chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Loss of consciousness, Pain in extremity, Urine abnormality, Visual impairment
Clinical narrative: Prediabetic; Blackout; Foamy urine; Pain in feet; Lost Quality of sight; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS (Prediabetic) and LOSS OF CONSCIOUSNESS (Blackout) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, ALBUTEROL [SALBUTAMOL] for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2020, the patient experienced URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight). On an unknown date, the patient experienced DIABETES MELLITUS (Prediabetic) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Prediabetic), LOSS OF CONSCIOUSNESS (Blackout), URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were reported were aolrapadine Allergy and  Cpap Machine for apnea. The treatment information was not provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   This case was linked to MOD-2021-237497 (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 events, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Hepatic enzyme increased, Prostatomegaly, Renal failure
Clinical narrative: kidney failure/ going into renal failure; enlarged prostate; wearing a catheter on leg because he cant pee; High liver, kidney enzymes; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure/ going into renal failure) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (kidney failure/ going into renal failure) (seriousness criterion medically significant), PROSTATOMEGALY (enlarged prostate), DYSURIA (wearing a catheter on leg because he cant pee) and HEPATIC ENZYME INCREASED (High liver, kidney enzymes). At the time of the report, RENAL FAILURE (kidney failure/ going into renal failure), PROSTATOMEGALY (enlarged prostate), DYSURIA (wearing a catheter on leg because he cant pee) and HEPATIC ENZYME INCREASED (High liver, kidney enzymes) outcome was unknown.            The Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  It was reported that the patient had high liver and kidney enzymes, and his health declined quickly following the covid-19 vaccine administration. No concomitant medications were reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information is not expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Chest discomfort, Chest pain, Dizziness
Clinical narrative: rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Palpitations, SARS-CoV-2 test
Clinical narrative: rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Optic neuritis, Vision blurred
Clinical narrative: OPTIC NEURITIS; Blurred Vision; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OPTIC NEURITIS (OPTIC NEURITIS) in a 39-year-old female patient 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OPTIC NEURITIS (OPTIC NEURITIS) (seriousness criterion medically significant) and VISION BLURRED (Blurred Vision). At the time of the report, OPTIC NEURITIS (OPTIC NEURITIS) outcome was unknown and VISION BLURRED (Blurred Vision) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: optic neuritis (abnormal) Vaccine triggered Optic Neuritis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product details was not reported.  Treatment details was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: she spotted (had a spotty menstrual period); This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (she spotted (had a spotty menstrual period)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Postmenopause.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (she spotted (had a spotty menstrual period)) (seriousness criterion medically significant). In May 2021, POSTMENOPAUSAL HAEMORRHAGE (she spotted (had a spotty menstrual period)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The concomitant medications were not reported. The treatment information was not provided. 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.   This case was linked to MOD-2021-238550 (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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Contraception, Nervous system disorder, Tic, Tremor
Clinical narrative: Systemic: Shakiness-Medium. Additional Details: Patient received the vaccine on 06/28/2021. Two days later, she developed what she described as a nervous tic, which is still manifests even after 7 days. The patient received the vaccination on the same arm she has a Nexplanon implant.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypotension, Syncope, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: MOTHER WHO IS A NURSE REPORTED SIMILAR SYNCOPY LIKE REACTIONS TO YEARLY FLU SHOT - BUT NOT AS SEVERE
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: MOTHER WHO IS A NURSE REPORTED SIMILAR SYNCOPY LIKE REACTIONS TO YEARLY FLU SHOT - BUT NOT AS SEVERE
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Body Aches, Joint Pain
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: Swelling of left arm after injection at site of injection
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Skin discolouration
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: pt became very white, started to look like he was going to faint, got wet towels and applied to face, neck, arms. kept him conscious be talking to him, called ems but by the time they arrived, he had color and was ok
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: pt became very white, started to look like he was going to faint, got wet towels and applied to face, neck, arms. kept him conscious be talking to him, called ems but by the time they arrived, he had color and was ok
