chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dyskinesia, Pain
Clinical narrative: spine pain is more localized to the area of injury; brain fog, was a little bit disoriented; muscle jumping a little bit in my hands; A spontaneous report was received from a nurse concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine and experienced brain fog, a little disoriented, muscle jumping in her hands, spinal pain was more localized. The patient's medical history, as provided by the reporter, included frozen shoulder, inability to raise her arms up, broken right shoulder (2015), shoulder surgery (2016), severe arthritis in her spine, back surgery, spinal pain and spinal injury (2000). Concomitant medications reported included levothyroxine, pravastatin, apixaban, hydrocodone/acetaminophen and hydrochlorothiazide.  On 29 Dec 2020 at approximately 11:00AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29 Dec 2020, approximately one and half hours after receiving the mRNA-1273 vaccination, the patient experienced brain fog and was a little disoriented at lunch and her muscles were jumping in her hands. So much so that she "knocked my drink over" at lunch.   On 30 Dec 2020, the patient noticed an improvement in her movement and agility. She was now able to raise her arm about 70 degrees and lean down to pick up toys. She stated her back leg raised up, like kids do. She noticed an improvement in the spinal pain. It was more localized now, rather than involving her whole spine. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, brain fog, a little disoriented, muscle jumping in her hands, ability to now raise her arm about 70 degrees, ability to lean down to pick up items, spinal pain was more localized, and improvement in her arthritic pain, movement and agility were unknown.  The reporter's assessment of causality of the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of severe arthritis in her spine, back surgery, spinal pain and spinal injury remains confounder.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Both hands are swelling; Hives all over both arm which is itchy; Hives all over both arm which is itchy; A spontaneous report was received from a consumer concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and who developed hives all over both arms which was itchy and both hands were swelling.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29 Dec 2020 the patient received his first of two planned doses of mRNA-1273 (LOT-025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, 2 to 3 days after vaccination he started having hives all over both arm which was itchy.  On 03 Jan 2021, both of his hands had begun to swell.   Treatment for the event included diphenhydramine.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of hives all over both arms which was itchy and both hands were swelling were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site pain, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: soreness of the arm; cough; sore throat; lymph nodes on right side of neck have swelled; in pain; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm/injection site pain, cough, sore throat/oropharyngeal pain, swollen lymph nodes/lymphadenopathy and pain.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient began to experience soreness of the arm and developed a cough and sore throat that progressively had gotten worse. She reported swollen lymph nodes on the side of her neck with pain radiating from her right side to her ear.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, soreness of the arm, cough, sore throat, swollen lymph nodes and pain, were considered unknown.  ; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Skin lesion
Clinical narrative: Light numbness on her right middle face; sore on arm; Little sore and hurt her right arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Light numbness on her right middle face), SKIN LESION (sore on arm) and PAIN IN EXTREMITY (Little sore and hurt her right arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02sl20a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CABERGOLINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SKIN LESION (sore on arm) and PAIN IN EXTREMITY (Little sore and hurt her right arm). On 07-Jan-2021 at 12:30 AM, the patient experienced HYPOAESTHESIA (Light numbness on her right middle face). At the time of the report, HYPOAESTHESIA (Light numbness on her right middle face) outcome was unknown and SKIN LESION (sore on arm) and PAIN IN EXTREMITY (Little sore and hurt her right arm) was resolving.        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.   Concomitant medications included allergy medication.  The patient started experiencing some light numbness on her right middle face, she could move her lips and nose, but it felt different, also had a little sore and hurt a little bit her right arm.  No treatment information was provided.  Company comment: This case concerns a 37-year-old female who experienced NS unexpected events of facial hypoesthesia and skin lesion and NS expected event of pain in extremity.  Event onset occurred 30 minutes after the first dose of mRNA-1273. Treatment not reported. Arm pain and skin lesion resolving, but other outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 37-year-old female who experienced NS unexpected events of facial hypoaesthesia and skin lesion and NS expected event of pain in extremity.  Event onset occurred 30 minutes after the first dose of mRNA-1273. Treatment not reported. Arm pain and skin lesion resolving, but other outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Injection site pain
