chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Tested positive but had the Moderna; Left arm was sore and it went away the next day; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive but had the Moderna) and VACCINATION SITE PAIN (Left arm was sore and it went away the next day) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive but had the Moderna) and VACCINATION SITE PAIN (Left arm was sore and it went away the next day). At the time of the report, COVID-19 (Tested positive but had the Moderna) outcome was unknown and VACCINATION SITE PAIN (Left arm was sore and it went away the next day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a reaction with antibody infusion. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tender arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (tender arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for an unknown indication.    Concomitant products included NIFEDIPINE, AVENA SATIVA FLUID EXTRACT (AVEENO), VITAMINS NOS, COLECALCIFEROL, FISH OIL, TROSPIUM CHLORIDE, SIMVASTATIN, ALENDRONATE SODIUM, HYDROXYZINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE, ASPIRIN [ACETYLSALICYLIC ACID], METHYLPREDNISOLONE and CITALOPRAM for an unknown indication.   In May 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every other day. On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE PAIN (tender arm). At the time of the report, VACCINATION SITE PAIN (tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant medical history was reported. Patient administered aveeno clear complexion bar and citalopram. Dupixent therapy administered via pre-filled syringe. Approximately 4 months following the first dose intake of dupilumab and unknown latency with moderna covid-19 vaccine. No treatment drug 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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Patient initial, age, gender, concomitant medication, Suspect and co-suspect start date were added. Narrative updated.
Age: 88.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eczema, Joint stiffness, Joint swelling, Peripheral swelling
Clinical narrative: eczema from her neck down to her feet/ Eczema aggrevated; swollen legs, arms, and ankle/swollen arm; swollen ankles; ankles are still stiff; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema from her neck down to her feet/ Eczema aggrevated), PERIPHERAL SWELLING (swollen legs, arms, and ankle/swollen arm), JOINT SWELLING (swollen ankles) and JOINT STIFFNESS (ankles are still stiff) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In 2021, the patient experienced ECZEMA (eczema from her neck down to her feet/ Eczema aggrevated), PERIPHERAL SWELLING (swollen legs, arms, and ankle/swollen arm), JOINT SWELLING (swollen ankles) and JOINT STIFFNESS (ankles are still stiff). At the time of the report, ECZEMA (eczema from her neck down to her feet/ Eczema aggrevated), PERIPHERAL SWELLING (swollen legs, arms, and ankle/swollen arm), JOINT SWELLING (swollen ankles) and JOINT STIFFNESS (ankles are still stiff) outcome was unknown.            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.  The concomitant medication was not reported.  On an unknown date in 2021, patient developed events following first and last dose intake of Dupilumab (unknown latency) and following the first and last dose intake of Moderna covid-19 vaccine.  The treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Significant follow up was received . Updated patient age, gender, suspect product information updated
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint swelling, Pain
Clinical narrative: SWELLING IN JOINTS/ Joint swelling; REALLY ACHY/ Ache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (SWELLING IN JOINTS/ Joint swelling) and PAIN (REALLY ACHY/ Ache) 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) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-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) CITRATE FREE. On an unknown date, the patient experienced JOINT SWELLING (SWELLING IN JOINTS/ Joint swelling) and PAIN (REALLY ACHY/ Ache). At the time of the report, JOINT SWELLING (SWELLING IN JOINTS/ Joint swelling) and PAIN (REALLY ACHY/ Ache) was resolving. Relevant concomitant medications were not reported. Treatment information was not provided. 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal pain
Clinical narrative: Sore throat; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and FEELING ABNORMAL (Feeling bad) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and AZATHIOPRINE for an unknown indication.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK and AZATHIOPRINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FEELING ABNORMAL (Feeling bad). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had resolved with sequelae and FEELING ABNORMAL (Feeling bad) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter assessed the events as not related with 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.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Food poisoning, Illness, Vaccination site swelling
