chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acrochordon, Acrochordon excision
Clinical narrative: Skin tag removal; Skin tag; This spontaneous case was reported by a consumer and describes the occurrence of ACROCHORDON (Skin tag) and ACROCHORDON EXCISION (Skin tag removal) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included Dry cough on 14-Dec-2020, Exhaustion on 14-Dec-2020 and Fatigue on 14-Dec-2020. Concurrent medical conditions included Loss of taste since 14-Dec-2020 and Loss of smell since 14-Dec-2020. Concomitant products included ALPRAZOLAM (XANAX) from 10-Oct-2005 to an unknown date for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 2013 to an unknown date for GERD, VERAPAMIL from 10-May-1999 to an unknown date for Migraine, MULTIVITAMIN [VITAMINS NOS] from June 2002 to an unknown date for Routine health maintenance, TRAZODONE from 12-Jul-2010 to an unknown date for Sleep disorder therapy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ACROCHORDON (Skin tag). On an unknown date, the patient experienced ACROCHORDON EXCISION (Skin tag removal). At the time of the report, ACROCHORDON (Skin tag) and ACROCHORDON EXCISION (Skin tag removal) had resolved.            Treatment medications were unknown.   This case was linked to MOD-2021-065988 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills; fever; nausea; pain in my arm was more sharp; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain in my arm was more sharp), CHILLS (chills) and PYREXIA (fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Bleeding nose (Bloody nose after receiving the flu shot). Concurrent medical conditions included Drug allergy (Since childhood, cannot take aspirin due to thin blood).   On 14-Apr-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 12-May-2021 at 7:00 PM, the patient experienced NAUSEA (nausea) and VACCINATION SITE PAIN (pain in my arm was more sharp). On 13-May-2021 at 4:00 AM, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (IBALGIN) for Adverse event, at a dose of 400 milligram. On 13-May-2021, CHILLS (chills) had resolved. On 13-May-2021 at 12:00 PM, VACCINATION SITE PAIN (pain in my arm was more sharp) had resolved. On 14-May-2021, NAUSEA (nausea) had resolved. On 14-May-2021 at 11:00 PM, PYREXIA (fever) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Body temperature: 100.5 (High) Fever.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant medications were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills; fever; nausea; pain in my arm was more sharp; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain in my arm was more sharp), CHILLS (chills) and PYREXIA (fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Bleeding nose (Bloody nose after receiving the flu shot). Concurrent medical conditions included Drug allergy (Since childhood, cannot take aspirin due to thin blood).   On 14-Apr-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 12-May-2021 at 7:00 PM, the patient experienced NAUSEA (nausea) and VACCINATION SITE PAIN (pain in my arm was more sharp). On 13-May-2021 at 4:00 AM, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (IBALGIN) for Adverse event, at a dose of 400 milligram. On 13-May-2021, CHILLS (chills) had resolved. On 13-May-2021 at 12:00 PM, VACCINATION SITE PAIN (pain in my arm was more sharp) had resolved. On 14-May-2021, NAUSEA (nausea) had resolved. On 14-May-2021 at 11:00 PM, PYREXIA (fever) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Body temperature: 100.5 (High) Fever.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: negative reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE REACTION (negative reaction) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information provided by reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (negative reaction). At the time of the report, ADVERSE REACTION (negative reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant or treatment medications provided by reporter. Reporter states the consumer does not want to receive the second dose of Moderna vaccine due to negative reaction that happened after first dose. The consumer would like to receive the Pfizer Covid-19 vaccination as her second dose but has not done so yet.    Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye; Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye) and VISUAL IMPAIRMENT (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulpha), GERD and Blood pressure high (Higher since vaccination). Concomitant products included METOPROLOL SUCCINATE (TOPROL) for Blood pressure high, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, PANTOPRAZOLE for GERD, AMLODIPINE and ALPRAZOLAM (ZOLAX [ALPRAZOLAM]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VISION BLURRED (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye) and VISUAL IMPAIRMENT (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, VISION BLURRED (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color."/Film over rt eye) and VISUAL IMPAIRMENT (Vision in her right eye became blurry, "greyed out" and she saw "bolts of color.\ Flashes of color/shapes) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported blood pressure fluctuation and noted high blood pressure since vaccination.   This case was linked to MOD-2021-152857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Follow up for AE Contact/Patient Details Update On 05-Jul-2021: Patient demography, medical history, concomitant medication and event outcome updated.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Moderna shot today, received Pfizer shot in Mar 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Moderna shot today, received Pfizer shot in Mar 2021) in a female patient of an unknown age 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 February 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1. In March 2021, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 2. