chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the second vaccination shot; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) but missed the second vaccination dose.   The patient's medical history was not provided. Concomitant product use was not reported.   On 14 -an-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 11-Feb-2021, she was scheduled for second dose but missed the vaccination dose due to being in quarantine. No adverse event were reported, and no treatment medications were reported.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event missed the second vaccination dose was considered resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of  Missed dose for mRNA-1273, lot # unknown with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Breakout of hives down both her legs, thighs.; Rash on her mid back.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Breakout of hives down both her legs, thighs.) and RASH (Rash on her mid back.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Hives in September 2020.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced URTICARIA (Breakout of hives down both her legs, thighs.) and RASH (Rash on her mid back.). At the time of the report, URTICARIA (Breakout of hives down both her legs, thighs.) and RASH (Rash on her mid back.) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication included diphenhydramine topical cream.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Having neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Having neck pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NECK PAIN (Having neck pain). At the time of the report, NECK PAIN (Having neck pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was included took  acetaminophen for pain to help her sleep.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received including Event outcome was updated to recovered/resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Headache, Nausea, Pain
Clinical narrative: Trouble swallowing; Rash from neck to torso; High fever of 102.3 F; Chills; Body aches; Headache; Nausea; Intermittent increased heart rate; Swollen face and neck; Swollen face and neck; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever of 102.3 F), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma and COVID-19. Concomitant products included METHIMAZOLE, ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (High fever of 102.3 F), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea), PALPITATIONS (Intermittent increased heart rate), SWELLING FACE (Swollen face and neck), SWELLING (Swollen face and neck) and RASH (Rash from neck to torso). On 04-Mar-2021, the patient experienced DYSPHAGIA (Trouble swallowing). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency and DL- LACTIC ACID (EUCERIN DERMO PURIFYER) ongoing since an unknown date for Rash, at an unspecified dose and frequency. On 04-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), PALPITATIONS (Intermittent increased heart rate) and DYSPHAGIA (Trouble swallowing) had resolved. On 05-Mar-2021, CHILLS (Chills), PAIN (Body aches), SWELLING FACE (Swollen face and neck) and SWELLING (Swollen face and neck) had resolved. At the time of the report, PYREXIA (High fever of 102.3 F) and RASH (Rash from neck to torso) outcome was unknown.    No treatment information was provided.   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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Rash, Swelling, Swelling face
Clinical narrative: Trouble swallowing; Rash from neck to torso; High fever of 102.3 F; Chills; Body aches; Headache; Nausea; Intermittent increased heart rate; Swollen face and neck; Swollen face and neck; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever of 102.3 F), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma and COVID-19. Concomitant products included METHIMAZOLE, ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (High fever of 102.3 F), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea), PALPITATIONS (Intermittent increased heart rate), SWELLING FACE (Swollen face and neck), SWELLING (Swollen face and neck) and RASH (Rash from neck to torso). On 04-Mar-2021, the patient experienced DYSPHAGIA (Trouble swallowing). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency and DL- LACTIC ACID (EUCERIN DERMO PURIFYER) ongoing since an unknown date for Rash, at an unspecified dose and frequency. On 04-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), PALPITATIONS (Intermittent increased heart rate) and DYSPHAGIA (Trouble swallowing) had resolved. On 05-Mar-2021, CHILLS (Chills), PAIN (Body aches), SWELLING FACE (Swollen face and neck) and SWELLING (Swollen face and neck) had resolved. At the time of the report, PYREXIA (High fever of 102.3 F) and RASH (Rash from neck to torso) outcome was unknown.    No treatment information was provided.   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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: mild pain in eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (mild pain in eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Unilateral blindness (at age 40; eye sight did come back), Viral meningitis (at age 40 (diagnosed via spinal tap)) and Optic neuritis (at age 40). Concurrent medical conditions included Rosacea, Degenerative disc disease and Prolapsed disc NOS.