chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Immune-mediated adverse reaction, Pharyngeal erythema
Clinical narrative: Very red throat; Feeling Bad; Immune related; Sick for a month; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL ERYTHEMA (Very red throat), FEELING ABNORMAL (Feeling Bad), ILLNESS (Sick for a month) and IMMUNE-MEDIATED ADVERSE REACTION (Immune related) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication.    Concurrent medical conditions included Drug allergy (ORENCIA), Drug allergy (HUMIRA) and Drug allergy (CIMZIA (Xeljanz XR) ).   On 28-May-2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Sick for a month). In September 2021, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Immune related). On an unknown date, the patient experienced PHARYNGEAL ERYTHEMA (Very red throat) and FEELING ABNORMAL (Feeling Bad). In 2021, ILLNESS (Sick for a month) had resolved. In September 2021, IMMUNE-MEDIATED ADVERSE REACTION (Immune related) had resolved. At the time of the report, PHARYNGEAL ERYTHEMA (Very red throat) and FEELING ABNORMAL (Feeling Bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medication included Atorvastatin, Metoprolol, Prozac, Calcium+D, Gabapentin, Hydrochlorothiazide, Xarelto and Omeprazole. Patient stated that she was off XELJANZ XR for the whole month of September 2021 due to having a really bad time with the covid shot (moderna). No other treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mentions soreness in her arm after the Moderna Vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Mentions soreness in her arm after the Moderna Vaccines) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 from March 2020 to April 2020 and Cancer. Family history included Rheumatoid arthritis since an unknown date and Celiac disease (Her daughter has Celiac disease.) since an unknown date. Concurrent medical conditions included Lupus erythematosus and Immunocompromised (immunocompromised due to lupus,immune system goes up and down up and down).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mentions soreness in her arm after the Moderna Vaccines). At the time of the report, PAIN IN EXTREMITY (Mentions soreness in her arm after the Moderna Vaccines) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Ethnicity reported as private.  No concomitant medications were reported.   Patient mentions soreness in her arm after the Moderna vaccines. states only that it wasn't bad, says it was like normal little soreness after a shot.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626128 (Patient Link).
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Obesity since 15-Apr-2016 and ADHD since 17-Jan-2019.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 17-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that patient was due to receive his first dose of pfizer covid 19 vaccine but got 0.25 ml moderna covid vaccine instead.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia, Vaccination site rash
Clinical narrative: Flu like symptoms; her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow; had a high fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE RASH (her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow) and PYREXIA (had a high fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome (was diagnosed with Down's syndrome at birth. It was genetic before the vaccine).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received 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 INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE RASH (her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow) and PYREXIA (had a high fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE RASH (her daughter experienced covid arm rash / Had a rash from her shoulder to her elbow) and PYREXIA (had a high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: ran a 101 fever which is high for her.         Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-626226 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PNEUMONIA (Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant) (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 PNEUMONIA (Double pneumonia in the both lungs/fully vaccinated and still got a Delta variant) outcome was unknown.            Concomitant medication was not reported.  Patient received Moderna vaccine. Patient was hospitalized due to double pneumonia in both lungs. Patient was fully vaccinated and still got a Delta variant. Treatment details were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of COVID-19 pneumonia, which occurred after the second dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of COVID-19 pneumonia, which occurred after the second dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) 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.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  The patient was having itching since February 2021 but there was no rash.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Reporter address was updated. Moderna vaccine administration date has been confirmed.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot; States the arm soreness and swelling and redness started about 2 days after the 1st shot; States the arm soreness and swelling and redness started about 2 days after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot), VACCINATION SITE SWELLING (States the arm soreness and swelling and redness started about 2 days after the 1st shot) and VACCINATION SITE ERYTHEMA (States the arm soreness and swelling and redness started about 2 days after the 1st shot) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Autoimmune disorder NOS (she has autoimmune problems and anything foreign gets super angry ).    