Clinical narrative: chills; loss of taste; soreness to arm (left arm injection site); A spontaneous report was received from a  female consumer patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of arm injection site on the 1st and 2nd day, chills and loss of taste.  The patient's medical history was not provided. No concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced soreness at the injection site.   On 07 Jan 2021, the patient developed chills and loss of taste. The patient reported that she took her temperature, but it was within normal range. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The event, soreness to arm injection site on the 1st and 2nd day was resolved on 05 Jan 2021. The outcome for the events, chills and loss of taste was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Infusion site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Great big round ball on her arm of the size of a tangerine, swollen; Hot; Big red circle on her arm; Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (headache), INJECTION SITE SWELLING (Great big round ball on her arm of the size of a tangerine, swollen), INJECTION SITE WARMTH (Hot) and INFUSION SITE ERYTHEMA (Big red circle on her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Great big round ball on her arm of the size of a tangerine, swollen), INJECTION SITE WARMTH (Hot) and INFUSION SITE ERYTHEMA (Big red circle on her arm). On 19-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE SWELLING (Great big round ball on her arm of the size of a tangerine, swollen), INJECTION SITE WARMTH (Hot) and INFUSION SITE ERYTHEMA (Big red circle on her arm) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications included sleeping pill and blood pressure medication.  Event treatment: Tylenol (acetaminophen) for headache.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid19) 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 21-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 COVID-19 (Covid19). At the time of the report, COVID-19 (Covid19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.; Sender's Comments: Based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headache; A report was received from a consumers husband concerning a  67 years old, Female patient was participating in the mRNA-1273 Emergency Use Program and developed/experienced  migraine headache.  Medical history not provided by reporter. Relevant concomitant medications were not reported.  On [02Feb2021 ], the patient received their second of two planned doses of mRNA-1273 in  the [Left arm] for prophylaxis of COVID-19 infection.    While participating in this program, and preceding this event, the patient experienced the adverse event(s) of special interest of [Migraine headache)If it is known that the event occurred after the second dose of mRNA-1273 on 03Feb2021.  No treatment information was provided, the reporter wants to know if his wife can take Relpax, her migraine .   The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the event(s) is not applicable.   The outcome of the event, MIigraine headache was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Myalgia, Tremor
Clinical narrative: chills; body ache; felt so cold; Shaking; A spontaneous report was received from a Healthcare Professional Dear concerning a 72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, very strong chills, shaking, body ache, and felt so cold.  The patient's medical history was not provided. Concomitant medications reported were Humaira Once a week (last injection Monday 01 Feb 2021), Atorvastatin: 20 mg Once daily in the morning, Lisinopril HCTZ 20-12.5 mg Once daily, Amlodipine: 5 mg Once daily, Baby aspirin for drug use for unknown indication.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events, very strong chills. shaking, body ache, and felt so cold.  Treatment details included Tylenol Extra Strength Rapid Release gel 500 mg: 2 tablet in the morning at 9 am.  Action taken with mRNA-1273 in response to the events, very strong chills, shaking, body ache, felt so cold was not reported.   On 4 Feb 2021 the outcome of events, very strong chills was resolved and shaking was resolved. On an unknown date the outcome of events include body ache and felt so cold was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got COVID after first dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient got COVID after first dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced COVID-19 (Patient got COVID after first dose of vaccine). At the time of the report, COVID-19 (Patient got COVID after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Test positive on 1/10..     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 reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Palpitations, Throat irritation
