chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Irritable bowel syndrome, Nausea, Pain
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING FACE (Swelling on her face on the left side/swelling continued today, a little bit subsided), CHILLS (Extreme chills/shivering/chattering), FATIGUE (Extremely tired), IRRITABLE BOWEL SYNDROME (irritable bowel syndrome was triggered) and PAIN (Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING FACE (Swelling on her face on the left side/swelling continued today, a little bit subsided). On an unknown date, the patient experienced CHILLS (Extreme chills/shivering/chattering), FATIGUE (Extremely tired), IRRITABLE BOWEL SYNDROME (irritable bowel syndrome was triggered), PAIN (Pain) and NAUSEA (Extremely nauseous). At the time of the report, SWELLING FACE (Swelling on her face on the left side/swelling continued today, a little bit subsided) was resolving and CHILLS (Extreme chills/shivering/chattering), FATIGUE (Extremely tired), IRRITABLE BOWEL SYNDROME (irritable bowel syndrome was triggered), PAIN (Pain) and NAUSEA (Extremely nauseous) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were mentioned. Treatment details stated as Not provided.This case was linked to MOD-2021-388700 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING FACE (Swelling on her face on the left side/swelling continued today, a little bit subsided), CHILLS (Extreme chills/shivering/chattering), FATIGUE (Extremely tired), IRRITABLE BOWEL SYNDROME (irritable bowel syndrome was triggered) and PAIN (Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING FACE (Swelling on her face on the left side/swelling continued today, a little bit subsided). On an unknown date, the patient experienced CHILLS (Extreme chills/shivering/chattering), FATIGUE (Extremely tired), IRRITABLE BOWEL SYNDROME (irritable bowel syndrome was triggered), PAIN (Pain) and NAUSEA (Extremely nauseous). At the time of the report, SWELLING FACE (Swelling on her face on the left side/swelling continued today, a little bit subsided) was resolving and CHILLS (Extreme chills/shivering/chattering), FATIGUE (Extremely tired), IRRITABLE BOWEL SYNDROME (irritable bowel syndrome was triggered), PAIN (Pain) and NAUSEA (Extremely nauseous) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were mentioned. Treatment details stated as Not provided.This case was linked to MOD-2021-388700 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Endometrial cancer (18mg Lenvima daily, taking with Keytruda). Concomitant products included LENVATINIB MESILATE (LENVIMA) from 26-Oct-2021 to an unknown date and PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer. 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms). The patient was treated with LISINOPRIL on 02-Nov-2021 for Hypertension, at a dose of 10 mg once a day. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 02-Nov-2021, Blood pressure measurement: 177/94 (High) 177/94.On 06-Nov-2021, Blood pressure measurement: elevated (High) Diastolic has been in the 80s as opposed to the 90s lately (around 06-Nov-2021).The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Patient reported having diarrhea symptoms since starting Lenvima. The patient had originally got the vaccine she had the same reaction that lasted about 3 days prior to Lenvima. Patient had diarrhea symptoms had been less severe lately (around 09-Nov-2021). This case was linked to MOD-2021-388710 (Patient Link).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Influenza like illness, Pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Light flu like symptoms), PAIN (Little achy) and ACCIDENTAL OVERDOSE (5 mL administered instead of 0.5 mL as 1st dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 5 milliliter. On 13-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (5 mL administered instead of 0.5 mL as 1st dose). On 14-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Light flu like symptoms) and PAIN (Little achy). On 13-Nov-2021, ACCIDENTAL OVERDOSE (5 mL administered instead of 0.5 mL as 1st dose) had resolved. On 15-Nov-2021, INFLUENZA LIKE ILLNESS (Light flu like symptoms) and PAIN (Little achy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter.No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Intentional underdose, Throat tightness
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Pharmacist felt it was anxiety and not anaphylaxis), THROAT TIGHTNESS (his throat closed for a few seconds and then it opened back up during booster shot) and INTENTIONAL UNDERDOSE (Pharmacist stopped administering the booster and only gave patient 0.1mL instead of .25mL) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .1 ml. 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 16-Nov-2021, the patient experienced ANXIETY (Pharmacist felt it was anxiety and not anaphylaxis), THROAT TIGHTNESS (his throat closed for a few seconds and then it opened back up during booster shot) and INTENTIONAL UNDERDOSE (Pharmacist stopped administering the booster and only gave patient 0.1mL instead of .25mL). On 16-Nov-2021, THROAT TIGHTNESS (his throat closed for a few seconds and then it opened back up during booster shot) and INTENTIONAL UNDERDOSE (Pharmacist stopped administering the booster and only gave patient 0.1mL instead of .25mL) had resolved. At the time of the report, ANXIETY (Pharmacist felt it was anxiety and not anaphylaxis) outcome was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No relevant concomitant medications were reported.No treatment information was provided. This case was linked to MOD-2021-388934 