chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Feeling abnormal, Impaired driving ability, Pain, Pain in extremity
Clinical narrative: Before having my 2nd shot on the 17/12/21, I advised the nurse that after my first shot my heart started a little weird arythmia after 5 minutes of receiving the vaccine, that one week after the vaccine I had to stop exercising as my heart was jumping all over the place.   She advised I should wait a few minutes before going out to the waiting room  to see how I was.  Within 1 minute of receiving the vaccine, I felt my heart racing.  I started to feel light headed and was told to lie down by the nurse.  My heart continued to race, the nurse checked my blood pressure 3 times.  I started getting tingling in my legs and arms and within 10 minutes quite sore up my left arm.  My head was so light headed, I thought I would never be able to stand up again I felt so bad.  The ambulance was called.  I was taken into the ambulance where they did a thorough ECG.  Everything was fine after an hour.  I couldnt drive.  The rest of the day was uneasy breathing.  The next day had aches and pains.  Took panadol.. Little palpatations have begun daily since Saturday.  My arm is still sore, red, swollen and itchy.  Very different to my first vaccine.  Have done all the icing regularly etc. But feels odd.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Before having my 2nd shot on the 17/12/21, I advised the nurse that after my first shot my heart started a little weird arythmia after 5 minutes of receiving the vaccine, that one week after the vaccine I had to stop exercising as my heart was jumping all over the place.   She advised I should wait a few minutes before going out to the waiting room  to see how I was.  Within 1 minute of receiving the vaccine, I felt my heart racing.  I started to feel light headed and was told to lie down by the nurse.  My heart continued to race, the nurse checked my blood pressure 3 times.  I started getting tingling in my legs and arms and within 10 minutes quite sore up my left arm.  My head was so light headed, I thought I would never be able to stand up again I felt so bad.  The ambulance was called.  I was taken into the ambulance where they did a thorough ECG.  Everything was fine after an hour.  I couldnt drive.  The rest of the day was uneasy breathing.  The next day had aches and pains.  Took panadol.. Little palpatations have begun daily since Saturday.  My arm is still sore, red, swollen and itchy.  Very different to my first vaccine.  Have done all the icing regularly etc. But feels odd.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache
Clinical narrative: Within 12 hours - chills and headache Within 12-36 hours - chills, headache, fatigue After 36 -48hours - headache, fatigue 36-72 hours - headache After 1 week - chest pain on left side of  chest; off and on and varies spordically; chest pain continued for 4 weeks after initial symptoms with decreasing episodes over time
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Biopsy, Dysmenorrhoea, Heavy menstrual bleeding, Laboratory test
Clinical narrative: Severe ongoing hair loss, severe heavy painful irregular menstrual periods
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Ultrasound uterus
Clinical narrative: Severe ongoing hair loss, severe heavy painful irregular menstrual periods
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Swelling, Urticaria
Clinical narrative: Breaking out in swollen hives from head to toe. Visited urgent care on 12/13/21 and given a steroid shot and Benadryl shot. Prescription sent for steroids to take for 5 days and Benadryl (50 mg) to take for 2 days. I continue to break out in hives. Went to urgent care again on 12/19/21 and the ER.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough.  I had the first shot and the second shot of moderna and everything was fine. when I had the booster after two or three day days I started coughing. It has been 4 months now and I'm still coughing. MY coughs are dry and and often, no fever and no other symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: BODY COVERED IN HIVES FROM BOTTOM OF FEET TO TOP OF HEAD LASTED ONE WEEK 2 ER VISIT  MULTIPLE SHOTS OF EPPI STEROIDS BENEDRYL PEPCID AND 2 EPPI PENS TO HAVE AT HOME BECAUSE OF THE SWELLING TO FACE AND LIPS OUT OF CONTROL ITCHING LEAVING ME TO RUBBING THE SKIN OFF OF MY BODY UNTIL I GOT TO THE ER AND THEY GAVE ME IV MEDS AND SHOTS OF EPPI HIVES AND ITCHING DISAPPEARED AFTER A WEEK WITH HELP OF EPPI AND STEROIDS BENEDRYL AND PEPCID
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin irritation
Clinical narrative: Has some bumps on the skin that cause irritation.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash papular, Urticaria
Clinical narrative: Noticed a rash and hive about three hours after vaccination that left on it?s own an hour later. Ever since, every single day I have been getting rashes and hives. It first started on my neck and scalp. Now its all over my body on and off throughout the day. Hives in a long skinny appearance appear. Red raised bumps close in range appear. Redness across my arms stomach neck and back appear. They come and go hours or minutes apart?l, but not a single day has past since my Moderna booster that this hasnt happened.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Quick onset of major chills at 1:30 am. Achy body throughout night and day. Headache started around 10 am morning and throughout day all day that went away about 11 pm. Left arm where shot given was sore for 2 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Arrhythmia, Chest discomfort, Endocarditis, Extrasystoles
