chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: contact dermatitis on face and hands; This spontaneous case was reported by a physician and describes the occurrence of DERMATITIS CONTACT (contact dermatitis on face and hands) 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 March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DERMATITIS CONTACT (contact dermatitis on face and hands). At the time of the report, DERMATITIS CONTACT (contact dermatitis on face and hands) 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.   Doctor said that patient has a contact dermatitis from Poison Ivy on face and hands, would benefit by a course of oral steroid. Patient had first dose of vaccine 10 days ago, not immunosuppressed. Would we recommend he'd not do it or could is he do it without interfering the efficacy of the vaccine?  No concomitant were reported.
Sex: U
Vaccine: COVID19
Symptoms: Middle insomnia
Clinical narrative: in the middle of the night woke up swee; This spontaneous case was reported by an other health care professional and describes the occurrence of MIDDLE INSOMNIA (in the middle of the night woke up swee) 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 December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MIDDLE INSOMNIA (in the middle of the night woke up swee). In December 2021, MIDDLE INSOMNIA (in the middle of the night woke up swee) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got vaccinated in the morning, and in the middle of the night patient woke up swee No concomitant medication were given. No treatment information were given.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node/big bump under her arm; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node/big bump under her arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node/big bump under her arm). At the time of the report, LYMPHADENOPATHY (Swollen lymph node/big bump under her arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided          No concomitant medication reported. No treatment information was provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product colour issue, Vaccination site swelling
Clinical narrative: Area of injection swelled up; Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Area of injection swelled up) and PRODUCT COLOUR ISSUE (Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced VACCINATION SITE SWELLING (Area of injection swelled up) and PRODUCT COLOUR ISSUE (Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish). On 22-Dec-2021, PRODUCT COLOUR ISSUE (Color of the vials that they received were different than usual, color is not white, but more opaque and yellowish) had resolved. At the time of the report, VACCINATION SITE SWELLING (Area of injection swelled up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated  that the color was not white, but more opaque and yellowish and that color was not only seen in the vial, but in the product inside as well. Reporter further stated that inside the syringe the color of the vaccine looked normal, and that the discoloration was only seen in the vial.   No concomitant drug was reported.  No treatment drug was reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Physical examination
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Chronic diarrhoea, Weight loss, Nausea, Abdominal pain generalized, Pain in thoracic spine, Viral syndrome, Contusion of chest wall, Closed fracture of four ribs, Chest discomfort, Esophageal spasm (Nutcracker Esophagus), Dysphagia, Ankle sprain (Let ankle sprain), Headache, Appetite lost and Fatigue. Concurrent medical conditions included Mood disorder, Memory loss, Primary sclerosing cholangitis, Anxiety, Chest wall pain (Chronic from closed rib fractures), Chest wall discomfort (left posterolateral) and Acid reflux (esophageal). Concomitant products included CELECOXIB (CELEBREX) for Pain, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: results not provided Physical exam, routine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other investigations include Lab exam, pre operative examination, Observation and evaluation for suspected exposure to other biological agent, Screening for prostate cancer, skin cancer, lung cancer, colon cancer, physical examination.  Concomitant medications include long term use of non steroidal anti inflammatory drugs.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave a booster dose too early to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave a booster dose too early to a patient) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First shot  Lot number: EW0198 Expiration date: Unknown) on 19-Jul-2021 and PFIZER BIONTECH COVID-19 VACCINE (second shot Lot number: FA7484 Expiration date: Unknown) on 09-Aug-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave a booster dose too early to a patient). On 23-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave a booster dose too early to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Neuralgia
Clinical narrative: abdominal pain; nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain) and NEURALGIA (nerve pain) 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 ABDOMINAL PAIN (abdominal pain) and NEURALGIA (nerve pain). At the time of the report, ABDOMINAL PAIN (abdominal pain) and NEURALGIA (nerve pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M204 and 010L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: HCP just prescribed doxycycline; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (HCP just prescribed doxycycline) 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 ADVERSE DRUG REACTION (HCP just prescribed doxycycline). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (HCP just prescribed doxycycline) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.  