chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I got the shot and still got it real bad; still got it real bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shot and still got shingles really bad. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, now following up to get second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 provided as follows: The case was reported by registered pharmacist. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. On the day of reporting, the patient was following up to get the 2nd dose. However, it could not be confirmed if the patient received the second dose or not. The patient was present at the pharmacy. The reporter called for medical guidance concerning restarting the series or not and it was suggested that it was not necessary to restart, but that she should get the second dose as soon as possible.  Then, the call was transferred to Medical Information for further education for the reporter, as he was not completely comfortable with the suggested response. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose on 17Jan2022 that had expired 01Jan2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number 95SN2, expiry date 1st January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 17th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered a dose of Engerix-B on 17th January 2022 that had expired 1st January 2022, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had her shingrix shots about 16 months apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had her shingrix shots about 16 months apart, which led to lengthening of vaccination schedule. Her doctor wanted her to do another series of the two doses so they are the 2 and 6 months. Chat got disconnected and no information other than this phrase was gathered. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: returned 16 months after initial dose to complete series; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th December 2019).   On 11th March 2021, the patient received the 2nd dose of Shingrix. On 11th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix, however did not return within recommended time frame to complete the series. The patient returned 16 months after initial Shingrix dose to complete the series, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Autopsy, Death, Seizure, Unevaluable event, Weight decreased
Clinical narrative: several heath issues; weight loss; passed away from seizure; This case was reported by a nurse via sales rep and described the occurrence of seizure in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria death and GSK medically significant). On an unknown date, the patient experienced unevaluable event and weight loss. On an unknown date, the outcome of the seizure was fatal and the outcome of the unevaluable event and weight loss were unknown. The patient died in January 2022. The reported cause of death was seizure. An autopsy was performed.   It was unknown if the reporter considered the seizure, unevaluable event and weight loss to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient (high schools senior) received Bexsero.  The patient passed away from seizure over this weekend (date unknown). The patient had Men B vaccine (Bexsero) doctor said it stood out to her as the autopsy report on 18th January 2022, showed vaccine was in the system. The reporter did not know what caused the issue and might not be the cause of death, but patient had several heath issues past year and severe weight loss.  The reporter mentioned that the health care professional would call back tomorrow with more details as she was in a rush. Consent was not provided at this time by health care professional. Consent to follow up with GlaxoSmithKline sales representative was acquired. The reporter did not consent to follow-up. No other information was available.; Reported Cause(s) of Death: Seizure (vaccine was in the system)
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 1/8/2020, second dose on 8/26/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2020).   On 26th August 2021, the patient received the 2nd dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, an unknown patient received shingrix vaccine doses later than the recommended interval, which led to lengthening of vaccination schedule. The reporter dd not consent to follow-up. The reporter did not want to provide any of the patient information.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MILD SIDE EFFECTS THAT WERE ECLECTIC; This spontaneous report received from a patient via Social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose, 1 total, 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 mild side effects that were eclectic. (Dose number in series:1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series:2) (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The patient did not experienced any adverse event following the covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects that were eclectic was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Liver disorder, Renal disorder, Skin plaque