Clinical narrative: Sickness; Food poisoning; Vaccination site swelling/ Swelled up after took moderna booster shot; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning), ILLNESS (Sickness) and VACCINATION SITE SWELLING (Vaccination site swelling/ Swelled up after took moderna booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling/ Swelled up after took moderna booster shot). On 16-Nov-2021, the patient experienced FOOD POISONING (Food poisoning). On an unknown date, the patient experienced ILLNESS (Sickness). In November 2021, FOOD POISONING (Food poisoning) and VACCINATION SITE SWELLING (Vaccination site swelling/ Swelled up after took moderna booster shot) had resolved. At the time of the report, ILLNESS (Sickness) had resolved.            It was unknown if she was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. Vomiting and Diarrhea were symptoms of Food poisoning.  On an unknown date, the patient experienced sick after took COVID 19 Pfizer vaccine.  The reporter's causality for the event(s) of Food poisoning, arm Swelled up after took Moderna booster shot and Sick after took covid 19 PFIZER vaccine with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) vomiting and diarrhea was not provided.  The reporter's causality for the event(s) of Food poisoning, vomiting, diarrhea, Vaccination site swelling with PFIZER BIONTECH COVID-19 vaccine was not provided and with Sickness was not related.  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
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain
Clinical narrative: very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very sore) 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 INFLUENZA VACCINE for an unknown indication.    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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (very sore). At the time of the report, PAIN (very sore) outcome was unknown. No concomitant medication were reported. No treatment medication 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: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Brain operation, Illness
Clinical narrative: sickness; Brain operation; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN OPERATION (Brain operation) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No other medical history was reported. .    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2021, the patient experienced BRAIN OPERATION (Brain operation) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, BRAIN OPERATION (Brain operation) and ILLNESS (sickness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On an unknown date, the patient experienced sick. In July 2021, the patient experienced brain surgery. Moderna vaccine was also considered suspect.  She took Covid shot and got sick after taking Humira.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided.  This Case was Identified as part of retrospective email clean-up activity which included identification and booking-in of historical emails.   Company comment: This is a spontaneous case reported by a consumer. A 38-year-old female patient, in treatment with Adalimumab for Crohn's disease, received a dose of mRNA-1273 vaccine and experienced medically significant event of brain operation and non serious event of illness. Vaccination date was not provided; hence, latency cannot be assessed. It was reported that, in Jul 2021, the patient had brain surgery. She received Covid vaccine and got sick after taking Humira. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent condition Crohn's disease and concomitant product Humira could be contributory factors for event illness. 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. A 38-year-old female patient, in treatment with Adalimumab for Crohn's disease, received a dose of mRNA-1273 vaccine and experienced medically significant event of brain operation. Vaccination date was not provided; hence, latency cannot be assessed. It was reported that, in Jul 2021, the patient had brain surgery. She received Covid vaccine and got sick after taking Humira. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent condition Crohn's disease and concomitant product Humira could be contributory factors for event illness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Makes both arms sore as hell worth it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Makes both arms sore as hell worth it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Makes both arms sore as hell worth it). At the time of the report, VACCINATION SITE PAIN (Makes both arms sore as hell worth it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. There will be no information available on the batch number for this case. 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 15-Nov-2021: Significant follow up received included suspect product information updated
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram, Lymphadenopathy, Pain in extremity
Clinical narrative: Lymphoid under left arm; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain) and LYMPHADENOPATHY (Lymphoid under left arm) in a 63-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.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PAIN IN EXTREMITY (Right arm pain). In April 2021, the patient experienced LYMPHADENOPATHY (Lymphoid under left arm). At the time of the report, PAIN IN EXTREMITY (Right arm pain) had not resolved and LYMPHADENOPATHY (Lymphoid under left arm) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: Lymphoid under left arm thought being that it was small, do not even felt it..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. On an unknown date, patient had Chest X-ray (result not provided).. No treatment information was reported. 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.
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema has gotten a little worse; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Eczema has gotten a little worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Eczema.   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 ECZEMA (Eczema has gotten a little worse). At the time of the report, ECZEMA (Eczema has gotten a little worse) outcome was unknown.            Concomitant medications details were not reported.  The patient stated that he felt that his eczema had gotten a little worse ever since he took the first two moderna COVID vaccine.  No additional information provided.  No treatment information 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.
