chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Pain in extremity
Clinical narrative: FLU SYMPTOMS; SORE ARM; This spontaneous report received from a patient concerned a 74 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 07-APR-2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced sore arm (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered at 11:00 or 12:00 on 14-JAN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 74 years old. No concomitant medications were reported.  On 14-JAN-2022 at 18:00, the patient started experiencing sore arm, chills, fever, headache, and muscle pain (muscle pain lasted 5 days) (dose number in series 2). The patient also started experiencing shaking, feeling freezing cold and patient couldn't get warm (dose number in series 2). Patient states she just wanted to go to bed but needed lots of blankets and warmed up by 02:00. When patient woke around 02:00 on 15-JAN-2022, she had fever of 102 (Body temperature) which lasted until probably 20:00 (dose number in series 2). The patient had highest fever for 12 hours mark after injection, and then symptoms started to subside. Patient states it was regular flu symptoms (dose number in series 2). Patient got hit with it and then all of a sudden it was over, patient links it to her COVID-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and sore arm on JAN-2022. This report was non-serious. This case, involving the same patient is linked to 20231055429.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune dermatitis, COVID-19
Clinical narrative: Autoimmune skin disease; COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AUTOIMMUNE DERMATITIS (Autoimmune skin disease) and COVID-19 (COVID-19) 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DERMATITIS (Autoimmune skin disease) and COVID-19 (COVID-19). At the time of the report, AUTOIMMUNE DERMATITIS (Autoimmune skin disease) and COVID-19 (COVID-19) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported after the Pfizer booster, on unreported dates, the patient got COVID-19. She also got a weird eczema and burning skin. She went to the dermatologist. The dermatologist stated she had an autoimmune skin disease and was seeing more of this in her medical practice. She also stated she thinks the mRNA vaccines are the cause.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2, FLUX, RVX
Symptoms: Diarrhoea, Feeling abnormal
Clinical narrative: I am not feeling good; Having Diarrhea pretty bad really dark; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (I am not feeling good) and DIARRHOEA (Having Diarrhea pretty bad really dark) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect products included non-company products RSV VACCINE for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form, dose of RSV VACCINE (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I am not feeling good) and DIARRHOEA (Having Diarrhea pretty bad really dark). At the time of the report, FEELING ABNORMAL (I am not feeling good) and DIARRHOEA (Having Diarrhea pretty bad really dark) outcome was unknown.            Concomitant and treatment medications were not reported.  Consumer stated that he thought he got this vaccine later. He thought he got like few weeks ago but cannot find and did not think to call the pharmacist. Consumer cannot find a date on anything they gave him handout it's not it stated December 22. Consumer don't think he got this packet May because this was, consumer thinks a last one he got. Consumer got his flu (Name could not clarified hence captured as Unspecified Flu shot) Consumer got the RSV (Suspect captured as Unspecified RSV Vaccine) then he got this. But it could be found out through the Pharmacy.  Consumer further stated that he had been having Diarrhea pretty bad really dark Diarrhea. Consumer never had Moderna before he can till this point he had, what's the other name one other than Moderna. Anyway he had that for his other vaccinations for two boosters (suspect as Unspecified boosters).  Consumer further stated that he doesn't think he had the right information, can he ask. He like to call his pharmacy real quick and check on this. Consumer don't know if he had a right print out for this. Consumer kept all his vaccinations things and a sack from his primary care doctor and he think he does not had the right print Out.