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced EYE PAIN (mild pain in eye). At the time of the report, EYE PAIN (mild pain in eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Vaccine leaked out while administering; Vaccine ran down arm; leaked out from patient's arm; A spontaneous report was received from a pharmacist concerning an unknown old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine leaked out while administering.  The patient's medical history and products known to have been used by the patient were not reported.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 029A21A) on 5 Feb 2021,  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, while administering the Moderna COVID-19 Vaccine the vaccine leaked out, a lot of liquid came out of patient's arm. The patient did not developed symptoms.   No treatment information was provided.    No relevant laboratory details were included.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the even is not applicable.  The event, was considered  recovered/resolved.; Reporter's Comments: This report refers to a case of underdose, exposure via skin contact and device connection issue for mRNA-1273 (lot # 029A21A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Stress
Clinical narrative: rash that spread from neck to chest; stress; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash that spread from neck to chest) and STRESS (stress) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Rash (Developing rashes under stress).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH (rash that spread from neck to chest) and STRESS (stress). At the time of the report, RASH (rash that spread from neck to chest) and STRESS (stress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypertension, Pain in extremity
Clinical narrative: Blood pressure was high today; Arm was hurting more; shoulder blades and back were hurting; shoulder blades and back were hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting more), ARTHRALGIA (shoulder blades and back were hurting), BACK PAIN (shoulder blades and back were hurting) and HYPERTENSION (Blood pressure was high today) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event on 05-Mar-2021. Concurrent medical conditions included Diabetes.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting more), ARTHRALGIA (shoulder blades and back were hurting) and BACK PAIN (shoulder blades and back were hurting). On 05-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was high today). On 05-Mar-2021, PAIN IN EXTREMITY (Arm was hurting more), ARTHRALGIA (shoulder blades and back were hurting) and BACK PAIN (shoulder blades and back were hurting) had resolved. At the time of the report, HYPERTENSION (Blood pressure was high today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.     This case was linked to MOD21-046711 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-046711:Crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Dysgeusia, Erythema, Headache
Clinical narrative: Whole upper arm was red, sore and itchy; Whole upper arm was red, sore and itchy; Reaction site was very hot; Whole upper arm was red, sore and itchy; Developed a fairly large rash on her arm where the vaccine was given; Slept all day/ slept for many hours; Running a temp of 100.5 F; dizzy; nauseated; Major headache; Metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), HYPERSOMNIA (Slept all day/ slept for many hours), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy) and PAIN (Whole upper arm was red, sore and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MC0A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  No treatment information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated). On 05-Mar-2021, the patient experienced HYPERSOMNIA (Slept all day/ slept for many hours). On 06-Mar-2021, the patient experienced PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given). On 05-Mar-2021, HYPERSOMNIA (Slept all day/ slept for many hours) had resolved. On 06-Mar-2021, DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Injection site warmth, Nausea, Pain, Pruritus
Clinical narrative: Whole upper arm was red, sore and itchy; Whole upper arm was red, sore and itchy; Reaction site was very hot; Whole upper arm was red, sore and itchy; Developed a fairly large rash on her arm where the vaccine was given; Slept all day/ slept for many hours; Running a temp of 100.5 F; dizzy; nauseated; Major headache; Metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), HYPERSOMNIA (Slept all day/ slept for many hours), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy) and PAIN (Whole upper arm was red, sore and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MC0A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  No treatment information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated). On 05-Mar-2021, the patient experienced HYPERSOMNIA (Slept all day/ slept for many hours). On 06-Mar-2021, the patient experienced PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given). On 05-Mar-2021, HYPERSOMNIA (Slept all day/ slept for many hours) had resolved. On 06-Mar-2021, DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Whole upper arm was red, sore and itchy; Whole upper arm was red, sore and itchy; Reaction site was very hot; Whole upper arm was red, sore and itchy; Developed a fairly large rash on her arm where the vaccine was given; Slept all day/ slept for many hours; Running a temp of 100.5 F; dizzy; nauseated; Major headache; Metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), HYPERSOMNIA (Slept all day/ slept for many hours), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy) and