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Moderna shot today, received Pfizer shot in Mar 2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Moderna shot today, received Pfizer shot in Mar 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Interchange of Vaccines. No concomitant medications were reported by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No concomitant medications was reported. No Medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in arm). At the time of the report, VACCINATION SITE PAIN (Pain in arm) outcome was unknown.            No allergies, current illness, lab data and medical history was reported by patient.  No concurrent and treatment medication was reported by patient.  Patient reported that she had pain in arm after 1 dose and no adverse events after 2 dose. patient received 1 dose of COVID-19 Vaccine manufactured by Moderna, on an unknown date and patient received 2 dose of COVID-19 Vaccine manufactured by Moderna.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-may-2021 contains Email_Clarification of suspect product On 25-May-2021: Follow up received on 25- may-2021 contains Initial Additional-2 document which contains Clarification on suspect drug and narrative
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (very sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The reporter was a sister to the male patient. No medical history and patient information were provided. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) had resolved. The reporter was a sister to the male patient. No medical history and patient information were provided. The patient did not seek medical intervention  This case was linked to MOD-2021-129280.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications information not provided. Treatment medications information not provided   This case was linked to MOD-2021-129280, MOD-2021-153078 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Headache, SARS-CoV-2 test, Vomiting
Clinical narrative: diarrhea; headache; vomiting; Covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive), DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 02A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced COVID-19 (Covid positive). On an unknown date, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting). At the time of the report, COVID-19 (Covid positive), DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: bump on my left index finger popped up/ I was told it was osteoarthritis; pain while walking and going up stairs; welt, that was a size of a softball, but flat; Fever; Body ache; Tired; Left knee pain/shoulder pain; ganglion cyst; welt size of softball on arm/bump on index finger; ringing in left ear; rash; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (ganglion cyst), PERIPHERAL SWELLING (welt size of softball on arm/bump on index finger), TINNITUS (ringing in left ear), OSTEOARTHRITIS (bump on my left index finger popped up/ I was told it was osteoarthritis) and PAIN IN EXTREMITY (pain while walking and going up stairs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Sulfur antibiotic- Rash all over body, swelling, itchy and throat closing) since 2018. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal congestion.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SYNOVIAL CYST (ganglion cyst), PERIPHERAL SWELLING (welt size of softball on arm/bump on index finger), TINNITUS (ringing in left ear), RASH (rash) and ARTHRALGIA (Left knee pain/shoulder pain). On an unknown date, the patient experienced OSTEOARTHRITIS (bump on my left index finger popped up/ I was told it was osteoarthritis), PAIN IN EXTREMITY (pain while walking and going up stairs), URTICARIA (welt, that was a size of a softball, but flat), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) at a dose of UNK dosage form. At the time of the report, SYNOVIAL CYST (ganglion cyst), PERIPHERAL SWELLING (welt size of softball on arm/bump on index finger), TINNITUS (ringing in left ear), OSTEOARTHRITIS (bump on my left index finger popped up/ I was told it was osteoarthritis), PAIN IN EXTREMITY (pain while walking and going up stairs), URTICARIA (welt, that was a size of a softball, but flat), RASH (rash), PYREXIA (Fever), ARTHRALGIA (Left knee pain/shoulder pain), MYALGIA (Body ache) and FATIGUE (Tired) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-154482 (E2B Linked Report). This case was linked to MOD-2021-153684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant follow up appended- Patient demographic details, Past Medical history, Concomitant medications and new Events updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154482:Crosslinked case of reporter second dose
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Insomnia) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced INSOMNIA (Insomnia). The patient was treated with MELATONIN at an unspecified dose and frequency and EMERGEN C at an unspecified dose and frequency. On 12-May-2021, INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications information were not reported  Treatment medications also include sleep aid herbal relaxing. Patient had normal sleep after sixth day of vaccination
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received 1st dose of Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up report  received on 06 Jul 2021 included non-significant information On 20-Jul-2021: Follow up report  received on 20 Jul 2021 included non-significant information
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: sore arm; vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge) and PAIN IN EXTREMITY (sore arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (vaccine from expired vial has been administered/was past the 12 hours puncture time.  Vial had been kept cold in the fridge) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155542, US-MODERNATX, INC.-MOD-2021-155523 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up information received.  Reporter details.  Medical history.  Vaccination batch number, time and site of administration.  Event verbatim updated and added event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155542: US-MODERNATX, INC.-MOD-2021-155523:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Myalgia, Paraesthesia