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient's throat closed for a few seconds and opened back up during booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of THROAT TIGHTNESS (Patient's throat closed for a few seconds and opened back up during booster shot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Patient's throat closed for a few seconds and opened back up during booster shot). At the time of the report, THROAT TIGHTNESS (Patient's throat closed for a few seconds and opened back up during booster shot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported. This case was linked to MOD-2021-388922 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 26-Mar-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown. Patient mentioned that she got sick for one day after vaccination.No concomitant medication  were reported.No treatment information was provided.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Follow up received contains no new information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Hepatic enzyme increased, Immune system disorder, Immunoglobulins
Clinical narrative: AST was 35; Immunoglobulin is at 1800; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (AST was 35) and IMMUNE SYSTEM DISORDER (Immunoglobulin is at 1800) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Liver cirrhosis since 2021. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEPATIC ENZYME INCREASED (AST was 35) and IMMUNE SYSTEM DISORDER (Immunoglobulin is at 1800). The patient was treated with BUDESONIDE at a dose of 3 mg. At the time of the report, HEPATIC ENZYME INCREASED (AST was 35) and IMMUNE SYSTEM DISORDER (Immunoglobulin is at 1800) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 01-Nov-2021, Aspartate aminotransferase: 35 (High) AST was 35. On 01-Nov-2021, Immunoglobulins: 1800 (High) Immunoglobulin is at 1800. No concomitant medications were reported. This case was linked to MOD-2021-389011 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (aches), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MYALGIA (aches), CHILLS (chills) and PYREXIA (fever) outcome was unknown. No treatment information were reported by the reporter. This case was linked to MOD-2021-389054 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is killing her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is killing her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.No Medical History information was reported.In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Nov-2021, the patient experienced VACCINATION SITE PAIN (arm is killing her). At the time of the report, VACCINATION SITE PAIN (arm is killing her) outcome was unknown. No concomitant and treatment information were reported by the reporter.The date of the first Moderna COVID-19 dose was unknown.This case was linked to MOD-2021-389053 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Soreness; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) and FATIGUE (Feeling tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20-2A) for COVID-19 vaccination. No Medical History information was reported.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness) and FATIGUE (Feeling tired). At the time of the report, MYALGIA (Soreness) and FATIGUE (Feeling tired) outcome was unknown. No concomitant medications was reported.No treatment drug details was reported. This case was linked to MOD-2021-389097, MOD-2021-389050 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses given >12 hours post vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given >12 hours post vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given >12 hours post vial puncture). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Doses given >12 hours post vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was reported. The pharmacist reported that they had a vial on Moderna that was punctured at 10:45am on 15-Nov-2021. This vial was kept at room temperature and doses were drawn after 12 hours. Two doses were given the next day from the punctured vial. On 16-Nov-2021 administration of 1 vaccine at 1:35PM, 26hrs, 50mins at room temperature. On 16-Nov-2021 administration of 2 vaccine at 4:30PM, 29hrs, 45mins at room temperature.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever for 1 day after second vaccine; fever and chills after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 1 day after second vaccine) and CHILLS (fever and chills after second vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 002B21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever for 1 day after second vaccine) and CHILLS (fever and chills after second vaccine). On 09-Apr-2021, PYREXIA (fever for 1 day after second vaccine) and CHILLS (fever and chills after second vaccine) had resolved. No concomitant medications were reported. Treatment information was not provided. Patient reported no adverse reactions after first dose.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: Blurriness to vision and headache
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Heart rate increased, Palpitations
Clinical narrative: After my second vaccine, I experienced a racing heart rate that continued for approximately 8 hours. My heart was pounding and beating extremely fast.  The following morning my heart rate returned to normal but I am concerned that I may experience problems with my heart later.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pallor, Vomiting
