chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb injury, Pain
Clinical narrative: Right shoulder injury; Achiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Right shoulder injury) in a 59-year-old male 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) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced PAIN (Achiness) and FATIGUE (Fatigue). On an unknown date, the patient experienced LIMB INJURY (Right shoulder injury) (seriousness criterion medically significant). The patient was treated with Surgery (underwent shoulder Surgery on 11-Apr-2022) for Limb injury. At the time of the report, LIMB INJURY (Right shoulder injury), PAIN (Achiness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. He had fatigue and achiness due to the covid-19 vaccine and had these reactions to all the vaccine. The reporter's causality for the event of right shoulder injury, fatigue and achiness was not provided. AbbVie's opinion was that there was no reasonable possibility that the events of right shoulder injury, fatigue and achiness are related to Humira(Adalimumab). It was unknown if patient was enrolled in covid -19 vaccine trial. No treatment medication was reported. COMPANY COMMENT: This is an spontaneous case concerning a  59-years-old male patient with  medical history of Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis who experienced the unexpected events   of  LIMB INJURY, PAIN and other expected event unknown days after  receiving the  1st  dose of  mRNA-1273 vaccine. The medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-569453.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  59-years-old male patient with  medical history of Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis who experienced the unexpected events   of  LIMB INJURY, PAIN and other expected event unknown days after  receiving the  1st  dose of  mRNA-1273 vaccine. The medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Caller states his booster dose was .5; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Caller states his booster dose was .5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Caller states his booster dose was .5). At the time of the report, ACCIDENTAL OVERDOSE (Caller states his booster dose was .5) outcome was unknown.            No concomitant medication information was provided. It was reported that patient's first booster was 0.5 ml instead of 0.25 ml. It was not confirmed that patient was immunocompromised or not. No treatment medication were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: started feeling joint pain at knee area; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (started feeling joint pain at knee area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient experienced ARTHRALGIA (started feeling joint pain at knee area). At the time of the report, ARTHRALGIA (started feeling joint pain at knee area) outcome was unknown.            No concomitant medications were provided.  On 15-May-2022 around 4 pm, Patient received the 2nd booster dose.  On 16-May-2022 around evening 8 pm, Patient was totally okay until yesterday and started feeling joint pain at knees.  No treatment medications were provided.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Have symptoms and test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Have symptoms and test positive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Diabetes.   On 02-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 02-May-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022 at 4:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Have symptoms and test positive). At the time of the report, COVID-19 (Have symptoms and test positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Patient took full dose of Paxlovid and 7 days later had symptoms and tested positive.  No treatment medications were provided.  Company Comment: This spontaneous case concerns a 62-year-old female patient with no relevant medical history, who experienced the and unexpected non-serious AESI of COVID-19 which occurred 12 days after receiving the fourth dose of mRNA-1273 vaccine. Its reported that patient took a full dose of Paxlovid as a covid-19 treatment and 7 days later she still had symptoms and was tested positive. COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient with no relevant medical history, who experienced the and unexpected non-serious AESI of COVID-19 which occurred 12 days after receiving the fourth dose of mRNA-1273 vaccine. Its reported that patient took a full dose of Paxlovid as a covid-19 treatment and 7 days later she still had symptoms and was tested positive. COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: very tired; did not feel like doing anything for a day afterwards; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (did not feel like doing anything for a day afterwards) and FATIGUE (very tired) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (did not feel like doing anything for a day afterwards) and FATIGUE (very tired). At the time of the report, FEELING ABNORMAL (did not feel like doing anything for a day afterwards) had resolved and FATIGUE (very tired) outcome was unknown. No concomitant medications were reported.  The patient received first booster dose at the end of April 2022 or early May 2022. The lot number and expiration date were not available.  No treatment medications were reported.   This case was linked to MOD-2022-569656, MOD-2022-569659 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna vaccine) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The HCP (health care professional) reported that an expired Moderna vaccine was administered to 36 patients from 15-Apr-2022 through 06-May-2022. The HCP confirmed no side effects were reported. No treatment medications were reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Lip swelling
