chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine. Additional details were provided are as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and in 2021, the patient had shingles, worst pain ever and still had nerve pain daily at the time of reporting. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2021AMR260504).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and chills. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced fever and chills. The patient commented that it sounds good compared to what he/she was reading. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260504:Same reporter, same product, same patient, case for different dose
Age: 0.75
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of overdose in a 9-month-old male patient who received HAV (Havrix adult) (batch number U95H7, expiry date 22nd May 2022) for prophylaxis. Co-suspect products included HAV (Havrix adult) (batch number U95H7, expiry date unknown) for prophylaxis. Previously administered products included Havrix (received first dose on unknown date). On 12th September 2021, the patient received the 3rd dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix adult. On 12th September 2021, unknown after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced overdose, adult product administered to child and extra dose administered. On an unknown date, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the overdose, adult product administered to child, extra dose administered, adult product administered to child and overdose were unknown. Additional details were provided as follows: The pharmacist reported that patient received the adult dose of the Havrix vaccine inadvertently for their second and third dose of the series. The patients were administered the third dose of the vaccine series, which led to overdose, adult product administered to child, extra dose administered. The batch number was for second and third dose of Havrix vaccine was same. The reporter consented to follow up. The case has been linked to US2021254948 and US2021254932, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021254948:Same reporter. US-GLAXOSMITHKLINE-US2021254932:Same reporter.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 24-JUN-2021 to left arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 15-DEC-2021, the patient started having lost of taste and smell, low grade fever, cough and runny nose (suspected covid-19 infection). A day after on 16-DEC-2021, the patient got a positive Antigen Rapid Test for Covid 19, (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208053.; Sender's Comments: V0: 20211247761-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative via social media concerned a 75 year old patient of unspecified sex, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin was not reported, and batch number: unknown expiry: unknown) dose was not reported, 01 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On APR-2021, 5 hours after vaccination the patient went to the emergency room with a stroke. The doctor said that the stroke was because of the patient's age and not because of the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211248815-Covid-19 vaccine ad26.CoV-2.s- Stroke. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via a company representative from social media concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number were not reported, and expiry: UNKNOWN) 1 total, dose number in series 1, 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. Concomitant medications included acetylsalicylic acid. On an unspecified date, the patient experienced "stroke". It was reported that "I had the Johnson and Johnson vaccine and three weeks later I had a stroke up until then I wasn't even taking so much is an aspirin I'm not taking any boosters from anybody" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211248907-Covid-19 vaccine ad26.CoV-2.s- Stroke. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; 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, intramuscular, batch number was 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 DEC-2021, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 on DEC-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash erythematous
Clinical narrative: red rash; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and HEADACHE (severe headache) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and HEADACHE (severe headache). At the time of the report, RASH ERYTHEMATOUS (red rash) and HEADACHE (severe headache) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-419257, MOD-2021-419298 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing; Fast/racing heartbeat 1 hour after booster; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing) and HEART RATE INCREASED (Fast/racing heartbeat 1 hour after booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A and 007821A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Kidney disorder and Hypertension. Concomitant products included INSULIN DEGLUDEC (TRESIBA FLEXTOUCH), DILTIAZEM, IRBESARTAN, CARVEDILOL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ROSUVASTATIN CALCIUM (CRESTOR) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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 DYSPNOEA (Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing) and HEART RATE INCREASED (Fast/racing heartbeat 1 hour after booster). On 16-Dec-2021, DYSPNOEA (Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing) and HEART RATE INCREASED (Fast/racing heartbeat 1 hour after booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, Blood pressure measurement: normal (normal) Normal. On 20-Dec-2021, Electrocardiogram: normal (normal) Normal.         The patient developed adverse events about 1 hour after the booster shot. They lasted for a couple hours.  The patient thought that her breathing was labored because of the fast/racing heartbeat as the heartbeat and breathing goes hand in hand. The heart and breathing was not severe enough to go to the hospital; she was not gasping for oxygen.  The patients concomitant included Diltiazem 24 hour extended release.   No treatment medication were provided.  On 20-Dec-2021, the patient went to see her cardiologist for a routine check up but she had forgotten to mention the adverse events to the cardiologist.  On 20-Dec-2021, the patient again felt difficulty breathing when she had a mask on, and was exerting herself, she was not sure if this was noteworthy. The difficulty in breathing was resolved when she took off her mask.  The patient had no history of myocarditis or pericarditis.   This case was linked to MOD-2021-420648 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Rash, Urticaria