Sex: U
Vaccine: UNK
Symptoms: Illness
Clinical narrative: got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported.  It was reported that, reporter knows someone who did got the Moderna and got sick because patient was exposed to unvaccinated people, and both got sick.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: Noticed another significant improvement in my stamina and alertness; suffering for two days with exhaustion from the vaccine; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Noticed another significant improvement in my stamina and alertness) and FATIGUE (suffering for two days with exhaustion from the vaccine) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Bedridden and Gait disturbance. Concurrent medical conditions included Chronic fatigue syndrome (Chronic fatigue immune dysfuction syndrome), Cerebral disorder (fogged brain, searching for words and difficulty with simple math) and Memory loss.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Noticed another significant improvement in my stamina and alertness) and FATIGUE (suffering for two days with exhaustion from the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Noticed another significant improvement in my stamina and alertness) and FATIGUE (suffering for two days with exhaustion from the vaccine) outcome was unknown.            Concomitant and treatment medication were not reported.  After Spikevax administration on 26-Sep-2023, the patient had noticed another significant improvement in stamina and alertness. The patient felt it was important for research in the area of vaccine and the effect on chronic fatigue dysfunction syndrome.   This case was linked to MOD-2022-583908 (Patient Link).
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 51-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Oct-2023, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN in October 2023 at a dose of 500 milligram twice a day. At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant medications were not reported.  Patient had Grade 1 headache on Day 3. Resolved Day 4.  Patient received Acetaminophen on day 2.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: head and body/aches; body/aches; fever; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     The patient was not diagnosed with/ tested positive for COVID-19.  Previously administered products included for Anxiety: Clonazepam since 21-Apr-2020; for Product used for unknown indication: Pfizer on 19-Feb-2021, Pfizer on 09-Mar-2021, Pfizer on 09-Oct-2021 and Flu vaccine on 01-Oct-2023. Past adverse reactions to the above products included No adverse event with Clonazepam, Flu vaccine, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Osteoporosis (just).    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  After each of her 6 COVID vaccinations, Patient have experienced head and body/aches, fever, and fatigue for approximately 36 hours.   Patient would like to know was it unusual to have fevers, a few aches and fatigue after having the Moderna Spikevax vaccine. She reported it packed more of a punch this time. This one hit her pretty hard. She was feeling well last night and then started feeling achy and had a fever but not high. She was really sick on Sunday night after she got the vaccine and typically has a fever. She was just concerned since it was 36 hours after the vaccine that she was still experiencing these reactions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743743 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Live follow up received contains reference number added. On 23-Oct-2023: Live Follow up received: Date of administration of suspect vaccine, historical vaccine, events has been added, and batch number updated, narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743743:Monovalent case
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: head and body/aches; body/aches; fever; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7642B and 055F22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, HEADACHE (head and body/aches), MYALGIA (body/aches), PYREXIA (fever) and FATIGUE (fatigue) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  After each of my 6 COVID vaccinations, I have experienced head and body/aches, fever, and fatigue for approximately 36 hours.  Patient would like to know was it unusual to have fevers, a few aches and fatigue after having the Moderna Spikevax vaccine. She reported it packed more of a punch this time. This one hit her pretty hard. She was feeling well last night and then started feeling achy and had a fever but not high. She was really sick on Sunday night after she got the vaccine and typically has a fever. She was just concerned since it was 36 hours after the vaccine that she was still experiencing these reactions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743743 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Live follow up received contains reference number added. On 23-Oct-2023: Live Follow up received: Events added, Batch number updated, Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743743:Bivalent case
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: All my previous COVID vaccine doses were with the Moderna product and while there was some initial discomfort; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (All my previous COVID vaccine doses were with the Moderna product and while there was some initial discomfort) in a 61-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (All my previous COVID vaccine doses were with the Moderna product and while there was some initial discomfort). At the time of the report, DISCOMFORT (All my previous COVID vaccine doses were with the Moderna product and while there was some initial discomfort) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.     No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745684 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745684:Same Reporter for different product
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Patient had a mild tiredness and mild diarrhea; Patient had a mild tiredness and mild diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Patient had a mild tiredness and mild diarrhea) and FATIGUE (Patient had a mild tiredness and mild diarrhea) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Patient had a mild tiredness and mild diarrhea) and FATIGUE (Patient had a mild tiredness and mild diarrhea). At the time of the report, DIARRHOEA (Patient had a mild tiredness and mild diarrhea) and FATIGUE (Patient had a mild tiredness and mild diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The other Covid-19 vaccines that the patient provided were all Pfizer vaccines.   This case was linked to MOD-2023-746825 (Patient Link).