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Breast swelling, Injection site swelling, Peripheral swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: came for second dose vaccine on 7/5.reported swelling under right armpit area/side of breast that appeared 3 days after receiving first dose and that this has happened to him once in the past as well. Pt went to md for visit and was told it was nothing and gave abx which he didnt take.Swelling noticeable, but does not cause pain/affect his daily activity.RPh asked patient if he wants to get it checked by his pcp before receiving second dose, pt refused and wanted 2nd dose.monitoring 30mins
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: seizure for 30 sec on next day-Mild
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: AFTER RECIEVING THEIR 2ND PFIZER COVID VAC DOSE, PT DISCLOSED TO PHARMACIST THAT HE EXPERIENCED CHEST PAIN AFTER HIS FIRST DOSE. PATIENT REPORTED THAT AFTER HIS FIRST DOSE HE WALKED HOME AND EXPERINCED AN ISOLATED INCIDENT OF CHEST PAIN LASTING APPROXIMATELY 30 SECONDS.  RPH ADVISED HIM TO REPORT THE INCIDENT TO HIS PCP AND TO SEEK MEDICAL ATTENTION IN FUTURE CASES OF CHEST PAIN.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Throat irritation, Vomiting
Clinical narrative: Systemic: Vomiting-Mild, Additional Details: He vomited on the floor for about 5 minutes after receiving the vaccination, but stopped vomiting after 2 or 3 times. He had no fever but a little bit of sweating. He said it felt like food was stuck in his throat and refused to drink water and call the ambulance. He trowed up chicken chunks.  He waited in the post vaccination care area for another 20 minutes and felt better so he left.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic dilatation, Atrial fibrillation, Bronchitis, Chest pain, Electrocardiogram
Clinical narrative: Irregular and fast beating heart, chest pains, headache
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Headache, Heart rate increased, Heart rate irregular, Ultrasound scan
Clinical narrative: Irregular and fast beating heart, chest pains, headache
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Additional Details: patient vomited 5 minutes after the injection. felt better after the event
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blood uric acid normal, Cytomegalovirus test negative, Full blood count normal, Isocitrate dehydrogenase gene mutation, Lymphadenopathy
Clinical narrative: left supraclavicular and axillary lymphadenopathy on ipsilateral side of injection, normal labs, resolved over next month
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: left supraclavicular and axillary lymphadenopathy on ipsilateral side of injection, normal labs, resolved over next month
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Hyperventilation, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Additional Details: post vaccination after receiving the modern avaccine, the patient waited for 15 minutes, however returned to the pharmacy complaining of experiencing fast heart beat, along with rapid breething. The patient acknowledged improvement as time went on, however, as precautionary measures EMS was called and the patient was escorted out of the pharmacy. Event after this are unknown
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Nausea-Mild
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Disorientation, Dizziness, Fatigue
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: The patient appeared shaky and disoriented after given the Pfizer vaccination.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Lethargy, Syncope, Tinnitus
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: The patient appeared shaky and disoriented after given the Pfizer vaccination.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Mild, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: The patient appeared shaky and disoriented after given the Pfizer vaccination.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Flushing, Hyperhidrosis, Hypertension
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient came out of vaccine area to wait for 15 minutes to be monitored when he started sweating profusely, was pale white and asked for someone to come talk to him. After reviewing potential adverse effects, patient was able to breathe, no swelling or trouble breathing. But complained of arm tingling/dizziness/weakness at which point rescue squad was dispatched for further evaluation. I stayed with patient and reviewed symptoms with rescue squad, patient choose not to go with rescue squad.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor, Paraesthesia, Tremor
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient came out of vaccine area to wait for 15 minutes to be monitored when he started sweating profusely, was pale white and asked for someone to come talk to him. After reviewing potential adverse effects, patient was able to breathe, no swelling or trouble breathing. But complained of arm tingling/dizziness/weakness at which point rescue squad was dispatched for further evaluation. I stayed with patient and reviewed symptoms with rescue squad, patient choose not to go with rescue squad.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: PT REPORTED HAVING MILD DIZZINESS AFTER 15 MINUTES OF OBSERVATION. RPH HAD PT LIE DOWN WITH ELEVATED LEGS. DURING OBSERVATION, PT WAS QUITE RESPONSIVE, PT STATED HE'S FEELING BETTER AND CHOSE TO LEAVE AT 3:52PM. RPH CALLED PT AT 6:46PM, PT REPORTED HE'S WELL AND DOESN'T FEEL DIZZY ANYMORE.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Arthralgia in both knees.  No visible swelling.  Symptoms became progressively worse.  Pain and difficulty walking peaked 5 days after administration.    On the sixth day the symptoms stopped completely.  No longer in pain.  Walking returned to normal.  I participated in the Pfizer m-RNA clinical study.  Received my second m-RNA dose in October 2021.  After the second m-RNA dose I made a VAERS report of pain in joints.  I should not have made the decision to take the booster dose.  I made this decision on my own.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Injection site pain, Interchange of vaccine products, Sensory disturbance
