chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Her arm was sore; Had fever; Chills the night after injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), PYREXIA (Had fever) and CHILLS (Chills the night after injection) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) 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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm was sore), PYREXIA (Had fever) and CHILLS (Chills the night after injection). At the time of the report, PAIN IN EXTREMITY (Her arm was sore), PYREXIA (Had fever) and CHILLS (Chills the night after injection) outcome was unknown.        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.   Concomitant medication was not provided. Patient received flu shot in the same arm at the same time. No lot number was provided for Moderna vaccine. She experienced events the night after injection. Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste in his mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (loss of taste in his mouth) in a 78-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205F232A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1; batch/lot number: AS7143C) on 07-Sep-2021 and Moderna (Dose 2; batch/lot number: 040C21A) on 22-Oct-2021; for Product used for unknown indication: Flu shot on 13-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna and Moderna.    On 29-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced AGEUSIA (loss of taste in his mouth). At the time of the report, AGEUSIA (loss of taste in his mouth) had not resolved.            No concomitant medications were reported. Approximately 8 hours after receiving the vaccine, the patient experienced loss of taste in his mouth. Patient has reported to HCP that it is miserable and wants to know if the taste will ever come back. Patient has received 2 doses of the Moderna COVID-19 vaccine previously and did not experience any side effects. HCP was calling on behalf of the patient if this side effect has been reported by others and if there is any information on how long the patient can expect it to last. No Allergies reported and COVID-19 diagnosis was unknown. HCP states that the given lot numbers were not sure as they were handwritten. No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a health care professional, concerning a 78-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of Ageusia, which occurred 8 hours after an unspecified dose of SPIKEVAX 2023-2024 vaccine. 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: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 antibody test, Somnolence
Clinical narrative: very very sleepy; got covid in spring of 2022 after their last Moderna shot/had long covid; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (got covid in spring of 2022 after their last Moderna shot/had long covid) and SOMNOLENCE (very very sleepy) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (2nd dose) on 11-Feb-2021, COVID-19 vaccine (1st dose, Lot: DU4M20A) on 04-Apr-2021 and COVID-19 VACCINE (Lot: 05E21A) on 29-Oct-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Blood pressure high, House dust mite allergy, Penicillin allergy, Allergy to molds, Allergy to plants (certain plants) and Allergic reaction to antibiotics (Reactions to different antibiotics). Concomitant products included CLONIDINE, METOPROLOL and AMLODIPINE for Blood pressure high.    On 21-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced POST-ACUTE COVID-19 SYNDROME (got covid in spring of 2022 after their last Moderna shot/had long covid). On an unknown date, the patient experienced SOMNOLENCE (very very sleepy). At the time of the report, POST-ACUTE COVID-19 SYNDROME (got covid in spring of 2022 after their last Moderna shot/had long covid) and SOMNOLENCE (very very sleepy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 antibody test: 21,000 proteins.    It was reported that patient got covid in spring of 2022 after last moderna shot. She has had long covid and had a spike protein test and had 21,000 proteins. Patient could not get any tireder than they were right now. The only reaction had to the vaccine was that they were very very sleepy. when got covid it was the same problem they had. With long covid patient was physically exhausted.   Treatment medication was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Pain in extremity, Vaccination site urticaria
Clinical narrative: Slept. Almost all day; started to sweat; left arm started to get sore; left arm injection site has got this big red welts where they injected the Vaccine; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept. Almost all day), HYPERHIDROSIS (started to sweat), VACCINATION SITE URTICARIA (left arm injection site has got this big red welts where they injected the Vaccine) and PAIN IN EXTREMITY (left arm started to get sore) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031488) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Primary monovalent (Shot 1: First Moderna Primary monovalent dose) in 2021, Moderna Primary monovalent (Shot 2: 2nd Moderna Primary monovalent dose) in 2021 and First Moderna Monovalent Booster dose (Shot 3: First Moderna Monovalent Booster dose) in 2022; for Product used for unknown indication: Pfizer (Shot 4: Pfizer) in 2022. Past adverse reactions to the above products included No adverse event with First Moderna Monovalent Booster dose, Moderna Primary monovalent, Moderna Primary monovalent and Pfizer.    