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pruritus, Rash, Rash pruritic
Clinical narrative: itching of her scalp; The patient did have a sore injection site arm after her Spikevax vaccine; developed a rash on her torso.; The rash itches a lot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching of her scalp), RASH PRURITIC (The rash itches a lot), VACCINATION SITE PAIN (The patient did have a sore injection site arm after her Spikevax vaccine) and RASH (developed a rash on her torso.) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine. Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, BUDESONIDE and PANTOPRAZOLE for an unknown indication.    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced RASH PRURITIC (The rash itches a lot) and RASH (developed a rash on her torso.). On 18-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (The patient did have a sore injection site arm after her Spikevax vaccine). On 19-Oct-2023, the patient experienced PRURITUS (itching of her scalp). At the time of the report, PRURITUS (itching of her scalp), RASH PRURITIC (The rash itches a lot), VACCINATION SITE PAIN (The patient did have a sore injection site arm after her Spikevax vaccine) and RASH (developed a rash on her torso.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The patient received Moderna vaccines in the past on 25-Jan-2021 (Dose:1, lot number 028L20A, location: unknown), 22-Feb-2021 (Dose:2, lot number 015M20A, location: unknown), 26-Aug-2021 (Dose:3, lot number 088D21A, location: unknown), 05-Apr-2022 (Dose:4, lot number 048L21A, location: unknown) and experienced same reactions fever, chills, and aching all over every time. The patient received fifth Moderna bivalelnt vaccine on 11-Oct-2022, (lot number 050022A) and had a sore arm.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747030, US-MODERNATX, INC.-MOD-2023-747032 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747030:Same patient (different vaccine) US-MODERNATX, INC.-MOD-2023-747032:Master case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Knee surgery NOS in November 2022.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had Knee surgery in NOV 2022. She stated, tested positive for COVID in APR or MAY 2022, about 6 months after receiving the vaccine. She does not have vaccine information. All of hers previous doses were Moderna brand COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-746856 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746856:Husband case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Insomnia
Clinical narrative: She had a hard time urinating; She was awake all night last night; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (She had a hard time urinating) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced URINARY RETENTION (She had a hard time urinating) (seriousness criterion medically significant) and INSOMNIA (She was awake all night last night). At the time of the report, URINARY RETENTION (She had a hard time urinating) and INSOMNIA (She was awake all night last night) had not resolved.            Concomitant and treatment medications were not reported.  The patient's previous vaccination details were as follows: 1st dose - 26Feb2021 lot number 006M20A, 2nd dose - 28Mar2021 lot number - 028A21A, 3rd dose - 23Nov2021 lot number 031H21A, 4th dose - 16May2022 lot number - 004M21A, 5th dose - 07Nov2022 lot number - 062F22A.  On 23-Oct-2023, the patient was awake all the night. The patient was unable to urinate.  Company Comment This spontaneous case concerns a 73-year-old female patient with no medical history reported who experienced the unexpected seriousness criterion medically significant event of urinary retention and the unexpected event of insomnia the same day after a dose of mRNA-1273.815 vaccine. At the time of the report, the events had not resolved Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747049 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747049:Spikevax case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: Unable to urinate; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (Unable to urinate) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. 006M20A, 028A21A, 031H21A and 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced URINARY RETENTION (Unable to urinate) (seriousness criterion medically significant). At the time of the report, URINARY RETENTION (Unable to urinate) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that after the 1st dose either within the same day or the next day she had a hard time while urinating. This led to a lot of consultations with doctors. On 07-Nov-2022, the patient took dose 5 vaccine (062F22A).  Treatment medication was not reported. Company comment: This spontaneous case concerns a female patient of an unknown age, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Urinary retention, on the following two days of the first dose of the mRNA-1273 vaccine, but since the event was reported with no exact onset date, latency could not be properly assessed No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747047 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747047:SPIKEVAX  2023-2024 case