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 PAIN IN EXTREMITY (she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot), VACCINATION SITE SWELLING (States the arm soreness and swelling and redness started about 2 days after the 1st shot) and VACCINATION SITE ERYTHEMA (States the arm soreness and swelling and redness started about 2 days after the 1st shot). At the time of the report, PAIN IN EXTREMITY (she received the Moderna vaccine and her arm was sore/States the arm soreness and swelling and redness started about 2 days after the 1st shot), VACCINATION SITE SWELLING (States the arm soreness and swelling and redness started about 2 days after the 1st shot) and VACCINATION SITE ERYTHEMA (States the arm soreness and swelling and redness started about 2 days after the 1st shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient received the Moderna vaccine, and her arm was sore. The arm soreness and swelling and redness started about 2 days after the 1st shot and the symptoms lasted for about three weeks and was completely resolved. She had a cough from a cold she got from her 6 years old son and stated that the cough she has begun 2 weeks ago and was ongoing and better.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medications were not reported. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This spontaneous case concerns a 19-year-old patient of an unknown gender with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) event of Death on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as both the vaccination date and date of death were not disclosed. Cause of death was unknown, and no autopsy report was provided. No information on any other doses of COVID-19 vaccination was reported. Medical review is restricted by very limited information. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 19-year-old patient of an unknown gender with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) event of Death on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as both the vaccination date and date of death were not disclosed. Cause of death was unknown, and no autopsy report was provided. No information on any other doses of COVID-19 vaccination was reported. Medical review is restricted by very limited information. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pyrexia
Clinical narrative: 24 hours the patient had every symptom of covid; Patient got sick; Temperature 100.5; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (24 hours the patient had every symptom of covid), ILLNESS (Patient got sick) and PYREXIA (Temperature 100.5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 COVID-19 (24 hours the patient had every symptom of covid), ILLNESS (Patient got sick) and PYREXIA (Temperature 100.5). At the time of the report, COVID-19 (24 hours the patient had every symptom of covid), ILLNESS (Patient got sick) and PYREXIA (Temperature 100.5) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  The patient got sick in the last week of January of last year. The patient had a temperature of the caller thinks the patient had covid but was not sure. The patient stood on his heads 4 times a day to drain his lungs. 14 months after the patient had the covid virus, he took the Moderna coivd vaccine. The first shot was okay. After the second shot, for 24 hours the patient had every symptom of covid in the book, his temperature was 100.5. The patient never took a covid antibody test to find out if he actually had covid. The patient was over it now and fine.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Suspected COVID-19
Clinical narrative: COVID-19 like symptoms but did not get tested if it was COVID-19; Little reaction after the second shot; This spontaneous case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (COVID-19 like symptoms but did not get tested if it was COVID-19) and IMMUNISATION REACTION (Little reaction after the second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID-19 like symptoms but did not get tested if it was COVID-19) and IMMUNISATION REACTION (Little reaction after the second shot). At the time of the report, SUSPECTED COVID-19 (COVID-19 like symptoms but did not get tested if it was COVID-19) and IMMUNISATION REACTION (Little reaction after the second shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had COVID-19 like symptoms but did not get tested if it was COVID-19, he just stayed home and treated himself and 24 hours after the second dose had a little reaction with the Moderna vaccine.  No Concomitant medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: I have one Moderna and one Pfizer in me so far; I have one Moderna and one Pfizer in me so far; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (I have one Moderna and one Pfizer in me so far), COVID-19 IMMUNISATION (I have one Moderna and one Pfizer in me so far) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I have one Moderna and one Pfizer in me so far), COVID-19 IMMUNISATION (I have one Moderna and one Pfizer in me so far) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (I have one Moderna and one Pfizer in me so far), COVID-19 IMMUNISATION (I have one Moderna and one Pfizer in me so far) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Concomitant medications were not reported.  