Clinical narrative: Lip swelling; Adverse drug reaction; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip swelling) and ADVERSE DRUG REACTION (Adverse drug reaction) in a 34-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 Rheumatoid arthritis.    Concurrent medical conditions included Angioedema. Concomitant products included HYDROXYCHLOROQUINE from 01-May-2016 to an unknown date for an unknown indication.   On 01-May-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LIP SWELLING (Lip swelling) and ADVERSE DRUG REACTION (Adverse drug reaction). On 21-May-2021, LIP SWELLING (Lip swelling) and ADVERSE DRUG REACTION (Adverse drug reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received concomitant drug Hydrochloroquine from  01-May-2016 (400mg, 200 mg, 2 in 1D). The patient received Humira from 01-May-2002 to 21-May-2021. The patient received 2nd dose of Moderna on 21 May 2021  (intramuscular) and 3rd dose on 21 Jan 2022 (intramuscular). It was reported that the patient experienced adverse reaction to Humira and lips swelled. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event adverse reaction to Humira and lips swelled with Humira was a reasonable possibility.  No information on treatment medications was reported.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: Very bitter taste in my mouth within 30 minutes of taking medicine.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very bitter taste in my mouth within 30 minutes of taking medicine.) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Graves' disease. Concurrent medical conditions included Penicillin allergy. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and METHIMAZOLE for an unknown indication.   On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022 at 11:00 PM, the patient experienced DYSGEUSIA (Very bitter taste in my mouth within 30 minutes of taking medicine.). At the time of the report, DYSGEUSIA (Very bitter taste in my mouth within 30 minutes of taking medicine.) outcome was unknown.  The patient took other medications/products within 2 weeks of starting COVID-19 treatment No treatment medication was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Raised Injection Site after first booster; inflamed Injection Site for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Raised Injection Site after first booster) and VACCINATION SITE INFLAMMATION (inflamed Injection Site for 2 days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 036A21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Raised Injection Site after first booster) and VACCINATION SITE INFLAMMATION (inflamed Injection Site for 2 days). On 14-Nov-2021, VACCINATION SITE SWELLING (Raised Injection Site after first booster) and VACCINATION SITE INFLAMMATION (inflamed Injection Site for 2 days) had resolved.            No concomitant medications were reported. No treatment information were provided.   This case was linked to MOD-2022-569419, MOD-2022-569365, MOD-2021-225686 (Patient Link).   Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pain of skin, Somnolence, Vaccination site pain
Clinical narrative: patient slept  for several hours after his first dose/slept for 16 hours each day for two days.; everything ached.; Hurt to touch his skin; felt like he had the flu/Flu like symptoms resolved after 5 days; sore injection site left arm.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (patient slept  for several hours after his first dose/slept for 16 hours each day for two days.), PAIN (everything ached.), PAIN OF SKIN (Hurt to touch his skin), INFLUENZA LIKE ILLNESS (felt like he had the flu/Flu like symptoms resolved after 5 days) and VACCINATION SITE PAIN (sore injection site left arm.) in a 49-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Stroke (2 years ago) in 2020. Concurrent medical conditions included Broken hip (broken hip right), Blind left eye (blind in his left eye as of 2 years ago as a result of the stroke) and Homebound.    On 29-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced SOMNOLENCE (patient slept  for several hours after his first dose/slept for 16 hours each day for two days.), PAIN (everything ached.), PAIN OF SKIN (Hurt to touch his skin), INFLUENZA LIKE ILLNESS (felt like he had the flu/Flu like symptoms resolved after 5 days) and VACCINATION SITE PAIN (sore injection site left arm.). On 03-Apr-2022, INFLUENZA LIKE ILLNESS (felt like he had the flu/Flu like symptoms resolved after 5 days) had resolved. At the time of the report, SOMNOLENCE (patient slept  for several hours after his first dose/slept for 16 hours each day for two days.), PAIN (everything ached.), PAIN OF SKIN (Hurt to touch his skin) and VACCINATION SITE PAIN (sore injection site left arm.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  It was reported that, the patient was homebound and was receiving medical services at home. The patient's social worker arranged for the patient to receive his Moderna Covid-19 vaccine at home. However, no one has contacted the patient to arrange his second dose of the Moderna Covid-19 vaccine. The patient received the vaccine in his left arm shoulder deltoid muscle. Patient stated, a paramedic came to the house and administered the vaccine.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow-up document received includes no new information.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Itching; Tingling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and PARAESTHESIA (Tingling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, 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 received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching) and PARAESTHESIA (Tingling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and PARAESTHESIA (Tingling) had not resolved.            