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Abdominal pain upper, Alopecia, Contraindicated product administered
Clinical narrative: Hurt stomach; Hair fell out; Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Hurt stomach), ALOPECIA (Hair fell out) and CONTRAINDICATED PRODUCT ADMINISTERED (Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for an unknown indication, METHOTREXATE for an unknown indication, SULFASALAZINE for an unknown indication and LEFLUNOMIDE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK, METHOTREXATE (unknown route) at an unspecified dose, SULFASALAZINE (unknown route) at an unspecified dose and LEFLUNOMIDE (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Hurt stomach), ALOPECIA (Hair fell out) and CONTRAINDICATED PRODUCT ADMINISTERED (Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds). At the time of the report, ABDOMINAL PAIN UPPER (Hurt stomach) had resolved and ALOPECIA (Hair fell out) and CONTRAINDICATED PRODUCT ADMINISTERED (Doctor stated there was no other drug that could be taken with Humira/patient had been on Humira and also had taken other meds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. The reporter assessed the event Abdominal pain upper as not related to Humira, related to Methotrexate and Sulfasalazine. The reporter assessed the event Alopecia as related to Leflunomide. 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: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Therapeutic response unexpected
Clinical narrative: He used Botox after the getting the COVID vaccine and the Botox worked; This spontaneous case was reported by a physician and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (He used Botox after the getting the COVID vaccine and the Botox worked) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    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 and BOTULINUM TOXIN TYPE A (BOTOX) (unknown route) UNK 10 units. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (He used Botox after the getting the COVID vaccine and the Botox worked). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (He used Botox after the getting the COVID vaccine and the Botox worked) 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.   Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Reporter (HCP) to report LOE from Botox for a patient as well as himself. Medication was not confirmed as Botox Cosmetic. He utilized Botox from the same lot number that was used on the patient and he also did not have an effect from the Botox. He used 40 units of the 50 unit Botox vial on the patient and the remaining ten units left from the vial on himself. He also did not have an effect from the Botox. HCP has been using Botox for years, never saw a lack of effect from Botox; it is a coincidence that the patient and the HCP both did not have an effect from the vial. HCP says he is certain it was the Botox vial with that lot number and expiration date that caused the lack of effect; he stated he was very careful and has been using Botox for a long time. When he used Botox he will only used the vial on the same day it was first used. HCP thinks he had asymptomatic COVID because he had COVID antibodies prior to receiving the COVID vaccine. He used Botox after the getting the COVID vaccine and the Botox worked.  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
Clinical narrative: Did have a reaction when he was vaccinated, it was not severe and he was fine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Did have a reaction when he was vaccinated, it was not severe and he was fine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Did have a reaction when he was vaccinated, it was not severe and he was fine). At the time of the report, IMMUNISATION REACTION (Did have a reaction when he was vaccinated, it was not severe and he was fine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication information was reported. No treatment medication information 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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Respiratory tract congestion, Unevaluable event
Clinical narrative: Chest congestion; Still some spots; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT CONGESTION (Chest congestion) and UNEVALUABLE EVENT (Still some spots) in an elderly 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 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Chest congestion) and UNEVALUABLE EVENT (Still some spots). At the time of the report, RESPIRATORY TRACT CONGESTION (Chest congestion) had resolved and UNEVALUABLE EVENT (Still some spots) had not resolved.            No concomitant product was reported. The patient stated that he had mostly cleared up from taking Skyrizi but he still had some spots that did not go away but they did not itch or bother him. Chest congestion lasted about a day and then he felt fine. No treatment information was reported. 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills
Clinical narrative: Stomach pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and CHILLS (Chills) 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) for Rheumatoid arthritis.  No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first 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 ABDOMINAL PAIN UPPER (Stomach pain) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and CHILLS (Chills) had resolved.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.  No concomitant medication information was reported. No treatment medication information was reported. 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.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site pain
Clinical narrative: stinging at injection site; increase in allergies; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (stinging at injection site) and HYPERSENSITIVITY (increase in allergies) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Dyshidrosis.    Concurrent medical conditions included Dyshidrosis and Hypersensitivity.   On 04-Oct-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. 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 VACCINATION SITE PAIN (stinging at injection site) and HYPERSENSITIVITY (increase in allergies). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (stinging at injection site) had resolved and HYPERSENSITIVITY (increase in allergies) outcome was unknown.            No concomitant product reported by reporter.  The dupixent single dose pre-filled pen component of the combination product dupixent (Single-entity for initial use) has been identified with a device issue. It was unknown if the product was stored or used properly. The device was operated by the Patient. The product was not available for evaluation.  dupilumab was used for unapproved indication Dyshidrosis.  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 30-Dec-2021: Significant follow up- patient age, suspect product information updated
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache) 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) for Psoriatic arthritis.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Ache). At the time of the report, PAIN (Ache) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This cas was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alopecia