On 10-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 10-Nov-2023, the patient experienced HYPERHIDROSIS (started to sweat) and PAIN IN EXTREMITY (left arm started to get sore). On 11-Nov-2023, the patient experienced HYPERSOMNIA (Slept. Almost all day). In November 2023, the patient experienced VACCINATION SITE URTICARIA (left arm injection site has got this big red welts where they injected the Vaccine). On 12-Nov-2023, HYPERSOMNIA (Slept. Almost all day) had resolved. In November 2023, HYPERHIDROSIS (started to sweat) and PAIN IN EXTREMITY (left arm started to get sore) had resolved. At the time of the report, VACCINATION SITE URTICARIA (left arm injection site has got this big red welts where they injected the Vaccine) had not resolved.            No concomitant medications were reported.  Reported that on 10-Nov-2023, his left arm started to get sore and he started to sweat, Slept. Almost all-day Saturday. On Sunday, 12-Nov-2023, he got up and felt a lot better. He feels okay now, except his left arm injection site has got this big red welts where they injected the Vaccine.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 75-year-old male patient, with no medical history reported, who experienced the unexpected and non-serious AESI of Hypersomnia, which occurred the same day after SPIKEVAX 2023-2024 vaccine, administered as fifth dose within COVID-19 vaccination schedule. As reported, the patient slept almost all-day after vaccination. No information disclosed about diagnostic tests performed or treatments received. The event resolved after 1 day. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy
Clinical narrative: HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection; Patient is greater than 30 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is greater than 30 weeks pregnant) in a 23-year-old female 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is greater than 30 weeks pregnant). At the time of the report, COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is greater than 30 weeks pregnant) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that female patient who previously had Moderna vaccine(s) had covid infection. Reported that patient was greater than 30 weeks pregnant.  No treatment medications were reported.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a 23-years-old female patient, with no medical history reported, who experienced the unexpected and non-serious event of COVID-19, which occurred on an unknown date after an unspecified dose of SPIKEVAX NOS, at greater than 30 weeks of gestation. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-749420 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749420:same reporter/patient 2
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) in a 20-year-old female 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 COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection). At the time of the report, COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that female patient who previously had Moderna vaccine(s) had covid infection.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749418 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749418:same reporter/patient 1
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal
Clinical narrative: With long COVID Disease Symptoms; felt poorly for 1 day and she was fine the next day; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (With long COVID Disease Symptoms) and FEELING ABNORMAL (felt poorly for 1 day and she was fine the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026d21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 21-Mar-2023, the patient experienced COVID-19 (With long COVID Disease Symptoms). On an unknown date, the patient experienced FEELING ABNORMAL (felt poorly for 1 day and she was fine the next day). At the time of the report, COVID-19 (With long COVID Disease Symptoms) had not resolved and FEELING ABNORMAL (felt poorly for 1 day and she was fine the next day) had resolved.            No concomitant medications were reported.  The patient reported that she received shot 4: 2nd Pfizer Booster dose on Fall 2022. She was not sure if this was a bivalent or not. She had COVID Disease from 21-MAR-2023 to 28-MAR-2023. She stated that on 13-NOV-2023, she still has COVID in her head, Dizzy, and Malaise. She also mentioned that after each vaccine she felt poorly for 1 day and she was fine the next day.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inflammation, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm for a long period; ache; inflammation to my cervical area which is damaged from fusions; 48-72hrs of fever; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm for a long period), PAIN (ache), INFLAMMATION (inflammation to my cervical area which is damaged from fusions), COVID-19 (COVID-19) and PYREXIA (48-72hrs of fever) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for a long period), PAIN (ache), INFLAMMATION (inflammation to my cervical area which is damaged from fusions) and PYREXIA (48-72hrs of fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm for a long period), PAIN (ache), INFLAMMATION (inflammation to my cervical area which is damaged from fusions) and COVID-19 (COVID-19) outcome was unknown and PYREXIA (48-72hrs of fever) had resolved.            Concomitant medications were not reported.  Reported that patient received the COVID vaccine on 04-Nov-2023 and did not experience any after effects. Patient received the initial (Moderna) shot in 2020, followed by the booster. Both time patient experienced sore arm for a long period and 48-72hrs of fever, aches, and inflammation to cervical area which was damaged from fusions.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) 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 COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  The patient did not provide the Pfizer medication.  The patient had COVID-19 infection.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain in extremity
