chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: I received the vaccine now my arm is red and warm to touch; I received the vaccine now my arm is red and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (I received the vaccine now my arm is red and warm to touch) and VACCINATION SITE ERYTHEMA (I received the vaccine now my arm is red and warm to touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (I received the vaccine now my arm is red and warm to touch) and VACCINATION SITE ERYTHEMA (I received the vaccine now my arm is red and warm to touch). At the time of the report, VACCINATION SITE WARMTH (I received the vaccine now my arm is red and warm to touch) and VACCINATION SITE ERYTHEMA (I received the vaccine now my arm is red and warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Concomitant medication was not reported. The Treatment history was not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Product dose omission issue, Tachycardia
Clinical narrative: tachycardia (fast heart beat); weakness; dizziness; hands were clammy; more than 35 days passed and she did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness), COLD SWEAT (hands were clammy) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-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 TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness), COLD SWEAT (hands were clammy) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose). At the time of the report, TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness) and COLD SWEAT (hands were clammy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication were provided.  No treatment medication were provided.  No lab data were provided.  Reporter decided not to get the second dose as she did not knew if she was allergic or not. Now she was thinking of getting the second dose and she wonders if she should get it, given her reaction and if she were to get it should she start the series all over and Would it be the same to get a booster shot.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Severe abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Severe abdominal pain). At the time of the report, ABDOMINAL PAIN (Severe abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: Feeling very sick; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling very sick) and VOMITING (Throwing up) 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 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced MALAISE (Feeling very sick) and VOMITING (Throwing up). At the time of the report, MALAISE (Feeling very sick) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing
Clinical narrative: constant sneezing; nose stuffy; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (Heart issues), Lung disease (Lung issues), Diabetes, Blood pressure high and Nervous system disorder NOS (Nervous system problems).    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy). At the time of the report, SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously). On 30-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  Patient got their 2 shots of Pfizer previously, one of them got 2nd Pfizer shot on 25 Aug and took modern booster after 5 days.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a some sort of blockage; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Had a some sort of blockage) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a some sort of blockage). At the time of the report, VACCINATION COMPLICATION (Had a some sort of blockage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose from expired vial administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose from expired vial administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Shell fish allergy) and Iodine allergy (Iodine allergy).    On 01-Sep-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose from expired vial administered). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose from expired vial administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient did not experience any adverse events. Treatment information was not reported   This case was linked to MOD-2021-306120, MOD-2021-306124 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received: added ethnicity, allergy history, route of administration, dose number, site of administration.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Additional Details: PATIENT STATES HEADACHE ONSET 4 DAYS AFTER ADMIN OF VACCINE, HAS HAD HEADACHE EVER SINCE (STATES DOES NOT GET HEADACHES), ARM STILL SWOLLEN AFTER ADMIN
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Approximately 5 minutes after injection patient reported feeling faint. Pharmacist was at patient's side. Patient appeared pale, started sweating then fainted.  Pharmacist kept patient safely in chair, patient was unconcious for approximately 2 minutes before regaining conciousness.  EMS was called, they evaluated patient on site. Vitals were normal, blood sugar normal.  Patient felt better and refused transportation to the hospital.  Patient left pharmacy after approximately 30 minutes.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Approximately 5 minutes after injection patient reported feeling faint. Pharmacist was at patient's side. Patient appeared pale, started sweating then fainted.  Pharmacist kept patient safely in chair, patient was unconcious for approximately 2 minutes before regaining conciousness.  EMS was called, they evaluated patient on site. Vitals were normal, blood sugar normal.  Patient felt better and refused transportation to the hospital.  Patient left pharmacy after approximately 30 minutes.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Hypotension
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: PT RECEIVED THE 1ST SHOT ON 9/8. STARTED HAVING SXS OF LOW BP AND CHEST PAIN THE NEXT MORNING. WENT TO A HOSPITAL TO RECEIVE TREATMENT
