chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Tenderness, Underdose
Clinical narrative: Tenderness in the arm; Vaccine leaked during injection, patient not sure if full dose was received; Vaccine leaked during injection, patient not sure if full dose was received; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the arm), UNDERDOSE (Vaccine leaked during injection, patient not sure if full dose was received) and DEVICE CONNECTION ISSUE (Vaccine leaked during injection, patient not sure if full dose was received) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 939902) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HCTZ, LOSARTAN, POTASSIUM and VITAMIN D3 for an unknown indication.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced UNDERDOSE (Vaccine leaked during injection, patient not sure if full dose was received) and DEVICE CONNECTION ISSUE (Vaccine leaked during injection, patient not sure if full dose was received). On an unknown date, the patient experienced TENDERNESS (Tenderness in the arm). On 13-Jul-2021, UNDERDOSE (Vaccine leaked during injection, patient not sure if full dose was received) and DEVICE CONNECTION ISSUE (Vaccine leaked during injection, patient not sure if full dose was received) had resolved. At the time of the report, TENDERNESS (Tenderness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medications No treatment medications were provided.   This case was linked to MOD-2021-321449 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant FU ADR form includes indications of concomitants and 2nd dose events, batch number, its outcome, treatment which were added in the 2nd dose case.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle fatigue, Myalgia, Vaccination site pain
Clinical narrative: she wakes up with her back muscles exhausted; Pain on the injection arm/Her muscles continue to be bad; Pain on shoulder and scapula; Little tiredness; Little pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (she wakes up with her back muscles exhausted), VACCINATION SITE PAIN (Pain on the injection arm/Her muscles continue to be bad), ARTHRALGIA (Pain on shoulder and scapula), FATIGUE (Little tiredness) and MYALGIA (Little pain in muscle) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE FATIGUE (she wakes up with her back muscles exhausted), VACCINATION SITE PAIN (Pain on the injection arm/Her muscles continue to be bad), ARTHRALGIA (Pain on shoulder and scapula), FATIGUE (Little tiredness) and MYALGIA (Little pain in muscle). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCLE FATIGUE (she wakes up with her back muscles exhausted), VACCINATION SITE PAIN (Pain on the injection arm/Her muscles continue to be bad), ARTHRALGIA (Pain on shoulder and scapula), FATIGUE (Little tiredness) and MYALGIA (Little pain in muscle) 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 products were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown ), the reporter did not provide any causality assessment   This case was linked to MOD-2021-264250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up contains non-significant information with NNI On 16-Sep-2021: New event Fatigue and Myalgia added
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later; The patient was injected with Moderna's COVID-19 vaccine in error; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna's COVID-19 vaccine in error) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna's COVID-19 vaccine in error). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna's COVID-19 vaccine in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient was previously admitted for non-COVID related reasons.   The patient was previously vaccinated with J&J Covid-19 vaccine on 09-Jun-2021 via Intramuscular route (batch no. 207A21A, location LD). The reporter stated that they were initially unaware that the patient had received the J&J vaccine but learned about the J&J vaccination after the Moderna dose was given. The patient was fully vaccinated and currently had no untoward effects.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received. Updated Patient Race and ethnic group, Dose 2 details.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: itching; redness; hives; other people have a rash that didn't start until a week after the Moderna shot; 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 PRURITUS (itching), ERYTHEMA (redness), URTICARIA (hives) and RASH (other people have a rash that didn't start until a week after the Moderna shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034c21a and 048c21a) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Osteoporosis and Leg cramps. Concomitant products included LETROZOLE for Breast cancer, MAGNESIUM for Leg cramps, ALENDRONATE SODIUM, COLECALCIFEROL (FOSAMAX D) for Osteoporosis, FOLIC ACID and COLECALCIFEROL (D3) for an unknown indication.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PRURITUS (itching), ERYTHEMA (redness), URTICARIA (hives) and RASH (other people have a rash that didn't start until a week after the Moderna shot). The patient was treated with HYDROCORTISONE VALERATE (HYDROCORTISONE [HYDROCORTISONE VALERATE]) from 19-Aug-2021 to 23-Aug-2021 for Adverse event, at a dose of UNK, tid. On 23-Aug-2021, PRURITUS (itching), ERYTHEMA (redness), URTICARIA (hives) and RASH (other people have a rash that didn't start until a week after the Moderna shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD-2021-269939.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up was received on 17-SEP-2021 and patient demographic details, patient gender, concomitant medication, suspect product details, Treatment information and new events, causality were added.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old mistakenly injected with vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old mistakenly injected with vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stomach discomfort.   On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old mistakenly injected with vaccine). On 27-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old mistakenly injected with vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant products were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: The recent follow-up document contains Pfizer vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines. 2021     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product.  Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   Author commentclinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-245527, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284007 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-245527, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015, MOD-2021-245527 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated. Hence new reports generated. On 05-Jul-2021: Follow up received 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a vial that has an expiration date of 8 Aug 2021 was given to 6 patients/Product removed from refrigerator on 07Sep2021 at 1p./08Sep2021: Correct expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant Follow Up Appended: Patient Identifiers Added and lot number updated, correct expiration date updated. On 15-Sep-2021: Non Significant Follow up, patient contact details updated.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm start hurting today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm start hurting today) 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.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm start hurting today). At the time of the report, PAIN IN EXTREMITY (Arm start hurting today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was provided by the reporter.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Myocarditis, Troponin I
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 25-year-old male patient 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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: 55% (normal) left ventricular ejection fraction -55%. On an unknown date, Troponin I: 20.4 (ng/ml) (abnormal) 20.4 (ng/mL).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant medications were not reported. Therapy for the event was not reported. It was reported that all patients recovered within 6 days of their presentation with complications. This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-317975, MOD-2021-317976, MOD-2021-317977, MOD-2021-317978 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site anaesthesia, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: a rash on her arm/rash was about 4 inches long/the rash is resolving on its own; her left arm was warm and fairly red; doesn't itch too much; still feels a little sensation; her left arm was warm and fairly red/the color is already reducing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash on her arm/rash was about 4 inches long/the rash is resolving on its own), VACCINATION SITE WARMTH (her left arm was warm and fairly red), VACCINATION SITE PRURITUS (doesn't itch too much), VACCINATION SITE ANAESTHESIA (still feels a little sensation) and VACCINATION SITE ERYTHEMA (her left arm was warm and fairly red/the color is already reducing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE RASH (a rash on her arm/rash was about 4 inches long/the rash is resolving on its own), VACCINATION SITE WARMTH (her left arm was warm and fairly red), VACCINATION SITE PRURITUS (doesn't itch too much), VACCINATION SITE ANAESTHESIA (still feels a little sensation) and VACCINATION SITE ERYTHEMA (her left arm was warm and fairly red/the color is already reducing). At the time of the report, VACCINATION SITE RASH (a rash on her arm/rash was about 4 inches long/the rash is resolving on its own), VACCINATION SITE WARMTH (her left arm was warm and fairly red), VACCINATION SITE PRURITUS (doesn't itch too much), VACCINATION SITE ANAESTHESIA (still feels a little sensation) and VACCINATION SITE ERYTHEMA (her left arm was warm and fairly red/the color is already reducing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: have more energy than she had for 20years / decreased inflammation /more symptoms of the diseases: chronic progressive tendonitis & severe arthritis /an now walk without the use of her knee braces/constant inflamation in elbows, wrists,; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (have more energy than she had for 20years / decreased inflammation /more symptoms of the diseases: chronic progressive tendonitis & severe arthritis /an now walk without the use of her knee braces/constant inflamation in elbows, wrists,) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included Endometriosis (menaopause fixed that). Concurrent medical conditions included Food allergy (All corn products,), Latex allergy, Drug allergy (Allergy to Azithromycin), Tendonitis (had chronic progressive tendonitis for years), Arthritis (severe arthritis in the knees that had been treated with steroids), Drug allergy (erythromycin), Inflammation (Over time got many steroid shots. Now can't take steroids) since 1996, Tendinitis (stretcing and steroids. Now cant' take steroids) in 1996 and Glaucoma in 2015. Concomitant products included ALPRAZOLAM (ALPRAZOLAM 1 A PHARMA) for Anxiety, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) and FAMOTIDINE (FAMOTIDINE ACID REDUCER) for Heartburn and Endoscopy, ATORVASTATIN CALCIUM (ATORVASTATIN +PHARMA) for Lipids blood increased.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (have more energy than she had for 20years / decreased inflammation /more symptoms of the diseases: chronic progressive tendonitis & severe arthritis /an now walk without the use of her knee braces/constant inflamation in elbows, wrists,). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (have more energy than she had for 20years / decreased inflammation /more symptoms of the diseases: chronic progressive tendonitis & severe arthritis /an now walk without the use of her knee braces/constant inflamation in elbows, wrists,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP was informed, was only advised that they will monitor it. Patient performed activities such as gardening.  Patient had steroid-sensitive, Patient had digestive issues got better when I got off corn. No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: FU Received allergies on 16-Sep-2021 included Patient weight, historical Conditions, concomitants indication.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dysstasia, Fall, Fatigue