Clinical narrative: tingling in hand and buttocks; itchiness; burning sensation in the hand and buttocks; Dizziness; Body aches; Joint pain that still did not go away; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in hand and buttocks), PRURITUS (itchiness), BURNING SENSATION (burning sensation in the hand and buttocks), DIZZINESS (Dizziness) and MYALGIA (Body aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling in hand and buttocks), PRURITUS (itchiness), BURNING SENSATION (burning sensation in the hand and buttocks), DIZZINESS (Dizziness), MYALGIA (Body aches) and ARTHRALGIA (Joint pain that still did not go away). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling in hand and buttocks), PRURITUS (itchiness), BURNING SENSATION (burning sensation in the hand and buttocks), DIZZINESS (Dizziness), MYALGIA (Body aches) and ARTHRALGIA (Joint pain that still did not go away) had not resolved.            No concomitant medication was reported by the reporter.  Reported additional treatment was Advil.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up received
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: tingling in hand and buttocks; itchiness; burning sensation in the hand and buttocks; Dizziness; Body aches; Joint pain that still did not go away; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in hand and buttocks), PRURITUS (itchiness), BURNING SENSATION (burning sensation in the hand and buttocks), DIZZINESS (Dizziness) and MYALGIA (Body aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling in hand and buttocks), PRURITUS (itchiness), BURNING SENSATION (burning sensation in the hand and buttocks), DIZZINESS (Dizziness), MYALGIA (Body aches) and ARTHRALGIA (Joint pain that still did not go away). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling in hand and buttocks), PRURITUS (itchiness), BURNING SENSATION (burning sensation in the hand and buttocks), DIZZINESS (Dizziness), MYALGIA (Body aches) and ARTHRALGIA (Joint pain that still did not go away) had not resolved.            No concomitant medication was reported by the reporter.  Reported additional treatment was Advil.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up received
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concurrent medical conditions included Drug allergy (Sulfa allergy), Penicillin allergy and Allergy. Concomitant products included DIPHENHYDRAMINE, ZOLPIDEM TARTRATE (AMBIEN), FISH OIL, PROBIOTICS NOS and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Treatment information was not provided.   This case was linked to MOD21-050623, US-MODERNATX, INC.-MOD-2021-041005 (E2B Linked Report).; Sender's Comments:  MOD21-050623: US-MODERNATX, INC.-MOD-2021-041005:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chest pain, Illness, Lymphadenopathy
Clinical narrative: Abdomen pain; chest pain; back pain; He got sick; Early this morning, he started feeling nauseous; Yesterday, his lymph nodes on left side were swollen; By next day, pain radiated to the entire arm, Today, the pain is in his left arm; After receiving 2nd dose, on same day, he started with pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick) and VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No historical conditions were reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-May-2021, the patient experienced VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site). On 17-May-2021, the patient experienced MYALGIA (By next day, pain radiated to the entire arm, Today, the pain is in his left arm). On 19-May-2021, the patient experienced LYMPHADENOPATHY (Yesterday, his lymph nodes on left side were swollen). On 20-May-2021, the patient experienced ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick) and NAUSEA (Early this morning, he started feeling nauseous). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick), VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site), MYALGIA (By next day, pain radiated to the entire arm, Today, the pain is in his left arm), LYMPHADENOPATHY (Yesterday, his lymph nodes on left side were swollen) and NAUSEA (Early this morning, he started feeling nauseous) outcome was unknown.            No concomitant drugs were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: Abdomen pain; chest pain; back pain; He got sick; Early this morning, he started feeling nauseous; Yesterday, his lymph nodes on left side were swollen; By next day, pain radiated to the entire arm, Today, the pain is in his left arm; After receiving 2nd dose, on same day, he started with pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick) and VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No historical conditions were reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-May-2021, the patient experienced VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site). On 17-May-2021, the patient experienced MYALGIA (By next day, pain radiated to the entire arm, Today, the pain is in his left arm). On 19-May-2021, the patient experienced LYMPHADENOPATHY (Yesterday, his lymph nodes on left side were swollen). On 20-May-2021, the patient experienced ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick) and NAUSEA (Early this morning, he started feeling nauseous). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick), VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site), MYALGIA (By next day, pain radiated to the entire arm, Today, the pain is in his left arm), LYMPHADENOPATHY (Yesterday, his lymph nodes on left side were swollen) and NAUSEA (Early this morning, he started feeling nauseous) outcome was unknown.            No concomitant drugs were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (issues of high blood pressure, since last night his pressure has gone up, 16 for the highest and 10 for lowest.), PYREXIA (Woke up with a bit of fever) and HEADACHE (Woke up with a headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Seasonal allergy (seasonal allergies to pollen in spring). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, LOSARTAN for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced HYPERTENSION (issues of high blood pressure, since last night his pressure has gone up, 16 for the highest and 10 for lowest.). On 20-May-2021, the patient experienced PYREXIA (Woke up with a bit of fever) and HEADACHE (Woke up with a headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at a dose of 1 dosage form. At the time of the report, HYPERTENSION (issues of high blood pressure, since last night his pressure has gone up, 16 for the highest and 10 for lowest.), PYREXIA (Woke up with a bit of fever) and HEADACHE (Woke up with a headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood pressure measurement: high (High) Blood pressure has gone up, 16 for the highest and 10 for lowest. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Chills, Cough