No concomitant medications were reported. Patient reported that  5 to 6 days after receiving the second booster dose she started to experience a tingling feeling all over her. This was like an itching that was worse after showering. She took some Benadryl which helped for a little bit but the itching kept coming back. It continued till the day of report.   This case was linked to MOD-2022-569552 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060h21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 03-Dec-2021 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No Concomitant product use was reported.  It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient reported on 07-May-2022, the patient experienced relapse of COVID symptoms 1 week after finishing paxlovid and the symptoms included Increased congestion, mucus, sore throat Sinus pressure, headache, extreme fatigue.  The device date was reported as 14-May-2022.  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history, who experienced the and unexpected non-serious AESI of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. Its reported that the patient was treated with Nirmatrelvir and Ritonavir (Paxlovid) as a treatment for covid-19. The patient experienced relapse of COVID symptoms 1 week after finishing paxlovid with Increased congestion, mucus, sore throat, Sinus pressure, headache and extreme fatigue. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no relevant medical history, who experienced the and unexpected non-serious AESI of COVID-unspecified days after receiving the third dose of mRNA-1273 vaccine. Its reported that the patient was treated with Nirmatrelvir and Ritonavir (Paxlovid) as a treatment for covid-19. The patient experienced relapse of COVID symptoms 1 week after finishing paxlovid with Increased congestion, mucus, sore throat, Sinus pressure, headache and extreme fatigue. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Recurrence of symptoms runny nose, sore throat, congestion; Recurrence of symptoms runny nose, sore throat, congestion; Recurrence of symptoms runny nose, sore throat, congestion; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Recurrence of symptoms runny nose, sore throat, congestion), OROPHARYNGEAL PAIN (Recurrence of symptoms runny nose, sore throat, congestion) and NASAL CONGESTION (Recurrence of symptoms runny nose, sore throat, congestion) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 043B21A and 041B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Lactose intolerant.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022, the patient experienced RHINORRHOEA (Recurrence of symptoms runny nose, sore throat, congestion), OROPHARYNGEAL PAIN (Recurrence of symptoms runny nose, sore throat, congestion) and NASAL CONGESTION (Recurrence of symptoms runny nose, sore throat, congestion). At the time of the report, RHINORRHOEA (Recurrence of symptoms runny nose, sore throat, congestion), OROPHARYNGEAL PAIN (Recurrence of symptoms runny nose, sore throat, congestion) and NASAL CONGESTION (Recurrence of symptoms runny nose, sore throat, congestion) was resolving. Not Provided          No concomitant medication was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm  hurt for two days then it went away; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm  hurt for two days then it went away) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 010A21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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 experienced PAIN IN EXTREMITY (arm  hurt for two days then it went away). At the time of the report, PAIN IN EXTREMITY (arm  hurt for two days then it went away) had resolved.            No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2022-569364 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood test, Fatigue, Headache, Nausea
Clinical narrative: Pain; Really tired; Nausea; Fatigue; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Really tired), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 56-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 Rheumatoid arthritis.    Concomitant products included PREDNISONE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth 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 30-Apr-2022, the patient experienced NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Really tired). On 02-May-2022, NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Pain) and FATIGUE (Really tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: result not provided Result not Provided.         No concomitant medication information was provided. No treatment medication were provided.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Pain; Really tired; Nausea; Fatigue; Joint pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FATIGUE (Really tired), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 56-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 Rheumatoid arthritis.    Concomitant products included PREDNISONE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth 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 30-Apr-2022, the patient experienced NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Really tired). On 02-May-2022, NAUSEA (Nausea), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Pain) and FATIGUE (Really tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: result not provided Result not Provided.         No concomitant medication information was provided. No treatment medication were provided.