Patient's HCP just prescribed doxycycline. Patient would like to know if they should take the second dose of the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: It may be infected; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (It may be infected) 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 EAR INFECTION (It may be infected). At the time of the report, EAR INFECTION (It may be infected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported  Patient called 16Feb2021 stating that she is scheduled to take her second dose today, but had part of her earing's post break off in her ear lobe and thinks it may be infected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Leg edema (Leg edema, left), Dizziness, Sick sinus syndrome, Osteoarthritis (erosive osteoarthritis, osteoarthritis of right foot), Pain in joint (Pain in joint involving foot, right foot), Headache, Effects of radiation, unspecified, Sacroiliitis, Carpal tunnel syndrome, Migraine, Plantar fasciitis (plantar fasciitis, right), GERD, Pain in hip (Hip pain, right), Renal insufficiency, Microscopic hematuria, Preoperative care (Preoperative examination) and Hip replacement (right artificial hip joint). Previously administered products included for Product used for unknown indication: Influenza on 10-Oct-2018, Pfizer (1st dose of PFIZER batch no.-ER8737) on 12-Apr-2021 and PFIZER (2nd dose of PFIZER batch no. - ER8736) on 03-May-2021. Past adverse reactions to the above products included No adverse event with Influenza, PFIZER and Pfizer. Concurrent medical conditions included Drug allergy (Allergy to Bactrim (sulfamethoxazole-trimethoprim)), Iodine allergy, Drug allergy (Allergy to Codeine sulfate (moderate)), Drug allergy (Allergy to Tramadol HCL (moderate)), Drug allergy (Allergy to hydrocodone bitartrate (moderate)), Drug allergy (Allergy to Oxycodone HCL (moderate)), Drug allergy (Allergy to Morphine sulfate (moderate)), Seasonal allergy and Hyperlipidemia. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ESTROGENS CONJUGATED (PREMARIN), MAGNESIUM, ZINC GLUCONATE and VITAMIN D3 for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  Services due included, Hemoccult or Sigmoid, TD Booster, PAP Smear, Mammogram and Breast Exam. concomitant drug Vitamin b12 last refill was on 24-Jan-2018.  screen colon cancer, screen lung cancer, screen skin cancer , osteoporosis, screen, ovarian cancer, Screening cervical cancer, Screening for breast cancer-no results provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, C-reactive protein, Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Peripheral vascular disease, Knee pain (Right.), Thrombocytopenia, Leukopenia, Sinus bradycardia, Rotator cuff tear, Cough, Bronchitis, Hypoxemia, Acute pharyngitis, Neck pain, Foreign body in ear, Secondary thrombocytopenia, Diverticulosis, Impaired fasting glucose, Cataract, UTI, Lumbar radiculopathy, Lumbar strain, Grover's disease, Vertigo, Renal insufficiency, Urinary retention, Change in bowel habits, Abdominal bloating, Abdominal pain, Diarrhea, Hearing loss, Adenoma and Laceration of leg. Previously administered products included for Product used for unknown indication: Influenza vaccine (Series 1) on 03-Oct-2018, Influenza vaccine (Series 2) on 15-Sep-2021 and Influenza vaccine (Series1) on 28-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza vaccine, Influenza vaccine and Influenza vaccine. Concurrent medical conditions included Hyperlipidemia (Hyperlipidemia with low HDL), Iron deficiency, BPH, GERD, Obstructive sleep apnea syndrome, Osteoarthritis, Meniere's disease and Allergic rhinitis. Concomitant products included OXYGEN for Hypoxemia and Obstructive sleep apnoea hypopnoea syndrome, SILDENAFIL CITRATE (SILDENAFIL [SILDENAFIL CITRATE]) for Sexual problem, VITAMIN D3, SELENIUM, SAW PALMETTO [SERENOA REPENS], FOLIC ACID, TOCOPHEROL (VITAMIN E [TOCOPHEROL]), SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM), PANTOPRAZOLE, COENZYME Q10 [UBIDECARENONE], FLUOCINONIDE (FLUCINONIDE), ROSUVASTATIN, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]), MELATONIN, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) High and elevated (High) High. On an unknown date, C-reactive protein: elevated (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lung cancer screen, Skin cancer screen, Screening for Prostate cancer and colon cancer screen. Other concomitant medications included Centrum Silver oral tablet (Multiple vitamins Minerals) one by mouth once a day, Triple flex (glucosamine-chondroitin-MSM, 500-400-125 mg) oral tablet, one by mouth twice a day and SARS COV2 semi quantitative antibody 164090
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration
Clinical narrative: Had the Pfizer as their first two doses; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had the Pfizer as their first two doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included VALSARTAN, METFORMIN and OXYBUTYNIN for an unknown indication.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had the Pfizer as their first two doses). On an unknown date, the patient experienced CHILLS (Chills). On 11-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had the Pfizer as their first two doses) had resolved. At the time of the report, CHILLS (Chills) had resolved.            The patient only experienced chills for one day.  No treatment information was provided.   This case was linked to MOD-2021-425605 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased, Nausea
Clinical narrative: Couldn't do anything at all/had to stay in bed 24 hours/had to call off work; Very dizzy/was so dizzy; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't do anything at all/had to stay in bed 24 hours/had to call off work), DIZZINESS (Very dizzy/was so dizzy) and NAUSEA (Nausea) 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 MOBILITY DECREASED (Couldn't do anything at all/had to stay in bed 24 hours/had to call off work), DIZZINESS (Very dizzy/was so dizzy) and NAUSEA (Nausea). At the time of the report, MOBILITY DECREASED (Couldn't do anything at all/had to stay in bed 24 hours/had to call off work), DIZZINESS (Very dizzy/was so dizzy) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, HYDROCHLOROTHIAZIDE, MONTELUKAST, SIMVASTATIN, GLIMEPIRIDE, LEVOTHYROXINE, METOPROLOL, DILTIAZEM, GABAPENTIN and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter   This case was linked to MOD-2021-425598, MOD-2021-425592 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: nausea; Body aches; Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (nausea) 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 23-Dec-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was unknown.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Cough, Illness, Inappropriate schedule of product administration