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: She had no appetite until now; a fever right now. It was 106 last night; fatigue/She was tired; So weak; I have muscle pain; Chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (So weak), DECREASED APPETITE (She had no appetite until now), PYREXIA (a fever right now. It was 106 last night), MYALGIA (I have muscle pain) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol, Blood pressure high and Allergy. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 17-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ASTHENIA (So weak), MYALGIA (I have muscle pain) and CHILLS (Chills). On 17-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DECREASED APPETITE (She had no appetite until now), PYREXIA (a fever right now. It was 106 last night) and FATIGUE (fatigue/She was tired). At the time of the report, ASTHENIA (So weak), PYREXIA (a fever right now. It was 106 last night) and MYALGIA (I have muscle pain) had not resolved, DECREASED APPETITE (She had no appetite until now) was resolving and CHILLS (Chills) and FATIGUE (fatigue/She was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Body temperature: 100.6 F. On 17-Oct-2023, Body temperature: 106.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug included blood pressure medicine and high cholesterol medicine.  After taking Spikevax, patient had side effects. Patient asked if she could take like a Paracetamol or blood pressure medicine and high cholesterol medicine along this. Within 24 hours she had 100.6 F fever. She had muscle pain, was weak and had chills. She was tired and fatigue. She had no appetite until now. It been 3 days, she was finally working herself to eat. This was the worst her side effects ever been. Previously she only felt tired. This feels like she had flu symptoms.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Live follow-up received: Additional reporter, patient details, suspect details, concomitant vaccine, additional events and narrative was updated.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: She had no appetite until now; a fever right now. It was 106 last night; fatigue/She was tired; So weak; I have muscle pain; Chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (So weak), DECREASED APPETITE (She had no appetite until now), PYREXIA (a fever right now. It was 106 last night), MYALGIA (I have muscle pain) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol, Blood pressure high and Allergy. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 17-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ASTHENIA (So weak), MYALGIA (I have muscle pain) and CHILLS (Chills). On 17-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DECREASED APPETITE (She had no appetite until now), PYREXIA (a fever right now. It was 106 last night) and FATIGUE (fatigue/She was tired). At the time of the report, ASTHENIA (So weak), PYREXIA (a fever right now. It was 106 last night) and MYALGIA (I have muscle pain) had not resolved, DECREASED APPETITE (She had no appetite until now) was resolving and CHILLS (Chills) and FATIGUE (fatigue/She was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Body temperature: 100.6 F. On 17-Oct-2023, Body temperature: 106.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug included blood pressure medicine and high cholesterol medicine.  After taking Spikevax, patient had side effects. Patient asked if she could take like a Paracetamol or blood pressure medicine and high cholesterol medicine along this. Within 24 hours she had 100.6 F fever. She had muscle pain, was weak and had chills. She was tired and fatigue. She had no appetite until now. It been 3 days, she was finally working herself to eat. This was the worst her side effects ever been. Previously she only felt tired. This feels like she had flu symptoms.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Live follow-up received: Additional reporter, patient details, suspect details, concomitant vaccine, additional events and narrative was updated.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Malaise, Pain, Somnolence
Clinical narrative: achy/ she aches a little; she is doing is sleeping; She doesn't feel all that bad; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy/ she aches a little), SOMNOLENCE (she is doing is sleeping), FEELING ABNORMAL (She doesn't feel all that bad) and FATIGUE (tired) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to antibiotic (and different medications).    On 16-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy/ she aches a little), SOMNOLENCE (she is doing is sleeping), FEELING ABNORMAL (She doesn't feel all that bad) and FATIGUE (tired). At the time of the report, PAIN (achy/ she aches a little) and FATIGUE (tired) had not resolved and SOMNOLENCE (she is doing is sleeping) and FEELING ABNORMAL (She doesn't feel all that bad) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that she got all five shots, pneumonia, and shingles shot. She got the number five on Monday. Every day that week, she went back to bed and slept. She stated that's not her. She's not a sleeper. She was extra tired. She was wondering if that was ok. She has to go to a wedding next day and she was concerned. She repeated that she was tired and achy. She was not as sick as the first or second one. The patient mentioned that after her first shot, she got sick-sick. She got hives really bad. She had to go to the hospital. She just got so sick, sicker than this. After the second, she stated she had a little bit. After third and fourth, nothing. The patient states she was allergic to many antibiotics and different medications. No treatment information was provided.