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Hyperhidrosis, Immediate post-injection reaction, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt fainted right after receiving his 1 dose. Temperature taken before vaccine adminstration was 97.3 and blood pressure after fainting was 110/64 (normal).Ptleft with his mother and was advised to seek medical advise from his PCP.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt fainted right after receiving his 1 dose. Temperature taken before vaccine adminstration was 97.3 and blood pressure after fainting was 110/64 (normal).Ptleft with his mother and was advised to seek medical advise from his PCP.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Fall, Flushing, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Additional Details: Patient fell on the floor and hit the head which caused a deep laceration by the forehead area. Paramedics came in and took him to the hospital.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Skin laceration, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Additional Details: Patient fell on the floor and hit the head which caused a deep laceration by the forehead area. Paramedics came in and took him to the hospital.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 30-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously). On 30-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment history was reported.  Patient took modern third dose on 30 aug2021. One of the patient got their 2 shots of Pfizer previously, 2nd Pfizer shot on 25 aug2021, and took modern booster after 5 days.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Rash, Rash pruritic, Swelling face
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient called back to the pharmacy approximately 2 hours after receiving vaccine stating  that she had broken out with an itchy rash on her face and neck
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient called back to the pharmacy approximately 2 hours after receiving vaccine stating  that she had broken out with an itchy rash on her face and neck
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: I woke up with sores on roof of my mouth.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Error: Infection / Cellulitis (diagnosed by MD)-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third shot of Moderna, 2 Pfizer shots previously) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third shot of Moderna, 2 Pfizer shots previously). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third shot of Moderna, 2 Pfizer shots previously) had resolved.        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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Fatigue, Flushing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt fainted and sezied for 10 seconds, this was 3 minutes after vaccine. After 2 minutes this repeated again. Pt was okay after talking to her, given her cold water, orange juice, and juice drink x2. Took her 30 mins to recover
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypertension, Hyperventilation, Hypoaesthesia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt fainted and sezied for 10 seconds, this was 3 minutes after vaccine. After 2 minutes this repeated again. Pt was okay after talking to her, given her cold water, orange juice, and juice drink x2. Took her 30 mins to recover
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Paraesthesia, Seizure, Syncope
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt fainted and sezied for 10 seconds, this was 3 minutes after vaccine. After 2 minutes this repeated again. Pt was okay after talking to her, given her cold water, orange juice, and juice drink x2. Took her 30 mins to recover
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt fainted and sezied for 10 seconds, this was 3 minutes after vaccine. After 2 minutes this repeated again. Pt was okay after talking to her, given her cold water, orange juice, and juice drink x2. Took her 30 mins to recover
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypotension, Syncope
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles, painful rash on torso, started 5 days after second dose.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Swelling and tenderness noted to left posterior cervical lymph nodes-Medium, Systemic: Lymph Node Swelling-Medium
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Delayed second dose/  received vaccine in march and did not get second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed second dose/  received vaccine in march and did not get second dose) in a 28-year-old female patient 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. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delayed second dose/  received vaccine in march and did not get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delayed second dose/  received vaccine in march and did not get second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment drugs were not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Incomplete course of vaccination, Influenza like illness
Clinical narrative: On the morning of, Thursday 09/09/2021, at 0800 hours after working a graveyard shift, I went to the  Clinic in the hospital  for a regular annual checkup appointment at 0830. While the nurse took my vital signs, she offered me the SHINGRIX vaccine.  My wife had had both doses a couple of years ago, and we felt it was a good vaccine to get as we aged, so I said yes to the nurse. I received the first dose of the SHINGRIX vaccine at that time. I got home about 1100 hours.  I ate some lunch and went to bed with a sore left arm. I woke up earlier than normal to help cover a two-hour portion of a shift of a coworker who is out for a few days.  I felt a little dizzy as I got dressed and thought it was just from waking up. While I drove into work, I started to feel really sick, some flu like symptoms that I hadn't felt in over 5 years.  I actually don?t remember the last time I felt the way I was feeling.  I thought to myself that this was definitely connected to the SHINGRIX vaccine that I had earlier.  After I got to work, I signed into the logbook in the plant at 2200 hours.  I searched on the Internet and looked on the SHINGRIX website for side effects.   The SHINGRIX website and also the CDCs website; were nearly identical in noting the following side effects: Muscle Pain, Tiredness, Headache, Shivering, Fever, Upset stomach, Nausea, dizziness and a few other side effects listed.  I called the ER here and let them know I work here  on a graveyard shift and asked one of the nursing staff about the side effects of the SHINGRIX vaccine. They confirmed what the two websites were saying about the side effects.  They said I should go home immediately. Which I did. I felt like I was going to die. One concern I still have,  is the CDCs statement that the, "Symptoms went away on their own in about 2 to 3 days, but prevented those who experienced these side effects, from doing regular activities." However, I had to wait until 0200 hours in the morning to put in sick leave because of the sick leave I have used up to help my wife with eye surgery, the funeral for my mother and a bi-polar type 1 sister, who broke into our home, a few days ago while my wife was home.   