Clinical narrative: Patient reported feeling "fuzzy". Pallor in appearance. She vomitted once. This lasted 30 minutes.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, slight fever, fatigue, small headache
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever 103.5, extreme fatigue, headache, body ached, joint pain
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at the injection site (right arm), pain in right pectoral chest muscle, fatigue, joints ache various, both knees and overall body. 12-24 hours.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: At first my arm was sore like it typically is after my flu shot. I noticed that it was still really sore a week later and I had associated weakness and increased pain in my right shoulder.  I have pain with range of motion and when I first wake up I can barely use my right arm.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Gait disturbance, Joint swelling, Pain
Clinical narrative: Pain in front and back of my knees Pain on back of my Left elbow Left ankle swelling with burning pain Hard for me to walk Painful Bruising on both of my lower legs
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in front and back of my knees Pain on back of my Left elbow Left ankle swelling with burning pain Hard for me to walk Painful Bruising on both of my lower legs
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Chills, body aches, headache, fatigue, stiff neck, pain at injection site. Symptoms began 7 hours after injection and last for about 36 hours.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills, body aches, headache, fatigue, stiff neck, pain at injection site. Symptoms began 7 hours after injection and last for about 36 hours.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Sore arm at injection site for 3 days. Heavy fatigue for 2 days after injection.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Injection was made into the correct location of the deltoid, however, the patient reported immediate numbness from shoulder to finger tips.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Pyrexia, Vomiting
Clinical narrative: Fever and chills.  Upper leg cramps.  Vomiting
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature increased, Chills, Fatigue, Feeling hot
Clinical narrative: Began feeling warm with headache at 6pm on 11/21/21 and temp was 99 F. Tried to sleep around 12am and then awoke around 5am on 11/22/21 with fever of 102 F. Took 2 (200mg each) ibuprofen and went back to sleep and awoke around 10am still with fever. Took 2 more ibuprofen and continued checking temp. By 12pm fever had ceased but headache, chills, and fatigue remained. Awoke next day 11/23/21. With headache and extremely sore armpit in left side (side of injection). As of this report headache and armpit pain remained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Sleep disorder
Clinical narrative: Began feeling warm with headache at 6pm on 11/21/21 and temp was 99 F. Tried to sleep around 12am and then awoke around 5am on 11/22/21 with fever of 102 F. Took 2 (200mg each) ibuprofen and went back to sleep and awoke around 10am still with fever. Took 2 more ibuprofen and continued checking temp. By 12pm fever had ceased but headache, chills, and fatigue remained. Awoke next day 11/23/21. With headache and extremely sore armpit in left side (side of injection). As of this report headache and armpit pain remained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Client reported feeling dizzy and heart palpitations. Lasted for 15 minutes.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Significant rash and swelling at injection site (left arm) approximately 9 days after orange cap dosage for 7 year old
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Computerised tomogram, Deafness, Facial nerve disorder, Herpes zoster
Clinical narrative: Shingles in right ear. Chronic hearing loss, vertigo, and right facial nerve tingles.
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Paraesthesia, Scan with contrast, Vertigo
Clinical narrative: Shingles in right ear. Chronic hearing loss, vertigo, and right facial nerve tingles.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Approximately 2.5 hours after the injection, a headache developed. I took ibuprofen 400 mg to mitigate the pain. Headache went away after about 30 minutes. Every day the headaches come and go. On October 16, 2021, I spoke with a doctor. He recommended I see my primary care physician. The next day (October 17, 2021), following my annual physical, the headache returned without abating. On Monday, October 18, 2021, I still had the headache from the previous day.  I saw my primary care doctor. It was recommended I try Tylenol 1000mg and the neurology department would be contacted. The following day, I found Tylenol did nothing for my headache so I tried of ibuprofen 600mg. Within an hour, the headache was gone for the day. But return, usually a couple of times every day, coming and going.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth after vaccination
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of tongue, cheeks, and throat  Mild wheezing  Some difficulty breathing  Numb lower portion of face (cheeks, chin, lips)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling of tongue, cheeks, and throat  Mild wheezing  Some difficulty breathing  Numb lower portion of face (cheeks, chin, lips)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received a Moderna covid Vaccine, instead of a Pfizer covid vaccine.  Parent was made aware. Vaccinator was coached.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Intervertebral disc protrusion, Laboratory test