Clinical narrative: very exhausted; throat was very very itchy; Muscle ache; Joint pain; heart palpitations; This spontaneous case was reported by a nurse and describes the occurrence of THROAT IRRITATION (throat was very very itchy), MYALGIA (Muscle ache), ARTHRALGIA (Joint pain), PALPITATIONS (heart palpitations) and FATIGUE (very exhausted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced THROAT IRRITATION (throat was very very itchy), MYALGIA (Muscle ache), ARTHRALGIA (Joint pain) and PALPITATIONS (heart palpitations). On 04-Feb-2021, the patient experienced FATIGUE (very exhausted). At the time of the report, THROAT IRRITATION (throat was very very itchy) had resolved and MYALGIA (Muscle ache), ARTHRALGIA (Joint pain), PALPITATIONS (heart palpitations) and FATIGUE (very exhausted) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Patient was diagnosed with COVID-19.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue). On 04-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-021800 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: events are add
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site discolouration
Clinical narrative: red bumps on legs, front torso and up to hip; scratching R arm from writs to elbow/itching inside L arm from wrist to elbow; pinkish reaction on R arm from wrist to elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (scratching R arm from writs to elbow/itching inside L arm from wrist to elbow), VACCINATION SITE DISCOLOURATION (pinkish reaction on R arm from wrist to elbow) and ERYTHEMA (red bumps on legs, front torso and up to hip) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction (Temperature extremes makes her react with bumps on back.). Concomitant products included VITAMINS NOS 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 22-Jan-2021, the patient experienced PRURITUS (scratching R arm from writs to elbow/itching inside L arm from wrist to elbow) and VACCINATION SITE DISCOLOURATION (pinkish reaction on R arm from wrist to elbow). On an unknown date, the patient experienced ERYTHEMA (red bumps on legs, front torso and up to hip). In January 2021, PRURITUS (scratching R arm from writs to elbow/itching inside L arm from wrist to elbow) and VACCINATION SITE DISCOLOURATION (pinkish reaction on R arm from wrist to elbow) 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.   concomitants- bariatric medicine,osteoporosis medicine, for bladder sensitivity Treatment information as not reported.   This case was linked to MOD-2021-044321 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Patient not interested in follow up - NNI; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site warmth, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Red rash; red rash; warm to the touch; arm was sore at injection site; was tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included Back pain, Pneumonia (Legionnaires disease (double pneumonia)) in June 2007 and Breathing difficult (Legionnaires disease (double pneumonia) in June 2007 which has resulted in some breathing problems). Concurrent medical conditions included Diabetic. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for Back pain.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Red rash). At the time of the report, VACCINATION SITE RASH (Red rash) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Body temperature, Dizziness, Dyspnoea
Clinical narrative: dizziness and was light headed for about 30 seconds; terrible balance; shortness of breath after being sedate for a long period of time; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and was light headed for about 30 seconds), BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness and was light headed for about 30 seconds), BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia). On 05-Feb-2021, DIZZINESS (dizziness and was light headed for about 30 seconds) had resolved. At the time of the report, BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: 128/72 mmHg. On 05-Feb-2021, Body temperature: normal normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new/updated information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: dizziness and was light headed for about 30 seconds; terrible balance; shortness of breath after being sedate for a long period of time; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and was light headed for about 30 seconds), BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness and was light headed for about 30 seconds), BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia). On 05-Feb-2021, DIZZINESS (dizziness and was light headed for about 30 seconds) had resolved. At the time of the report, BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: 128/72 mmHg. On 05-Feb-2021, Body temperature: normal normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new/updated information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Weakness; Fatigue; Chills; Bones and muscles hurting to the point he couldn't get out of bed; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN, RABEPRAZOLE SODIUM (ACIPHEX) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). On 24-Jan-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Bones and muscles hurting to the point he couldn't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 3 hours and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK, Every 3 hours. On 31-Jan-2021, PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Bones and muscles hurting to the point he couldn't get out of bed) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) took 3-4 months to recover.