chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose approx 2 years ago, not yet received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received, 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter called on behalf of patient. The patient received did not yet receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter would not provide any patient demographics.
Age: 45.0
Sex: F
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 45 year old female. 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: 206AZ1A, expiry date: unknown) dose was not reported, dose number in series was 1, 01 total administered on 01-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient was exposed to her boyfriend who showed first symptoms on 02-JAN-2022. On 04-JAN-2022, the patient felt sick with fever, diarrhea, and coughing (suspected covid-19 infection), on 07-JAN-2022 she tested positive for coronavirus disease-19 (COVID-19) with a home kit test and had suspected clinical vaccination failure (dose number in series was 1). Patient denied having a COVID-19 PCR (polymerase chain reaction) test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority; Sender's Comments: V0: 20220116981 -COVID-19 VACCINE AD26.COV2.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.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cholecystitis, Computerised tomogram abdomen, Hypertension
Clinical narrative: CHOLECYSTITIS; ELEVATED BLOOD PRESSURE; This spontaneous report received from a physician concerned a 31 year old male. The patient's weight was 113.6 kilograms, and height was 183 centimeters. The patient's past medical history included: open fracture of radius and ulna -right arm, asymptomatic arrhythmia, asymptomatic/benign cardiac murmur, recreational use (3,4-methylenedioxymethamphetamine), cocaine use, sternal border pain, food-borne gastrointestinal illness, walking pneumonia, upper respiratory infection, and cannabis use, and concurrent conditions included: antibiotic allergy, intermittent back pain, attention deficit disorder, cold sores - oral inside cheeks, intermittent sinus infection, biaxin allergy, and heart murmur. The patient previously used doxycycline, salbutamol and codeine (guaifenesin cough syrup) for walking pneumonia and amoxicillin for upper respiratory infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 0.5 ml, dose number in series was 1, 01 in total was administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. In JUL-2021, the patient experienced elevated blood pressure. On 15-DEC-2021, the patient was seen in an ER (emergency room) for abdominal pain, diagnosed with acute cholecystitis (grade 3 severe AE (adverse event)) (dose number in series was 1) and then hospitalized. An abdominal CT (computerized tomography) scan showed gall stone. Cholecystectomy was performed on 16-DEC-2021. He was hospitalized for 2 days. The procedure was uncomplicated and the patient was discharged from the hospital on 17-DEC-2021. On the same day, his treatment medications included hydromorphone hydrochloride (Dilaudid).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cholecystitis on 16-DEC-2021, and elevated blood pressure on AUG-2021. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20220109570.; Sender's Comments: V0-20220122740-covid-19 vaccine ad26.cov2.s- Cholecystitis. 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).
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a physician concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry unknown) dose was not reported, 1 total, administered on 01-APR-2021 (first dose 1), and on an unspecified date in 2021 (second dose: off label use and inappropriate schedule of vaccine administered) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non company suspect drug include adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported on an unspecified date for moderate to severe ulcerative colitis. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20-Dec-2021, therapy with adalimumab was discontinued. The patient received Non-company suspect vaccine included: bnt 162 (dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced feeling bad, fever, tiredness (captured as confirmed covid-19 infection) and laboratory data included: COVID-19 virus test (NR: not provided) Positive. (dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The patient recovered from covid-19 virus test positive, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This report was associated with a product quality complaint:90000211928.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site scab, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SMALL SCAB ON HER LEFT ARM WHERE SHE HAD RECEIVED THE  SHOT; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had no known drug allergies, had no known medical conditions, and no medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: unknown) dose was not reported, dose number in series was 1, 01 total was administered on 10-SEP-2021 in her left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient contracted Corona virus disease (COVID-19) (suspected covid-19 infection) despite being vaccinated with the Janssen COVID-19 vaccine. On 23-DEC-2021, she stated she was tested at her work place COVID-19 virus test (two days before Christmas with a pool test) which was unknown, and hence resulting in suspected clinical vaccination failure (dose number in series was 1). She did not know if it was polymerase chain reaction (PCR) or rapid antigen but did state that the results did take a day or two from the hospital where she worked at and she was informed on Christmas day. She stated that her symptoms after contracting COVID were mild which included allergy like symptoms including nasal congestion and cold like symptoms. She also noted that she had a small scab on her left arm where she had received the shot. She stated all symptoms had gone away.  The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from suspected clinical vaccination failure, suspected covid-19 infection, and small scab on her left arm where she had received the shot. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority. The suspected regulatory authority has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on RA evaluation/investigation performed. This case, from the same reporter is linked to 20220124168.; Sender's Comments: V0: 20220124447-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DEATH; BLOOD CLOT; This spontaneous report received from a consumer via through 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) dose number in series 1, 1 total, dose and 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 blood clot and she could not have her needed daily dialysis. On an unspecified date, the patient died from unknown cause of death (dose number in series 1). It was unspecified whether an autopsy was performed. The consumer reported as "My sister in law died in a few days because her pokes caused her blood to clot, and she could not have her needed daily dialysis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on an unspecified date, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220126450, 20220126211, 20220126582, 20220126614, 20220126701 and 20220126708.; Sender's Comments: V0: 20220126177 -Covid-19 vaccine ad26.cov2.s- Death, Blood clot. 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: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer via a company representative concerned a several multiple patients 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 patients experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126582 and 20220126701.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media through a company representative concerned 3 patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown ) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date (two weeks after vaccination), the patients died from unknown cause of death. It was unspecified if an autopsy was performed. As reporter reported " "Same here but × 3"(In response to this comment: "I have a friend who was young, took the Johnson shot and died two weeks later"). 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 20220128561.; Sender's Comments: V0. 20220127876-covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: FEEL SICK; HEADACHES EVERY DAY/HEADACHES COME AND GO; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus headaches. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, since the booster the patient had headache every day. The patient reported that, the headache come and go, but enough that at times feel sick (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches every day/headaches come and go and feel sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, SARS-CoV-2 test, Tinnitus, Wheezing
Clinical narrative: CONFIRMED COVID-19 INFECTION; WHEEZING; RINGING IN EARS; EXPIRED VACCINE USED; This spontaneous report received from a patient concerned a 63 year old female. 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: 212AZ1A, expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 23-SEP-2021, the patient experienced expired vaccine used. On 17-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the patient experienced confirmed covid-19 infection, wheezing, and ringing in ears. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, ringing in ears, wheezing and expired vaccine used was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000212682.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 39 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 (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 18-SEP-2021) dose was not reported, 1 total, administered to right arm on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of covid after receiving the Covid 19 vaccine(dose number in series: 1), suspected covid-19 infection and suspected clinical vaccination failure The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000212824.; Sender's Comments: V0: 20220133988,covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Injection site discomfort, Musculoskeletal pain
Clinical narrative: ARM DISCOMFORT AT INJECTION SITE; PAIN WENT UP TO LEFT UPPER CHEST; PAIN WENT UP TO COLLARBONE NEAR ARMPIT / INCREASED PAIN; COUGHING; EXCRUCIATING PAIN IN SHOULDER BLADE; TIRED A LITTLE BIT; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 245 pounds, and height was 77 inches. The patient's concurrent conditions included: allergy to nuts, fish allergy, wheat allergy, and environmental allergy. 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, administered on 12-JAN-2022 for prophylactic vaccination.  No concomitant medications were reported.  On JAN-2022, the patient experienced tired a little bit. Treatment medications included: ibuprofen. On 14-JAN-2022, the patient experienced arm discomfort at injection site, pain went up to left upper chest, pain went up to collarbone near armpit / increased pain, coughing, and excruciating pain in shoulder blade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm discomfort at injection site, pain went up to left upper chest, excruciating pain in shoulder blade, tired a little bit, pain went up to collarbone near armpit / increased pain, and coughing. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ARM DISCOMFORT AT INJECTION SITE; PAIN WENT UP TO LEFT UPPER CHEST; PAIN WENT UP TO COLLARBONE NEAR ARMPIT / INCREASED PAIN; COUGHING; EXCRUCIATING PAIN IN SHOULDER BLADE; TIRED A LITTLE BIT; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 245 pounds, and height was 77 inches. The patient's concurrent conditions included: allergy to nuts, fish allergy, wheat allergy, and environmental allergy. 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, administered on 12-JAN-2022 for prophylactic vaccination.  No concomitant medications were reported.  On JAN-2022, the patient experienced tired a little bit. Treatment medications included: ibuprofen. On 14-JAN-2022, the patient experienced arm discomfort at injection site, pain went up to left upper chest, pain went up to collarbone near armpit / increased pain, coughing, and excruciating pain in shoulder blade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm discomfort at injection site, pain went up to left upper chest, excruciating pain in shoulder blade, tired a little bit, pain went up to collarbone near armpit / increased pain, and coughing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Weight decreased
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; LOST WEIGHT; This spontaneous pregnancy report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. 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. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy, and lost weight. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost weight and vaccine exposure during pregnancy was not reported. This report was non-serious. This case, from the same reporter is linked to 20220114730 and 20220137233.