The patient had took one Moderna and one Pfizer so far and wanted trifecta with Johnson and Johnson. So patient wanted to know whether patient could take a third dose.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: running a fever of 102F; First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021; hurting all over; left arm was sore where he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting all over), PYREXIA (running a fever of 102F), VACCINATION SITE PAIN (left arm was sore where he got the shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F214 and 93893) for COVID-19 prophylaxis.     Concurrent medical conditions included Sinus headache (has kind of been complaining of having sinus headaches and stuff), Depression (taking pills for a while now), Anxiety (taking pills for a while now), Throat discomfort and Swallowing difficult.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021). On 13-Dec-2021 at 2:30 AM, the patient experienced PYREXIA (running a fever of 102F). In December 2021, the patient experienced PAIN (hurting all over) and VACCINATION SITE PAIN (left arm was sore where he got the shot). At the time of the report, PAIN (hurting all over), VACCINATION SITE PAIN (left arm was sore where he got the shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021) outcome was unknown and PYREXIA (running a fever of 102F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Negative) Negative and (Positive) Positive. In December 2021, Body temperature: 102 102F.         Concomitant medications included patent has been taking unspecified pills for a while now for his depression and anxiety.  Caller stated that it has been a while, she thought at least 6 months because patient and his girlfriend they got tested twice. The first time patient was negative and his girlfriend had the virus, but then patient had it with no symptoms. Reporter was probed if her son's girlfriend had the vaccine, she responded saying that she did not think she got the vaccine.  Treatment medication was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: running a fever of 102F; First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021; hurting all over; left arm was sore where he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting all over), PYREXIA (running a fever of 102F), VACCINATION SITE PAIN (left arm was sore where he got the shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F214 and 93893) for COVID-19 prophylaxis.     Concurrent medical conditions included Sinus headache (has kind of been complaining of having sinus headaches and stuff), Depression (taking pills for a while now), Anxiety (taking pills for a while now), Throat discomfort and Swallowing difficult.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021). On 13-Dec-2021 at 2:30 AM, the patient experienced PYREXIA (running a fever of 102F). In December 2021, the patient experienced PAIN (hurting all over) and VACCINATION SITE PAIN (left arm was sore where he got the shot). At the time of the report, PAIN (hurting all over), VACCINATION SITE PAIN (left arm was sore where he got the shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021) outcome was unknown and PYREXIA (running a fever of 102F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Negative) Negative and (Positive) Positive. In December 2021, Body temperature: 102 102F.         Concomitant medications included patent has been taking unspecified pills for a while now for his depression and anxiety.  Caller stated that it has been a while, she thought at least 6 months because patient and his girlfriend they got tested twice. The first time patient was negative and his girlfriend had the virus, but then patient had it with no symptoms. Reporter was probed if her son's girlfriend had the vaccine, she responded saying that she did not think she got the vaccine.  Treatment medication was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old got 2 shots of pfizer and booster dose of moderna; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna) and NO ADVERSE EVENT (No Adverse Event) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer (2 shots of Pfizer COVID vaccine). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got 2 shots of pfizer and booster dose of moderna).    No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 53.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Blood test, Illness, Inflammation, Mobility decreased, Pain
Clinical narrative: VERY SICK; COULD NOT GET OUT OF BED FOR ONE DAY; Fever; Achy; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), PAIN (Achy), INFLAMMATION (Inflammation), MOBILITY DECREASED (COULD NOT GET OUT OF BED FOR ONE DAY) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Subcutaneous) at an unspecified dose. On 01-Nov-2021, the patient experienced ILLNESS (VERY SICK) and MOBILITY DECREASED (COULD NOT GET OUT OF BED FOR ONE DAY). In November 2021, the patient experienced PAIN (Achy), INFLAMMATION (Inflammation) and PYREXIA (Fever). The patient was treated with PREDNISONE for Inflammation, at an unspecified dose and frequency. In 2021, ILLNESS (VERY SICK) had resolved. On 01-Nov-2021, MOBILITY DECREASED (COULD NOT GET OUT OF BED FOR ONE DAY) had resolved. At the time of the report, PAIN (Achy) and PYREXIA (Fever) outcome was unknown and INFLAMMATION (Inflammation) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood test: increased Sedimentation rate.         Concomitant product use was not provided by the reporter.  On 28-Oct-2021, blood work showed increased sedimentation rate. On 28 Oct 2021 she had taken flu shot. In Nov-2021, the patient was achy, had fever, and inflammation. On 01-Nov-2021, the patient got very sick after covid booster and could not get out of bed for one day. In 2021, the very sick after covid booster resolved. She received a shot of prednisone and her inflammation was better. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.     This case was linked to MOD-2021-623528, MOD-2021-628641 (Patient Link).   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia
Clinical narrative: VERY SICK; COULD NOT GET OUT OF BED FOR ONE DAY; Fever; Achy; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), PAIN (Achy), INFLAMMATION (Inflammation), MOBILITY DECREASED (COULD NOT GET OUT OF BED FOR ONE DAY) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Subcutaneous) at an unspecified dose. On 01-Nov-2021, the patient experienced ILLNESS (VERY SICK) and MOBILITY DECREASED (COULD NOT GET OUT OF BED FOR ONE DAY). In November 2021, the patient experienced PAIN (Achy), INFLAMMATION (Inflammation) and PYREXIA (Fever). The patient was treated with PREDNISONE for Inflammation, at an unspecified dose and frequency. In 2021, ILLNESS (VERY SICK) had resolved. On 01-Nov-2021, MOBILITY DECREASED (COULD NOT GET OUT OF BED FOR ONE DAY) had resolved. At the time of the report, PAIN (Achy) and PYREXIA (Fever) outcome was unknown and INFLAMMATION (Inflammation) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood test: increased Sedimentation rate.         Concomitant product use was not provided by the reporter.  On 28-Oct-2021, blood work showed increased sedimentation rate. On 28 Oct 2021 she had taken flu shot. In Nov-2021, the patient was achy, had fever, and inflammation. On 01-Nov-2021, the patient got very sick after covid booster and could not get out of bed for one day. In 2021, the very sick after covid booster resolved. She received a shot of prednisone and her inflammation was better. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.     This case was linked to MOD-2021-623528, MOD-2021-628641 (Patient Link).   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever; LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN; HEADACHE; FATIGUE; BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), LYMPHADENOPATHY (LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and MYALGIA (BODY ACHES) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In August 2021, the patient experienced PYREXIA (Fever), LYMPHADENOPATHY (LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and MYALGIA (BODY ACHES). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In September 2021, PYREXIA (Fever), LYMPHADENOPATHY (LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and MYALGIA (BODY ACHES) had resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of Lymphadenopathy axillary,fever, Headache, Fatigue, body ache was not reported for cosuspect humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622532 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            Patient experienced headache after second dose of vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624213 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: patient experienced feet/toes feel soar; Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient experienced feet/toes feel soar) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021). On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (patient experienced feet/toes feel soar). At the time of the report, PAIN IN EXTREMITY (patient experienced feet/toes feel soar) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 1 Apr 2021 and second dose on 15 Apr 2021) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622298 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: COUGH; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (COUGH) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 23-Nov-2021, the patient experienced COUGH (COUGH). At the time of the report, COUGH (COUGH) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-621428 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620794 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-621183 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, SARS-CoV-1 test
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 67-year-old 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.   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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-1 test: (Positive) Tested positive. In 2021, Blood test: unknown.         No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had rheumatoid arthritis flares and was put on Prednisone for 25 days and had been able to taper off to five days in the last five months. She just done blood work to see if she get tapered down none at all. She had Covid 19 vaccine symptoms of body aches, nausea and fatigued on the second shot. The reporter's causality for the event of BODY ACHES and NAUSEA with RINVOQ was no reasonable possibility. The reporter's causality for the event of TESTED POSITIVE FOR COVID and RHEUMATOID ARTHRITIS FLARES was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-620779 (Patient Link).