Clinical narrative: Could hardly stand; headache; fatigue; little dizzy; barley walk; was falling in the walls; frequently urinate; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls), POLLAKIURIA (frequently urinate) and DYSSTASIA (Could hardly stand) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant (12 year ago.) in November 2008. Concurrent medical conditions included Drug allergy (ciprofloxacin). Concomitant products included SIROLIMUS (RAPAMUNE) for Immunosuppressant drug level NOS, VITAMINS;MINERALS;LYSINE and CALCIUM for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls) and POLLAKIURIA (frequently urinate). On 22-Aug-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSSTASIA (Could hardly stand). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fatigue, at an unspecified dose and frequency. On 22-Aug-2021, DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls) and HEADACHE (headache) had resolved. At the time of the report, POLLAKIURIA (frequently urinate) and DYSSTASIA (Could hardly stand) outcome was unknown and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 34,37,23,1.43, 40, 31.3,13.3 (High) ALT-34,AGT-39, BUN-23,CREATINE-1.43, DIRECT BILLI..-40, MCH-31.3, MID-13.3 and 57.20,7.0 (Low) GRANULOCYTES-57.20, MPV-7.0.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter states that patient had blood test after 3 days of vaccination and liver and kidney level was elevated.  patient will  be going for another blood test after couple of days to see it return to normal.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up events and new reporter and event outcome and tests are added , and I narrative updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Pollakiuria
Clinical narrative: Could hardly stand; headache; fatigue; little dizzy; barley walk; was falling in the walls; frequently urinate; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls), POLLAKIURIA (frequently urinate) and DYSSTASIA (Could hardly stand) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant (12 year ago.) in November 2008. Concurrent medical conditions included Drug allergy (ciprofloxacin). Concomitant products included SIROLIMUS (RAPAMUNE) for Immunosuppressant drug level NOS, VITAMINS;MINERALS;LYSINE and CALCIUM for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls) and POLLAKIURIA (frequently urinate). On 22-Aug-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced DYSSTASIA (Could hardly stand). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fatigue, at an unspecified dose and frequency. On 22-Aug-2021, DIZZINESS (little dizzy), GAIT DISTURBANCE (barley walk), FALL (was falling in the walls) and HEADACHE (headache) had resolved. At the time of the report, POLLAKIURIA (frequently urinate) and DYSSTASIA (Could hardly stand) outcome was unknown and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 34,37,23,1.43, 40, 31.3,13.3 (High) ALT-34,AGT-39, BUN-23,CREATINE-1.43, DIRECT BILLI..-40, MCH-31.3, MID-13.3 and 57.20,7.0 (Low) GRANULOCYTES-57.20, MPV-7.0.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter states that patient had blood test after 3 days of vaccination and liver and kidney level was elevated.  patient will  be going for another blood test after couple of days to see it return to normal.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up events and new reporter and event outcome and tests are added , and I narrative updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Injection site induration, Pollakiuria, Renal disorder, Urine output increased
Clinical narrative: full bladder feeling/ feeling a need to urinate; having excessive urination; something was causing trouble in her bladder & kidneys; something was causing trouble in her bladder & kidneys; injection sites felt hard; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination), RENAL DISORDER (something was causing trouble in her bladder & kidneys), BLADDER DISORDER (something was causing trouble in her bladder & kidneys) and INJECTION SITE INDURATION (injection sites felt hard) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sensitive to sodium) and Immunocompromised.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination), RENAL DISORDER (something was causing trouble in her bladder & kidneys), BLADDER DISORDER (something was causing trouble in her bladder & kidneys) and INJECTION SITE INDURATION (injection sites felt hard). At the time of the report, POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination), RENAL DISORDER (something was causing trouble in her bladder & kidneys), BLADDER DISORDER (something was causing trouble in her bladder & kidneys) and INJECTION SITE INDURATION (injection sites felt hard) outcome was unknown.        No concomitant medication was reported. No treatment medication was reported. Reporter was confused because the email mentioned she received a booster and she was told that there was no booster and that she received a third dose of the vaccine on a previous call with a MI agent.   This case was linked to MOD-2021-319270, MOD-2021-319619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received contains additional new events renal disorder and bladder disorder were added.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (patient was 36 weeks pregnant.) and Allergy to vaccine (Allergic to flu shot). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, BUSPIRONE for Anxiety, NIFEDIPINE (PROCARDIA [NIFEDIPINE]) for Blood pressure, CELECOXIB (CELEXA [CELECOXIB]) for Depression, OMEPRAZOLE for GERD, DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Irritable bowel syndrome.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy. The patient received the first dose of vaccine at approximately 36 weeks of gestation, no other adverse events were reported. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.   This case was linked to MOD-2021-307461.; Sender's Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of Maternal exposure during pregnancy. The patient received the first dose of vaccine at approximately 36 weeks of gestation, no other adverse events were reported. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The reporter declined being aware if the patient experienced any side effects   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeding disorder, Gait inability, Mobility decreased
