chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Metamorphopsia, Ultrasound Doppler, Visual field defect
Clinical narrative: ocular abnormalities; Peripheral vision; kaleidoscopic vision for 2 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of VISUAL IMPAIRMENT (ocular abnormalities), VISUAL FIELD DEFECT (Peripheral vision) and METAMORPHOPSIA (kaleidoscopic vision for 2 weeks) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No concomitant medications were taken by patient.  The patient's past medical history included Migraine since an unknown date. Concurrent medical conditions included Diabetes and High cholesterol.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VISUAL IMPAIRMENT (ocular abnormalities), VISUAL FIELD DEFECT (Peripheral vision) and METAMORPHOPSIA (kaleidoscopic vision for 2 weeks). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 21-Feb-2021, METAMORPHOPSIA (kaleidoscopic vision for 2 weeks) had resolved. At the time of the report, VISUAL IMPAIRMENT (ocular abnormalities) and VISUAL FIELD DEFECT (Peripheral vision) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) A blood work was made and he discovered he is diabetic and has high cholesterol levels. On an unknown date, Magnetic resonance imaging: (Inconclusive) Negative. On an unknown date, Ultrasound Doppler: (Inconclusive) Negative.     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.   Caller's husband received the 1st dose on 27Jan2021 and on 07Feb2021 he had ocular abnormalities, kaleidoscopic vision for 2 weeks, he lost some of his peripheral vision, doctorsmade MRI, vascular testing, everything turned out negative now he's symptom-free. He has a history of migraine. A blood work was  made and he discovered he is diabetic and has high cholesterol levels, so he was put on medication for cholesterol and folic acid which he wasn't taking at the moment of the 1st dose   This case was linked to MOD-2021-056249, MOD-2021-056249 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: ocular abnormalities; Peripheral vision; kaleidoscopic vision for 2 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of VISUAL IMPAIRMENT (ocular abnormalities), VISUAL FIELD DEFECT (Peripheral vision) and METAMORPHOPSIA (kaleidoscopic vision for 2 weeks) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No concomitant medications were taken by patient.  The patient's past medical history included Migraine since an unknown date. Concurrent medical conditions included Diabetes and High cholesterol.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VISUAL IMPAIRMENT (ocular abnormalities), VISUAL FIELD DEFECT (Peripheral vision) and METAMORPHOPSIA (kaleidoscopic vision for 2 weeks). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 21-Feb-2021, METAMORPHOPSIA (kaleidoscopic vision for 2 weeks) had resolved. At the time of the report, VISUAL IMPAIRMENT (ocular abnormalities) and VISUAL FIELD DEFECT (Peripheral vision) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) A blood work was made and he discovered he is diabetic and has high cholesterol levels. On an unknown date, Magnetic resonance imaging: (Inconclusive) Negative. On an unknown date, Ultrasound Doppler: (Inconclusive) Negative.     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.   Caller's husband received the 1st dose on 27Jan2021 and on 07Feb2021 he had ocular abnormalities, kaleidoscopic vision for 2 weeks, he lost some of his peripheral vision, doctorsmade MRI, vascular testing, everything turned out negative now he's symptom-free. He has a history of migraine. A blood work was  made and he discovered he is diabetic and has high cholesterol levels, so he was put on medication for cholesterol and folic acid which he wasn't taking at the moment of the 1st dose   This case was linked to MOD-2021-056249, MOD-2021-056249 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Irritability
Clinical narrative: severe anxiousness; Irritable; agitated that she could not go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (severe anxiousness), IRRITABILITY (Irritable) and AGITATION (agitated that she could not go to sleep) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ANXIETY (severe anxiousness), IRRITABILITY (Irritable) and AGITATION (agitated that she could not go to sleep). On 25-Feb-2021, ANXIETY (severe anxiousness), IRRITABILITY (Irritable) and AGITATION (agitated that she could not go to sleep) had resolved.            Treatment details included the patient drink Chamomile tea and a shower and symptoms subsided after 5 hours.  Action taken with mRNA-1273 in response to the events was not reported.; Sender'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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Rash erythematous, Vaccination site pruritus, Vaccination site rash