Clinical narrative: bones ache; bad cough; chills; running a fever; sick/ sick as a dog; inappropriate schedule of vaccine administered; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick/ sick as a dog), BONE PAIN (bones ache), COUGH (bad cough), VOMITING (vomiting) and CHILLS (chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (6 months ago Second dose) and Pfizer (6 months ago First dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VOMITING (vomiting). On 21-Dec-2021, the patient experienced ILLNESS (sick/ sick as a dog) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced BONE PAIN (bones ache), COUGH (bad cough), CHILLS (chills) and PYREXIA (running a fever). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, ILLNESS (sick/ sick as a dog) had not resolved and BONE PAIN (bones ache), COUGH (bad cough), VOMITING (vomiting), CHILLS (chills) and PYREXIA (running a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results pending Results pending.         Concomitant medications included sweat pill and vitamin. No treatment medications were reported. They went to the emergency clinic today where they tested him for COVID-19. The results have not come back yet.   This case was linked to MOD-2021-425588 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: bones ache; bad cough; chills; running a fever; sick/ sick as a dog; inappropriate schedule of vaccine administered; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick/ sick as a dog), BONE PAIN (bones ache), COUGH (bad cough), VOMITING (vomiting) and CHILLS (chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (6 months ago Second dose) and Pfizer (6 months ago First dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VOMITING (vomiting). On 21-Dec-2021, the patient experienced ILLNESS (sick/ sick as a dog) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced BONE PAIN (bones ache), COUGH (bad cough), CHILLS (chills) and PYREXIA (running a fever). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, ILLNESS (sick/ sick as a dog) had not resolved and BONE PAIN (bones ache), COUGH (bad cough), VOMITING (vomiting), CHILLS (chills) and PYREXIA (running a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: results pending Results pending.         Concomitant medications included sweat pill and vitamin. No treatment medications were reported. They went to the emergency clinic today where they tested him for COVID-19. The results have not come back yet.   This case was linked to MOD-2021-425588 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Root canal surgery after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Root canal surgery after vaccine) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TOOTH DISORDER (Root canal surgery after vaccine). At the time of the report, TOOTH DISORDER (Root canal surgery after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Illness, Pyrexia
Clinical narrative: Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster; Sick after booster; Fever after booster; Chills after booster; Headache after booster; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster), ILLNESS (Sick after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and HEADACHE (Headache after booster) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067421A, 027A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced ILLNESS (Sick after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and HEADACHE (Headache after booster). On 15-Dec-2021, the patient experienced COUGH (Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster). At the time of the report, COUGH (Cough started 2 days after booster/Very bad cough, after booster/Cough got worst, after booster) had not resolved and ILLNESS (Sick after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and HEADACHE (Headache after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (shingles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  The first and second dose was given on Left.   This case was linked to MOD-2021-426367 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: lesions of shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (lesions of shingles) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 044A21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 27-Oct-2021, the patient experienced HERPES ZOSTER (lesions of shingles). At the time of the report, HERPES ZOSTER (lesions of shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  A pharmacist reported that she had the lesions of shingles on 27-Oct-2021 and the diagnosis was confirmed on 01-Nov-2021.   This case was linked to MOD-2021-426367, MOD-2021-425615 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Patient had lower leg cramps, mainly at night; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Patient had lower leg cramps, mainly at night) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced MUSCLE SPASMS (Patient had lower leg cramps, mainly at night). At the time of the report, MUSCLE SPASMS (Patient had lower leg cramps, mainly at night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Patient had second dose of Moderna COVID-19 Vaccine on 25-May-2021, Lot 019107A.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Feeling abnormal, Insomnia, Pain