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24 Jun 2021 contains non-significant information. Patient demographic was updated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Weakness; Fatigue; Chills; Bones and muscles hurting to the point he couldn't get out of bed; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN, RABEPRAZOLE SODIUM (ACIPHEX) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). On 24-Jan-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Bones and muscles hurting to the point he couldn't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 3 hours and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK, Every 3 hours. On 31-Jan-2021, PAIN (Body aches), ASTHENIA (Weakness), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Bones and muscles hurting to the point he couldn't get out of bed) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) took 3-4 months to recover.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24 Jun 2021 contains non-significant information. Patient demographic was updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling cold, Heart rate, Hypersomnia, Injection site pain
Clinical narrative: lymph gland painful on the arm pit; My body was frozen; Muscular pain injection site - right arm; starting to be sleepier than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (starting to be sleepier than usual), FEELING COLD (My body was frozen), INJECTION SITE PAIN (Muscular pain injection site - right arm) and AXILLARY PAIN (lymph gland painful on the arm pit) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (left hand two fingures).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HYPERSOMNIA (starting to be sleepier than usual) and INJECTION SITE PAIN (Muscular pain injection site - right arm). On 30-Jan-2021, the patient experienced FEELING COLD (My body was frozen). On 03-Feb-2021, the patient experienced AXILLARY PAIN (lymph gland painful on the arm pit). On 31-Jan-2021, INJECTION SITE PAIN (Muscular pain injection site - right arm) had resolved. On 04-Feb-2021, AXILLARY PAIN (lymph gland painful on the arm pit) had resolved. On 06-Feb-2021, HYPERSOMNIA (starting to be sleepier than usual) and FEELING COLD (My body was frozen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Heart rate: 126 beats/min (High) 126 beats/min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 30-Jan-2021, the patient's body temperature was 98.4 and she was wearing a watch vivo fit 4, it shows extreme heart beat of 126 beats/min. On 06-Feb-2021, all the symptoms were gone except for the heart beat still monitoring it. On 12-Jan-2021, the patient was given antibiotics after surgery for 7 days. Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received included no new significant information
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is feeling a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is feeling a little sore) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm is feeling a little sore). At the time of the report, VACCINATION SITE PAIN (arm is feeling a little sore) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Maternal exposure during pregnancy, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; fever; groggy overall; not feeling too well; lethargy; 25 weeks pregnant and got her 2nd dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose), SOMNOLENCE (groggy overall), MALAISE (not feeling too well), LETHARGY (lethargy) and PAIN IN EXTREMITY (arm soreness) in a 35-year-old female patient (gravida 1) 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 was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 15-Feb-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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose). On 24-Feb-2021, the patient experienced SOMNOLENCE (groggy overall), MALAISE (not feeling too well) and LETHARGY (lethargy). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (fever). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Pain in arm, at a dose of UNK dosage form. On 15-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose) had resolved. At the time of the report, SOMNOLENCE (groggy overall), MALAISE (not feeling too well), LETHARGY (lethargy) and PYREXIA (fever) outcome was unknown and PAIN IN EXTREMITY (arm soreness) had resolved.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: arm soreness; fever; groggy overall; not feeling too well; lethargy; 25 weeks pregnant and got her 2nd dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose), SOMNOLENCE (groggy overall), MALAISE (not feeling too well), LETHARGY (lethargy) and PAIN IN EXTREMITY (arm soreness) in a 35-year-old female patient (gravida 1) 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 was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 15-Feb-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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose). On 24-Feb-2021, the patient experienced SOMNOLENCE (groggy overall), MALAISE (not feeling too well) and LETHARGY (lethargy). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (fever). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Pain in arm, at a dose of UNK dosage form. On 15-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant and got her 2nd dose) had resolved. At the time of the report, SOMNOLENCE (groggy overall), MALAISE (not feeling too well), LETHARGY (lethargy) and PYREXIA (fever) outcome was unknown and PAIN IN EXTREMITY (arm soreness) had resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: The next day laid in bed until 2pm, was exhausted; sore arm; itchy arm, it was a big circle around injection site; got up from the couch and thought that was going to pass out; so weak; did not sleep that night; went to bed with a terrible headache; chills; A spontaneous report was received from a 67 year old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced got up from the couch and thought that was going to pass out, so weak, went to bed with a terrible headache, chills, did not sleep that night, The next day laid in bed until 2pm was exhausted, sore arm, itchy arm and it was a big circle around injection site.  