Clinical narrative: my reactions were milder with the boosters; soreness in arm; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (my reactions were milder with the boosters) and PAIN IN EXTREMITY (soreness in arm) in a 75-year-old female 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 IMMUNISATION REACTION (my reactions were milder with the boosters) and PAIN IN EXTREMITY (soreness in arm). At the time of the report, IMMUNISATION REACTION (my reactions were milder with the boosters) and PAIN IN EXTREMITY (soreness in arm) outcome was unknown.            It was unknown if the patient had other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient had strong reactions to vaccines, she go with milder vaccines. She explained that mild one work just as good. She had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong, her reactions were milder with the boosters. Some examples reported were, she had to rest for a day, soreness in arm, just normal reactions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749696 (E2B Linked Report). This case was linked to MOD-2023-749696 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749696:Same Patient (Monovalent case)
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: allergy reaction to Moderna Covid-19 vaccine, causing rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (allergy reaction to Moderna Covid-19 vaccine, causing rash) in an adult male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (allergy reaction to Moderna Covid-19 vaccine, causing rash). At the time of the report, RASH (allergy reaction to Moderna Covid-19 vaccine, causing rash) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Illness
Clinical narrative: She states that every time she got vaccinated, she got sicker and sicker; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (She states that every time she got vaccinated, she got sicker and sicker) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 046C21A, 025J20A and 025J20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) for an unknown indication.    No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2022, the patient received fifth dose of FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She states that every time she got vaccinated, she got sicker and sicker). At the time of the report, ILLNESS (She states that every time she got vaccinated, she got sicker and sicker) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that patient states that every time she got vaccinated, she got sicker and sicker. She had 5 vaccines mix of Pfizer and Moderna. She had side effects and felt sick after Pfizer and Moderna COVID-19 vaccination.   No treatment medications were reported.   This case was linked to MOD-2023-750035 (Patient Link).   Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 071F21A, 011M20A and 042L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Iodine allergy, Drug allergy (Morphine), Food allergy (Dextrose makes fluid build up in lungs), Food allergy (Corn syrup and all corn products), Fructose intolerance, Fish allergy, Allergy to nuts, Atrial fibrillation since 10-Jun-2020, Pancreatic exocrine insufficiency since 01-Jul-2021, Hypertension since 01-May-1966 and Arrhythmia. Concomitant products included APIXABAN (ELIQUIS) from 14-Jun-2020 to an unknown date for Anticoagulant therapy, METOPROLOL from 14-Jun-2020 to an unknown date for Arrhythmia, EPLERENONE from 14-Jul-2020 to an unknown date and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]) from 01-Jun-2002 to an unknown date for Hypertension, PANCREATIN (CREON) from 01-Jul-2021 to an unknown date for Pancreatic exocrine insufficiency.   On 17-Jan-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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): On 25-Jun-2022, Polymerase chain reaction: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746629:Same patient, different variant
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract infection, Vaccination site pain
Clinical narrative: She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot; she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT INFECTION (She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot) and VACCINATION SITE PAIN (she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-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 an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot) and VACCINATION SITE PAIN (she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022). At the time of the report, RESPIRATORY TRACT INFECTION (She mentions that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot) had resolved and VACCINATION SITE PAIN (she only had a sore arm with the her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022) outcome was unknown.            No concomitant medication was reported.  Patient only had a sore arm with her last dose which was the Moderna COVID-19 bivalent vaccine in DEC2022. She mentioned that she had a respiratory infection in SEP2023 and OCT2023, during which time she was coughing a lot.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750042 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750042:Master case for dose 6 (Spikevax 2023-2024)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye swelling, Lip swelling, Pruritus, Skin discolouration