Clinical narrative: Day after I had chills, body aches and fatigue.  I spent 15 hours in bed and woke up with lower back pain.  Within several hours I could walk due to severe pain.  I presented to the emergency department the following morning and have a herniated disc with tear and lumbar sprain/spasms.  I?m on day 3 of admission for pain management.   The disc and tear may not be new or vaccine related but this severe back pain i think could be.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ligament sprain, Magnetic resonance imaging, Muscle spasms, Pain
Clinical narrative: Day after I had chills, body aches and fatigue.  I spent 15 hours in bed and woke up with lower back pain.  Within several hours I could walk due to severe pain.  I presented to the emergency department the following morning and have a herniated disc with tear and lumbar sprain/spasms.  I?m on day 3 of admission for pain management.   The disc and tear may not be new or vaccine related but this severe back pain i think could be.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Nightmare
Clinical narrative: Extremely vivid and graphic nightmares
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Canalith repositioning procedure, Dizziness, Mobility decreased
Clinical narrative: Dizziness / apparent vertigo: First noticed during my bike ride to work, around 25 minutes into the 30 minute ride.  When I was about to resume riding after stopping at a stop light, I felt unsteady and dizzy to the point of nearly blacking out momentarily, but it subsided as quickly it started and I made it to work unscathed.  Throughout the day, if a tilted my head to either side, I would feel unsteady, but I was able to work relatively normally (but attempted to keep my head as straight as possible).  I attempted the Epley maneuver toward the end of the morning; I didn't experience nystagmus during the first step, but seemed better for at least an hour afterwards before it came back (though it remained mild).  The next day, Saturday, I initially thought the problem was over, but while I was at work, I had several brief episodes, but again, tried to keep my head straight and didn't experience any problems during the bikes to and from work.  On Sunday, the problem was intermittent at work.  I continued to try to keep my head straight.  On Monday, I had one intense episode in the morning after getting out of bed and entering the bathroom, but no others , though I tried to keep my head as straight as possible during my work-day.  I had no episodes today, Tuesday.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Headache, Pain, Pain of skin
Clinical narrative: 1:50am woke up with aches all over body, skin hurt, teeth hurt, fever, headache. Mid afternoon the stabbing chest pain that I could feel in my upper middle back started. Had last chest pain around 11pm, went to bed. Woke up with just a headache the next morning.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: 1:50am woke up with aches all over body, skin hurt, teeth hurt, fever, headache. Mid afternoon the stabbing chest pain that I could feel in my upper middle back started. Had last chest pain around 11pm, went to bed. Woke up with just a headache the next morning.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain
Clinical narrative: Chest pain
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Seizure
Clinical narrative: Heart rate 93 during seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Heart rate 93 during seizure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The patient's past medical history included Diverticulosis and Breast cancer (Breast cancer survivor). Concurrent medical conditions included Food allergy (Allergy to tree nut), Drug allergy (Allergy to statin), Horner's syndrome (Chronic horners syndrome), Pure hypercholesterolemia, ANA (High ANA) and Adverse reaction (Adverse reaction to all caines, amides and esters. Resistance to all caines, opiods). On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Heart rate 93 during seizure). On 15-Nov-2021, SEIZURE (Heart rate 93 during seizure) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 15-Nov-2021, Heart rate: 93 (abnormal) 93.No concomitant medications were reported. Treatment information was not provided.The patient's medical history included Lisfranc. The patient had mild myoclonic shaking with some jerks. She laid down and rested for short time after injection and reported that the event was not serious. Company Comment : This case concerns a 74 year old female with relevant medical history of high ANA, hypercholesterolemia Horner's syndrome, who experienced non-serious , unexpected event of Seizure which occurred on the same day after vaccination with the 3rd dose ( booster dose ) of mRNA -1273 vaccine  ( Moderna Covid 19 Vaccine ) . The event was reported as possibly related by the reporter.  The re-challenge for this case is not applicable since no additional doses will be administered to the patient. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74 year old female with relevant medical history of high ANA, hypercholesterolemia Horner's syndrome, who experienced non-serious , unexpected event of Seizure which occurred on the same day after vaccination with the 3rd dose ( booster dose ) of mRNA -1273 vaccine  ( Moderna Covid 19 Vaccine ) . The event was reported as possibly related by the reporter.  The re-challenge for this case is not applicable since no additional doses will be administered to the patient. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Computerised tomogram, Gait inability, Magnetic resonance imaging