Clinical narrative: Ropey-looking rash or welt on the back; Ropey-looking rash; Feeling out of breath; Feeling rapid heartbeat; Feeling chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Feeling out of breath), HEART RATE INCREASED (Feeling rapid heartbeat), CHEST PAIN (Feeling chest pain), URTICARIA (Ropey-looking rash or welt on the back) and RASH (Ropey-looking rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson COVID-19 in March 2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson COVID-19.    On 17-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced DYSPNOEA (Feeling out of breath), HEART RATE INCREASED (Feeling rapid heartbeat) and CHEST PAIN (Feeling chest pain). On 17-Dec-2021, the patient experienced URTICARIA (Ropey-looking rash or welt on the back) and RASH (Ropey-looking rash). On 18-Dec-2021, URTICARIA (Ropey-looking rash or welt on the back) and RASH (Ropey-looking rash) had resolved. At the time of the report, DYSPNOEA (Feeling out of breath), HEART RATE INCREASED (Feeling rapid heartbeat) and CHEST PAIN (Feeling chest pain) had not resolved.            No any concomitant medications were reported.  No any treatment medications were reported.  Patient took Johnson & Johnson COVID-19 vaccine as their primary dose in March 2021 and received the Moderna COVID-19 vaccine as their booster shot on 17-Dec-2021.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Fatigue, Parosmia, Product dose omission issue
Clinical narrative: loss of energy; blood sugar dropped; taste of chemical thing; smell of chemical thing; she was tired; Scheduled for second shot on 14Dec2021. But hasn't gotten it yet; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (loss of energy), BLOOD GLUCOSE DECREASED (blood sugar dropped), TASTE DISORDER (taste of chemical thing), PAROSMIA (smell of chemical thing) and FATIGUE (she was tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She experienced a chemical smell or taste at the time.) in August 2021.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (loss of energy), BLOOD GLUCOSE DECREASED (blood sugar dropped), TASTE DISORDER (taste of chemical thing), PAROSMIA (smell of chemical thing), FATIGUE (she was tired) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second shot on 14Dec2021. But hasn't gotten it yet). At the time of the report, ASTHENIA (loss of energy), BLOOD GLUCOSE DECREASED (blood sugar dropped) and FATIGUE (she was tired) had resolved, TASTE DISORDER (taste of chemical thing) and PAROSMIA (smell of chemical thing) had not resolved and PRODUCT DOSE OMISSION ISSUE (Scheduled for second shot on 14Dec2021. But hasn't gotten it yet) 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.   Patient is on unspecified blood pressure and cholesterol medications. Patient has not taken second dose of vaccine which was scheduled on 14-Dec-2021. The patient did not take any treatment medications.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: loss of energy; blood sugar dropped; taste of chemical thing; smell of chemical thing; she was tired; Scheduled for second shot on 14Dec2021. But hasn't gotten it yet; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (loss of energy), BLOOD GLUCOSE DECREASED (blood sugar dropped), TASTE DISORDER (taste of chemical thing), PAROSMIA (smell of chemical thing) and FATIGUE (she was tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She experienced a chemical smell or taste at the time.) in August 2021.    On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (loss of energy), BLOOD GLUCOSE DECREASED (blood sugar dropped), TASTE DISORDER (taste of chemical thing), PAROSMIA (smell of chemical thing), FATIGUE (she was tired) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second shot on 14Dec2021. But hasn't gotten it yet). At the time of the report, ASTHENIA (loss of energy), BLOOD GLUCOSE DECREASED (blood sugar dropped) and FATIGUE (she was tired) had resolved, TASTE DISORDER (taste of chemical thing) and PAROSMIA (smell of chemical thing) had not resolved and PRODUCT DOSE OMISSION ISSUE (Scheduled for second shot on 14Dec2021. But hasn't gotten it yet) 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.   Patient is on unspecified blood pressure and cholesterol medications. Patient has not taken second dose of vaccine which was scheduled on 14-Dec-2021. The patient did not take any treatment medications.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Excursion duration refrigerator was below 36°F for 2 hours and 45 minutes total; vaccine administered after an excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration refrigerator was below 36°F for 2 hours and 45 minutes total) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after an excursion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration refrigerator was below 36°F for 2 hours and 45 minutes total) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after an excursion). On 21-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration refrigerator was below 36°F for 2 hours and 45 minutes total) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after an excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine was administered intramuscularly in the upper deltoid muscle to the patient. No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Sore; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Sciatica (with 3 bulging herniated disks on oxycontin), Alzheimer's disease (symptoms of Alzheimer's) and Schizophrenia (seen 12 psychiatrists at a nearby clinic). Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL, SIMVASTATIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN (Sore). In March 2021, PAIN (Sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she did not have history of bipolar disorder or seizures.  No treatment drugs were reported.    This case was linked to MOD-2021-421460, MOD-2021-421502 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Inflammation, Lymphadenopathy, Pyrexia
