chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: hard spot at the injection site; itchy red bumps at the injection site; itchy red bumps at the injection site; itchy red bumps at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (chronic nerve and muscle pain). Concomitant products included CANNABIDIOL and MARIJUANA for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard spot at the injection site), VACCINATION SITE PRURITUS (itchy red bumps at the injection site), VACCINATION SITE URTICARIA (itchy red bumps at the injection site) and VACCINATION SITE ERYTHEMA (itchy red bumps at the injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable Patient stated she was on opiates for 4 years   This case was linked to MOD-2021-229938 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bite, Dry skin, Erythema, Papule, Rash erythematous
Clinical narrative: Red rash appeared on that arm; Large red bump under my left eye; Arms are now fully red from elbow to top of hands both arms; Dry skin; Spots on my legs that look like I've been bit; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye), ERYTHEMA (Arms are now fully red from elbow to top of hands both arms), DRY SKIN (Dry skin) and BITE (Spots on my legs that look like I've been bit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN, CARVEDILOL, ESOMEPRAZOLE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, 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 experienced RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye), ERYTHEMA (Arms are now fully red from elbow to top of hands both arms), DRY SKIN (Dry skin) and BITE (Spots on my legs that look like I've been bit). The patient was treated with MACROGOL, PROPYLENE GLYCOL, SIMETICONE, SORBIC ACID, SORBITOL, WHITE SOFT PARAFFIN (VANICREAM) for Dry skin, at a dose of 1 dosage form; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and TRIAMCINOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash appeared on that arm), PAPULE (Large red bump under my left eye) and DRY SKIN (Dry skin) had not resolved and ERYTHEMA (Arms are now fully red from elbow to top of hands both arms) and BITE (Spots on my legs that look like I've been bit) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-039266 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose of Moderna COVID-19 vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received 1st dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) 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 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 PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided by the reporter.  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pruritus, Rash
Clinical narrative: light swelling like a bee sting apper on left wrist; itching/pruritus; rash "like a bee sting" of left wrist; This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (light swelling like a bee sting apper on left wrist), PRURITUS (itching/pruritus) and RASH (rash "like a bee sting" of left wrist) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013A214) for COVID-19 vaccination.     Concomitant products included MELOXICAM from 02-Jan-2010 to an unknown date and VALSARTAN from 02-Jan-2010 to an unknown date for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash "like a bee sting" of left wrist). On an unknown date, the patient experienced JOINT SWELLING (light swelling like a bee sting apper on left wrist) and PRURITUS (itching/pruritus). At the time of the report, JOINT SWELLING (light swelling like a bee sting apper on left wrist), PRURITUS (itching/pruritus) and RASH (rash "like a bee sting" of left wrist) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant included pain killer was included. GBmetalic hcl for unknown indication on 02-Jan-2010.   No treatment information was provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received include no new significant information On 27-Jul-2021: Updated race, height, con med added.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jun-2021 and was forwarded to the company on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment information not provided. Consent for follow up accepted.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They used this expired vial and administered 4 doses to 4 patients; 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 EXPIRED PRODUCT ADMINISTERED (They used this expired vial and administered 4 doses to 4 patients) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used this expired vial and administered 4 doses to 4 patients).        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: patient cannot stop vomiting after receiving the second dose on Friday; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (patient cannot stop vomiting after receiving the second dose on Friday) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (patient cannot stop vomiting after receiving the second dose on Friday). At the time of the report, VOMITING (patient cannot stop vomiting after receiving the second dose on Friday) outcome was unknown.            No concomitant medication was reported No treatment medication was reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: ALS got better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (ALS got better) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included ALS.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (ALS got better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (ALS got better) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking ALS medications concomitantly.  The patient felt that her ALS got better after getting the vaccine. She stated that 3 weeks after her first dose, it was easy for her to get up off the bed, it normally takes her a lot of effort to get up. She was able to stand up on her own. 3 days later, she had more energy to roll over in her bed. It usually takes a lot of effort. No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Antiphospholipid antibodies, Antithrombin III, Coagulation factor VII level, Protein C