Clinical narrative: This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received ustekinumab (solution for infusion, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-APR-2021 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 drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced kidney disorder, liver disorder, and skin plaque. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ustekinumab, and adalimumab was withdrawn. The patient had not recovered from kidney disorder, liver disorder, and skin plaque. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 74.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, 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 via a company representative concerned a 74-year-old of unspecified sex of unknown race and ethnicity. Initial information was processed along with the additional information received on 18-JAN-2022. The patient's height and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number:1808980, expiry: unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The patient received non-company suspect vaccine included: mrna 1273(Dose number in series 2) (form of admin, route of admin, and batch number: unknown, expiry: unknown)1 total, dose was not reported, administered on DEC-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 29-DEC-2021, the patient had covid symptoms and started feeling better. By 01-JAN-2022 was not feeling so great but not terrible, so the patient took the rapid test twice which both resulted positive (experienced suspected covid-19 infection, and suspected clinical vaccination failure) (Dose number in series 2)(Dose number in series 1), and the doctor started giving paxlovid (antiviral) which the reporter took for three days had some side effects that were not extreme like nausea. Overall was not feeling good. The patient also experienced suspected covid-19 infection, and suspected clinical vaccination failure. (Dose number in series 2)(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s 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 is related with product quality complaint: 90000211927.; Sender's Comments: V0: 20220123706-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: 74.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Illness, Malaise, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 74-year-old of unspecified sex of unknown race and ethnicity. Initial information was processed along with the additional information received on 18-JAN-2022. The patient's height and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number:1808980, expiry: unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The patient received non-company suspect vaccine included: mrna 1273(Dose number in series 2) (form of admin, route of admin, and batch number: unknown, expiry: unknown)1 total, dose was not reported, administered on DEC-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 29-DEC-2021, the patient had covid symptoms and started feeling better. By 01-JAN-2022 was not feeling so great but not terrible, so the patient took the rapid test twice which both resulted positive (experienced suspected covid-19 infection, and suspected clinical vaccination failure) (Dose number in series 2)(Dose number in series 1), and the doctor started giving paxlovid (antiviral) which the reporter took for three days had some side effects that were not extreme like nausea. Overall was not feeling good. The patient also experienced suspected covid-19 infection, and suspected clinical vaccination failure. (Dose number in series 2)(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s 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 is related with product quality complaint: 90000211927.; Sender's Comments: V0: 20220123706-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: 54.0
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 55 year old Hispanic or Latino female. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, and batch number: 1808980, expiry: Unknown) dose was not reported, 1 total administered to right arm on 06-MAY-2021 for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 05-NOV-2021 for prophylactic vaccination. The patient used to take medicine for allergy. On 13-JAN-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sore throat, runny nose, headache, loss of taste and felt it may be due to covid (coded as suspected covid-19 infection, suspected clinical vaccination failure) (Dose number in series 2). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) not reported, was awaiting results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220123821 (dose number in series 1). This case is associated with product quality complaint: 90000211932.; Sender's Comments: V0-20220124204- 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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age of unspecified race and ethnicity. Initial information was processed along with the additional information received on 14-JAN-2022. 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, (Dose number in series was 1) administered 1 in total to the left arm on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) positive. On 31-DEC-2021, the patient experienced his first symptom. On 04-JAN-2022, the patient had PCR test and on 08-JAN-2022 the results came for PCR test as positive which was a confirmed clinical vaccination failure, and confirmed covid-19 infection, patient denied receiving any booster dose. On 14-JAN-2022 patient only has little cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211920.regulatory authority; Sender's Comments: V0:20220126030-covid-19 vaccine ad26.cov2.s-Confirmed 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: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, dose number in series was 1, 01 in total was administered on FEB-2021 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 31-DEC-2021, the patient contracted coronavirus disease (COVID-19) (suspected COVID-19 infection) breakthrough infection roughly 2 weeks ago (end of December beginning of January) which resulted in suspected clinical vaccination failure (dose number in series was 1). 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). The case was associated with regulatory authority.; Sender's Comments: V0 20220126472-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: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 58 year old female with not ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: non-smoker and non alcoholic. The patient has no known allergies. The patient does not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number:1805020 and expiry: unknown) 1 total, dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination (Dose number in series 1).  No concomitant medications were reported.  