Clinical narrative: My mom suffered a stroke after the second Moderna COVID-19 vaccination. She can no longer walk and she is now wheelchair bound. She struggles to find words. Lost the use of her left side for three months. Has never recovered fully
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Wheelchair user
Clinical narrative: My mom suffered a stroke after the second Moderna COVID-19 vaccination. She can no longer walk and she is now wheelchair bound. She struggles to find words. Lost the use of her left side for three months. Has never recovered fully
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Chills, fever,  full body aches (more extreme at vaccine site), headache
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reported that RECOMBIV AX HB that had expired yesterday (11/2/2021) was administered to a patient today (11/3/2021).; Information has been received from a medical assistant, referring to a 9 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2021, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # S030794, expiration date on 02-NOV-2021 (anatomical location and administration route were not reported) for prophylaxis. No additional adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; Medical assistant reports administration of an improperly stored dose of VAQTA to a patient on 22-OCT-2021; This spontaneous report has been received from a medical assistant, concerning to 5-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On an unspecified date, the hepatitis a vaccine, inactivated (VAQTA) was improperly stored at below 36 degrees Fahrenheit (F) (34.7F) for a timeframe of 0 hour, 25 minutes and 0 seconds; below 36 F (35.4F) for a timeframe of 5 hour, 25 minutes and 0 seconds; below 36 F (35.6F) for a timeframe of 3 hour, 20 minutes and 0 seconds; below 36 F (35.9F) for a timeframe of 0 hour, 25 minutes and 0 seconds; below 36 F (35.7F) for a timeframe of 0 hour, 25 minutes and 0 seconds; below 36 F (35.2 F) for a timeframe of 3 hour, 20 minutes and 0 seconds; below 36 F (33.8F) for a timeframe of 18 hour, 20 minutes and 0 seconds; below 36 F (32.1F) for a timeframe of 23 hour, 45 minutes and 0 seconds; below 36 F (32.5F) for a timeframe of 9 hour, 35 minutes and 0 seconds (product storage error).   On 22-OCT-2021, the patient was vaccinated with the improperly stored hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliters (mL), "one time" (lot number T031201 has been verified to be a valid lot number, expiration date reported and established as 14-JUN-2022) as prophylaxis (vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported). No other adverse events (AE) reported (no adverse event).  This is one from several reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA003192: US-009507513-2111USA003125: US-009507513-2111USA003270:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Improperly storage vaccine was administered; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 08-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status of recombinant human albumin [rHA]) (PROQUAD) (strength, dose, route, frequency, were not provided) for prophylaxis; lot No. U010745 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live; expiration date reported as 03-OCT-2022 and upon internal validation established as the same.   The reporter stated that the administered dose of the vaccine was improperly stored (incorrect product storage). The administered dose of the vaccine experienced a temperature excursion of -14.6 degrees Celsius (°C), for 6 hours (temperature Excursion had occurred on 08-OCT-2021). It was reported that previous temperature excursion occurred on 04-OCT-2021, from -10°C to 8°C (0.91 °C) for 6 hours; and on 05-OCT-2021, from -10°C to 8°C (1.45 °C) for 6 hours. Additional excursion had occurred after patient was administered the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on 13-OCT-2021, from -10°C to 8°C (0.54°C) for 13 hours. There was no additional adverse event (AE). No product quality complaint (PQC) involved.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE reported; administration of an improperly stored dose of V ARlV AX; This spontaneous report was received from an office manager and refers to a male patient of unknown age. Information on his concurrent conditions, medical history, drug reactions and allergies and concomitant medications was not provided.      On 20-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 mL, lot # T017688, expiry date 21-MAY-2022 (route of administration was not reported) for prophylaxis (product storage error). The vaccine experienced temperature excursion of -10 to 8 degrees Celsius (-0.1 C) for 2 hours 3 minutes. There were also previous temperature excursions reported: -10 to 8 degrees Celsius (4.1 C) for 11 hours 2 minutes, -10 to 8 degrees Celsius (-7.1 C) for 1 hour 26 minutes, -10 to 8 degrees Celsius (6.6 C) for 5 hours 23 minutes. No further adverse event was reported. There was no product quality complaint.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Skin odour abnormal