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) from 01-Jan-2019 to an unknown date for Birth control.    On 06-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Activated partial thromboplastin time: 25.4, 25.3 Second (Low) aPTT 25.4, 25.3. On 25-May-2021, Antiphospholipid antibodies: not detected (Inconclusive) Lupus anticoagulant qual Not detected. On 25-May-2021, Antithrombin III: 124 (Inconclusive) Antithrombin III activity % 124. On 25-May-2021, Coagulation factor VII level: 55 (Inconclusive) Factor VII activity clotting % 55. On 25-May-2021, Protein C: 146 (High) Protein S Activity% 146(H). On 25-May-2021, Protein S: 127 (High) Protein S Activity% 127(H). On 25-May-2021, Prothrombin time: 9.5 Second (High) PT sec 9.5, 9.5 INR 0.9. On 25-May-2021, Russell's viper venom time: 26.9 Second (Inconclusive) Dilute Russell viper venom time 26.9 sec.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details provided.   This case was linked to MOD-2021-168832 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Protein S, Prothrombin time, Russell's viper venom time, Vaccination site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) from 01-Jan-2019 to an unknown date for Birth control.    On 06-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Activated partial thromboplastin time: 25.4, 25.3 Second (Low) aPTT 25.4, 25.3. On 25-May-2021, Antiphospholipid antibodies: not detected (Inconclusive) Lupus anticoagulant qual Not detected. On 25-May-2021, Antithrombin III: 124 (Inconclusive) Antithrombin III activity % 124. On 25-May-2021, Coagulation factor VII level: 55 (Inconclusive) Factor VII activity clotting % 55. On 25-May-2021, Protein C: 146 (High) Protein S Activity% 146(H). On 25-May-2021, Protein S: 127 (High) Protein S Activity% 127(H). On 25-May-2021, Prothrombin time: 9.5 Second (High) PT sec 9.5, 9.5 INR 0.9. On 25-May-2021, Russell's viper venom time: 26.9 Second (Inconclusive) Dilute Russell viper venom time 26.9 sec.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details provided.   This case was linked to MOD-2021-168832 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Tired/Fatigue; Lack of interest in doing anything (Used to read books); Pain Injection Site came back again and the pain spread to other body parts after second Shot; Aches and Pain on Both Upper Arms after second Shot; Pain on the Injection site after second Shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot), PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot), FATIGUE (Tired/Fatigue), VACCINATION SITE PAIN (Pain on the Injection site after second Shot) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus non-insulin-dependent and Blood pressure high. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure, METFORMIN for Diabetes mellitus, LOVASTATIN and INDAPAMIDE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the Injection site after second Shot). On 20-Mar-2021, the patient experienced PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot) and PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot). On an unknown date, the patient experienced FATIGUE (Tired/Fatigue) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Pain, at an unspecified dose and frequency and MELOXICAM for Pain, at an unspecified dose and frequency. On 11-Feb-2021, VACCINATION SITE PAIN (Pain on the Injection site after second Shot) had resolved. At the time of the report, PAIN (Pain Injection Site came back again and the pain spread to other body parts after second Shot), PAIN IN EXTREMITY (Aches and Pain on Both Upper Arms after second Shot), FATIGUE (Tired/Fatigue) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Lack of interest in doing anything (Used to read books)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been having aches and pain on both upper arms for 3 months.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Nausea
Clinical narrative: Headache; Chills; Sweating; Nausea; Feel awful; Woke up in middle of night; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and FEELING ABNORMAL (Feel awful) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night). At the time of the report, HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Headache; Chills; Sweating; Nausea; Feel awful; Woke up in middle of night; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and FEELING ABNORMAL (Feel awful) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night). At the time of the report, HEADACHE (Headache), CHILLS (Chills), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), FEELING ABNORMAL (Feel awful) and SLEEP DISORDER (Woke up in middle of night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: loss of hair alot; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (loss of hair alot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (loss of hair alot). At the time of the report, ALOPECIA (loss of hair alot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Muscle spasms, Pain
Clinical narrative: spasming pain; Couldn't lift her head; Neck spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Neck spasms), HEAD DISCOMFORT (Couldn't lift her head) and PAIN (spasming pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced MUSCLE SPASMS (Neck spasms). On 19-May-2021, the patient experienced HEAD DISCOMFORT (Couldn't lift her head). On an unknown date, the patient experienced PAIN (spasming pain). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. On 21-May-2021, MUSCLE SPASMS (Neck spasms), HEAD DISCOMFORT (Couldn't lift her head) and PAIN (spasming pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment narcotic (unspecified)  for pain medicine.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration joint, Blood test, Gait disturbance, Insomnia, Joint swelling