Sex: U
Vaccine: COVID19
Symptoms: Skin papilloma
Clinical narrative: WART; 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 wart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wart was not reported. This report was non-serious.
Sex: F
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 consumer 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 was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: HORRIBLE REACTION TO THE JJ COVID VACCINE; 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, expiry: 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 horrible reaction to the jj covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from horrible reaction to the jj covid vaccine. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Aches; Chills; Fatigue; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic. Concomitant products included LORAZEPAM (ATIVAN) for Sleep disorder, METOPROLOL, MONTELUKAST, SERTRALINE and ZOLPIDEM for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.  It was reported that the patient had aches, chills, fatigue, nausea, and a low grade fever.  Reported that patient was grateful that he received the Moderna Covid-19 vaccine.   This case was linked to MOD-2022-455495, MOD-2022-455496 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Mini seizures; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SEIZURE (Mini seizures) 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 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced SEIZURE (Mini seizures) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 11-Jan-2022 due to SEIZURE. At the time of the report, SEIZURE (Mini seizures) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided. on Saturday 08-JAN-2022 at 6 pm his wife had what he thought was a stork.  Company Comment: This spontaneous case concerns a female patient with unknown age with no medical history reported, who experienced , Serious ( Medically significant , Hospitalization ) , unexpected , AESI event of Seizure which occurred sometime January 2022 after vaccination with the 3rd dose of mRNA-1273 ( Moderna Covid 19 vaccine) . This patient was hospitalized because of the event and was discharged on the 11th of January , 4 day post vaccination with the 3rd dose of the vaccine. The re-challenge for this case is not applicable since the event occurred after the 3rd dose and no additional doses will be given and also the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with unknown age with no medical history reported, who experienced , Serious ( Medically significant , Hospitalization ) , unexpected , AESI event of Seizure which occurred sometime January 2022 after vaccination with the 3rd dose of mRNA-1273 ( Moderna Covid 19 vaccine) . This patient was hospitalized because of the event and was discharged on the 11th of January , 4 day post vaccination with the 3rd dose of the vaccine. The re-challenge for this case is not applicable since the event occurred after the 3rd dose and no additional doses will be given and also the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid-19 symptoms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (had Covid-19 symptoms). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (had Covid-19 symptoms) outcome was unknown. No concomitant medications were reported. Patient had Covid-19 symptoms after second dose which were mentioned as chills, upset stomach and diarrhea. Company Comment: This case concerns an 80-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid 19 Symptoms (mentioned as chills, upset stomach and diarrhea) unspecified days after receiving second dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-451541, MOD-2022-451531 (Patient Link). Sender's Comments: This case concerns an 80-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid-19 Symptoms (mentioned as chills, upset stomach and diarrhea) unspecified days after receiving second dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Headache, Tinnitus
Clinical narrative: hearing loss; tinnitus; severe headaches since my 2nd dose of the Moderna Covid-19 vaccine last April (April 2021)/ It feels like a vice fell on my head /My headaches are sharp; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease (Have been on thyroid medicine since  patient's daughter was born.) and Autoimmune disorder.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), TINNITUS (tinnitus) and HEADACHE (severe headaches since my 2nd dose of the Moderna Covid-19 vaccine last April (April 2021)/ It feels like a vice fell on my head /My headaches are sharp). At the time of the report, DEAFNESS (hearing loss), TINNITUS (tinnitus) and HEADACHE (severe headaches since my 2nd dose of the Moderna Covid-19 vaccine last April (April 2021)/ It feels like a vice fell on my head /My headaches are sharp) outcome was unknown.            No concomitant drug information provided. The patient was recommended to have hearing aid and was provided with IV medicines to treat the headaches.  The Neurologist told the patient to get medical marijuana.  The patient had been to the hospital for headaches. It felt like a vice fall on head.