Clinical narrative: GI problems; Hair falling out; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (GI problems) and ALOPECIA (Hair falling out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 013A21A and 037F21A) for COVID-19 vaccination.     The patient's past medical history included Heavy smoker. Previously administered products included for Smoker: Chantix (Batch/lot number: 00022175 Expiry Date: Sep2022 Dosage previously discontinued/treatment completed. During the Chantix, she was chewing Nicorette to help.) until May 2020, Chantix (Taking 1 tablet and twice a day and then started taking one tablet in the morning and half of a tablet at night.) until May 2020; for Heavy smoker: Nicorette (Lot: 0HV1799, Expiry date: Apr2022 4mg, Lot: BA856 and Expiry date: Oct2023). Past adverse reactions to the above products included Hypertensive with Chantix; No adverse effect with Nicorette; and Sleep difficult with Chantix.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, 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 ABDOMINAL DISCOMFORT (GI problems) and ALOPECIA (Hair falling out). At the time of the report, ABDOMINAL DISCOMFORT (GI problems) had not resolved and ALOPECIA (Hair falling out) outcome was unknown.            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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Pelvic pain
Clinical narrative: COVID-19; Pelvis pain; Painful hips; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PELVIC PAIN (Pelvis pain) and ARTHRALGIA (Painful hips) in a 63-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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ARTHRALGIA (Painful hips). On an unknown date, the patient experienced COVID-19 (COVID-19) and PELVIC PAIN (Pelvis pain). At the time of the report, COVID-19 (COVID-19), PELVIC PAIN (Pelvis pain) and ARTHRALGIA (Painful hips) outcome was unknown.       No concomitant product was reported. Patient needed a hip replacement. No treatment information was reported. For Rinvoq, dechallenge was reported as yes. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality with Rinvoq for the event COVID-19 was a reasonable possibility and for the event Arthralgia was no reasonable possibility. 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: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt a little bit after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt a little bit after booster shot) in an elderly 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.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt a little bit after booster shot). At the time of the report, VACCINATION SITE PAIN (Arm hurt a little bit after booster shot) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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 received in the moderna were missed to be booked-in.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-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) at an unspecified dose. In 2021, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) was resolving.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Red rashes at injection sites; Red rashes at injection sites; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever), INJECTION SITE ERYTHEMA (Red rashes at injection sites) and INJECTION SITE RASH (Red rashes at injection sites) in a 50-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 18-Aug-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PAIN (Body aches), PYREXIA (Fever), INJECTION SITE ERYTHEMA (Red rashes at injection sites) and INJECTION SITE RASH (Red rashes at injection sites). In August 2021, PAIN (Body aches) and PYREXIA (Fever) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red rashes at injection sites) and INJECTION SITE RASH (Red rashes at injection sites) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication was reported.  The reporter's causality for the events of body aches and fever with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of red rashes at injection sites onset in August 2021 and red rashes at injection sites onset in August 2021 with Humira (adalimumab) was a reasonable possibility.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for covid 19; Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid 19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-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) at an unspecified dose. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose). On 16-Aug-2021, the patient experienced COVID-19 (Tested positive for covid 19). In 2021, COVID-19 (Tested positive for covid 19) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient experienced inconsistent dosing/ On 30 Mar 2021, received 1st dose and on 20 Apr 2021, received 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: (Positive) Positive.         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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: she had a bad reaction to the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had a bad reaction to the Moderna shot) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Dermatitis atopic and Prophylactic vaccination.    Past medical history, medical treatments and family history of patient were not provided.  Concomitant products included CIMETIDINE (TAGAMET HB), FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY), TRAZODONE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE, SERTRALINE HCL, TRIAMCINOLONE ACETONIDE, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR), DENOSUMAB (PROLIA), MELOXICAM, LEVOTHYROXINE SODIUM, FAMOTIDINE, CYCLOBENZAPRINE HYDROCHLORIDE, MUPIROCIN, MECLIZINE HCL, GABAPENTIN, OXYCODONE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]), CLONAZEPAM and ALBUTEROL SULFATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On an unknown date, the patient experienced IMMUNISATION REACTION (she had a bad reaction to the Moderna shot). At the time of the report, IMMUNISATION REACTION (she had a bad reaction to the Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.  On an unknown date the patient unsure if medication Dupixent was meeting treatment expectation with no reported adverse event.  It was not reported if the patient received a corrective treatment for the events.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant follow up- concomitant medication, suspect product information updated.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hidradenitis
Clinical narrative: HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA; HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included DOXYCYCLINE for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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) 1 dosage form. On an unknown date, the patient experienced HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA). At the time of the report, HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA was not provided.  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 21-Dec-2021: Live-Significant Follow up-Moderna vaccine first dose date was updated, Event outcome was updated.