Clinical narrative: Chest tightening and pressure on chest with random arrhythmia ?skipped beats?.  Adverse reaction started 03/15/21 -10/15/2021, 7 months of intermittent myocarditis/endocarditis symptoms
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Chest tightening and pressure on chest with random arrhythmia ?skipped beats?.  Adverse reaction started 03/15/21 -10/15/2021, 7 months of intermittent myocarditis/endocarditis symptoms
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: After receiving booster dose of 0.25mL patient started feeling numbness and tingling in left leg.  It has lasted for 3 days.  Also under left arm, and spreading to breast area, numbness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Influenza like illness, Nausea
Clinical narrative: Within 6 hours of receiving the COVID-19 Pfizer booster shot, I developed a fever reaching 105.2°F. I also developed other severe flu-like symptoms, including extreme body aches (especially in right elbow where I had recent surgery), shivering and chills, loss of appetite, nausea, and severe headache (non-migraine).  At times of high fever,  I could hear my pulse in my ear. I treated the fever with 1000mg acetaminophen every 6 hours for 48 hours. Symptoms began to resolve 54 hours after injection, except for a lingering,  mild headache. The medication was effective in reducing the fever to the range of 102-103°F but fever returned to 104.8-105.2°F exactly 6 hours after taking the acetaminophen. My fever did not "break" until 50 hours after injection.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: Within 6 hours of receiving the COVID-19 Pfizer booster shot, I developed a fever reaching 105.2°F. I also developed other severe flu-like symptoms, including extreme body aches (especially in right elbow where I had recent surgery), shivering and chills, loss of appetite, nausea, and severe headache (non-migraine).  At times of high fever,  I could hear my pulse in my ear. I treated the fever with 1000mg acetaminophen every 6 hours for 48 hours. Symptoms began to resolve 54 hours after injection, except for a lingering,  mild headache. The medication was effective in reducing the fever to the range of 102-103°F but fever returned to 104.8-105.2°F exactly 6 hours after taking the acetaminophen. My fever did not "break" until 50 hours after injection.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Colonoscopy, Crohn's disease, Gastritis, Intestinal haemorrhage
Clinical narrative: About 2months of getting the vax I have experienced a flare up. With severe inflammation in my gut/intestinal bleeding/severe colitis/rectal bleeding.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: About 2months of getting the vax I have experienced a flare up. With severe inflammation in my gut/intestinal bleeding/severe colitis/rectal bleeding.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Condition aggravated, Hypertension, Muscular weakness, Osteoarthritis
Clinical narrative: Acute knee pain - flare up of osteoarthritis.  Leg weakness that still continues.  High blood pressure.  Trips to ER for ultrasound and xray of the the knee.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Ultrasound scan, X-ray limb
Clinical narrative: Acute knee pain - flare up of osteoarthritis.  Leg weakness that still continues.  High blood pressure.  Trips to ER for ultrasound and xray of the the knee.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: Arm continues to be itchy with small bumps around injection site.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 3 grand mal seizures/1st 12:00am/2nd 3:00am/3rd 5:30am
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypoxia, Pneumonia
Clinical narrative: Developed pneumonia, hypoxemia and new onset atrial fibrillation all diagnosed within two days of the vaccine.  Had COVID19 in 2020 but got three immunizations anyway in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED 2 WEEKS AFTER GETTING SECOND SHOT; This spontaneous report received from a consumer via Social media via a company representative concerned a male of unspecified age, race and ethnicity.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer)(suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died 2 weeks after getting second shot from unspecified cause. It was reported that "My husbands friend died 2 weeks after getting his second shot." (Dose number in series 2). It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211230043.; Sender's Comments: V0:20211229704-COVID-19 VACCINE AD26.COV2.S-Died 2 weeks after getting second shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIED 2 WEEKS AFTER GETTING SECOND SHOT