Clinical narrative: This spontaneous report received from a patient concerned a 64 year old male.The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient did not experience any body odor issue previously and no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced bad smell like poop/sewerage around him.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from bad smell like poop/sewerage around him.This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.). On 27-Oct-2021, PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION ERROR (Some of the vials were punctured more than 20 times, some up to 23, 24, & 25 times.) to be not related. No concomitant medications were reported.No treatment information was provided.On 27-Oct-2021, 29-Oct-2021, 01-Nov-2021 and 03-Nov-2021, there was a combined total of 30 vials that were punctured more than 20 times. The staff drawing up vaccine was unaware of vial puncture limit. The event did not cause the patient to seek medical advice. It was unknown if the patient experienced a similar event in the past.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Significant Follow-up received: Reporter causality updated. Adverse event information added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blepharospasm, Insomnia, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleepless for months after both doses of the vaccine/Night after night of no sleep/Prevented her from sleeping/Wide awake during the day and night/When did fall asleep, woke up frequently/Sleeping pills doctor prescribed didn't work/Couldn't fall asl), TREMOR (Gave anxiety and shaking like a leaf), ANXIETY (Gave anxiety and shaking like a leaf), BLEPHAROSPASM (Couldn't fall asleep - when in bed, eyeballs would be palpitating.) and INSOMNIA (Night after night of no sleep/prevented her from sleeping) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L21A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety.Concomitant products included CLOFIBRATE (FIBRATE) for Triglycerides. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INSOMNIA (Sleepless for months after both doses of the vaccine/Night after night of no sleep/Prevented her from sleeping/Wide awake during the day and night/When did fall asleep, woke up frequently/Sleeping pills doctor prescribed didn't work/Couldn't fall asl), TREMOR (Gave anxiety and shaking like a leaf), ANXIETY (Gave anxiety and shaking like a leaf), BLEPHAROSPASM (Couldn't fall asleep - when in bed, eyeballs would be palpitating.) and INSOMNIA (Night after night of no sleep/prevented her from sleeping). The patient was treated with LORAZEPAM (ATIVAN) for Anxiety, at an unspecified dose and frequency; ZOLPIDEM TARTRATE (AMBIEN) for Adverse event, at an unspecified dose and frequency; ESZOPICLONE (LUNESTA) for Adverse event, at an unspecified dose and frequency and TRAZODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Sleepless for months after both doses of the vaccine/Night after night of no sleep/Prevented her from sleeping/Wide awake during the day and night/When did fall asleep, woke up frequently/Sleeping pills doctor prescribed didn't work/Couldn't fall asl), TREMOR (Gave anxiety and shaking like a leaf), ANXIETY (Gave anxiety and shaking like a leaf), BLEPHAROSPASM (Couldn't fall asleep - when in bed, eyeballs would be palpitating.) and INSOMNIA (Night after night of no sleep/prevented her from sleeping) 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.Concomitant medications used were Supplements and antibiotic for bladder infection. 3 other medications were used as treatment medications.Sleep studies were done on patient and the result was negative for sleep apnea. This case was linked to MOD-2021-387074 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Vomiting
Clinical narrative: sick for 4 days; Vomiting; headaches /  escalated to the second shot, which was even worse; aching all over body /  escalated to the second shot, which was even worse; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 4 days), VOMITING (Vomiting), HEADACHE (headaches /  escalated to the second shot, which was even worse) and MYALGIA (aching all over body /  escalated to the second shot, which was even worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis.Concomitant products included IBUPROFEN and NAPROXEN SODIUM (ALEVE) for Arthritis.On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (sick for 4 days), VOMITING (Vomiting), HEADACHE (headaches /  escalated to the second shot, which was even worse) and MYALGIA (aching all over body /  escalated to the second shot, which was even worse). In February 2021, ILLNESS (sick for 4 days) had resolved. At the time of the report, VOMITING (Vomiting) outcome was unknown and HEADACHE (headaches /  escalated to the second shot, which was even worse) and MYALGIA (aching all over body /  escalated to the second shot, which was even worse) had not resolved. After first dose Patient experienced bad reaction. She thought she got over it, but she didn't. She has headaches, aching all over her body. It escalated to the second shot, which was even worse. She is wondering if anyone else is experiencing the same thing. Consent declined for safety to contact the patient's HCP. She taken booster dose on 12-Nov-2021This case was linked to MOD-2021-387075, MOD-2021-387124 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: A little bit of a sore arm; Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Bactrim allergy), Allergy to antibiotic (Allergy to gentamycin eye drop), Osteoporosis and Atrophic vaginitis. Concomitant products included ESTRADIOL (VAGIFEM) for Atrophic vaginitis, CALCIUM, COLECALCIFEROL (CALCIUM D [CALCIUM;COLECALCIFEROL]) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (A little bit of a sore arm) and PYREXIA (Fever) to be related. No treatment medications were provided.This case was linked to MOD-2021-387064 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Added patient demographics, Allergies, Medical history, Updated Vaccine start date of dose 2, Added Concomitant medications, Event fever, Event outcome and causality.