PAIN (Whole upper arm was red, sore and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015MC0A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  No treatment information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated). On 05-Mar-2021, the patient experienced HYPERSOMNIA (Slept all day/ slept for many hours). On 06-Mar-2021, the patient experienced PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given). On 05-Mar-2021, HYPERSOMNIA (Slept all day/ slept for many hours) had resolved. On 06-Mar-2021, DYSGEUSIA (Metallic taste in her mouth), BODY TEMPERATURE INCREASED (Running a temp of 100.5 F), DIZZINESS (dizzy), HEADACHE (Major headache) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN (Whole upper arm was red, sore and itchy), PRURITUS (Whole upper arm was red, sore and itchy), INJECTION SITE WARMTH (Reaction site was very hot), ERYTHEMA (Whole upper arm was red, sore and itchy) and VACCINATION SITE RASH (Developed a fairly large rash on her arm where the vaccine was given) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: very severe itching sensation; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very severe itching sensation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRURITUS (very severe itching sensation). At the time of the report, PRURITUS (very severe itching sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Food refusal, Musculoskeletal discomfort
Clinical narrative: dry heaving; shoulder feels like it's on fire; sick to his stomach; dizzy; afraid to eat; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (dry heaving), MUSCULOSKELETAL DISCOMFORT (shoulder feels like it's on fire), ABDOMINAL DISCOMFORT (sick to his stomach), DIZZINESS (dizzy) and FOOD REFUSAL (afraid to eat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First dose received on unspecified date). Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (dry heaving), MUSCULOSKELETAL DISCOMFORT (shoulder feels like it's on fire), ABDOMINAL DISCOMFORT (sick to his stomach), DIZZINESS (dizzy), FOOD REFUSAL (afraid to eat) and NAUSEA (nauseated). At the time of the report, DYSPNOEA (dry heaving), MUSCULOSKELETAL DISCOMFORT (shoulder feels like it's on fire), ABDOMINAL DISCOMFORT (sick to his stomach), DIZZINESS (dizzy), FOOD REFUSAL (afraid to eat) and NAUSEA (nauseated) outcome was unknown.            No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dry heaving; shoulder feels like it's on fire; sick to his stomach; dizzy; afraid to eat; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (dry heaving), MUSCULOSKELETAL DISCOMFORT (shoulder feels like it's on fire), ABDOMINAL DISCOMFORT (sick to his stomach), DIZZINESS (dizzy) and FOOD REFUSAL (afraid to eat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE (First dose received on unspecified date). Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (dry heaving), MUSCULOSKELETAL DISCOMFORT (shoulder feels like it's on fire), ABDOMINAL DISCOMFORT (sick to his stomach), DIZZINESS (dizzy), FOOD REFUSAL (afraid to eat) and NAUSEA (nauseated). At the time of the report, DYSPNOEA (dry heaving), MUSCULOSKELETAL DISCOMFORT (shoulder feels like it's on fire), ABDOMINAL DISCOMFORT (sick to his stomach), DIZZINESS (dizzy), FOOD REFUSAL (afraid to eat) and NAUSEA (nauseated) outcome was unknown.            No treatment information was provided.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate
Clinical narrative: Had my blood pressure 190/97 and pulse was 83 for 5 hours; A spontaneous report was received from a consumer concerning a 62 years old male patient who experienced a blood pressure 190/97 (blood pressure increased).  The patient's medical history included pacemaker insertion. Concomitant medications included metoprolol, lisinopril, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, and salbutamol sulfate.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced a blood pressure reading of 190/97 and his pulse was 83 for 5 hours. The patient called his cardiologist who placed a pacer in his heart, and he was advised to take an extra dose of metoprolol, 20 minutes later RR went down to 180.  Treatment included extra dose of Metoprolol (05 Mar 2021).  Action taken with mRNA-1273 in response to the event was not reported.   The event, a blood pressure 190/97 (blood pressure increased), was considered recovering.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Amnesia, Chills, Disorientation, Dyspepsia
Clinical narrative: very sick,very sick for atleast a week or more; problems with memory; blurred vision; Brain fog; have lost all since of time space and location; feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine; memory loss; gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines; Pain; Stomach on fire, very bad stomach problems; Chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision) and FEELING ABNORMAL (Brain fog) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Very tired). On 07-Mar-2021, the patient experienced PAIN (Pain) and DYSPEPSIA (Stomach on fire, very bad stomach problems). On an unknown date, the patient experienced ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines). At the time of the report, PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), CHILLS (Chills) and FATIGUE (Very tired) outcome was unknown and AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Email On 18-May-2021: Email: New AEs added. Ongoing issues. On 10-Jul-2021: Email included additional events (temporo-spatial disorientation, feeling hot, memory loss, feeling abnormal, abdominal discomfort), outcome of events memory loss and abdominal discomfort.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Illness, Memory impairment