The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1855190 and expiry: unknown) 1 total, dose was not reported, administered at left arm on 12-JAN-2022 for prophylactic vaccination (Dose number in series 2).  On 15-JAN-2022, the patient tested positive for Covid-19 using home rapid test (Dose number in series 1). The patient has not sought medical treatment.   The patient had not recovered from covid-19 test positive. This report was non-serious. This report was associated with a product quality complaint: 90000211983.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-NOV-2021, the patient underwent COVID-19 virus test (NR: not provided) Positive (confirmed clinical vaccination failure, and confirmed covid-19 infection). On 21-NOV-2021 (Day 7), patient's lungs were inflamed, irritated, and easily winded. The patient reported that, "Tested positive for Covid on 14-NOV-2021 despite getting the J and J shot in April. It whooped my butt. I ended up getting monoclonal antibody treatment which made a huge difference in my recovery. We were learning the J and J shot isn't as effective as Jensen is painting it to be. By day 7 my lungs felt inflamed, irritated, and was easily winded. I made an appointment with a treatment center. I was afraid it would progress and did not want to end up in the hospital. Thankfully I was still within that 10 days window.'' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211988.; Sender's Comments: V0:20220127908-covid-19 vaccine ad26.cov2.s-Confirmed 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 20220127908-covid-19 vaccine ad26.cov2.s-Confirmed Covid -19 infection.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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Injection site pain, Insomnia, Oxygen saturation
Clinical narrative: BLURRY VISION (ALARMED HIM); VERY BAD INSOMNIA; INJECTION SITE ARM PAIN; OXYGEN SATURATION AT 88; HEART RATE OF 105; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: penicillin allergy, and allergic to sulfa and other pre-existing medical conditions included: The patient had known medical conditions and no previous medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 14-JAN-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-JAN-2022, post receiving vaccine the patient experienced arm pain in the injection site arm. On 16-JAN-2022, patient blurry vision which alarmed the patient. Patient was not sure whether to contact a physician or go to work. On 16-JAN-2022, patient experienced the very bad insomnia and was not slept at all. In JAN-2022, the patient checked the oxygen saturation and heart rate. Oxygen saturation was at 88 and heart rate was 105.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site arm pain, blurry vision (alarmed him), very bad insomnia, heart rate of 105 and oxygen saturation at 88 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220128712-COVID-19 VACCINE AD26.COV2.S- oxygen saturation at 88. 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Vision blurred
Clinical narrative: BLURRY VISION (ALARMED HIM); VERY BAD INSOMNIA; INJECTION SITE ARM PAIN; OXYGEN SATURATION AT 88; HEART RATE OF 105; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: penicillin allergy, and allergic to sulfa and other pre-existing medical conditions included: The patient had known medical conditions and no previous medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 14-JAN-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-JAN-2022, post receiving vaccine the patient experienced arm pain in the injection site arm. On 16-JAN-2022, patient blurry vision which alarmed the patient. Patient was not sure whether to contact a physician or go to work. On 16-JAN-2022, patient experienced the very bad insomnia and was not slept at all. In JAN-2022, the patient checked the oxygen saturation and heart rate. Oxygen saturation was at 88 and heart rate was 105.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site arm pain, blurry vision (alarmed him), very bad insomnia, heart rate of 105 and oxygen saturation at 88 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220128712-COVID-19 VACCINE AD26.COV2.S- oxygen saturation at 88. 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old male. Initial information was processed with the additional information received on 18-JAN-2022. 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient had suspected clinical vaccination failure and suspected covid-19 infection (symptoms of sore throat, stuffy nose, headache and body ache). Laboratory data included: COVID-19 rapid test (NR: not provided) was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000212145.; Sender's Comments: V0-20220130118-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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Impaired work ability, Insomnia
Clinical narrative: COUGHING; BODY ACHES; DID NOT SLEEP WELL; SORE SCARTCHY THROAT; DID NOT DO INTO WORK; THROUGH THE NIGHT FEVER SPIKED VERY HIGH; FEELS VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer survivor, and latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205a21a, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced coughing, body aches, did not sleep well, sore scartchy throat, did not do into work, through the night fever spiked very high, and feels very tired. Laboratory data included: Body temperature (NR: not provided) very high. On 18-JAN-2022, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from did not sleep well, through the night fever spiked very high, coughing, body aches, sore scartchy throat, and feels very tired, and the outcome of did not do into work was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: COUGHING; BODY ACHES; DID NOT SLEEP WELL; SORE SCARTCHY THROAT; DID NOT DO INTO WORK; THROUGH THE NIGHT FEVER SPIKED VERY HIGH; FEELS VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer survivor, and latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205a21a, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced coughing, body aches, did not sleep well, sore scartchy throat, did not do into work, through the night fever spiked very high, and feels very tired. Laboratory data included: Body temperature (NR: not provided) very high. On 18-JAN-2022, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from did not sleep well, through the night fever spiked very high, coughing, body aches, sore scartchy throat, and feels very tired, and the outcome of did not do into work was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dry throat, Fatigue, Gait disturbance