Clinical narrative: feeling bad; aches and pains; couldn't sleep; arm hurt; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), PAIN (aches and pains), INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had test which showed 6.6 antibodies back in February).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (feeling bad), PAIN (aches and pains), INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (feeling bad), PAIN (aches and pains), INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 6.6 (abnormal) 6.6 antibodies back in February.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. He had been diagnosed with covid-19 prior to receiving the first dose of the vaccine and had a test which showed 6.6 antibodies back in February. He had not taken a second dose of the vaccine.  Treatment information was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feeling bad; aches and pains; couldn't sleep; arm hurt; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), PAIN (aches and pains), INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had test which showed 6.6 antibodies back in February).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (feeling bad), PAIN (aches and pains), INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (feeling bad), PAIN (aches and pains), INSOMNIA (couldn't sleep), PAIN IN EXTREMITY (arm hurt) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 6.6 (abnormal) 6.6 antibodies back in February.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. He had been diagnosed with covid-19 prior to receiving the first dose of the vaccine and had a test which showed 6.6 antibodies back in February. He had not taken a second dose of the vaccine.  Treatment information was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Pruritus
Clinical narrative: her entire body is itching/Her entire body has been itching for 22 days; felt pressure on her chest on her way home; Entire body tired; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (her entire body is itching/Her entire body has been itching for 22 days), CHEST DISCOMFORT (felt pressure on her chest on her way home) and FATIGUE (Entire body tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067FZ1A, 044A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PRURITUS (her entire body is itching/Her entire body has been itching for 22 days) and CHEST DISCOMFORT (felt pressure on her chest on her way home). In December 2021, the patient experienced FATIGUE (Entire body tired). At the time of the report, PRURITUS (her entire body is itching/Her entire body has been itching for 22 days), CHEST DISCOMFORT (felt pressure on her chest on her way home) and FATIGUE (Entire body tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (her entire body is itching/Her entire body has been itching for 22 days), CHEST DISCOMFORT (felt pressure on her chest on her way home) and FATIGUE (Entire body tired) to be related.    The reporter was a Public health program manager.  Concomitant medication of the patient was not reported.  The patient was still having the symptoms. Her entire body was itching so much that the itching cream was not working.   As per the pharmacist, the adverse events were probably the side effects from the vaccine. Her next appointment with her doctor was in next month.  Treatment information for rest of the events were not reported by the reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 0401321A and 002B12A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture). On 24-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine booster dose administered dose/administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vial was opened on 23 DEC 2021 and was administered after 12 hours post puncture as booster dose on 24-DEC-2021 and it was given post 24 hours after it was opened. No concomitant and treatment information were reported by the reporter.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Contusion, Dizziness, Fall
Clinical narrative: fell/tried to get up and fell again/he dropped/fell down; thirsty; did not feel any of his body parts/He was like twilight zone; can't drive; won't work for some days.; his legs gave out; bruised; Lost balance; injury in the shoulder; may be a fracture/breaks a bone; felt dizzy; the top of his shoulder is aching from the fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive) and IMPAIRED WORK ABILITY (won't work for some days.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2021.   On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 23-Dec-2021, the patient experienced FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall). At the time of the report, FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-425596 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Fracture, Impaired driving ability, Impaired work ability, Limb discomfort
Clinical narrative: fell/tried to get up and fell again/he dropped/fell down; thirsty; did not feel any of his body parts/He was like twilight zone; can't drive; won't work for some days.; his legs gave out; bruised; Lost balance; injury in the shoulder; may be a fracture/breaks a bone; felt dizzy; the top of his shoulder is aching from the fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive) and IMPAIRED WORK ABILITY (won't work for some days.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2021.   On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 23-Dec-2021, the patient experienced FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall). At the time of the report, FALL (fell/tried to get up and fell again/he dropped/fell down), THIRST (thirsty), FEELING ABNORMAL (did not feel any of his body parts/He was like twilight zone), IMPAIRED DRIVING ABILITY (can't drive), IMPAIRED WORK ABILITY (won't work for some days.), LIMB DISCOMFORT (his legs gave out), CONTUSION (bruised), BALANCE DISORDER (Lost balance), LIMB INJURY (injury in the shoulder), FRACTURE (may be a fracture/breaks a bone), DIZZINESS (felt dizzy) and ARTHRALGIA (the top of his shoulder is aching from the fall) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-425596 (Patient Link).