Clinical narrative: terrible itching; swelling of face, eyes, lip; Huge hives/hives turn to deep purple marks on skin; swelling of face, eyes, lip; swelling of face, eyes, lip; Huge hives/hives turn to deep purple marks on skin; severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip) and LIP SWELLING (swelling of face, eyes, lip) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031914) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu on 25-Oct-2023. Past adverse reactions to the above products included No adverse event with flu. Concurrent medical conditions included Multiple myeloma and Orthostatic hypotension.    On 25-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 05-Nov-2023, the patient experienced PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip), LIP SWELLING (swelling of face, eyes, lip), URTICARIA (Huge hives/hives turn to deep purple marks on skin) and ARTHRALGIA (severe joint pain). The patient was treated with PREDNISONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency; MORPHINE at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip), LIP SWELLING (swelling of face, eyes, lip), URTICARIA (Huge hives/hives turn to deep purple marks on skin) and ARTHRALGIA (severe joint pain) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. On first ER visit: Prednisone, benedryl, famododine, IV fluids, second ER visit Morphine, Torodol, Benedryl, famodidine, decadron, IV fluids and sent home on 60 mg of prednisone, 25 mg hydroxizine, 40 mg famododine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: terrible itching; swelling of face, eyes, lip; Huge hives/hives turn to deep purple marks on skin; swelling of face, eyes, lip; swelling of face, eyes, lip; Huge hives/hives turn to deep purple marks on skin; severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip) and LIP SWELLING (swelling of face, eyes, lip) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031914) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu on 25-Oct-2023. Past adverse reactions to the above products included No adverse event with flu. Concurrent medical conditions included Multiple myeloma and Orthostatic hypotension.    On 25-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 05-Nov-2023, the patient experienced PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip), LIP SWELLING (swelling of face, eyes, lip), URTICARIA (Huge hives/hives turn to deep purple marks on skin) and ARTHRALGIA (severe joint pain). The patient was treated with PREDNISONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency; MORPHINE at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (terrible itching), SWELLING FACE (swelling of face, eyes, lip), SKIN DISCOLOURATION (Huge hives/hives turn to deep purple marks on skin), EYE SWELLING (swelling of face, eyes, lip), LIP SWELLING (swelling of face, eyes, lip), URTICARIA (Huge hives/hives turn to deep purple marks on skin) and ARTHRALGIA (severe joint pain) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. On first ER visit: Prednisone, benedryl, famododine, IV fluids, second ER visit Morphine, Torodol, Benedryl, famodidine, decadron, IV fluids and sent home on 60 mg of prednisone, 25 mg hydroxizine, 40 mg famododine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Lymphadenopathy, Myalgia
Clinical narrative: swollen lymph nodes; Joint Pain; Weakness; Explosive headache; Muscle pain; fever for 1.5 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and LYMPHADENOPATHY (swollen lymph nodes) in a 60-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.     No Medical History information was reported.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and ARTHRALGIA (Joint Pain). On 13-Nov-2023, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 11-Nov-2023, ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving.            Concomitant medication was not reported.  It was reported that the patient had explosive headache, weakness, joint and muscle pain, fever for 1.5 days, 4 days later, swollen lymph nodes.   Treatment medication was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: swollen lymph nodes; Joint Pain; Weakness; Explosive headache; Muscle pain; fever for 1.5 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and LYMPHADENOPATHY (swollen lymph nodes) in a 60-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.     No Medical History information was reported.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and ARTHRALGIA (Joint Pain). On 13-Nov-2023, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 11-Nov-2023, ASTHENIA (Weakness), HEADACHE (Explosive headache), MYALGIA (Muscle pain), PYREXIA (fever for 1.5 days) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving.            Concomitant medication was not reported.  It was reported that the patient had explosive headache, weakness, joint and muscle pain, fever for 1.5 days, 4 days later, swollen lymph nodes.   Treatment medication was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain in extremity
Clinical narrative: I had to rest for a day, soreness in arm, just normal reactions; she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I had to rest for a day, soreness in arm, just normal reactions) and IMMUNISATION REACTION (she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 15-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I had to rest for a day, soreness in arm, just normal reactions) and IMMUNISATION REACTION (she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong). At the time of the report, PAIN IN EXTREMITY (I had to rest for a day, soreness in arm, just normal reactions) and IMMUNISATION REACTION (she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient mentioned that because she had strong reactions to vaccines, she goes with milder vaccines. She explained that mild one work just as good. Reporter stated that she's had all Moderna vaccine starting with first dose received 3 yrs ago, and with the first one, the reactions were strong, her reactions were milder with the boosters. Some examples reported were, she had to rest for a day, soreness in arm, just normal reactions.  