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 21 year old male. The patient's weight was not reported and height was 69 inches. The patient's concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced felt like could not walk, where muscles would not be able to hold up, sweating profusely, difficulty speaking, throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, body shaking, muscle weakness, severe chills, headache, fever of 102.5, felt tired/exhaustion, and pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 102.5. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, headache, felt tired/exhaustion, and pain at injection site (left arm) on JUL-2021, body shaking, muscle weakness, and severe chills on 16-JUL-2021, and fever of 102.5, and the outcome of felt like could not walk, where muscles would not be able to hold up, sweating profusely and difficulty speaking was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Muscular weakness, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 21 year old male. The patient's weight was not reported and height was 69 inches. The patient's concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced felt like could not walk, where muscles would not be able to hold up, sweating profusely, difficulty speaking, throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, body shaking, muscle weakness, severe chills, headache, fever of 102.5, felt tired/exhaustion, and pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 102.5. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, headache, felt tired/exhaustion, and pain at injection site (left arm) on JUL-2021, body shaking, muscle weakness, and severe chills on 16-JUL-2021, and fever of 102.5, and the outcome of felt like could not walk, where muscles would not be able to hold up, sweating profusely and difficulty speaking was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Tremor, Vaccination site pain
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 21 year old male. The patient's weight was not reported and height was 69 inches. The patient's concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient experienced felt like could not walk, where muscles would not be able to hold up, sweating profusely, difficulty speaking, throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, body shaking, muscle weakness, severe chills, headache, fever of 102.5, felt tired/exhaustion, and pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 102.5. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat was incredibly dry, severe body pain radiating from the injection site on left arm down left side the right side had pulsating pain that originated from left/body aches, headache, felt tired/exhaustion, and pain at injection site (left arm) on JUL-2021, body shaking, muscle weakness, and severe chills on 16-JUL-2021, and fever of 102.5, and the outcome of felt like could not walk, where muscles would not be able to hold up, sweating profusely and difficulty speaking was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 250 pounds, and height was 68 inches. 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: 1805031) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, involving the same patient is linked to 20211265893.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: MILD COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included: surgery. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced mild covid-19 infection. On NOV-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000212541.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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 not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220136393.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FEELS LIKE GETTING STUNG BY A SCORPION; 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 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 feels like getting stung by a scorpion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels like getting stung by a scorpion was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: VERY SWOLLEN GLANDS UNDER CHIN (SIZE OF HALF TENNIS BALL); This spontaneous report received from a parent 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very swollen glands under chin (size of half tennis ball). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very swollen glands under chin (size of half tennis ball). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised recieved a dose of 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised recieved a dose of 0.25 ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised recieved a dose of 0.25 ml). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised recieved a dose of 0.25 ml) 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.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: patients following 6 months after receiving the vaccine "don't have antibodies"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (patients following 6 months after receiving the vaccine "don't have antibodies") 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 DRUG INEFFECTIVE (patients following 6 months after receiving the vaccine "don't have antibodies"). At the time of the report, DRUG INEFFECTIVE (patients following 6 months after receiving the vaccine "don't have antibodies") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported.  Treatment information was not reported.