The consumer's medical history included Covid infection in Nov 2020. Relevant concomitant medications included atorvastatin, bupropion, donepezil, vitamins and prilosec (stomach).  The consumer received the first of the two planned doses of mRNA-1273 on 13-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same night, she thought she was going to pass out as she got up from the couch; felt weak. She went to bed with a terrible headache and chills; did not sleep that night.  On 14-FEB-2021, she laid in bed until 2pm, exhausted chilling and with a headache. However, she felt better by the same evening. She also experienced an itchy arm which resolved in a week. There was a big circle around injection site and still has a bit of a sore arm.  Tylenol was given as a treatment.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events got up from the couch and thought that was going to pass out, so weak, went to bed with a terrible headache, chills, did not sleep that night, the next day laid in bed until 2pm, was exhausted sore arm was unknown and for, itchy arm and it was a big circle around injection site was resolved.  The consumer did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vaccination site pain, Vaccination site pruritus
Clinical narrative: The next day laid in bed until 2pm, was exhausted; sore arm; itchy arm, it was a big circle around injection site; got up from the couch and thought that was going to pass out; so weak; did not sleep that night; went to bed with a terrible headache; chills; A spontaneous report was received from a 67 year old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced got up from the couch and thought that was going to pass out, so weak, went to bed with a terrible headache, chills, did not sleep that night, The next day laid in bed until 2pm was exhausted, sore arm, itchy arm and it was a big circle around injection site.  The consumer's medical history included Covid infection in Nov 2020. Relevant concomitant medications included atorvastatin, bupropion, donepezil, vitamins and prilosec (stomach).  The consumer received the first of the two planned doses of mRNA-1273 on 13-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same night, she thought she was going to pass out as she got up from the couch; felt weak. She went to bed with a terrible headache and chills; did not sleep that night.  On 14-FEB-2021, she laid in bed until 2pm, exhausted chilling and with a headache. However, she felt better by the same evening. She also experienced an itchy arm which resolved in a week. There was a big circle around injection site and still has a bit of a sore arm.  Tylenol was given as a treatment.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events got up from the couch and thought that was going to pass out, so weak, went to bed with a terrible headache, chills, did not sleep that night, the next day laid in bed until 2pm, was exhausted sore arm was unknown and for, itchy arm and it was a big circle around injection site was resolved.  The consumer did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nasopharyngitis, Neck pain
Clinical narrative: Cold; Neck pain; Headaches; Muscle pain; Fever of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees). At the time of the report, NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 100 degrees (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 JULY 2021 and contains Non significant information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cold; Neck pain; Headaches; Muscle pain; Fever of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees). At the time of the report, NASOPHARYNGITIS (Cold), NECK PAIN (Neck pain), HEADACHE (Headaches), MYALGIA (Muscle pain) and PYREXIA (Fever of 100 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 100 degrees (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 JULY 2021 and contains Non significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: didn't want to eat anything; aching feeling; 1st dose - I had fever; feel tired, laid around in bed for 2 days (for 3-4 days); chills (cold chills); This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (didn't want to eat anything), PAIN (aching feeling), PYREXIA (1st dose - I had fever), CHILLS (chills (cold chills)) and FATIGUE (feel tired, laid around in bed for 2 days (for 3-4 days)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DECREASED APPETITE (didn't want to eat anything), PAIN (aching feeling), PYREXIA (1st dose - I had fever) and FATIGUE (feel tired, laid around in bed for 2 days (for 3-4 days)). In January 2021, the patient experienced CHILLS (chills (cold chills)). At the time of the report, DECREASED APPETITE (didn't want to eat anything), PAIN (aching feeling), PYREXIA (1st dose - I had fever), CHILLS (chills (cold chills)) and FATIGUE (feel tired, laid around in bed for 2 days (for 3-4 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication detail were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-036083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Reporter's contact details updated, patient demographic updated.