chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered
Clinical narrative: VIAL FIRST PUNCTURED THE DAY BEFORE NOT A SPECIFIC AMOUNT OF TIME BUT GREATER THAN 6 HOURS AFTER PUNCTURE; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age, 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 vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown and expiry; Unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following primary vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported,1 total, administered on 10-DEC-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 10-DEC-2021, after receiving the booster shot the patient came to know that the product given came from a vial first punctured the day before, not a specific amount of time but greater than 6 hours after puncture (Out of specification product use) (also reported as expired dose give (after 6 hours post puncture)) (dose number in series 2). The only side effect she experienced was sore arm (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial first punctured the day before not a specific amount of time but greater than 6 hours after puncture and sore arm was unknown. This report was non-serious. This case, from the same reporter is linked to 20211247381.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: SICKNESS; SICK TO STOMACH; This spontaneous report received from a parent concerned a female of unspecified age. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sickness, and sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sickness, and sick to stomach. This report was non-serious. This case, from the same reporter is linked to 20211240250.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product use in unapproved indication
Clinical narrative: OFF LABEL USE; PRODUCT USE IN UNAPPROVED INDICATION; This spontaneous report received from a pharmacist concerned a 75 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 (Moderna) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 10-FEB-2021 for prophylactic vaccination (Dose number in series 1). The reporter did not report any adverse events following vaccination with mrna 1273 (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination (Dose number in series 2), which was off label and product use in unapproved indication (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. As reported, the patient was looking to receive their "third dose of Pfizer COVID-19 vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product use in unapproved indication was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Migraine, Pyrexia
Clinical narrative: MIGRAINE; CHILLS; FEVER; 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 (Dose number in series: 1) (suspension for injection, route of admin not reported, and batch number: UNKNOWN) 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 migraine, chills, and fever.  (Dose number in series: 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, chills, and fever. This report was non-serious. This case, involving the same patient is linked to 20211249027 (Dose number in series: 2).
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; NIGHT SWEATING; This spontaneous report received from a patient concerned a  female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: unknown) dose was not reported, 1 total administered at left arm on 06-MAY-2021 for prophylactic vaccination (Dose number in series 1).  No concomitant medications were reported.  On 20-DEC-2021, the patient experienced sore throat, body ache (suspected covid-19 infection), night sweating that are pretty much gone. On 22-DEC-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive (twice) and had 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, night sweating, and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208226.; Sender's Comments: V0-20211251848 -Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Brain operation, Cerebrovascular accident, Rehabilitation therapy, Thrombosis
Clinical narrative: SUFFERED FOUR STROKES; BLOOD CLOTS SUSTAINED FROM THE VACCINE; MULTIPLE BRAIN SURGERIES; CONTINUALLY NEEDING REHAB; This spontaneous report received from a consumer via social media  via a company representative concerned a female 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, and batch number were not reported and expiry: unknown) dose, 1 total administered and start therapy date were not reported for prophylactic vaccination (Dose number in series was 1). 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 reported stated that, campaign for a young woman who suffered 4 strokes and multiple brain surgeries of blood clots sustained from the J&J vaccine and continually needing rehab from her vaccine induced injuries. Picture attached, shows 2 images a young girl smiling at the camera, and (presumably) the same girl in a hospital bed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suffered four strokes, multiple brain surgeries, blood clots sustained from the vaccine and continually needing rehab was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211252273-Covid-19 vaccine ad26.cov2.s-Suffered four strokes, Blood clots sustained from the vaccine, Multiple brain surgeries, Continually needing rehab. 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).
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; 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 weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). 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 heart attack. The consumer reported as " My brother in laws sisters husband died in his living room, heart attack, double deaths". It was unknown if an autopsy was performed. On an unspecified date, the patient died from heart attack.  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 20211254072, 20211254110, 20211253879 and 20211247927.; Sender's Comments: V0-20211254092-Covid-19 vaccine ad26.CoV-2.s- Heart attack. 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.; Reported Cause(s) of Death: HEART ATTACK
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative via social media concerned a 50 year old male of unspecified 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 (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total, administered 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 DEC-2021 (3 weeks ago), the reporter stated that, the patient experienced stroke and now he was disabled. (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to 20211254092, 20211253879, 20211254072 and 20211247927.; Sender's Comments: V0: 20211254110- COVID-19 VACCINE AD26.COV2.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: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART ISSUES; This spontaneous report received from a consumer via a company representative concerned multiple patients.  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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues was not reported. This report was non-serious. This case, from the same reporter is linked to 20211245826.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had not experienced any harm from the product problem (no associated adverse event). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) .5 ml, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211237771.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: RIGHT ARM SWELLED UP THAT WAS INJECTED AND IT GOT WORSE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: environmental allergies, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage and allergy to drug but not sure about the nature of allergy to both medications. The patient experienced drug allergy when treated with amoxicillin, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced right arm swelled up that was injected and it got worse, and sore right arm. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative for blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right arm swelled up that was injected and it got worse, and sore right arm on 26-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: SORE MUSCLES IN BOTH ARMS WHERE RECEIVED THE SHOTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 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 sore muscles in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore muscles in both arms where received the shots was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 68 year old male. 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: 204B21A expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tested positive for covid-19. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a 20 year old male. 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 chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211245426.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211256220.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HAD COVID TWICE; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. 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 had covid twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had covid twice was not reported. This report was non-serious. This case, from the same reporter is linked to 20211256286. This report was associated with product quality complaint: 90000208731
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; 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 sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious. This case, from the Others is linked to 20211245214.