Clinical narrative: big red rash the size of his palm; his arm was sore; stiffness; swelled up; rash; an itch near his injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PRURITUS (an itch near his injection site) and VACCINATION SITE SWELLING (swelled up) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A or 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (an itch near his injection site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE SWELLING (swelled up) and VACCINATION SITE RASH (rash). At the time of the report, RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE SWELLING (swelled up) and VACCINATION SITE RASH (rash) outcome was unknown and VACCINATION SITE PRURITUS (an itch near his injection site) had resolved.        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.   Patient received the first dose on 13FEB2021 and his arm was sore for two days and then went away. On 26FEB2021 last night he had an itch near his injection site. He saw that the area has swelled up with a rash and a stiffness. It is a big red rash the size of his palm and now the itchiness went away. He states it looks as if someone had slipped a cardboard underneath his skin
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: big red rash the size of his palm; his arm was sore; stiffness; swelled up; rash; an itch near his injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PRURITUS (an itch near his injection site) and VACCINATION SITE SWELLING (swelled up) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A or 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (an itch near his injection site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE SWELLING (swelled up) and VACCINATION SITE RASH (rash). At the time of the report, RASH ERYTHEMATOUS (big red rash the size of his palm), PAIN IN EXTREMITY (his arm was sore), MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE SWELLING (swelled up) and VACCINATION SITE RASH (rash) outcome was unknown and VACCINATION SITE PRURITUS (an itch near his injection site) had resolved.        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.   Patient received the first dose on 13FEB2021 and his arm was sore for two days and then went away. On 26FEB2021 last night he had an itch near his injection site. He saw that the area has swelled up with a rash and a stiffness. It is a big red rash the size of his palm and now the itchiness went away. He states it looks as if someone had slipped a cardboard underneath his skin
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination complication
Clinical narrative: cannot lift the arm; unbearable pain in shoulder; unbearable pain to elbow; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (cannot lift the arm), ARTHRALGIA (unbearable pain in shoulder) and ARTHRALGIA (unbearable pain to elbow) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Jan-2021. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) and INSULIN GLARGINE (LANTUS) for Diabetes mellitus, FLUOXETINE HYDROCHLORIDE (PROZAC) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (cannot lift the arm), ARTHRALGIA (unbearable pain in shoulder) and ARTHRALGIA (unbearable pain to elbow). At the time of the report, VACCINATION COMPLICATION (cannot lift the arm), ARTHRALGIA (unbearable pain in shoulder) and ARTHRALGIA (unbearable pain to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller received her initial dose of Moderna vaccine yesterday, February 26. Unbearable pain on her LEFT shoulder to elbow and she cannot lift her shoulder
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101.9 deg F; Fever 102.5 deg. F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102.5 deg. F) and PYREXIA (Fever 101.9 deg F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Fever 102.5 deg. F). On an unknown date, the patient experienced PYREXIA (Fever 101.9 deg F). At the time of the report, PYREXIA (Fever 102.5 deg. F) and PYREXIA (Fever 101.9 deg F) outcome was unknown.            Patient said that he got vaccinated with his 2nd dose of Moderna Covid 19 vaccine yesterday and today he have a fever said that his body temperature that he was able to record was 102.5 deg. F and 101.9 deg F. Said that he did not have this with his first dose.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin discolouration