Clinical narrative: cough; Maybe he had a coronavirus cold at some point; Terrible headache/headache; Feels like he has a cold much of the time; Chest tightness; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough), SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) and HEADACHE (Terrible headache/headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030l20a and 042l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN from 01-Jan-2018 to an unknown date for Heart disease, unspecified, VITAMIN D [VITAMIN D NOS] from 01-Jan-2019 to an unknown date and PROBIOTICS NOS from 01-Jan-2017 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness) and HEADACHE (Terrible headache/headache). On an unknown date, the patient experienced COUGH (cough) and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point). On 27-Feb-2021, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough) and HEADACHE (Terrible headache/headache) had not resolved and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: 110/66 (normal) 110/66 mmHg. On 21-May-2021, Body temperature: 96.6 (normal) 96.6 F. On 21-May-2021, Heart rate: 64 (normal) 64 beats per minute. On 21-May-2021, Respiratory rate: 16 breaths per minute (normal) 16 breaths per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up appended. Concomitant medications added, new events was updated, outcome was updated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Nasopharyngitis, Respiratory rate
Clinical narrative: cough; Maybe he had a coronavirus cold at some point; Terrible headache/headache; Feels like he has a cold much of the time; Chest tightness; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough), SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) and HEADACHE (Terrible headache/headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030l20a and 042l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN from 01-Jan-2018 to an unknown date for Heart disease, unspecified, VITAMIN D [VITAMIN D NOS] from 01-Jan-2019 to an unknown date and PROBIOTICS NOS from 01-Jan-2017 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness) and HEADACHE (Terrible headache/headache). On an unknown date, the patient experienced COUGH (cough) and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point). On 27-Feb-2021, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough) and HEADACHE (Terrible headache/headache) had not resolved and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: 110/66 (normal) 110/66 mmHg. On 21-May-2021, Body temperature: 96.6 (normal) 96.6 F. On 21-May-2021, Heart rate: 64 (normal) 64 beats per minute. On 21-May-2021, Respiratory rate: 16 breaths per minute (normal) 16 breaths per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up appended. Concomitant medications added, new events was updated, outcome was updated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: cough; Maybe he had a coronavirus cold at some point; Terrible headache/headache; Feels like he has a cold much of the time; Chest tightness; Chills; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough), SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) and HEADACHE (Terrible headache/headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030l20a and 042l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN from 01-Jan-2018 to an unknown date for Heart disease, unspecified, VITAMIN D [VITAMIN D NOS] from 01-Jan-2019 to an unknown date and PROBIOTICS NOS from 01-Jan-2017 to an unknown date for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness) and HEADACHE (Terrible headache/headache). On an unknown date, the patient experienced COUGH (cough) and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point). On 27-Feb-2021, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, NASOPHARYNGITIS (Feels like he has a cold much of the time), CHEST DISCOMFORT (Chest tightness), COUGH (cough) and HEADACHE (Terrible headache/headache) had not resolved and SUSPECTED COVID-19 (Maybe he had a coronavirus cold at some point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood pressure measurement: 110/66 (normal) 110/66 mmHg. On 21-May-2021, Body temperature: 96.6 (normal) 96.6 F. On 21-May-2021, Heart rate: 64 (normal) 64 beats per minute. On 21-May-2021, Respiratory rate: 16 breaths per minute (normal) 16 breaths per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up appended. Concomitant medications added, new events was updated, outcome was updated.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: cannot lift anything up or drive; painful arm between the elbow and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). At the time of the report, MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder) outcome was unknown.            No concomitant medications were reported No treatment information provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Night sweats, Peripheral swelling, Tenderness
Clinical narrative: night sweat; chills; swelling at the right arm; tenderness at the right arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling at the right arm), TENDERNESS (tenderness at the right arm), NIGHT SWEATS (night sweat) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 17-May-2021, the patient experienced PERIPHERAL SWELLING (swelling at the right arm) and TENDERNESS (tenderness at the right arm). On 18-May-2021, the patient experienced NIGHT SWEATS (night sweat) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling at the right arm), TENDERNESS (tenderness at the right arm), NIGHT SWEATS (night sweat) and CHILLS (chills) had not resolved.            no concomitant medications and treatment details reported.