Clinical narrative: Ability to walk limited; Cant sleep; Night sweat; Right knee swelled\right knee swelled to the size of a melon; Pain high; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), PAIN (Pain high), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included INSULIN GLARGINE (BASAGLAR) from 11-Jan-2018 to an unknown date, METFORMIN from 11-Jan-2018 to an unknown date, LISINOPRIL from 11-Jan-2018 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 11-Jan-2018 to an unknown date for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (Pain high). On 17-May-2021, the patient experienced JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon). On 18-May-2021, the patient experienced NIGHT SWEATS (Night sweat). On an unknown date, the patient experienced GAIT DISTURBANCE (Ability to walk limited) and INSOMNIA (Cant sleep). The patient was treated with CORTISONE at a dose of 1 dosage form, Right knee; PREDNISONE at a dose of UNK dosage form; METHOTREXATE at a dose of UNK dosage form and Physical therapy for Joint swelling. At the time of the report, JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) outcome was unknown and PAIN (Pain high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Aspiration joint: abnormal (Inconclusive) 55 milliliters of fluid was removed from the patients right knee.. On 07-May-2021, Aspiration joint: abnormal (Inconclusive) 35 milliliters were removed from the right knee.. On an unknown date, Blood test: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown (normal) No structural damage.         This case was linked to MOD-2021-229819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Initial Additional Document received and contains significant information. updated with patient demographic information, concomitant drug information, non serious events and its outcome.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Night sweats, Pain
Clinical narrative: Ability to walk limited; Cant sleep; Night sweat; Right knee swelled\right knee swelled to the size of a melon; Pain high; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), PAIN (Pain high), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included INSULIN GLARGINE (BASAGLAR) from 11-Jan-2018 to an unknown date, METFORMIN from 11-Jan-2018 to an unknown date, LISINOPRIL from 11-Jan-2018 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 11-Jan-2018 to an unknown date for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (Pain high). On 17-May-2021, the patient experienced JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon). On 18-May-2021, the patient experienced NIGHT SWEATS (Night sweat). On an unknown date, the patient experienced GAIT DISTURBANCE (Ability to walk limited) and INSOMNIA (Cant sleep). The patient was treated with CORTISONE at a dose of 1 dosage form, Right knee; PREDNISONE at a dose of UNK dosage form; METHOTREXATE at a dose of UNK dosage form and Physical therapy for Joint swelling. At the time of the report, JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) outcome was unknown and PAIN (Pain high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Aspiration joint: abnormal (Inconclusive) 55 milliliters of fluid was removed from the patients right knee.. On 07-May-2021, Aspiration joint: abnormal (Inconclusive) 35 milliliters were removed from the right knee.. On an unknown date, Blood test: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown (normal) No structural damage.         This case was linked to MOD-2021-229819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Initial Additional Document received and contains significant information. updated with patient demographic information, concomitant drug information, non serious events and its outcome.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch at injection site; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia
Clinical narrative: body aches; very tired; pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back). At the time of the report, MYALGIA (body aches), FATIGUE (very tired) and BACK PAIN (pain in the back) 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 considered BACK PAIN (pain in the back) to be possibly related. No further causality assessments were provided for MYALGIA (body aches) and FATIGUE (very tired).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Somnolence
Clinical narrative: Feeling groggy; Really tired; Achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy). At the time of the report, SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment medications were not provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Menstrual disorder
Clinical narrative: started her period again, but it was bright pink and red; intense abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (intense abdominal cramping) and MENSTRUAL DISORDER (started her period again, but it was bright pink and red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included Opiates (On opiates for 14 years). Concomitant products included CANNABIDIOL and MARIJUANA for an unknown indication.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced ABDOMINAL PAIN (intense abdominal cramping). On 12-Jun-2021, the patient experienced MENSTRUAL DISORDER (started her period again, but it was bright pink and red). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 11-Jun-2021, ABDOMINAL PAIN (intense abdominal cramping) had resolved. At the time of the report, MENSTRUAL DISORDER (started her period again, but it was bright pink and red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-229893 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Swelling