Sex: U
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: 6 patients develop aggressive cases of Cataracts after receiving a Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (6 patients develop aggressive cases of Cataracts after receiving a Covid-19 vaccine) 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 CATARACT (6 patients develop aggressive cases of Cataracts after receiving a Covid-19 vaccine) (seriousness criterion medically significant). At the time of the report, CATARACT (6 patients develop aggressive cases of Cataracts after receiving a Covid-19 vaccine) 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.   The concomitant medication was not reported. The treatment medication was not reported.  It was reported that the Ophthalmologist said that he has had six patients who developed aggressive cases of cataracts after receiving a Covid-19 vaccine.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender,  with no medical history reported, who experienced the unexpected, serious event of cataract (aggressive case) after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The outcome of the event  was unknown at the time of the report. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow up report contains information of additional reporter were added.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender,  with no medical history reported, who experienced the unexpected, serious event of cataract (aggressive case) after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The outcome of the event  was unknown at the time of the report. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Her lung infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Her lung infection) 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 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Her lung infection) (seriousness criterion medically significant). The patient was treated with DOXYCYCLINE for Lung infection, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Her lung infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. It was reported that, patient took Moderna COVID 19 vaccine on 28-Jan-2021 and couple of days back her doctor prescribed doxycycline for her lung infection and she is taking it since few days. She wanted to know that whether doxycycline effects immune response of vaccine. Company comment This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of PNEUMONIA. The event occurred approximately two days after the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of PNEUMONIA. The event occurred approximately two days after the administration of a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Cancer patient received half dose booster instead of 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Cancer patient received half dose booster instead of 3rd full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer.   On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Cancer patient received half dose booster instead of 3rd full dose). On 13-Dec-2021, ACCIDENTAL UNDERDOSE (Cancer patient received half dose booster instead of 3rd full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. Reporter stated that this is not an error. Patient did not ask for the full dose at the time of vaccination.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After they had been punctured more than 12 hours prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After they had been punctured more than 12 hours prior to administration) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 014C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After they had been punctured more than 12 hours prior to administration). On 23-Dec-2021, EXPIRED PRODUCT ADMINISTERED (After they had been punctured more than 12 hours prior to administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038321A) for COVID-19 vaccination.     The patient's past medical history included Cough, Vitamin D deficiency, Vitamin B12 deficiency, Lumbar radiculopathy (L5.), Musculoskeletal pain (Lowback pain.), Atrophy (Mild on MRI), Hyperlipidemia, Cognitive impairment (Mild), Word finding difficulty, Fatigue, Cerebral small vessel ischemic disease and Lumbar disc disease. Concomitant products included FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), L-METHYLFOLATE, ACETYLSALICYLIC ACID (ASPIRIN LOW), VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3, UBIDECARENONE (COQ-10) and INFLUENZA VACCINE (INFLUENZA) from 30-Nov-2021 to an unknown date for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 12-Nov-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.   Patient had screening for CAD, skin cancer, colon cancer, lung cancer and prostrate cancer.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Insomnia, Muscular weakness
Clinical narrative: I was dizzy as heck when I got up; Low grade fever; Chills real bad; Weakness in my muscles; I couldn't sleep; I coughed all night long from tickle in throat; Tickle in throat; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat) and DIZZINESS (I was dizzy as heck when I got up) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L213, 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat), PYREXIA (Low grade fever) and CHILLS (Chills real bad). On 24-Dec-2021, the patient experienced DIZZINESS (I was dizzy as heck when I got up). At the time of the report, MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat), DIZZINESS (I was dizzy as heck when I got up), PYREXIA (Low grade fever) and CHILLS (Chills real bad) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.  The patient said if he fall, then won't be able to get up. He had no side effects after second dose.   This case was linked to MOD-2021-426713 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: I was dizzy as heck when I got up; Low grade fever; Chills real bad; Weakness in my muscles; I couldn't sleep; I coughed all night long from tickle in throat; Tickle in throat; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat) and DIZZINESS (I was dizzy as heck when I got up) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L213, 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat), PYREXIA (Low grade fever) and CHILLS (Chills real bad). On 24-Dec-2021, the patient experienced DIZZINESS (I was dizzy as heck when I got up). At the time of the report, MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat), DIZZINESS (I was dizzy as heck when I got up), PYREXIA (Low grade fever) and CHILLS (Chills real bad) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.  The patient said if he fall, then won't be able to get up. He had no side effects after second dose.   This case was linked to MOD-2021-426713 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling cold, Myalgia, Nausea