Clinical narrative: felt the sting or prick travel down to her hand and felt a little sting and jerked a little; the middle section of the middle finger was a little bit red; Her right arm is black and blue and swollen; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt the sting or prick travel down to her hand and felt a little sting and jerked a little), ERYTHEMA (the middle section of the middle finger was a little bit red), SKIN DISCOLOURATION (Her right arm is black and blue and swollen) and PAIN (pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (felt the sting or prick travel down to her hand and felt a little sting and jerked a little), ERYTHEMA (the middle section of the middle finger was a little bit red), SKIN DISCOLOURATION (Her right arm is black and blue and swollen) and PAIN (pain). At the time of the report, PAIN (felt the sting or prick travel down to her hand and felt a little sting and jerked a little), ERYTHEMA (the middle section of the middle finger was a little bit red), SKIN DISCOLOURATION (Her right arm is black and blue and swollen) and PAIN (pain) 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.   Patient got the first dose of the Moderna vaccination in her right arm at the hospital with lot number 011A21A. When she received the injection, she felt the sting or prick travel down to her hand and felt a little sting and jerked a little. When she looked at her hand and the middle section of the middle finger was a little bit red. She chose not to receive the vaccine in her left arm as she has a more serious and pins and needles sensation in that arm. She states her right arm has a little bit of arthritis. Her right arm is black and blue and swollen. Patient used cold compress for the pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Drug hypersensitivity, Fatigue, Feeling abnormal
Clinical narrative: still feels very odd; off balance like feeling kind of drunk.; allergic reaction to antibiotic.; dizziness; lost of balance; headache; was very tired the whole day; nausea; little bit of headache; acial flushing; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (acial flushing), DIZZINESS (dizziness), BALANCE DISORDER (lost of balance), FEELING ABNORMAL (still feels very odd) and FEELING DRUNK (off balance like feeling kind of drunk.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    Concurrent medical conditions included Allergy to antibiotic (no medication history reported). Concomitant products included TAMOXIFEN for Breast cancer, MAGNESIUM, CALCIUM and MINOCYCLINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced FLUSHING (acial flushing) and HEADACHE (little bit of headache). On 25-Feb-2021, the patient experienced FATIGUE (was very tired the whole day) and NAUSEA (nausea). On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (lost of balance) and HEADACHE (headache). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (still feels very odd), FEELING DRUNK (off balance like feeling kind of drunk.) and DRUG HYPERSENSITIVITY (allergic reaction to antibiotic.). At the time of the report, FLUSHING (acial flushing), DIZZINESS (dizziness), BALANCE DISORDER (lost of balance), FEELING ABNORMAL (still feels very odd), FEELING DRUNK (off balance like feeling kind of drunk.), DRUG HYPERSENSITIVITY (allergic reaction to antibiotic.), FATIGUE (was very tired the whole day), NAUSEA (nausea), HEADACHE (headache) and HEADACHE (little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol tablet was taken as treatment. received the first dose of the Moderna vaccine on Wednesday, 24Feb2021 on her RIGHT deltoid. She had facial flushing and a little bit of headache. On Thursday, she was very tired the whole day. Then yesterday, was fine but had a sudden wave of nausea, dizziness, headache and lost of balance that continued until today. She said that she still feels very odd, her head feels foggy and off balance like feeling kind of drunk. She has allergic reaction to antibiotic.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Flushing, Headache, Nausea
Clinical narrative: still feels very odd; off balance like feeling kind of drunk.; allergic reaction to antibiotic.; dizziness; lost of balance; headache; was very tired the whole day; nausea; little bit of headache; acial flushing; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (acial flushing), DIZZINESS (dizziness), BALANCE DISORDER (lost of balance), FEELING ABNORMAL (still feels very odd) and FEELING DRUNK (off balance like feeling kind of drunk.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    Concurrent medical conditions included Allergy to antibiotic (no medication history reported). Concomitant products included TAMOXIFEN for Breast cancer, MAGNESIUM, CALCIUM and MINOCYCLINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced FLUSHING (acial flushing) and HEADACHE (little bit of headache). On 25-Feb-2021, the patient experienced FATIGUE (was very tired the whole day) and NAUSEA (nausea). On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (lost of balance) and HEADACHE (headache). On 27-Feb-2021, the patient experienced FEELING ABNORMAL (still feels very odd), FEELING DRUNK (off balance like feeling kind of drunk.) and DRUG HYPERSENSITIVITY (allergic reaction to antibiotic.). At the time of the report, FLUSHING (acial flushing), DIZZINESS (dizziness), BALANCE DISORDER (lost of balance), FEELING ABNORMAL (still feels very odd), FEELING DRUNK (off balance like feeling kind of drunk.), DRUG HYPERSENSITIVITY (allergic reaction to antibiotic.), FATIGUE (was very tired the whole day), NAUSEA (nausea), HEADACHE (headache) and HEADACHE (little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol tablet was taken as treatment. received the first dose of the Moderna vaccine on Wednesday, 24Feb2021 on her RIGHT deltoid. She had facial flushing and a little bit of headache. On Thursday, she was very tired the whole day. Then yesterday, was fine but had a sudden wave of nausea, dizziness, headache and lost of balance that continued until today. She said that she still feels very odd, her head feels foggy and off balance like feeling kind of drunk. She has allergic reaction to antibiotic.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: in the injection site it was swollen; arm in the injection site it was red; left arm and it was a little sore afterwards; she had Covid; Aspontaneous case report from a consumer on 15-FEB-2021, which refers to a Female aged 78 Years experienced the events,a little sore,COVID arm in the injection site it was red,in the injection site it was swollen.  Concomitant medications included: ESOMEPRAZOLE[] ,LISINOPRIL[] ,ATENOLOL[] ,ROSUVASTATIN[] ,EZETIMIBE[] ,MONTELUKAST[] ,HYDROCHLOROTHIAZIDE[]  .  Relevant medical history was not provided.  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  11 days later,  the patient developed pain in arm. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed COVID-19,injection site swelling,injection site redness. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Pain in extremity . .  The patient was treated for the event with TYLENOL .    On 05FEB201 Outcome of Covid was Recovered/Resolved,and on 16FEB2021 left arm and it was a little sore afterwards Recovered/Resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dry eye, Dry mouth, Erythema, Fatigue
Clinical narrative: fatugue; Itchy in her upper trunk area; prickly in her upper trunk area; eyes dry; mouth dry; lips dry; ears were burning; redness; Rash on upper torso; watery eyes; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry) and LIP DRY (lips dry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (redness), RASH (Rash on upper torso) and LACRIMATION INCREASED (watery eyes). On 12-Feb-2021, the patient experienced PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry), LIP DRY (lips dry) and BURNING SENSATION (ears were burning). On 13-Feb-2021, the patient experienced FATIGUE (fatugue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 12-Feb-2021, PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry), LIP DRY (lips dry) and BURNING SENSATION (ears were burning) had resolved. On 14-Feb-2021, FATIGUE (fatugue) had resolved. At the time of the report, ERYTHEMA (redness), RASH (Rash on upper torso) and LACRIMATION INCREASED (watery eyes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure pills and B12 shot.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Event was added -Rash on her upper torso, dry mouth, watery eyes, and redness.Added pregnant status also as NO.Added Anatomical location as RIGHT ARM.Added reporter details also -Address, email, city, state, postal code, occupation, reporter type.Added secondary reporter details also-Address, phone number, city, state, postal code. On 15-Apr-2021: NNI
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Lip dry, Miliaria, Pruritus, Rash
Clinical narrative: fatugue; Itchy in her upper trunk area; prickly in her upper trunk area; eyes dry; mouth dry; lips dry; ears were burning; redness; Rash on upper torso; watery eyes; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry) and LIP DRY (lips dry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (redness), RASH (Rash on upper torso) and LACRIMATION INCREASED (watery eyes). On 12-Feb-2021, the patient experienced PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry), LIP DRY (lips dry) and BURNING SENSATION (ears were burning). On 13-Feb-2021, the patient experienced FATIGUE (fatugue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 12-Feb-2021, PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry), LIP DRY (lips dry) and BURNING SENSATION (ears were burning) had resolved. On 14-Feb-2021, FATIGUE (fatugue) had resolved. At the time of the report, ERYTHEMA (redness), RASH (Rash on upper torso) and LACRIMATION INCREASED (watery eyes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure pills and B12 shot.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Event was added -Rash on her upper torso, dry mouth, watery eyes, and redness.Added pregnant status also as NO.Added Anatomical location as RIGHT ARM.Added reporter details also -Address, email, city, state, postal code, occupation, reporter type.Added secondary reporter details also-Address, phone number, city, state, postal code. On 15-Apr-2021: NNI