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Heart rate increased, Pyrexia
Clinical narrative: chest tightness; heart rate was very high; fever; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (heart rate was very high) and PYREXIA (fever) in a 38-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     There was no history of COVID-19. There was no history of Myocarditis/pericarditis. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if the patient had experienced symptoms like this before receiving the Moderna COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Pfizer COVID-19 vaccines (All Pfizer COVID-19 vaccines previously). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccines. Concurrent medical conditions included Hypertension, Hypercholesterolemia (high cholesterol) and Drug allergy (sulfa medications.).    On 19-Oct-2023 at 10:30 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023 at 2:00 AM, the patient experienced CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (heart rate was very high) and PYREXIA (fever). At the time of the report, CHEST DISCOMFORT (chest tightness), HEART RATE INCREASED (heart rate was very high) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Heart rate: high  it has been ranging from 130s-150s bpm.         No concomitant medication was reported. The dosage text was reported as Unknown. The patient woke up this morning at around 2 AM with a really bad fever and the heart rate was very high. It had been ranging from 130s-150s bpm and had not gone down in these last few hours. The patient does not think he had a fever anymore. The patient had received all Pfizer COVID-19 vaccines previously and this was his first Moderna shot. The patient was not sure but says that this was the fifth or sixth dose in the series of COVID-19 vaccines. The patient was not sure if it was anxiety or something else, but his chest does feel tight. At this time as the patient was at the ER waiting to be seen for the increased heart rate. ECG, cardiac test, cardiac enzymes tests were not done. No treatment medication was given to the patient.
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy; hives; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy) and URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PRURITUS (itchy) and URTICARIA (hives). The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency and HYDROXYZINE HYDROCHLORIDE (ITERAX) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) and URTICARIA (hives) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that patient had new vaccine a couple of weeks ago and about 2-3 days after she was feeling itchy all over. At the time of reporting she already consulted her doctor and was prescribed with Benadryl and Iterax but it was not working.
Sex: U
Vaccine: UNK
Symptoms: Chills, Myalgia, Pain
Clinical narrative: I ache all over; chills temp says 99; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (I ache all over) and CHILLS (chills temp says 99) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced MYALGIA (I ache all over) and CHILLS (chills temp says 99). At the time of the report, MYALGIA (I ache all over) and CHILLS (chills temp says 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2023: Live follow up received: Date of administration of suspect added and narrative was updated.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness on upper arm day of injection. Same numbness persisted for two weeks and traveled to forearm; numbed areas turned to a burning sensation and more sensitive and tingly when touched.; joints were on sporadic pain in left arm; joints were on sporadic pain in left arm; numbed areas turned to a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (numbed areas turned to a burning sensation), HYPOAESTHESIA (Numbness on upper arm day of injection. Same numbness persisted for two weeks and traveled to forearm), PARAESTHESIA (numbed areas turned to a burning sensation and more sensitive and tingly when touched.), ARTHRALGIA (joints were on sporadic pain in left arm) and PAIN IN EXTREMITY (joints were on sporadic pain in left arm) in a 23-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In 2023, the patient experienced BURNING SENSATION (numbed areas turned to a burning sensation), PARAESTHESIA (numbed areas turned to a burning sensation and more sensitive and tingly when touched.), ARTHRALGIA (joints were on sporadic pain in left arm) and PAIN IN EXTREMITY (joints were on sporadic pain in left arm). On 30-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HYPOAESTHESIA (Numbness on upper arm day of injection. Same numbness persisted for two weeks and traveled to forearm). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (numbed areas turned to a burning sensation), HYPOAESTHESIA (Numbness on upper arm day of injection. Same numbness persisted for two weeks and traveled to forearm), ARTHRALGIA (joints were on sporadic pain in left arm) and PAIN IN EXTREMITY (joints were on sporadic pain in left arm) had not resolved and PARAESTHESIA (numbed areas turned to a burning sensation and more sensitive and tingly when touched.) outcome was unknown.            No relevant concomitant medications were reported. It was reported that same numbness (no pain besides second day of injection) persisted for two weeks and traveled to forearm. Patient visited with provider and was given meloxicam. That same week joints were on sporadic pain in left arm and numbed areas turned to a burning sensation and more sensitive and tingly when touched.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pain, Pyrexia