There is enough going on in my life to have these side effects have such a severe effect on me, feeling as though I was about to die.  I still feel weak and am out of leave to take time off.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: On the morning of, Thursday 09/09/2021, at 0800 hours after working a graveyard shift, I went to the  Clinic in the hospital  for a regular annual checkup appointment at 0830. While the nurse took my vital signs, she offered me the SHINGRIX vaccine.  My wife had had both doses a couple of years ago, and we felt it was a good vaccine to get as we aged, so I said yes to the nurse. I received the first dose of the SHINGRIX vaccine at that time. I got home about 1100 hours.  I ate some lunch and went to bed with a sore left arm. I woke up earlier than normal to help cover a two-hour portion of a shift of a coworker who is out for a few days.  I felt a little dizzy as I got dressed and thought it was just from waking up. While I drove into work, I started to feel really sick, some flu like symptoms that I hadn't felt in over 5 years.  I actually don?t remember the last time I felt the way I was feeling.  I thought to myself that this was definitely connected to the SHINGRIX vaccine that I had earlier.  After I got to work, I signed into the logbook in the plant at 2200 hours.  I searched on the Internet and looked on the SHINGRIX website for side effects.   The SHINGRIX website and also the CDCs website; were nearly identical in noting the following side effects: Muscle Pain, Tiredness, Headache, Shivering, Fever, Upset stomach, Nausea, dizziness and a few other side effects listed.  I called the ER here and let them know I work here  on a graveyard shift and asked one of the nursing staff about the side effects of the SHINGRIX vaccine. They confirmed what the two websites were saying about the side effects.  They said I should go home immediately. Which I did. I felt like I was going to die. One concern I still have,  is the CDCs statement that the, "Symptoms went away on their own in about 2 to 3 days, but prevented those who experienced these side effects, from doing regular activities." However, I had to wait until 0200 hours in the morning to put in sick leave because of the sick leave I have used up to help my wife with eye surgery, the funeral for my mother and a bi-polar type 1 sister, who broke into our home, a few days ago while my wife was home.   There is enough going on in my life to have these side effects have such a severe effect on me, feeling as though I was about to die.  I still feel weak and am out of leave to take time off.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my doctor told me to go ahead and take the third booster shot at month 6. I inadvertently took it a month early.; fever of 101.2/ fever of 101.2 wiped me out; Extreme Soreness at the inection site; All over Joint pain; I feel pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel pretty bad), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my doctor told me to go ahead and take the third booster shot at month 6. I inadvertently took it a month early.), PYREXIA (fever of 101.2/ fever of 101.2 wiped me out), VACCINATION SITE PAIN (Extreme Soreness at the inection site) and ARTHRALGIA (All over Joint pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055E21A, 020B71A and 025AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease since September 2010 and Penicillin allergy. Concomitant products included DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO) from October 2020 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced FEELING ABNORMAL (I feel pretty bad) and PYREXIA (fever of 101.2/ fever of 101.2 wiped me out). 01-Sep-2021, the patient experienced VACCINATION SITE PAIN (Extreme Soreness at the inection site) and ARTHRALGIA (All over Joint pain). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my doctor told me to go ahead and take the third booster shot at month 6. I inadvertently took it a month early.). On 04-Sep-2021, VACCINATION SITE PAIN (Extreme Soreness at the inection site) and ARTHRALGIA (All over Joint pain) had resolved. At the time of the report, FEELING ABNORMAL (I feel pretty bad), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (my doctor told me to go ahead and take the third booster shot at month 6. I inadvertently took it a month early.) and PYREXIA (fever of 101.2/ fever of 101.2 wiped me out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever of 101.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   No treatment medication was reported.    Only on the 3rd day same symptoms experienced only at night. Resolved completely by the 4th day.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant follow up. Patient details added. Concomitant medication updated. New AE like Extreme Soreness at Injection site and All over Joint Pain added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they had some vials of Moderna COVID-19 vaccine in the freezer ( Lot Unknown &  Exp. Date:28AUG2021).  On 31AUG2021 they administered expired vaccine to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they had some vials of Moderna COVID-19 vaccine in the freezer ( Lot Unknown &  Exp. Date:28AUG2021).  On 31AUG2021 they administered expired vaccine to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they had some vials of Moderna COVID-19 vaccine in the freezer ( Lot Unknown &  Exp. Date:28AUG2021).  On 31AUG2021 they administered expired vaccine to patients). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (they had some vials of Moderna COVID-19 vaccine in the freezer ( Lot Unknown &  Exp. Date:28AUG2021).  On 31AUG2021 they administered expired vaccine to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not provided by reporter. Treatment information not provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: tinnitus has intensified since last week; little soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus has intensified since last week) and PAIN IN EXTREMITY (little soreness on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (Patient had tinnitus for a long time already and it was tolerable.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus has intensified since last week) and PAIN IN EXTREMITY (little soreness on the arm). At the time of the report, TINNITUS (tinnitus has intensified since last week) outcome was unknown and PAIN IN EXTREMITY (little soreness on the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient confirms of taking daily prescribed medications but none to manage tinnitus. No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling of body temperature change, Heavy menstrual bleeding, Liver function test