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with medical history of Hashimoto's disease and autoimmune disorder, who experienced serious unexpected event of Deafness, as well as non-serious events of Tinnitus and Headache in an unknown timeframe after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with medical history of Hashimoto's disease and autoimmune disorder, who experienced serious unexpected event of Deafness, as well as non-serious events of Tinnitus and Headache in an unknown timeframe after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed with COVID-19) 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 12-Jan-2022, the patient experienced COVID-19 (diagnosed with COVID-19). At the time of the report, COVID-19 (diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe with the unknown dose number of mRNA-1273 vaccine. The exact details regarding the vaccine administration were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe with the unknown dose number of mRNA-1273 vaccine. The exact details regarding the vaccine administration were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: paralyzed in one leg; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (paralyzed in one leg) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 MONOPLEGIA (paralyzed in one leg) (seriousness criterion medically significant). At the time of the report, MONOPLEGIA (paralyzed in one leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a  patient of an unknown age and gender, with unknown medical history, who experienced serious unexpected MONOPLEGIA. The event occurred in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). The rechallenge is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  patient of an unknown age and gender, with unknown medical history, who experienced serious unexpected MONOPLEGIA. The event occurred in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). The rechallenge is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Admitted for a fever of 102.4 degrees Farenheight; Myalgia; Shortness breath; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Admitted for a fever of 102.4 degrees Farenheight) and MYALGIA (Myalgia) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METRONIDAZOLE, CEFEPIME and VANCOMYCIN for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Admitted for a fever of 102.4 degrees Farenheight) (seriousness criterion hospitalization), MYALGIA (Myalgia) (seriousness criterion hospitalization) and DYSPNOEA (Shortness breath). The patient was hospitalized on 02-Mar-2021 due to MYALGIA and PYREXIA. At the time of the report, PYREXIA (Admitted for a fever of 102.4 degrees Farenheight), MYALGIA (Myalgia) and DYSPNOEA (Shortness breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: high (High) Fever of 104 degrees Fahrenheit temperature at home and admitted for a 102.4 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were given.  Patient did not had myocarditis or pericarditis. Cause of symptoms was not determined. Reporter mentioned that hospital lists a reason for admission that is different from the vaccine side effect. Company comment:This is case concerning a female patient of 64-year-old with no medical history, who experienced the unexpected serious events of Pyrexia and Myalgia (seriousness criterion Hospitalization) which occurred one day after patient received the second dose of mRNA-1273 and outcome was reported as unknown. Patient required hospitalization however, there is no medical assessment or treatment information provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is case concerning a female patient of 64-year-old with no medical history, who experienced the unexpected serious events of Pyrexia and Myalgia (seriousness criterion Hospitalization) which occurred one day after patient received the second dose of mRNA-1273 and outcome was reported as unknown. Patient required hospitalization however, there is no medical assessment or treatment information provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Had a heartattack  8weeks ago; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION (Had a heartattack  8weeks ago) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Had a heartattack  8weeks ago) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Had a heartattack  8weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had a heart attack 8weeks ago.  Patient got booster dose on 14 Jan 2022.  Treatment information was not provided.  Company comment:  This case concerns a patient with no medical history reported who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the 2nd dose of the mRNA-1273.  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient with no medical history reported who experienced serious unexpected AESI of myocardial infarction, that occurred unspecified time after the 2nd dose of the mRNA-1273.  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: friend had the booster and they also had the same thing (Bell's Palsy).; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (friend had the booster and they also had the same thing (Bell's Palsy).) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (friend had the booster and they also had the same thing (Bell's Palsy).) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (friend had the booster and they also had the same thing (Bell's Palsy).) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.  Company Comment - This regulatory authority case concerns a patient of unknown age and gender with no relevant medical history, who experienced the serious expected event of Bell's Palsy. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-456142 (Patient Link).; Sender's Comments: This regulatory authority case concerns a patient of unknown age and gender with no relevant medical history, who experienced the serious expected event of Bell's Palsy. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 symptoms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 symptoms). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.  Company Comment : This case concerns an 82-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid 19 Symptoms unspecified days after receiving first dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-451540, MOD-2022-451531 (Patient Link).; Sender's Comments: This case concerns an 82-year old female patient with no medical history, who experienced the unexpected non serious AESI event of Covid 19 Symptoms unspecified days after receiving first dose of mRNA-1273 Vaccine. Elderly age of the patient and current pandemic can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.