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: THE WORST THING WAS THE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced the worst thing was the headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the worst thing was the headache. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a breakthrough COVID-19 infection) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced COVID-19 (a breakthrough COVID-19 infection). The patient was treated with DAYQUIL AND NYQUIL SEVERE+ VICKS VAPOCOOL COLD AND FLU at an unspecified dose and frequency. At the time of the report, COVID-19 (a breakthrough COVID-19 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medications were reported Symptoms: It was reported that the patient had experienced a breakthrough COVID-19 infection, and was diagnosed on 01-Nov-2021, while the symptoms were began on 29-Oct-2021, there were no side effects from Moderna COVID-19 vaccine reported, and the symptoms were ongoing. Patient wanted to knowif he could get a booster dose of vaccine following a breakthrough infection. Company comment: This spontaneous case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 9 months after the initial schedule of mRNA- 1273 vaccine, schedule of vaccination unknown. Clinical manifestations included fatigue, oropharyngeal pain, rhinorrhoea and dizziness. At the time of the report, the symptoms were ongoing. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.  Vaccination failure/ Drug ineffective is not assessable since the actual schedule of vaccination is unknown. Sender's Comments: This spontaneous case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 9 months after the initial schedule of mRNA- 1273 vaccine, schedule of vaccination unknown. Clinical manifestations included fatigue, oropharyngeal pain, rhinorrhoea and dizziness. At the time of the report, the symptoms were ongoing. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.  Vaccination failure/ Drug ineffective is not assessable since the actual schedule of vaccination is unknown.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives 10 days after booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Full body hives 10 days after booster) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 002B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Full body hives 10 days after booster). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Itching, at a dose of UNK, qd. At the time of the report, URTICARIA (Full body hives 10 days after booster) had not resolved.  No concomitant medication was reported. The patient's gave antihistamine, and Zyrtec, once a day. On 08-Dec-2021, he still had the hives and itching all over the body.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) outcome was unknown.            Concomitant medicine include Birth control pills.  No treatment information were reported by the reporter.  Company Comment: This spontaneous case concerns a 38-year-old, female patient with no medical history reported, who experienced the unexpected, serious event of loss of consciousness. The event occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38-year-old, female patient with no medical history reported, who experienced the unexpected, serious event of loss of consciousness. The event occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced HYPOAESTHESIA (Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.) (seriousness criterion hospitalization). At the time of the report, HYPOAESTHESIA (Within 15 minutes started to experience numbness on the left side of my face. Then with 30 minutes the whole left side of my face then my left arm.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient was admitted in the hospital for test and to make sure patient was not having a stroke. Patient had numbness off and on throughout the night not lasting more than a few minutes. Patient was advised by primary care physician to not take the second vaccine. Patient still had numb patch in the back of patient's head at times but this may not have anything to do with the vaccine.  No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected serious event of Hypoaesthesia. The event occurred on the same month after the first dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome was not resolved . The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history, who experienced the unexpected serious event of Hypoaesthesia. The event occurred on the same month after the first dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome was not resolved . The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Menstrual disorder, Pruritus, Swelling
Clinical narrative: Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; Sometimes it itches on the body; Like red spots; swollen; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (swollen). At the time of the report, MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose) outcome was unknown and PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (swollen) had not resolved.            No concomitant medication information was provided. No treatment medication were provided. The  itches on the body, like red spots and was swollen and that sometimes it goes and come. The menstruation problems appeared after 15 days from the second dose.   This case was linked to MOD-2021-413408 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) 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 information were reported.    