Clinical narrative: lethargy; body pain/aches/pain; malaise; fever; This spontaneous case was reported by a pharmacist and describes the occurrence of LETHARGY (lethargy) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Cardiovascular disorder.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 10-Oct-2023, the patient experienced LETHARGY (lethargy) (seriousness criterion life threatening), PAIN (body pain/aches/pain), MALAISE (malaise) and PYREXIA (fever). At the time of the report, LETHARGY (lethargy), PAIN (body pain/aches/pain), MALAISE (malaise) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided. Company comment This spontaneous case concerns a 60-year-old female patient with medical history of Arthritis and Cardiovascular disorder, who experienced the unexpected, serious (life-threatening), event of lethargy on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) and had not resolved at the time of the last observation. It was reported that patient experienced fever, lethargy, aches, pain, body pain, malaise. No further clinical information was provided for review. The medical history of Arthritis and Cardiovascular disorder could have certain complications and be a confounder for lethargy. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site mass, Vaccination site swelling
Clinical narrative: Hard lump at site of injection; Swelling, redness and pain at injection site; Swelling, redness and pain at injection site; Swelling, redness and pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling, redness and pain at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and pain at injection site), VACCINATION SITE PAIN (Swelling, redness and pain at injection site) and VACCINATION SITE MASS (Hard lump at site of injection) in a 29-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, the patient experienced VACCINATION SITE SWELLING (Swelling, redness and pain at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and pain at injection site) and VACCINATION SITE PAIN (Swelling, redness and pain at injection site). On an unknown date, the patient experienced VACCINATION SITE MASS (Hard lump at site of injection). In October 2023, VACCINATION SITE SWELLING (Swelling, redness and pain at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and pain at injection site) and VACCINATION SITE PAIN (Swelling, redness and pain at injection site) had resolved. At the time of the report, VACCINATION SITE MASS (Hard lump at site of injection) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, patient had swelling, redness and pain at injection site lasting 3 days and had hard lump at site of injection.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: My booster crushed me for a good 24 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (My booster crushed me for a good 24 hours) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (My booster crushed me for a good 24 hours). At the time of the report, IMMUNISATION REACTION (My booster crushed me for a good 24 hours) had resolved.            No relevant concomitant medications were reported. No treatment medication reported.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Supraventricular extrasystoles
Clinical narrative: Bigeminy PACs; This spontaneous case was reported by a patient and describes the occurrence of SUPRAVENTRICULAR EXTRASYSTOLES (Bigeminy PACs) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058081) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 12-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (Bigeminy PACs). At the time of the report, SUPRAVENTRICULAR EXTRASYSTOLES (Bigeminy PACs) had not resolved.            No concomitant drug was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment drug was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 73-year-old female patient, with no medical history reported, who experienced the unexpected and non-serious AESI of Supraventricular extrasystoles, which occurred 2 days after an unspecified dose of SPIKEVAX 2023-2024. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Hot painful hard lump at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Hot painful hard lump at injection site) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031488) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 21-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE MASS (Hot painful hard lump at injection site). At the time of the report, VACCINATION SITE MASS (Hot painful hard lump at injection site) was resolving.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.