Clinical narrative: Liver issue; Periods have gotten really bad; Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow); Gets weak (from blood loss); Feelings of hot then cold; Her arm hurt, but not as bad as with the first shot; A little achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIVER INJURY (Liver issue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Morbid obesity, Blood pressure high, Asthma, Immunocompromised (Immunocompromised secondary) and Sciatica (Patient received cortisone shots for her back pain.). Concomitant products included LOSARTAN and METOPROLOL SUCCINATE (TOPROL) for an unknown indication, HYDROCHLOROTHIAZIDE.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot then cold), PAIN IN EXTREMITY (Her arm hurt, but not as bad as with the first shot), PAIN (A little achy) and CHILLS (Chills). In March 2021, the patient experienced MENSTRUAL DISORDER (Periods have gotten really bad), HEAVY MENSTRUAL BLEEDING (Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow)) and ASTHENIA (Gets weak (from blood loss)). In August 2021, the patient experienced LIVER INJURY (Liver issue) (seriousness criterion medically significant). On 18-Feb-2021, PAIN (A little achy) and CHILLS (Chills) had resolved. At the time of the report, MENSTRUAL DISORDER (Periods have gotten really bad), FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot then cold), HEAVY MENSTRUAL BLEEDING (Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow)), ASTHENIA (Gets weak (from blood loss)), LIVER INJURY (Liver issue) and PAIN IN EXTREMITY (Her arm hurt, but not as bad as with the first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Liver function test: abnormal (abnormal) Liver issue/Patient had a liver panel drawn and  one of the liver enzymes was elevated..         Patient took water pill (sounds like hydrochlorothiazide) and allergy pills as a concomitant product.  She reiterated several times her periods had been completely normal, occurring on a 28 day cycle, until she received the vaccine. She had one child and had  no  fertility issues.   This case was linked to MOD-2021-305798 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Liver injury, Menstrual disorder, Pain, Pain in extremity
Clinical narrative: Liver issue; Periods have gotten really bad; Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow); Gets weak (from blood loss); Feelings of hot then cold; Her arm hurt, but not as bad as with the first shot; A little achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIVER INJURY (Liver issue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Morbid obesity, Blood pressure high, Asthma, Immunocompromised (Immunocompromised secondary) and Sciatica (Patient received cortisone shots for her back pain.). Concomitant products included LOSARTAN and METOPROLOL SUCCINATE (TOPROL) for an unknown indication, HYDROCHLOROTHIAZIDE.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot then cold), PAIN IN EXTREMITY (Her arm hurt, but not as bad as with the first shot), PAIN (A little achy) and CHILLS (Chills). In March 2021, the patient experienced MENSTRUAL DISORDER (Periods have gotten really bad), HEAVY MENSTRUAL BLEEDING (Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow)) and ASTHENIA (Gets weak (from blood loss)). In August 2021, the patient experienced LIVER INJURY (Liver issue) (seriousness criterion medically significant). On 18-Feb-2021, PAIN (A little achy) and CHILLS (Chills) had resolved. At the time of the report, MENSTRUAL DISORDER (Periods have gotten really bad), FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot then cold), HEAVY MENSTRUAL BLEEDING (Periods have gotten heavier/feel the blood flowing out/Periods have gotten longer/Clots (in the flow)), ASTHENIA (Gets weak (from blood loss)), LIVER INJURY (Liver issue) and PAIN IN EXTREMITY (Her arm hurt, but not as bad as with the first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Liver function test: abnormal (abnormal) Liver issue/Patient had a liver panel drawn and  one of the liver enzymes was elevated..         Patient took water pill (sounds like hydrochlorothiazide) and allergy pills as a concomitant product.  She reiterated several times her periods had been completely normal, occurring on a 28 day cycle, until she received the vaccine. She had one child and had  no  fertility issues.   This case was linked to MOD-2021-305798 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.) 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 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took modern third dose on 30 aug2021. They got their 2 shots of Pfizer / got 2nd Pfizer shot on 25 aug, and took modern booster after 5 days.) had resolved.            Relevant concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Non-significant follow up added.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 17-aug-21) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) 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.   Concomitant product was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-305779 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dizziness, Dyspnoea, Feeling abnormal, Heart rate decreased
Clinical narrative: pulse is low, around 45-50; feels like they are going to have a heart attack; strong dizziness; feels like their going to stop breathing; cannot explain what is happening to them.; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (pulse is low, around 45-50) and CARDIAC DISCOMFORT (feels like they are going to have a heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. notprovided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Aug-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 01-Sep-2021, the patient experienced HEART RATE DECREASED (pulse is low, around 45-50), CARDIAC DISCOMFORT (feels like they are going to have a heart attack), DIZZINESS (strong dizziness), DYSPNOEA (feels like their going to stop breathing) and FEELING ABNORMAL (cannot explain what is happening to them.). At the time of the report, HEART RATE DECREASED (pulse is low, around 45-50), CARDIAC DISCOMFORT (feels like they are going to have a heart attack), DIZZINESS (strong dizziness), DYSPNOEA (feels like their going to stop breathing) and FEELING ABNORMAL (cannot explain what is happening to them.) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.