Age: 22.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug interaction
Clinical narrative: Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Drug interaction) in a 22-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In January 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen,Citrate free. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). At the time of the report, DRUG INTERACTION (Drug interaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Lack of drug effect reported after humira with start date as on unknown date in 2022 Booster dose received by patient via intramuscular route. No treatment medication was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 5 days after finishing paxlovid, started feeling symptomatic again and tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (5 days after finishing paxlovid, started feeling symptomatic again and tested positive) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination.    Concurrent medical conditions included Anxiety, Depression, Asthma, Peanut allergy, Allergy to nuts (Tree nut), Sesame allergy and Fruit allergy (Stone fruit). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (5 days after finishing paxlovid, started feeling symptomatic again and tested positive). At the time of the report, COVID-19 (5 days after finishing paxlovid, started feeling symptomatic again and tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test negative (Negative) Tested negative after 5 day course of paxlovid.. On 15-May-2022, SARS-CoV-2 test: positive (Positive) positive and.          Treatment was not received. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine.  Tested negative after 5 day course of paxlovid. 5 days after finishing paxlovid, started feeling symptomatic again and tested positive. Device Date :16May2022. COMPANY COMMENT: This is an spontaneous case concerning a  27-years-old female patient with  medical history of Anxiety, Depression, Asthma,several allergies, Concomitant products included ESCITALOPRAM for an unknown indication, NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination who experienced the unexpected AESI event   of COVID-19, 197 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  27-years-old female patient with  medical history of Anxiety, Depression, Asthma,several allergies, Concomitant products included ESCITALOPRAM for an unknown indication, NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination who experienced the unexpected AESI event   of COVID-19, 197 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received first dose on 5MAR2021, second dose on 12APR2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 5MAR2021, second dose on 12APR2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 5MAR2021, second dose on 12APR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received first dose on 5MAR2021, second dose on 12APR2021) outcome was unknown.            No concomitant drug was reported. The patient received 4 doses of the Moderna covid-19 vaccine by intramuscular injection. No treatment drug was reported.   This case was linked to MOD-2022-569444 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not take any other medications/products within two weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Concurrent medical conditions included Allergy.   On 25-Apr-2022 at 4:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022 at 1:00 AM, the patient experienced COVID-19 (I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.). At the time of the report, COVID-19 (I rebounded after 6 days of finishing Paxlovid treatment. Symptoms returned, strong positive test result after 3 days negative. Incred bly upsetting and disruptive.) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: strong positive test (Positive) strong positive test and negative (Negative) Negative.         No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning a  51-years-old male patient with  medical history of Allergy, non-company product NIRMATRELVIR, RITONAVIR for COVID-19 treatment who experienced the unexpected AESI event   of COVID-19, 21 days after  receiving the  4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a  51-years-old male patient with  medical history of Allergy, non-company product NIRMATRELVIR, RITONAVIR for COVID-19 treatment who experienced the unexpected AESI event   of COVID-19, 21 days after  receiving the  4th  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia
Clinical narrative: COVID-19; Strong bitter taste in mouth, sometimes metallic; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DYSGEUSIA (Strong bitter taste in mouth, sometimes metallic) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No Medical History information was reported.   On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 1:00 PM, the patient experienced DYSGEUSIA (Strong bitter taste in mouth, sometimes metallic). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and DYSGEUSIA (Strong bitter taste in mouth, sometimes metallic) had not resolved.            No Concomitant medication was reported Device Date was reported as 13-May-2022 Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency cannot be assessed. It was reported that the patient received Paxlovid (ritonavir) as COVID-19 treatment, approximately 9 months after the third dose of mRNA-1273 vaccine. No details of primary doses were provided. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was reported with no onset date; hence latency cannot be assessed. It was reported that the patient received Paxlovid (ritonavir) as COVID-19 treatment, approximately 9 months after the third dose of mRNA-1273 vaccine. No details of primary doses were provided. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry; Patient received Moderna Covid-19 vaccine that was expired.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.) and PRODUCT STORAGE ERROR (Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (first Covid-19 vaccine). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that was expired.) and PRODUCT STORAGE ERROR (Date of expiry of vaccine 25-march-2022 , the vail stored in referigerator post expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported. The vial did not undergo any temperature excursion. The vial was initially stored in the refrigerator 28-MAR-2022 (1 vial).