Clinical narrative: very sick,very sick for atleast a week or more; problems with memory; blurred vision; Brain fog; have lost all since of time space and location; feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine; memory loss; gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines; Pain; Stomach on fire, very bad stomach problems; Chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision) and FEELING ABNORMAL (Brain fog) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Very tired). On 07-Mar-2021, the patient experienced PAIN (Pain) and DYSPEPSIA (Stomach on fire, very bad stomach problems). On an unknown date, the patient experienced ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines). At the time of the report, PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), CHILLS (Chills) and FATIGUE (Very tired) outcome was unknown and AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Email On 18-May-2021: Email: New AEs added. Ongoing issues. On 10-Jul-2021: Email included additional events (temporo-spatial disorientation, feeling hot, memory loss, feeling abnormal, abdominal discomfort), outcome of events memory loss and abdominal discomfort.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vision blurred
Clinical narrative: very sick,very sick for atleast a week or more; problems with memory; blurred vision; Brain fog; have lost all since of time space and location; feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine; memory loss; gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines; Pain; Stomach on fire, very bad stomach problems; Chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision) and FEELING ABNORMAL (Brain fog) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Very tired). On 07-Mar-2021, the patient experienced PAIN (Pain) and DYSPEPSIA (Stomach on fire, very bad stomach problems). On an unknown date, the patient experienced ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines). At the time of the report, PAIN (Pain), DYSPEPSIA (Stomach on fire, very bad stomach problems), ILLNESS (very sick,very sick for atleast a week or more), VISION BLURRED (blurred vision), FEELING ABNORMAL (Brain fog), DISORIENTATION (have lost all since of time space and location), FEELING HOT (feeling of very hot sensation heat of some type passing through my intestines/passing some heat through my intestine), CHILLS (Chills) and FATIGUE (Very tired) outcome was unknown and AMNESIA (memory loss) and ABDOMINAL DISCOMFORT (gut discomfort/ very bad stomachic problems feels like hot claw marks in my intestines) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Email On 18-May-2021: Email: New AEs added. Ongoing issues. On 10-Jul-2021: Email included additional events (temporo-spatial disorientation, feeling hot, memory loss, feeling abnormal, abdominal discomfort), outcome of events memory loss and abdominal discomfort.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accident at home, Dizziness, Headache, Nausea, Somnolence
Clinical narrative: An accident and fractured her toe and sprained her ankle; Vertigo; Drowsiness; Dizziness; Worst headache she had in 6 months; Extreme nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENT AT HOME (An accident and fractured her toe and sprained her ankle), VERTIGO (Vertigo), SOMNOLENCE (Drowsiness), DIZZINESS (Dizziness) and HEADACHE (Worst headache she had in 6 months) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (She has a titanium knee), Arthritis and X-ray on 03-Mar-2021.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Mar-2021, the patient experienced ACCIDENT AT HOME (An accident and fractured her toe and sprained her ankle), VERTIGO (Vertigo), SOMNOLENCE (Drowsiness), HEADACHE (Worst headache she had in 6 months) and NAUSEA (Extreme nausea). 02-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, ACCIDENT AT HOME (An accident and fractured her toe and sprained her ankle), VERTIGO (Vertigo), SOMNOLENCE (Drowsiness), DIZZINESS (Dizziness) and HEADACHE (Worst headache she had in 6 months) outcome was unknown and NAUSEA (Extreme nausea) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: An accident and fractured her toe and sprained her ankle; Vertigo; Drowsiness; Dizziness; Worst headache she had in 6 months; Extreme nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACCIDENT AT HOME (An accident and fractured her toe and sprained her ankle), VERTIGO (Vertigo), SOMNOLENCE (Drowsiness), DIZZINESS (Dizziness) and HEADACHE (Worst headache she had in 6 months) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (She has a titanium knee), Arthritis and X-ray on 03-Mar-2021.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Mar-2021, the patient experienced ACCIDENT AT HOME (An accident and fractured her toe and sprained her ankle), VERTIGO (Vertigo), SOMNOLENCE (Drowsiness), HEADACHE (Worst headache she had in 6 months) and NAUSEA (Extreme nausea). 02-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, ACCIDENT AT HOME (An accident and fractured her toe and sprained her ankle), VERTIGO (Vertigo), SOMNOLENCE (Drowsiness), DIZZINESS (Dizziness) and HEADACHE (Worst headache she had in 6 months) outcome was unknown and NAUSEA (Extreme nausea) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema
Clinical narrative: red spot has become elongated and is traveling down the patient's arm; red spot on arm at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot has become elongated and is traveling down the patient's arm) and VACCINATION SITE ERYTHEMA (red spot on arm at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red spot has become elongated and is traveling down the patient's arm) and VACCINATION SITE ERYTHEMA (red spot on arm at injection site). At the time of the report, RASH MACULAR (red spot has become elongated and is traveling down the patient's arm) and VACCINATION SITE ERYTHEMA (red spot on arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Lot of pressure in the brain; pain in head; R arm is in pain; A spontaneous report was received from a consumer (patient's son) concerning a 74-year-old elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "lot of pressure in the brain, pain in head and R arm is in pain.  The patient's medical history included Parkinson, diabetes type 2 and thyroid. Concomitant product use was provided by the reporter.  On 04 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 029A21A) via unknown route in right arm for COVID-19 infection prophylaxis.  On 04 Mar 2021, after first dose of vaccine, the patient had lot of pressure in the brain, pain in his head and all the R arm is in pain. Treatment medication included Acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events lot of pressure in the brain, pain in his head and R arm is in pain was unknown at the time of this report.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Heart rate increased, Palpitations
Clinical narrative: Palpitation; Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation) and HEART RATE INCREASED (Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first 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. On 04-Mar-2021, the patient experienced PALPITATIONS (Palpitation) and HEART RATE INCREASED (Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm). At the time of the report, PALPITATIONS (Palpitation) and HEART RATE INCREASED (Her heartbeat is 20 bpm higher than usual.generally at 60 bpm but has increased to 80 to 90 bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate abnormal (60-60): increased 80-90 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lab data : Heart beat increased by 20 bpm. Normal is 60 bpm, increased to 80-90 bpm.  No concomitant medication information provided.  Treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: slight headache this morning; sore arm; felt a chill last night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (felt a chill last night) and HEADACHE (slight headache this morning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (felt a chill last night). On 05-Mar-2021, the patient experienced HEADACHE (slight headache this morning). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (felt a chill last night) had resolved. On 05-Mar-2021, HEADACHE (slight headache this morning) had resolved.            No concomitant medications provided. Treatment included 2 doses of Excedrin and increased water intake.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Head discomfort, Headache, Malaise
Clinical narrative: headache; chills; didn't feel well; well. In the evening had a fever of over 100F; could not get warm; "not feeling great in her head"; arm became extremely sore /could barely lift it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm became extremely sore /could barely lift it), HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well) and PYREXIA (well. In the evening had a fever of over 100F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm became extremely sore /could barely lift it). On 04-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well), PYREXIA (well. In the evening had a fever of over 100F), FEELING COLD (could not get warm) and HEAD DISCOMFORT ("not feeling great in her head"). At the time of the report, PAIN IN EXTREMITY (arm became extremely sore /could barely lift it), HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well), PYREXIA (well. In the evening had a fever of over 100F), FEELING COLD (could not get warm) and HEAD DISCOMFORT ("not feeling great in her head") outcome was unknown.            No relevant concomitant medication was reported.  Treatment details included, acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: headache; chills; didn't feel well; well. In the evening had a fever of over 100F; could not get warm; "not feeling great in her head"; arm became extremely sore /could barely lift it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm became extremely sore /could barely lift it), HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well) and PYREXIA (well. In the evening had a fever of over 100F) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm became extremely sore /could barely lift it). On 04-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well), PYREXIA (well. In the evening had a fever of over 100F), FEELING COLD (could not get warm) and HEAD DISCOMFORT ("not feeling great in her head"). At the time of the report, PAIN IN EXTREMITY (arm became extremely sore /could barely lift it), HEADACHE (headache), CHILLS (chills), MALAISE (didn't feel well), PYREXIA (well. In the evening had a fever of over 100F), FEELING COLD (could not get warm) and HEAD DISCOMFORT ("not feeling great in her head") outcome was unknown.            No relevant concomitant medication was reported.  Treatment details included, acetaminophen.