Clinical narrative: He could barely move or even walk; He could barely move or even walk/for almost 3 days he could barely walk; Can barely eat; Feels weak/low energy; Legs wabblel; Feels nauseous; Being the 7th day since the vaccine, his body aches; Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out; Pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out), GAIT INABILITY (He could barely move or even walk), MOBILITY DECREASED (He could barely move or even walk/for almost 3 days he could barely walk), FEEDING DISORDER (Can barely eat) and PAIN (Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced DIZZINESS (Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out), FEEDING DISORDER (Can barely eat), ASTHENIA (Feels weak/low energy), TREMOR (Legs wabblel), NAUSEA (Feels nauseous) and MYALGIA (Being the 7th day since the vaccine, his body aches). On 09-Sep-2021, the patient experienced GAIT INABILITY (He could barely move or even walk) and MOBILITY DECREASED (He could barely move or even walk/for almost 3 days he could barely walk). In September 2021, the patient experienced PAIN (Pain). At the time of the report, DIZZINESS (Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out) outcome was unknown and GAIT INABILITY (He could barely move or even walk), MOBILITY DECREASED (He could barely move or even walk/for almost 3 days he could barely walk), FEEDING DISORDER (Can barely eat), PAIN (Pain), ASTHENIA (Feels weak/low energy), TREMOR (Legs wabblel), NAUSEA (Feels nauseous) and MYALGIA (Being the 7th day since the vaccine, his body aches) had not resolved.            No concomitant medications were provided.  Patient had visited to the hospital and got two shots to get relief from the pain.   This case was linked to MOD-2021-320695- Wife's case.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Tremor
Clinical narrative: He could barely move or even walk; He could barely move or even walk/for almost 3 days he could barely walk; Can barely eat; Feels weak/low energy; Legs wabblel; Feels nauseous; Being the 7th day since the vaccine, his body aches; Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out; Pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out), GAIT INABILITY (He could barely move or even walk), MOBILITY DECREASED (He could barely move or even walk/for almost 3 days he could barely walk), FEEDING DISORDER (Can barely eat) and PAIN (Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced DIZZINESS (Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out), FEEDING DISORDER (Can barely eat), ASTHENIA (Feels weak/low energy), TREMOR (Legs wabblel), NAUSEA (Feels nauseous) and MYALGIA (Being the 7th day since the vaccine, his body aches). On 09-Sep-2021, the patient experienced GAIT INABILITY (He could barely move or even walk) and MOBILITY DECREASED (He could barely move or even walk/for almost 3 days he could barely walk). In September 2021, the patient experienced PAIN (Pain). At the time of the report, DIZZINESS (Took his second dose on 9/8. Immediately after getting the shot, he felt light headed, dizzy/ he is going to pass out) outcome was unknown and GAIT INABILITY (He could barely move or even walk), MOBILITY DECREASED (He could barely move or even walk/for almost 3 days he could barely walk), FEEDING DISORDER (Can barely eat), PAIN (Pain), ASTHENIA (Feels weak/low energy), TREMOR (Legs wabblel), NAUSEA (Feels nauseous) and MYALGIA (Being the 7th day since the vaccine, his body aches) had not resolved.            No concomitant medications were provided.  Patient had visited to the hospital and got two shots to get relief from the pain.   This case was linked to MOD-2021-320695- Wife's case.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (a sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (a sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient that got his first injection on May 18, 2021 and has not yet received second vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient that got his first injection on May 18, 2021 and has not yet received second vaccine) 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 18-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 PRODUCT DOSE OMISSION ISSUE (Patient that got his first injection on May 18, 2021 and has not yet received second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient that got his first injection on May 18, 2021 and has not yet received second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I received my first vaccine on August 2nd and on August 6th I had Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I received my first vaccine on August 2nd and on August 6th I had Covid) 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 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced COVID-19 (I received my first vaccine on August 2nd and on August 6th I had Covid). On 06-Aug-2021, COVID-19 (I received my first vaccine on August 2nd and on August 6th I had Covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported. No Concomitant medication was reported. No lab data was provided. Denied  to be followed by safety
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The date that the vial was 30 days in the refrigerator was 05Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The date that the vial was 30 days in the refrigerator was 05Sep2021) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The date that the vial was 30 days in the refrigerator was 05Sep2021). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The date that the vial was 30 days in the refrigerator was 05Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was stated that as a reminder, 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021. Lot was 007C21A Manufactured date 12-Mar-21, NDC of box 80777-273-99, 00380777273990 and and Expiration date was listed online as 12-Oct-2021  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-320340, MOD-2021-320876.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.    This case was linked to MOD-2021-320876 (Patient Link).