This case was linked to MOD-2021-395985 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: niece had the same side effect, cramping in her hands; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (niece had the same side effect, cramping in her hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (niece had the same side effect, cramping in her hands). At the time of the report, MUSCLE SPASMS (niece had the same side effect, cramping in her hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: highly allergic to medicines; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (highly allergic to medicines) 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 ALLERGY TO VACCINE (highly allergic to medicines). At the time of the report, ALLERGY TO VACCINE (highly allergic to medicines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment details were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 014M20A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that had been punctured more than 12 hours/ probably a total of 18 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient received booster dose from the vial in the fridge that was punctured on 14 Dec 2021 at 10 AM.   No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Non Significant follow up appended snapshot document appended.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache; some nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (some nausea) and PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced HEADACHE (Headache), NAUSEA (some nausea) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), NAUSEA (some nausea) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was provided. It was reported that for Treatment Headache medicine was took.  The lot number from the first or second shot (caller wasn't sure which) was 031H21A. The second dose was given on 10 Mar 2021.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Dermatitis allergic, Lacrimation increased, Rash, Rash pruritic
Clinical narrative: Still itchy and feeling allergic after resolution of rash after booster; Feels itchy and allergic from it; Eyes watering after resolution of rash after booster; Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster; Rash on lips and jaw; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Rash on lips and jaw), RASH PRURITIC (Still itchy and feeling allergic after resolution of rash after booster), DERMATITIS ALLERGIC (Feels itchy and allergic from it), LACRIMATION INCREASED (Eyes watering after resolution of rash after booster) and RASH (Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 040A21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced CHEILITIS (Rash on lips and jaw) and RASH (Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster). On an unknown date, the patient experienced RASH PRURITIC (Still itchy and feeling allergic after resolution of rash after booster), DERMATITIS ALLERGIC (Feels itchy and allergic from it) and LACRIMATION INCREASED (Eyes watering after resolution of rash after booster). At the time of the report, CHEILITIS (Rash on lips and jaw) and RASH (Rash on lips and jaw, arms, and part of the inner leg 2 weeks after booster) had resolved, RASH PRURITIC (Still itchy and feeling allergic after resolution of rash after booster) and DERMATITIS ALLERGIC (Feels itchy and allergic from it) had not resolved and LACRIMATION INCREASED (Eyes watering after resolution of rash after booster) outcome was unknown.            Patient reported that the batch number for booster dose as 077C21B or 077621B.  Concomitant medications details were not reported by the reporter.  Treatment details included antihistamine and steroid.   This case was linked to MOD-2021-416039, MOD-2021-416040 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After second dose developed hives over head which lasted 4 days; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (After second dose developed hives over head which lasted 4 days) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN (AVAPRO), APIXABAN (ELIQUIS), METOPROLOL, SPIRONOLACTONE and DILTIAZEM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (After second dose developed hives over head which lasted 4 days). In March 2021, URTICARIA (After second dose developed hives over head which lasted 4 days) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-416128 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypertension, Inflammation, Muscle spasms, Paraesthesia
Clinical narrative: spasms (only happen when she relaxes); Tinnitus very loud; Tingling in her hands; Inflammation in her hands; Blood pressure went up for a while; Sinus pressure; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (spasms (only happen when she relaxes)), TINNITUS (Tinnitus very loud), PARAESTHESIA (Tingling in her hands), INFLAMMATION (Inflammation in her hands) and HYPERTENSION (Blood pressure went up for a while) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MUSCLE SPASMS (spasms (only happen when she relaxes)), TINNITUS (Tinnitus very loud), PARAESTHESIA (Tingling in her hands), INFLAMMATION (Inflammation in her hands), HYPERTENSION (Blood pressure went up for a while), PARANASAL SINUS DISCOMFORT (Sinus pressure) and FEELING ABNORMAL (Brain fog). In May 2021, HYPERTENSION (Blood pressure went up for a while) had resolved. At the time of the report, MUSCLE SPASMS (spasms (only happen when she relaxes)), TINNITUS (Tinnitus very loud), PARAESTHESIA (Tingling in her hands) and INFLAMMATION (Inflammation in her hands) outcome was unknown and PARANASAL SINUS DISCOMFORT (Sinus pressure) and FEELING ABNORMAL (Brain fog) had resolved.            No concomitant medications were reported  No treatment information was provided  The patient stated that all the symptoms started 2 weeks after the second vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Tinnitus