Age: 22.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Taste disorder
Clinical narrative: developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    patient was allergic to unknown historical drug.  The patient's past medical history included Appendicitis and Pericarditis. Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Batch/Lot No: Lot ER8731 Location of injection: Arm Left) on 09-Apr-2021 and Pfizer / BioNTech (Batch/Lot No: Lot EW0175 Location of injection: Arm left) on 03-Jun-2021. Past adverse reactions to the above products included No adverse drug reaction with Pfizer / BioNTech; and No adverse event with Pfizer / BioNTech.   On 11-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 11:15 PM, the patient experienced TASTE DISORDER (developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.). At the time of the report, TASTE DISORDER (developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.) had not resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  patient did not took  any other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously receive a COVID-19 Vaccine.   Patient after taking the second round of pills developed  a plastic taste, It can be distracted with food and other flavored things, but plastic taste comes back and gets progressively stronger.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Pyrexia, SARS-CoV-2 test, Throat irritation, Upper respiratory tract congestion
Clinical narrative: Scratchy throat; Fever; Upper Respiratory Congestion; cold symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of UPPER RESPIRATORY TRACT CONGESTION (Upper Respiratory Congestion), NASOPHARYNGITIS (cold symptoms), THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 037C21A, 029L20A and 026L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Sulpha and Penicillin. Past adverse reactions to the above products included Allergy with Penicillin and Sulpha. Concurrent medical conditions included Breast cancer and Blood pressure high. Concomitant products included NEBIVOLOL, CYANOCOBALAMIN (NATURE MADE VITAMIN B-12), RISEDRONATE SODIUM (ACTONEL), ALOE VERA and KRILL OIL for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 1:45 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever). In May 2022, the patient experienced UPPER RESPIRATORY TRACT CONGESTION (Upper Respiratory Congestion) and NASOPHARYNGITIS (cold symptoms). On 15-May-2022, UPPER RESPIRATORY TRACT CONGESTION (Upper Respiratory Congestion) and PYREXIA (Fever) had resolved. At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved and THROAT IRRITATION (Scratchy throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Had negative rapid test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after taking last dose of Paxlovid on May 9 and having Negative rapid test and being asymptomatic patient started to run a fever and scratchy throat on May 13th. The fever and upper respiratory congestion continued until May 15. On May 16 patient had only cold symptoms.  It was confirmed that the patient was taking other medications within 2 weeks of starting COVID-19 treatment.  Treatment medication was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (diagnosed with shingles) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 035C21-2, 001A21A and 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product MYCOPHENOLATE MOFETIL for Autoimmune hepatitis.    Patient was not tested or diagnosed with COVID-19.  Concurrent medical conditions included Autoimmune hepatitis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started MYCOPHENOLATE MOFETIL (unknown route) 1500 microgram once a day. On an unknown date, the patient experienced HERPES ZOSTER (diagnosed with shingles). At the time of the report, HERPES ZOSTER (diagnosed with shingles) outcome was unknown.            The patient got shingles from a medication mycophenolate mofetil) which the patient was taking for autoimmune hepatitis.  The patient was due for the second booster but had shingles.  No treatment medication were provided.