Clinical narrative: Discomfort; Fever; inflammation of the lymph nodes between armpit and breast/inflammation in the armpit; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), INFLAMMATION (Inflammation), PYREXIA (Fever) and LYMPHADENOPATHY (inflammation of the lymph nodes between armpit and breast/inflammation in the armpit) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 DISCOMFORT (Discomfort), INFLAMMATION (Inflammation), PYREXIA (Fever) and LYMPHADENOPATHY (inflammation of the lymph nodes between armpit and breast/inflammation in the armpit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort), PYREXIA (Fever) and LYMPHADENOPATHY (inflammation of the lymph nodes between armpit and breast/inflammation in the armpit) outcome was unknown and INFLAMMATION (Inflammation) had resolved.            No concomitant medications were reported by reporter.  Patient had an inflammation there in arm pit for about 10 days were in the left side.   This case was linked to MOD-2021-421181 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021; 1st dose 21Apr2021; 2nd dose 23Jul2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)/ Moderna Covid-19 vaccine on 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 at 10:00am) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21Apr2021; 2nd dose 23Jul2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 047B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 4:11 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21Apr2021; 2nd dose 23Jul2021). On 16-Dec-2021 at 4:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)/ Moderna Covid-19 vaccine on 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 at 10:00am). On 23-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 21Apr2021; 2nd dose 23Jul2021) had resolved. On 16-Dec-2021 at 4:11 PM, EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16Nov2021/  (beyond the 30 use by date)/ Moderna Covid-19 vaccine on 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 at 10:00am) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported. How was the vial stored post puncture (ambient room temperature or refrigerator)? - refrigerator Total amount of time the vial was exposed to room temperature range (8° to 25°C/46° to 77°F) - 35-45 minutes
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 3:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 3:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date). On 16-Dec-2021 at 3:45 PM, EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 16-NOV-2021 at 10:00 A.M. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia
Clinical narrative: severe headache after the 2nd dose; headache left her on bed all day 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache after the 2nd dose) and HYPOKINESIA (headache left her on bed all day 2nd dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seizures and Heart murmur.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (severe headache after the 2nd dose) and HYPOKINESIA (headache left her on bed all day 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache after the 2nd dose) and HYPOKINESIA (headache left her on bed all day 2nd dose) outcome was unknown.            The patient reported that they got the second shot of the Moderna COVID-19 vaccine and experienced severe headache, which left the patient in bed all day.   The patient stated they suffered from other medical problems. Reportedly, the patient was taking concomitant/regular medications and had ten regular medications but didn't provide the details.  It was reported that the patient took Advil and wait and stayed in bed.   This case was linked to MOD-2021-421765 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced NIGHT SWEATS (Night sweats). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (Night sweats) outcome was unknown.            Patient stated that she was on no concomitant medication.   This case was linked to MOD-2021-417519 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided by the reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.  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 by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Medications details were provided. No Treatment Medications details were provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Myocardial necrosis marker increased, Myocarditis, Red blood cell sedimentation rate increased
Clinical narrative: 3 days after booster, developed chest pain, elevated cardiac enzymes, elevated ESR & CRP, suspected vaccine mediated myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: 3 days after booster, developed chest pain, elevated cardiac enzymes, elevated ESR & CRP, suspected vaccine mediated myocarditis
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Electrocardiogram, Magnetic resonance imaging, Myocarditis, Tachycardia
Clinical narrative: developed mycarditis, significant tachycardia
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: developed mycarditis, significant tachycardia
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: -Experienced pain, tingling, and extreme numbness in fingers, hand and arm all day and night after receiving shot -Experienced deep chills all night  I am a very healthy person with no medical conditions, so this was a surprising reaction.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Fibrin D dimer normal, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Patient admitted due to sudden onset tachypnea. No fevers or any other associated symptoms. Work up thus far includes a negative Quad panel (COVID, influenza A and B), negative respiratory viral panel, negative mycoplasma PCR, normal chest x-ray, and negative D-dimer. Patient is supposed to be on CPAP overnight at home but hasn't been using it for the past year due to her device being recalled and it has not been replaced yet. However, Mom reports that she did not have tachypnea or increased work of breathing until that evening after she received her COVID vaccine. She is currently in the ICU requiring CPAP during the day and at night (which is higher than her baseline support). We are slowly sprinting her during the day to room air as tolerated. Pulmonology, Oncology, and Infectious Diseases are involved in her management. If unable to wean her back to baseline support of CPAP at night only, plan is to consider chest CT and/or bronchoscopy. Per oncology, her chemotherapy medications are not associated with such side affects and wouldn't expect such an acute presentation. She is on pentamidine prophylaxis (against PJP) taken monthly. Per ID, this regimen is less than ideal so she does have a beta-d-glucan test pending, however, clinical suspicion for PCP is low given no associated hypoxia.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Intensive care, Mycoplasma test negative, Positive airway pressure therapy, Respiratory viral panel