Clinical narrative: spasms (only happen when she relaxes); Tinnitus very loud; Tingling in her hands; Inflammation in her hands; Blood pressure went up for a while; Sinus pressure; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (spasms (only happen when she relaxes)), TINNITUS (Tinnitus very loud), PARAESTHESIA (Tingling in her hands), INFLAMMATION (Inflammation in her hands) and HYPERTENSION (Blood pressure went up for a while) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MUSCLE SPASMS (spasms (only happen when she relaxes)), TINNITUS (Tinnitus very loud), PARAESTHESIA (Tingling in her hands), INFLAMMATION (Inflammation in her hands), HYPERTENSION (Blood pressure went up for a while), PARANASAL SINUS DISCOMFORT (Sinus pressure) and FEELING ABNORMAL (Brain fog). In May 2021, HYPERTENSION (Blood pressure went up for a while) had resolved. At the time of the report, MUSCLE SPASMS (spasms (only happen when she relaxes)), TINNITUS (Tinnitus very loud), PARAESTHESIA (Tingling in her hands) and INFLAMMATION (Inflammation in her hands) outcome was unknown and PARANASAL SINUS DISCOMFORT (Sinus pressure) and FEELING ABNORMAL (Brain fog) had resolved.            No concomitant medications were reported  No treatment information was provided  The patient stated that all the symptoms started 2 weeks after the second vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given moderna booster too early. booster too early; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given moderna booster too early. booster too early) 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 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 (Given moderna booster too early. booster too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given moderna booster too early. booster too early) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Myeloma. Concomitant products included DEXAMETHASONE for Myeloma.    On 18-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had three doses of Pfizer/ received a fourth dose, which was Moderna COVID19 Vaccine on 18Nov2021) had resolved.            No treatment information was reported.  Patient stated that he has myeloma and has been on dexamethasone for a number of years.   Patient had 3 doses of Pfizer, but tested negative for the antibodies and then received a fourth dose from Moderna and developed antibodies.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Fast heart rate/heartbeat after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast heart rate/heartbeat after booster shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 006B21A and 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PALPITATIONS (Fast heart rate/heartbeat after booster shot). At the time of the report, PALPITATIONS (Fast heart rate/heartbeat after booster shot) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported. After second shot the doctor prescribed anxiety medicine.   This case was linked to MOD-2021-416109 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysphonia, Eye disorder, Hypoacusis, Illness
Clinical narrative: Couldn't hear her/having heard time hearing her; incoherent; Change in seeing/couldn't see her/could see her when she moved close to her; Sick for a day; Unusual hoarseness; she will be there then doze off and it's like she is in a different zone; Appears confused at times; Few days after the booster injection,had strange looking things on her tongue/geographic tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Unusual hoarseness), SLEEP DISORDER (she will be there then doze off and it's like she is in a different zone), HYPOACUSIS (Couldn't hear her/having heard time hearing her), INCOHERENT (incoherent) and CONFUSIONAL STATE (Appears confused at times) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cataract (Cataract in one eye) and Diabetic.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced ILLNESS (Sick for a day). On 14-Dec-2021, the patient experienced HYPOACUSIS (Couldn't hear her/having heard time hearing her), INCOHERENT (incoherent) and EYE DISORDER (Change in seeing/couldn't see her/could see her when she moved close to her). In December 2021, the patient experienced DYSPHONIA (Unusual hoarseness), SLEEP DISORDER (she will be there then doze off and it's like she is in a different zone), CONFUSIONAL STATE (Appears confused at times) and TONGUE GEOGRAPHIC (Few days after the booster injection,had strange looking things on her tongue/geographic tongue). The patient was treated with Manual therapy (Cleaned ear out with an ear wax) for Hypoacusis. On 08-Dec-2021, ILLNESS (Sick for a day) had resolved. At the time of the report, DYSPHONIA (Unusual hoarseness), SLEEP DISORDER (she will be there then doze off and it's like she is in a different zone), HYPOACUSIS (Couldn't hear her/having heard time hearing her), INCOHERENT (incoherent), CONFUSIONAL STATE (Appears confused at times) and EYE DISORDER (Change in seeing/couldn't see her/could see her when she moved close to her) outcome was unknown and TONGUE GEOGRAPHIC (Few days after the booster injection,had strange looking things on her tongue/geographic tongue) was resolving.            Concomitant information was not provided.  It was reported that the patient was unable to see her sister when sister visited her but eventually she could see when her sister moved closer to her.  Ear wax remover was used to clear the ear out but there was not wax. The patient was on P.D dialysis.   This case was linked to MOD-2021-415970, MOD-2021-416207 (Patient Link).