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Feeling likes bugs inside his body-Medium, Additional Details: Per pt, got Pfizer COVID from pharmacy (time unknow). Patient didn't feel good so decided to walk-in to store on 06/13/2021 for Moderna vaccine. Patient didn't feel good so scheduled another Moderna vaccine via online at store on 06/20/2021. Patient did not inform rph at 10225 that he received his first dose at store on 06/13/2021. Patient came to store on 07/05/2021 complaining that he feels like there are bugs crawling inside his body since receiving COVID vaccines.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 10 minutes after receiving vaccine patient experienced shakiness, tingling, weakness, sweating and appeared pale.  Checked blood pressure initial reading 96/68.  Second BP taken 15 minutes later BP 107/72.  Pulse stable at 68 BPM.  Patient stayed 35min for oberservation and seemed to feel much better when he left.  Water provided to patient.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 10 minutes after receiving vaccine patient experienced shakiness, tingling, weakness, sweating and appeared pale.  Checked blood pressure initial reading 96/68.  Second BP taken 15 minutes later BP 107/72.  Pulse stable at 68 BPM.  Patient stayed 35min for oberservation and seemed to feel much better when he left.  Water provided to patient.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Bradycardia, Chills, Dizziness, Flushing
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Bradycardia-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient had not eaten all morning and felt very anxious about vaccine prior to administration.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Bradycardia-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient had not eaten all morning and felt very anxious about vaccine prior to administration.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Wheezing
Clinical narrative: Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient receive vaccine around 315p, pt called at 457p saying shes having she was having rash/hives all over her body and wheezing
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea, Vomiting
Clinical narrative: Systemic: dysgeusia-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: dysgeusia at onset followed by vomiting 3 days pater precipitating a trip to er and subsequent rx for ondansetron
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Systemic: dysgeusia-Mild, Additional Details: dysgeusia following vaccination....no other symptoms
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt sycope most likely due to fear of needles. ems called and evaluated pt. pt declined visit to hospital. pt released after ems eval.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Hip fracture
Clinical narrative: Broke her hip; 3 Major arthristis flare ups; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broke her hip) in a 90-year-old female patient 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 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (Broke her hip) (seriousness criterion medically significant) and ARTHRITIS (3 Major arthristis flare ups). At the time of the report, HIP FRACTURE (Broke her hip) and ARTHRITIS (3 Major arthristis flare ups) outcome was unknown.            It was reported that patient has been prescribed with steroids 3 times since she got the vaccine. Reporter did not have the lot or vaccine.  No concomitant drugs were reported. Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-116328 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: COVID-19 and pneumonia; Extended time after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 and pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended time after 1st dose). On 06-May-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 and pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (COVID-19 and pneumonia) and PRODUCT DOSE OMISSION ISSUE (Extended time after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. The patient reported that he was treated with steroids, antibiotics and inhaler for the pneumonia. Patient was scheduled to receive the second dose of the Moderna Covid19 vaccine 05June2021 however the patient was diagnosed with double pneumonia  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 pneumonia  and mRNA-1273 is assessed as not applicable. For the event product dose omission causality is assessed as not applicable too.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 pneumonia  and mRNA-1273 is assessed as not applicable. For the event product dose omission causality is assessed as not aplicable too.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Chest discomfort, Ventricular extrasystoles
Clinical narrative: ongoing arrhythmia with constant; chest continues to feel tight; 3 PVCs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (ongoing arrhythmia with constant) and VENTRICULAR EXTRASYSTOLES (3 PVCs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (3 PVCs) (seriousness criterion medically significant). On an unknown date, the patient experienced ARRHYTHMIA (ongoing arrhythmia with constant) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest continues to feel tight). On 17-Feb-2021, VENTRICULAR EXTRASYSTOLES (3 PVCs) outcome was unknown. At the time of the report, ARRHYTHMIA (ongoing arrhythmia with constant) and CHEST DISCOMFORT (chest continues to feel tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter.  No treatment details were provided by the reporter.  it was reported that Patient was referred to cardiologist who is in the middle of workup, having ordered a nuclear stress test and Echocardiogram, This week patient began one week patch monitoring protocol.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-239114 (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 events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.) in an elderly female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment information was reported by the reporter. Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Impaired work ability, Nausea, Pain in extremity