No treatment information was provided.   This case was linked to MOD-2023-749699 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I've taken all Moderna vaccines and had no reaction other than a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I've taken all Moderna vaccines and had no reaction other than a sore arm) in a 7-decade-old female 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 PAIN IN EXTREMITY (I've taken all Moderna vaccines and had no reaction other than a sore arm). At the time of the report, PAIN IN EXTREMITY (I've taken all Moderna vaccines and had no reaction other than a sore arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. Dosage text for suspect drug was reported as unknown. Patient scheduled to get Spikevax in a couple of hours. Patient took all Moderna vaccines and had no reaction other than a sore arm, which she did not consider to be a side effect. Patient did not have Lot information, nor mentioned names of Product.  The treatment medication was not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bronchitis, Diarrhoea, Liver injury, Ocular icterus
Clinical narrative: yellowing of eyes indicating liver damage; yellowing of eyes indicating liver damage; bronchitis; UTI; severe stomach cramping; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of LIVER INJURY (yellowing of eyes indicating liver damage) in a patient of an unknown age and gender 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 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (yellowing of eyes indicating liver damage) (seriousness criterion medically significant), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea). At the time of the report, LIVER INJURY (yellowing of eyes indicating liver damage), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Since receiving the vaccine, the patient experienced yellowing of eyes which indicated liver damage, bronchitis, UTI, severe stomach cramping and diarrhea.  No treatment medications were reported. Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced serious (medically significant) unexpected AESI of liver injury (reported as yellowing of eyes indicating liver damage) which occurred in context of SPIKEVAX 2023-2024 dose administration which was described as unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to event onset date unknown. The event was reported along with non-serious events of ocular icterus, bronchitis, urinary tract infection, abdominal pain upper and diarrhoea. There is no information provided regarding medical history, concomitant medications, diagnostic tests performed, clinical course, etiologic and diagnostic work up with treatment received. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Follow-up information included reference number updated.
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: yellowing of eyes indicating liver damage; yellowing of eyes indicating liver damage; bronchitis; UTI; severe stomach cramping; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of LIVER INJURY (yellowing of eyes indicating liver damage) in a patient of an unknown age and gender 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 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (yellowing of eyes indicating liver damage) (seriousness criterion medically significant), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea). At the time of the report, LIVER INJURY (yellowing of eyes indicating liver damage), OCULAR ICTERUS (yellowing of eyes indicating liver damage), BRONCHITIS (bronchitis), URINARY TRACT INFECTION (UTI), ABDOMINAL PAIN UPPER (severe stomach cramping) and DIARRHOEA (diarrhea) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Since receiving the vaccine, the patient experienced yellowing of eyes which indicated liver damage, bronchitis, UTI, severe stomach cramping and diarrhea.  No treatment medications were reported. Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced serious (medically significant) unexpected AESI of liver injury (reported as yellowing of eyes indicating liver damage) which occurred in context of SPIKEVAX 2023-2024 dose administration which was described as unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to event onset date unknown. The event was reported along with non-serious events of ocular icterus, bronchitis, urinary tract infection, abdominal pain upper and diarrhoea. There is no information provided regarding medical history, concomitant medications, diagnostic tests performed, clinical course, etiologic and diagnostic work up with treatment received. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Follow-up information included reference number updated.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the area between ring and pinky finger.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the area between ring and pinky finger.) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) 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 PAIN IN EXTREMITY (pain in the area between ring and pinky finger.). At the time of the report, PAIN IN EXTREMITY (pain in the area between ring and pinky finger.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2023: Live significant follow-up received on 15 Nov 2023, Reporter, patient, Product, Event information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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.  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 PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient got Moderna last time and she had fever and chills the next day.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2023: Live follow-up information received included updated reference section.