Clinical narrative: Patient admitted due to sudden onset tachypnea. No fevers or any other associated symptoms. Work up thus far includes a negative Quad panel (COVID, influenza A and B), negative respiratory viral panel, negative mycoplasma PCR, normal chest x-ray, and negative D-dimer. Patient is supposed to be on CPAP overnight at home but hasn't been using it for the past year due to her device being recalled and it has not been replaced yet. However, Mom reports that she did not have tachypnea or increased work of breathing until that evening after she received her COVID vaccine. She is currently in the ICU requiring CPAP during the day and at night (which is higher than her baseline support). We are slowly sprinting her during the day to room air as tolerated. Pulmonology, Oncology, and Infectious Diseases are involved in her management. If unable to wean her back to baseline support of CPAP at night only, plan is to consider chest CT and/or bronchoscopy. Per oncology, her chemotherapy medications are not associated with such side affects and wouldn't expect such an acute presentation. She is on pentamidine prophylaxis (against PJP) taken monthly. Per ID, this regimen is less than ideal so she does have a beta-d-glucan test pending, however, clinical suspicion for PCP is low given no associated hypoxia.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tachypnoea
Clinical narrative: Patient admitted due to sudden onset tachypnea. No fevers or any other associated symptoms. Work up thus far includes a negative Quad panel (COVID, influenza A and B), negative respiratory viral panel, negative mycoplasma PCR, normal chest x-ray, and negative D-dimer. Patient is supposed to be on CPAP overnight at home but hasn't been using it for the past year due to her device being recalled and it has not been replaced yet. However, Mom reports that she did not have tachypnea or increased work of breathing until that evening after she received her COVID vaccine. She is currently in the ICU requiring CPAP during the day and at night (which is higher than her baseline support). We are slowly sprinting her during the day to room air as tolerated. Pulmonology, Oncology, and Infectious Diseases are involved in her management. If unable to wean her back to baseline support of CPAP at night only, plan is to consider chest CT and/or bronchoscopy. Per oncology, her chemotherapy medications are not associated with such side affects and wouldn't expect such an acute presentation. She is on pentamidine prophylaxis (against PJP) taken monthly. Per ID, this regimen is less than ideal so she does have a beta-d-glucan test pending, however, clinical suspicion for PCP is low given no associated hypoxia.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: I was not aware that I was pregnant at the time of the vaccine, a week later I found out I was pregnant, and a couple days after that I had a miscarriage.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Constipation, Musculoskeletal stiffness, Vomiting
Clinical narrative: Severe pain and stiffness of lower back, lower spine, pelvic and hip muscles and bones 1 week after the Moderna booster.  Plus severe abdominal bowel pain, constipation and vomiting starting 5 days after booster. My previous two vaccines were Pfizer?s, April and May 2021.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Injection site pain, Lip discolouration, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: PT received vaccine and sat in waiting area chair, within 5 min, said "excuse me, I think I'm going to pass out" Went out to pt, was very pale, asked if he ate, said no, offerred water and chocolate said food made him nauseous, got orange juice, color came back to lips when drinking but faded, his Aunt brought him in and called both parents, she refused our request to call ambulance, said dad was emt and on his way, mother arrived and he left with her after several glasses of oj, color returned
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: PT received vaccine and sat in waiting area chair, within 5 min, said "excuse me, I think I'm going to pass out" Went out to pt, was very pale, asked if he ate, said no, offerred water and chocolate said food made him nauseous, got orange juice, color came back to lips when drinking but faded, his Aunt brought him in and called both parents, she refused our request to call ambulance, said dad was emt and on his way, mother arrived and he left with her after several glasses of oj, color returned
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea exertional, Exercise tolerance decreased, Pain, Swelling
Clinical narrative: The day after receiving the COVID-19 shot, on the same side as I received the shot in (left side) I started to swell under my arm all the way down to my waist.  It's gone down by about 75% at this time, but I'm swill swollen on my left side and it's painful.  I've also been a runner my entire adult life.  My runs have severely been affected, and I run out of breath much easier now, which occurred within 1 month of receiving the vaccine, and I've noticed I run out of energy and have to consume energy drinks and coffee throughout the day in order to make it through the day.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Neurological symptom
Clinical narrative: Stroke -- symptoms of stroke came on suddenly spent a month in hospital / rehab still going through physical therapy
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A low grade fever of 99.6° started of 12/19 soon after waking and persisted for 3 days.  Average temperature of this child is 97.6°
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Pulmonary embolism
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Bilateral Pulmonary Embolism-Severe
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Rash swelling local pain
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Rash swelling local pain
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Photopsia, Visual impairment
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: SHE REPORTED EYE FLASHES AND EYE FLOATINGS ON 12/20/2021 VIA PHONE. SHE HAD AN APPOINTMENT WITH MD ON 12/20/21.