptoms 5 days after completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving a dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 18th to 22nd May2022. She had a rebound symptoms 5 days after completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Rash papular
Clinical narrative: Covid-19; papular rash to b/l LE; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid-19) and RASH PAPULAR (papular rash to b/l LE) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Anxiety, Depression, GERD and Allergy to nuts (Tree nuts). Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), LEVOCETIRIZINE, MONTELUKAST, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced RASH PAPULAR (papular rash to b/l LE). On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 25-May-2022 to 27-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 and RASH PAPULAR (papular rash to b/l LE) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included antihistamines and  Device Date was reported 27-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with relevant medical history of Asthma, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine (Primary doses - unknown). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, and developed a papular rash one day after starting treatment. The outcome of the event was reported as not resolved. The patient's medical history of Asthma puts the patient at a higher risk of developing 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 of an unknown age and gender, with relevant medical history of Asthma, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine (Primary doses - unknown). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, and developed a papular rash one day after starting treatment. The outcome of the event was reported as not resolved. The patient's medical history of Asthma puts the patient at a higher risk of developing COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough
Clinical narrative: After recovering from Covid (initially had a cough and it went away after about 7 days. About 2 weeks later, the cough returned and with a vengeance; This spontaneous case was reported by a patient and describes the occurrence of COUGH (After recovering from Covid (initially had a cough and it went away after about 7 days. About 2 weeks later, the cough returned and with a vengeance) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 prophylaxis.    Concurrent medical conditions included Hypothyroidism, Allergy to antibiotic (Amoxicillin), Drug allergy (Vicodin) and Fruit allergy (avocados).   On 29-Apr-2021 at 4:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 14-May-2022, the patient experienced COUGH (After recovering from Covid (initially had a cough and it went away after about 7 days. About 2 weeks later, the cough returned and with a vengeance). On 20-May-2022 at 2:00 PM, COUGH (After recovering from Covid (initially had a cough and it went away after about 7 days. About 2 weeks later, the cough returned and with a vengeance) had resolved with sequelae.    It was reported patient was not taking any medications/products within 2 weeks of starting COVID-19 treatment. Patient had received previously COVID-19 Vaccine. Device date was reported as 28May2022.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Rebound infection; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Rebound infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Psoriatic arthritis and Drug allergy. Concomitant products included LEVONORGESTREL (MIRENA) and SECUKINUMAB (COSENTYX) for an unknown indication.   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 29-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound infection). At the time of the report, COVID-19 (Rebound infection) had not resolved.            Treatment information was not provided.  Company Comment: This spontaneous case reported by non-health professional concerns a patient of unknown age and gender, with relevant medical history of psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19, approximately 8 ½ months after receiving a third dose of mRNA-1273.  The patient was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid) for Covid19, then reported a rebound infection 5 days later.  Information about the first 2 doses of Covid19 vaccination were not available.  The ongoing Covid19 pandemic could be contributory factor.  The patient's medical history of psoriatic arthritis could also be a confounder.  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 non-health professional concerns a patient of unknown age and gender, with relevant medical history of psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19, approximately 8 ½ months after receiving a third dose of mRNA-1273.  The patient was treated with a 5-day course of Nirmatrelvir/Ritonavir (Paxlovid) for Covid19, then reported a rebound infection 5 days later.  Information about the first 2 doses of Covid19 vaccination were not available.  The ongoing Covid19 pandemic could be contributory factor.  The patient's medical history of psoriatic arthritis could also be a confounder.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 007m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug).   On 15-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021 at 1:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient had taken unspecified Pfizer medication for treatment of COVID-19 on 11-May-2022 to 17-May-2022. (Batch number not provided). The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. It was reported that after 6 days and when patient finished the medication, got sick all over again and even tested positive after a negative test 6 days earlier.Device Date : 28May2022.  Company comment: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Phizer from 11-may-2022 to 17-may-2022. It is reported that after 6 days when patient finished medication got sick again test positive for Covid-19 after negative test 6 days earlier. The current pandemic situation of COVID 19 may remain as confounder to 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 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Phizer from 11-may-2022 to 17-may-2022. It is reported that after 6 days when patient finished medication got sick again test positive for Covid-19 after negative test 6 days earlier. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Rhinorrhoea
Clinical narrative: a mild cough /cough; Runny nose; Fatigue; brief chills; This spontaneous case was reported by a physician and describes the occurrence of COUGH (a mild cough /cough), RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and CHILLS (brief chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027h21b) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to unspecified drug).    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022 at 7:00 PM, the patient experienced COUGH (a mild cough /cough), RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and CHILLS (brief chills). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COUGH (a mild cough /cough), RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and CHILLS (brief chills) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that patient did not take any medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.; underage patient received Moderna COVID-19 Vaccine; The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received Moderna COVID-19 Vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, 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 PRODUCT TEMPERATURE EXCURSION ISSUE (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received Moderna COVID-19 Vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage patient received Moderna COVID-19 Vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The staff was not monitoring vaccine temperatures correctly. Each of the clinics were as long as 4 hours in length.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Storage condition at the time of the excursion was refrigerated; lot number and expiration date were unknown; maximum or minimum temperatures reached was unknown; excursion duration was reported as from 12-Jan-2021 to 22-Apr-2022 and the date when the vial(s) were moved from freezer to refrigerator were unknown. This error was discovered this in April 2022.  With these error condition, the patient received the possible 1st dose on 23-Apr-2021 and possible 2nd dose on 26-May-2021.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vomiting