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Weak; Dizzy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Dizzy) and PYREXIA (Fever) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event. Concomittant product usage was not included.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (Weak), DIZZINESS (Dizzy) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak), DIZZINESS (Dizzy) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient has requested for the follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Depersonalisation/derealisation disorder, Ear pain, Fatigue
Clinical narrative: I still don't feel like my old self; tired; aching all down her left side; I started feeling not well /I still don't feel like my old self/ tired; arm got very sore; extremely painful; headache; earache; nauseous; chills; A spontaneous report (United States) was received from a reporter like consumer concerning a 81yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like started feeling not well, arm got very sore, extremely painful, headache, earache, aching all down her left side, nauseous, chills, tired, still don't feel like my old self. The patient's medication history was not provided. Concomitant medications included Vitamin C Women's probiotic , Multivitamin. On 3feb2021 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 028L20A ) intramuscularly in the anatomical location in the left arm for prophylaxis  of COVID-19 infection. Following the vaccine administration the patient experienced feeling not well, arm got very sore, extremely painful, headache, earache, aching all down her left side, nauseous, chills, tired, still don't feel like my old self. Laboratory details were not provided.  Treatment information was not provided. The outcome of the event was recovered/resolved. Action taken with mRNA-1273 in response to the events was unknown.  Based on MSA comment all events (MAH causality assessment is missing)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity
Clinical narrative: I still don't feel like my old self; tired; aching all down her left side; I started feeling not well /I still don't feel like my old self/ tired; arm got very sore; extremely painful; headache; earache; nauseous; chills; A spontaneous report (United States) was received from a reporter like consumer concerning a 81yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like started feeling not well, arm got very sore, extremely painful, headache, earache, aching all down her left side, nauseous, chills, tired, still don't feel like my old self. The patient's medication history was not provided. Concomitant medications included Vitamin C Women's probiotic , Multivitamin. On 3feb2021 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 028L20A ) intramuscularly in the anatomical location in the left arm for prophylaxis  of COVID-19 infection. Following the vaccine administration the patient experienced feeling not well, arm got very sore, extremely painful, headache, earache, aching all down her left side, nauseous, chills, tired, still don't feel like my old self. Laboratory details were not provided.  Treatment information was not provided. The outcome of the event was recovered/resolved. Action taken with mRNA-1273 in response to the events was unknown.  Based on MSA comment all events (MAH causality assessment is missing)
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: headache; stiffness in the back of my neck; lower back pain; nausea when I eat; A spontaneous report (United States) was received from a consumer concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, stiffness in the back of my neck(musculoskeletal stiffness), lower back pain(pain), nausea when i eat(nausea).  The patient's medical history was not provided. Concomitant medications reported were estradiol, losartan, mirtazapine, Vitamin C, Calcium, Vitamin D, Multi vitamin, omeprazole, albuterol inhaler(salbutamol) for drug use for unknown indication.  On 12 Feb 2021, approximately 2 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache , stiffness in the back of my neck , lower back pain and nausea when eat.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, stiffness in the back of my neck , lower back pain and nausea when i eat was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: DIZZINESS; HEADACHE; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Denied) intramuscularly for prophylaxis of COVID-19 infection.   Dizziness, Headache.  Treatment details included unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizziness was unknown.The outcome of event(s), headache was unknown..