Clinical narrative: loss of appetite; felt cold; Chills; fever; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), FEELING COLD (felt cold), CHILLS (Chills), PYREXIA (fever) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 027B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, HYDROCHLOROTHIAZIDE, MONTELUKAST, SIMVASTATIN, GLIMEPIRIDE, LEVOTHYROXINE, LEVOTHYROXINE, METOPROLOL, DILTIAZEM, GABAPENTIN and VITAMIN B12 NOS for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 1 dosage form. In December 2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING COLD (felt cold), CHILLS (Chills), PYREXIA (fever), MYALGIA (body aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, DECREASED APPETITE (loss of appetite), FEELING COLD (felt cold), CHILLS (Chills), PYREXIA (fever), MYALGIA (body aches) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-425598, MOD-2021-425599 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: loss of appetite; felt cold; Chills; fever; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), FEELING COLD (felt cold), CHILLS (Chills), PYREXIA (fever) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 027B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, HYDROCHLOROTHIAZIDE, MONTELUKAST, SIMVASTATIN, GLIMEPIRIDE, LEVOTHYROXINE, LEVOTHYROXINE, METOPROLOL, DILTIAZEM, GABAPENTIN and VITAMIN B12 NOS for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 1 dosage form. In December 2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING COLD (felt cold), CHILLS (Chills), PYREXIA (fever), MYALGIA (body aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, DECREASED APPETITE (loss of appetite), FEELING COLD (felt cold), CHILLS (Chills), PYREXIA (fever), MYALGIA (body aches) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-425598, MOD-2021-425599 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (One of their patients may have been administered expired Moderna booster of .25 mL, that was in refrigerator for greater than 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The patient was well over 18 years of age.the vial was initially stored in the refrigerator on 07 APR 2021. expiration date 31 DEC 2069.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough, Throat irritation
Clinical narrative: scratchy throat; sore around the collar bone; could not stop coughing; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratchy throat), BONE PAIN (sore around the collar bone) and COUGH (could not stop coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 04-Feb-2021 and Pfizer on 21-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Iodine allergy, Allergy to chemicals (sulfur) and Penicillin allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-2021, the patient experienced THROAT IRRITATION (scratchy throat), BONE PAIN (sore around the collar bone) and COUGH (could not stop coughing). At the time of the report, THROAT IRRITATION (scratchy throat), BONE PAIN (sore around the collar bone) and COUGH (could not stop coughing) outcome was unknown.            Treatment included tea, honey and lemon, cough syrup, hot salt water, menthol, ice
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Pain in extremity, Rash, Rash macular
Clinical narrative: soreness in arm; Raw pink spot; Arm started to get darker; Started to peel like it was a chemical burn; Burn like blister; Arm got a huge rash all around upper arm and bicep/Moderna arm rash; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn) and BLISTER (Burn like blister) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 007C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn), BLISTER (Burn like blister), RASH (Arm got a huge rash all around upper arm and bicep/Moderna arm rash) and FATIGUE (kind of tired). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn), BLISTER (Burn like blister), RASH (Arm got a huge rash all around upper arm and bicep/Moderna arm rash) and FATIGUE (kind of tired) outcome was unknown.            Patient reports there was still a raw pink spot but other parts looks like it could have been getting better but she's not sure if it was or if it will peel again.   This case was linked to MOD-2021-402840, MOD-2021-402890, MOD-2021-402890 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received, contains non significant information,Pictures has been added
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin exfoliation
Clinical narrative: soreness in arm; Raw pink spot; Arm started to get darker; Started to peel like it was a chemical burn; Burn like blister; Arm got a huge rash all around upper arm and bicep/Moderna arm rash; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn) and BLISTER (Burn like blister) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 007C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn), BLISTER (Burn like blister), RASH (Arm got a huge rash all around upper arm and bicep/Moderna arm rash) and FATIGUE (kind of tired). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), RASH MACULAR (Raw pink spot), SKIN DISCOLOURATION (Arm started to get darker), SKIN EXFOLIATION (Started to peel like it was a chemical burn), BLISTER (Burn like blister), RASH (Arm got a huge rash all around upper arm and bicep/Moderna arm rash) and FATIGUE (kind of tired) outcome was unknown.            Patient reports there was still a raw pink spot but other parts looks like it could have been getting better but she's not sure if it was or if it will peel again.   This case was linked to MOD-2021-402840, MOD-2021-402890, MOD-2021-402890 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received, contains non significant information,Pictures has been added