Clinical narrative: The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one; My armpit were sore/The side I had injections on is swollen and sore; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one) and MYALGIA (My armpit were sore/The side I had injections on is swollen and sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-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 an unknown date, the patient experienced SWELLING (The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one) and MYALGIA (My armpit were sore/The side I had injections on is swollen and sore). At the time of the report, SWELLING (The side I had injections on is swollen and sore/the other side I had a lump/yesterday I noticed there's actually three pea sized lumps not just one) and MYALGIA (My armpit were sore/The side I had injections on is swollen and sore) outcome was unknown.            Concomitant medication information was not reported by the reporter. Treatment information was not provided. The action taken with mRNA-1273 with the events was considered as not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have some kind efdecrs and my mother too; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have some kind efdecrs and my mother too) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I have some kind efdecrs and my mother too). At the time of the report, VACCINATION COMPLICATION (I have some kind efdecrs and my mother too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant details were provided.   This case was linked to MOD-2021-230201 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia, Product dose omission issue, Rash
Clinical narrative: He did not get a 2nd dose of vaccine; Burning symptoms; Light rash; Head, face, back, hands and feet tingling and stinging; Head, face, back, hands and feet tingling and stinging; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine), PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging), BURNING SENSATION (Burning symptoms) and RASH (Light rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder and Hypertension.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging) and RASH (Light rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine) and BURNING SENSATION (Burning symptoms). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He did not get a 2nd dose of vaccine) had resolved and PARAESTHESIA (Head, face, back, hands and feet tingling and stinging), PAIN (Head, face, back, hands and feet tingling and stinging), BURNING SENSATION (Burning symptoms) and RASH (Light rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the concomitant medications included: Bipolar and blood pressure medications  I t was reported that the treatment information included Antihistamine and  topical cream for burning symptoms, tingling and stinging.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Additional Information received included no new information On 23-Jul-2021: Additional Information received included no new information On 27-Jul-2021: Additional Information received included patient's age.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site was red and itchy; injection site was red and itchy/she still has redness in the injection site; headache/she still has some headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was red and itchy), VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure fluctuation. Concomitant products included DICLOFENAC and MISOPROSTOL for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was red and itchy), VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 20-Jun-2021, VACCINATION SITE PRURITUS (injection site was red and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was red and itchy/she still has redness in the injection site) and HEADACHE (headache/she still has some headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetes medication and blood pressure medication(unspecified). Treatment included ice on the injection site.  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.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 and contain significant information. The events vaccination site erythema and headache became serious with criteria other medically important condition. Added vaccine batch number. Changed the outcome of the event vaccination site erythema from recovered to not recovered. Changed the outcome of the event headache from unknown to not recovered.; 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints; wrist hurt; Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints), ARTHRALGIA (wrist hurt) and BACK PAIN (Lower back pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B121A and 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced BACK PAIN (Lower back pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints) and ARTHRALGIA (wrist hurt). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (fingers started to hurt a lot, middle finger on the right hand and the fat fingers on both hands on the joints), ARTHRALGIA (wrist hurt) and BACK PAIN (Lower back pain) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Does your vaccine cause tinnitus?; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Does your vaccine cause tinnitus?) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Does your vaccine cause tinnitus?). At the time of the report, TINNITUS (Does your vaccine cause tinnitus?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment information was provided by the reporter.