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: tested positive for COVID; headaches; shortness of breath; bodyache; felt fatigued; A spontaneous report was received from a healthcare professional concerning a 33-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, shortness of breath, body aches, felt fatigued, tested positive for covid.  The patient's medical history was not provided. Concomitant medications reported were birth control medication.  On 23 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) ivia unknown route for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 042L20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events- headache, shortness of breath, body aches and felt fatigued. On 11 Feb 2021, the patient  tested positive for covid. She stated the symptoms subsided on their own  On 11 Feb 2021, the lab data performed included- Rapid test (negative) and PCR test (positive).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- headaches,shortness of breath, body aches,  fatigue and Covid 19 positive- was Recovering/Resolving.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; headaches; shortness of breath; bodyache; felt fatigued; A spontaneous report was received from a healthcare professional concerning a 33-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, shortness of breath, body aches, felt fatigued, tested positive for covid.  The patient's medical history was not provided. Concomitant medications reported were birth control medication.  On 23 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) ivia unknown route for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 042L20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events- headache, shortness of breath, body aches and felt fatigued. On 11 Feb 2021, the patient  tested positive for covid. She stated the symptoms subsided on their own  On 11 Feb 2021, the lab data performed included- Rapid test (negative) and PCR test (positive).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- headaches,shortness of breath, body aches,  fatigue and Covid 19 positive- was Recovering/Resolving.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Sensitive skin, Swelling
Clinical narrative: Sensitive; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitive), ERYTHEMA (Redness) and SWELLING (Swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), NORTRIPTYLINE and LORAZEPAM (ATIVAN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SENSITIVE SKIN (Sensitive), ERYTHEMA (Redness) and SWELLING (Swelling). At the time of the report, SENSITIVE SKIN (Sensitive), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Head discomfort, Headache
Clinical narrative: Not feeling very good; Head has been hurting so bad; Chilled all night long; severe headache; backache; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (backache), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (Not feeling very good), HEAD DISCOMFORT (Head has been hurting so bad) and HEADACHE (severe headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergies: nitrofurantoin, Flagyl (top of head and shins start itching).).    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced BACK PAIN (backache), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (severe headache). On an unknown date, the patient experienced MALAISE (Not feeling very good), HEAD DISCOMFORT (Head has been hurting so bad) and CHILLS (Chilled all night long). At the time of the report, BACK PAIN (backache), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (Not feeling very good), HEAD DISCOMFORT (Head has been hurting so bad), HEADACHE (severe headache) and CHILLS (Chilled all night long) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling very good; Head has been hurting so bad; Chilled all night long; severe headache; backache; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (backache), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (Not feeling very good), HEAD DISCOMFORT (Head has been hurting so bad) and HEADACHE (severe headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergies: nitrofurantoin, Flagyl (top of head and shins start itching).).    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced BACK PAIN (backache), ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (severe headache). On an unknown date, the patient experienced MALAISE (Not feeling very good), HEAD DISCOMFORT (Head has been hurting so bad) and CHILLS (Chilled all night long). At the time of the report, BACK PAIN (backache), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (Not feeling very good), HEAD DISCOMFORT (Head has been hurting so bad), HEADACHE (severe headache) and CHILLS (Chilled all night long) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle fatigue, Oral pain, Swelling face
Clinical narrative: Left side of face was swollen; Inside of mouth tender; Jaw fatigued; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Left side of face was swollen), ORAL PAIN (Inside of mouth tender), MUSCLE FATIGUE (Jaw fatigued) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FUROSEMIDE (LASIX [FUROSEMIDE]) and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWELLING FACE (Left side of face was swollen), ORAL PAIN (Inside of mouth tender), MUSCLE FATIGUE (Jaw fatigued) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Left side of face was swollen), ORAL PAIN (Inside of mouth tender), MUSCLE FATIGUE (Jaw fatigued) and HEADACHE (Headache) had not resolved.            On 01/Mar/2021, a consumer reported she was taking medications Synthroid, Eliquis, Lasix, Lotrel. On 17/Feb/2021, she received the second dose of the Moderna vaccine in her left arm, lot 010M20A. The next morning, left side of her face was swollen and had a headache, inside of mouth tender, her jaw fatigued when she tried to eat. She was only able to eat soft foods like smoothies, scrambled eggs, liquids, etc. She had seen her primary doctor the day the symptoms started. She had been taking Motrin. Still had the symptoms at the time of the report
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Felt a little bit sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt a little bit sluggish) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLUGGISHNESS (Felt a little bit sluggish). On 26-Feb-2021, SLUGGISHNESS (Felt a little bit sluggish) had resolved.            After second dose, friend's husband of reporter felt a little bit sluggish, and then felt fine the next day. Caller also reports for her friend who had the same symptoms   This case was linked to MOD-2021-030380 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Headache) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.