Clinical narrative: I was not able to work; seizure; nauseas; hurt in my joints; constant headache; arm was hurting to my elbow; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures (Seizure free since Feb-2021.).    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting to my elbow) and HEADACHE (constant headache). On 22-Jun-2021, the patient experienced NAUSEA (nauseas) and ARTHRALGIA (hurt in my joints). On 25-Jun-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (I was not able to work). At the time of the report, SEIZURE (seizure), PAIN IN EXTREMITY (arm was hurting to my elbow), IMPAIRED WORK ABILITY (I was not able to work), NAUSEA (nauseas), ARTHRALGIA (hurt in my joints) and HEADACHE (constant headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient will report to his MD and see if he thinks that patient should get the 2nd dose, but patient is very uncomfortable at this time No concomitant medications were reported.  No treatment information was provided.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I was not able to work; seizure; nauseas; hurt in my joints; constant headache; arm was hurting to my elbow; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures (Seizure free since Feb-2021.).    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting to my elbow) and HEADACHE (constant headache). On 22-Jun-2021, the patient experienced NAUSEA (nauseas) and ARTHRALGIA (hurt in my joints). On 25-Jun-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (I was not able to work). At the time of the report, SEIZURE (seizure), PAIN IN EXTREMITY (arm was hurting to my elbow), IMPAIRED WORK ABILITY (I was not able to work), NAUSEA (nauseas), ARTHRALGIA (hurt in my joints) and HEADACHE (constant headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient will report to his MD and see if he thinks that patient should get the 2nd dose, but patient is very uncomfortable at this time No concomitant medications were reported.  No treatment information was provided.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Pericarditis
Clinical narrative: felt like he was having heart attack/diagnosed with Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (felt like he was having heart attack/diagnosed with Pericarditis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PERICARDITIS (felt like he was having heart attack/diagnosed with Pericarditis) (seriousness criteria hospitalization and medically significant). On 09-Apr-2021, PERICARDITIS (felt like he was having heart attack/diagnosed with Pericarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) Pericarditis.         Treatment medicines include steroids unspecified Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pulmonary embolism
Clinical narrative: diagnosed with pulmonary embolism; started having chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (diagnosed with pulmonary embolism) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reflux esophagitis and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, FAMOTIDINE for Allergy and Reflux esophagitis, NADOLOL, LANSOPRAZOLE (LANZOPRAL), VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced CHEST PAIN (started having chest pain). On 25-May-2021, the patient experienced PULMONARY EMBOLISM (diagnosed with pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (diagnosed with pulmonary embolism) and CHEST PAIN (started having chest pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product information was provided It was reported that patient is in generally good health and has never experienced anything like this, patient is not sure if it is connected to the vaccine and if other people have experienced the same reaction but patient wanted to report this adverse reaction to Moderna.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol withdrawal syndrome, SARS-CoV-2 test
Clinical narrative: Alcohol withdrawal; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOL WITHDRAWAL SYNDROME (Alcohol withdrawal) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 ALCOHOL WITHDRAWAL SYNDROME (Alcohol withdrawal) (seriousness criterion hospitalization). At the time of the report, ALCOHOL WITHDRAWAL SYNDROME (Alcohol withdrawal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) he tested negative for covid.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment: Although a temporal association exists, based on the current available information, the event alcohol withdrawal is assessed as unlikely related.; Sender's Comments: Although a temporal association exists, based on the current available information, the event alcohol withdrawal is assessed as unlikely related.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Seizure
Clinical narrative: Seizures; 2nd dose missed (more than 42 days)/s rescheduling the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-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 SEIZURE (Seizures) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose missed (more than 42 days)/s rescheduling the 2nd dose). At the time of the report, SEIZURE (Seizures) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose missed (more than 42 days)/s rescheduling the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not  provided. Before the 2nd dose patient suffered seizures and 2nd dose was delayed. Patient is rescheduling the 2nd dose and  wondering if she will need to start all over again.  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.; 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.