Clinical narrative: Bad reaction (throwing up, not feeling well, and very tired); Bad reaction (throwing up, not feeling well, and very tired); Bad reaction (throwing up, not feeling well, and very tired); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Bad reaction (throwing up, not feeling well, and very tired)), VOMITING (Bad reaction (throwing up, not feeling well, and very tired)) and FATIGUE (Bad reaction (throwing up, not feeling well, and very tired)) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included MS.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Bad reaction (throwing up, not feeling well, and very tired)), VOMITING (Bad reaction (throwing up, not feeling well, and very tired)) and FATIGUE (Bad reaction (throwing up, not feeling well, and very tired)). At the time of the report, MALAISE (Bad reaction (throwing up, not feeling well, and very tired)), VOMITING (Bad reaction (throwing up, not feeling well, and very tired)) and FATIGUE (Bad reaction (throwing up, not feeling well, and very tired)) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant mediations were reported. It was reported that on an unknown date patient experienced bad reaction (throwing up, not feeling well, and very tired). No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; There were also 10 underage recipients.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. It was reported that reporter discovered this in April 2022.  Storage condition at the time of the excursion was Refrigerated. Excursion duration: Unknown (12Jan2021- 22Apr2022). Treatment information was not provided.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly; vaccine administered to an underage recipient; Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage recipient) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage recipient) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage recipient) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.  Vial had undergone temperature excursion at the time of refrigerated storage condition. In each of the clinics, the temperature excursion was as long as 4 hours in length.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; first dose was on 30-NOV-2021 and second dose was on 11-JAN-2022; There were also 10 underage recipients; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients), POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was on 30-NOV-2021 and second dose was on 11-JAN-2022) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was on 30-NOV-2021 and second dose was on 11-JAN-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients), POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was on 30-NOV-2021 and second dose was on 11-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  Storage condition at the time of the excursion: Refrigerated.  Excursion duration was unknown (12Jan2021- 22Apr2022).  No treatment medication was provided.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; There were also 10 underage recipients.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that reporter discovered this in April 2022.  Storage condition at the time of the excursion was Refrigerated. Excursion duration: Unknown (12Jan2021- 22Apr2022). No treatment medications were reported.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures; Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures; There were also 10 underage recipients.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients.), PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  Storage condition at the time of the excursion: Refrigerated.  Excursion duration was unknown (12Jan2021- 22Apr2022).  No treatment medication was provided.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; There were also 10 underage recipients; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (There were also 10 underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; Vaccine administered to underage recipients; Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to underage recipients), POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to underage recipients) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to underage recipients), POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) and PRODUCT TEMPERATURE EXCURSION ISSUE (Off-site clinics were being conducted & the staff was not monitoring vaccine temperatures) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly. The temperature excursion details provided were as follows: The storage condition at the time of the excursion was Refrigerated and the lot number was unknown. The maximum or minimum temperatures reached, as applicable (specify temp is in C or F) was unknown. The Excursion duration was Unknown (12-Jan-2021- 22-Apr-2022) and the date when the vials moved from freezer to refrigerator was unknown.  No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
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 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy. Concomitant products included AMITRIPTYLINE, FINASTERIDE and TAMSULOSIN for an unknown indication.   On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It had been reported that the patient taken other medications/products within 2 weeks of starting COVID-19 treatment. Company comment: This spontaneous case concerns a 66-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 43 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. Patient underwent treatment regimen of Paxlovid on May 17, 2022, 3 days after completion of the regimen, patient experienced rebound symptoms and a positive result on the antigen test. On May 27, 2022, patient underwent SARS-CoV-2 test which revealed a positive result. Details of concomitant medications and clinical course were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 43 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. Patient underwent treatment regimen of Paxlovid on May 17, 2022, 3 days after completion of the regimen, patient experienced rebound symptoms and a positive result on the antigen test. On May 27, 2022, patient underwent SARS-CoV-2 test which revealed a positive result. Details of concomitant medications and clinical course were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test
Clinical narrative: Bad metallic taste; Tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Bad metallic taste) and COVID-19 (Tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Bad metallic taste) and COVID-19 (Tested positive for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Bad metallic taste) and COVID-19 (Tested positive for covid) had 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.         No concomitant drug reported.  Product information was reported with code as, BNT162B2. The patient received booster dose from Pfizer. The patient took Paxlovid and it helped to recover faster.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 and a booster dose of other COVID-19 vaccine (Pfizer). The patient was treated with Nirmatrelvir/Ritonavir and the event had resolved at the time of the report. Interchange of vaccine products was also reported as the patient received primary doses of mRNA-1273 (unknown interval) and a booster dose of other COVID-19 vaccine (Pfizer). The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-580630 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 and a booster dose of other COVID-19 vaccine (Pfizer). The patient was treated with Nirmatrelvir/Ritonavir and the event had resolved at the time of the report. Interchange of vaccine products was also reported as the patient received primary doses of mRNA-1273 (unknown interval) and a booster dose of other COVID-19 vaccine (Pfizer). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2022 and was forwarded to Moderna on 31-May-2022.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. Reporter stated, 'Both her and her husband have been vaccinated with first and second (Moderna vaccines) and boosted from Pfizer  and both tested positive for covid after. They also took Paxlovid and it helped to recover faster. They are fine now.  Company comment- This is a spontaneous case of interchange of vaccine products (received as a booster dose TOZINAMERAN vaccine) concerning a male patient of unknown age with no medical history reported, who experienced the unexpected AESI COVID-19. Two doses of mRNA-1273 vaccine were administered on unknown dates. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. It was reported that patient tested positive for COVID after vaccination. He took Paxlovid and it helped to recover faster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of interchange of vaccine products (received as a booster dose TOZINAMERAN vaccine) concerning a male patient of unknown age with no medical history reported, who experienced the unexpected AESI COVID-19. Two doses of mRNA-1273 vaccine were administered on unknown dates. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. It was reported that patient tested positive for COVID after vaccination. He took Paxlovid and it helped to recover faster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.