chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: forgot to get my 2 year old the second dose of Bexsero/ 1st dose received by patient; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-year-old 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 the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 reporter was the patient's parent. The age at vaccination was not reported. The patient received 1st dose of Bexsero before recommended age, which led to inappropriate age at vaccine administration. The reporter stated that he/she forgot to get 2-year-old patient the 2nd dose of Bexsero. The reporter asked, should start again with 2 doses. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Wrong product administered
Clinical narrative: Hep A and Hep B for dose two of the series; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Twinrix.   On an unknown date, the patient received Hepatitis A vaccine and Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Twinrix for dose one and monovalent Hepatitis A and monovalent Hepatitis B for dose two of the series, which led to wrong vaccine administered. The health care professional did not have patient demographics, lot numbers and expiration dates. Discrepancy- Twinrix coded as historical vaccine though reported as suspect on source document because the patient received latest suspect vaccine as Hepatitis A and Hepatitis B which was considered event as wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose was on may 27 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th May 2021).   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 age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported  The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death, SARS-CoV-2 test
Clinical narrative: DEATH; This spontaneous report received from a health care professional concerned a 63-year-old female with an unspecified race and ethnic origin. The patient's height, and weight were not reported. On 30-DEC-2021, the patient was admitted to facility with COVID 19 unvaccinated status for nursing care due to her concurrent conditions which included epilepsy, atrial fibrillation, chronic obstructive pulmonary disease (COPD), iron deficiency anemia, cardiomyopathy, severe protein calorie malnutrition with adult failure to thrive, diabetes mellitus (DM) type II, constipation, contractures to both knees, peripheral vascular disease (PVD) with multiple venous stasis ulcers, neuromuscular bladder, postural kyphosis, hyperlipidemia, hypertension (HTN), gastroesophageal reflux disease (GERD), major depressive disorder, vitamin D Deficiency, history of brain cancer, and vascular dementia. She underwent pacemaker placement, gastrostomy tube (GT) placement for nutritional needs/medication administration and had history of clostridium difficile. On unspecified dates, the outbreak COVID 19 testing were performed which revealed negative tests on patient throughout course of stay.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A and expiry: 11-APR-2022) 0.5 ml, 01 in total was administered on 12-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. It was reported that her vital signs remained stable with her being afebrile throughout the process. Following vaccination with covid-19 vaccine ad26.cov2.s, on 13-JAN-2022 at approximately 10:20 hours, certified nursing assistants (CNAs) reported to Licensed practical nurse (LPA) that the patient was unresponsive and upon assessment, she was pronounced dead at 10:20 hours. It was unknown, if an autopsy was performed or not. On 13-JAN-2022 at 10:20 hours, the patient died from unknown cause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220124384-covid-19 vaccine ad26.cov2.s- death. 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
Age: 46.0
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 46 year old white male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on 25-MAR-2021 into right arm for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-DEC-2021 into right arm for prophylactic vaccination. No concomitant medications were reported.  On 20-JAN-2022, the patient tested positive for COVID-19 with rapid at home kit test, earlier he tested negative with a home kit test and later in the day around 15:00 he tested again and tested positive. Hence coded suspected clinical vaccination failure, and suspected covid-19 infection. The patient had slight cough and a headache (Subsumed under suspected covid-19 infection) that had been resolved on same day (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient 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 report was associated with product quality complaint.; Sender's Comments: V0:20220139590-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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER BEING STORED IN FREEZER; VACCINE PLACED IN FREEZER UPON RECEIPT ABOUT 1 WEEK LATER; This spontaneous report received from a health care professional concerned a 4 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine administered after being stored in freezer, and vaccine placed in freezer upon receipt about 1 week later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after being stored in freezer and vaccine placed in freezer upon receipt about 1 week later was not reported. This report was non-serious. This case, from the same reporter is linked to 20220146230.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Vaccination site discharge
Clinical narrative: Patient got a wet spot right below on the injection site; dizziness; Nausea; Patient fainted for a moment; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Patient fainted for a moment) in a 29-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.     No Medical History information was reported.    On 20-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced SYNCOPE (Patient fainted for a moment) (seriousness criterion medically significant), DIZZINESS (dizziness) and NAUSEA (Nausea). On 21-Jan-2022, the patient experienced VACCINATION SITE DISCHARGE (Patient got a wet spot right below on the injection site). At the time of the report, SYNCOPE (Patient fainted for a moment), VACCINATION SITE DISCHARGE (Patient got a wet spot right below on the injection site), DIZZINESS (dizziness) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication included Soloist, Description anti depressant. No treatment information was provided.  This is a spontaneous case concerning a 29-year-old, female patient with history  medical history treatment with soloist, who experienced the unexpected serious (hospitalization) event of fainting and no-serious events of Patient got a wet spot right below on the injection site, dizziness, nausea. The events started on unknown date on the same month of administration of a dose of mRNA-1273 vaccine. Past medical history of Soloist could be a confounder. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This is a spontaneous case concerning a 29-year-old, female patient with history  medical history treatment with soloist, who experienced the unexpected serious (hospitalization) event of fainting and no-serious events of Patient got a wet spot right below on the injection site, dizziness, nausea. The events started on unknown date on the same month of administration of a dose of mRNA-1273 vaccine. Past medical history of Soloist could be a confounder. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     The patient's past medical history included Migraine (Stress migraines).    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE PAIN (minor soreness in arm) and HEADACHE (mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a runner and was naïve to medications. Patient states he has no allergies, medical history, except stress migraines. Treatment product was not provided by the reporter.  Company Comment The events were downgraded to non serious due to being related to the first dose of the vaccine.   This case was linked to MOD-2021-388577 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Significant follow up. Reporter details was updated, patient history updated and lot/batch number was added. Sender's Comments: The events were downgraded to non serious due to being related to the first dose of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Lose sense of smell after booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (Lose sense of smell after booster) 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 ANOSMIA (Lose sense of smell after booster). At the time of the report, ANOSMIA (Lose sense of smell after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest - Anosmia (reported as lose sense of smell). The event occurred after the patient had received the booster dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown and no additional details regarding the clinical course of the events was provided. The rechallenge is not applicable as the event occurred following booster dose. 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 no medical history provided, who experienced non-serious unexpected event of special interest - Anosmia (reported as lose sense of smell). The event occurred after the patient had received the booster dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown and no additional details regarding the clinical course of the events was provided. The rechallenge is not applicable as the event occurred following booster dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients received vaccine from vial that had been left out at room temperature and was punctured on 14 DEC 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial that had been left out at room temperature and was punctured on 14 DEC 2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial that had been left out at room temperature and was punctured on 14 DEC 2021). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial that had been left out at room temperature and was punctured on 14 DEC 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported. Patient weight was 258 with unknown units. No other adverse reactions were reported.   This case was linked to MOD-2022-459158, MOD-2022-459165 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. It was reported that the patient continued to work around people who were turning up sick, and tested negative twice in 2021. The patient tested positive on Jan-2022, because of a major uptake among the employees, and 3.5 Days later, was improving without medical intervention.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 9 months after an unknown dose of mRNA-1273 vaccine administered on an unknown date in Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on two unknown dates in 2021 was negative and that done on an unknown date in Jan-22 was positive. At the time of report outcome of the event was Resolving. Further details about the event are not provided. 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 relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 9 months after an unknown dose of mRNA-1273 vaccine administered on an unknown date in Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on two unknown dates in 2021 was negative and that done on an unknown date in Jan-22 was positive. At the time of report outcome of the event was Resolving. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site warmth
Clinical narrative: and hot to the  touch; light rash all over that was itchy; Large red blotch around injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (light rash all over that was itchy), VACCINATION SITE WARMTH (and hot to the  touch) and VACCINATION SITE ERYTHEMA (Large red blotch around injection site) 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. In January 2022, the patient experienced RASH PRURITIC (light rash all over that was itchy). On an unknown date, the patient experienced VACCINATION SITE WARMTH (and hot to the  touch) and VACCINATION SITE ERYTHEMA (Large red blotch around injection site). In January 2022, RASH PRURITIC (light rash all over that was itchy) had resolved. At the time of the report, VACCINATION SITE WARMTH (and hot to the  touch) outcome was unknown and VACCINATION SITE ERYTHEMA (Large red blotch around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No Treatment medication was reported.  The case was considered to be invalid as there was no identifiable reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after being vaccinated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Tested positive for COVID after being vaccinated). At the time of the report, COVID-19 (Tested positive for COVID after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not provided. Treatment information was not provided.  Patient stated that he was tested positive after his daughter was exposed at school.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Jan-22, an unknown duration after the second dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. SARS-CoV-2 test done on an unknown date in Jan-22 was positive. At the time of report outcome of the events was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Jan-22, an unknown duration after the second dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. SARS-CoV-2 test done on an unknown date in Jan-22 was positive. At the time of report outcome of the events was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation, expiry date was unknown)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu shot and then I got the flu; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who reported i got the flu shot and then i got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization. In the context of COVID-19 crisis, the batch no and expiration date were not requested.  On an unknown date the patient developed a non-serious event "I got the flu shot and then i got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Flu Shot 30 years ago I got the flu shot and then I got the flu. My husband wanted me to get my money back. If it works for you, go for it. As for me, I'll pass".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu shot and then I got the flu).  At time of reporting, the outcome was Unknown for the event i got the flu shot and then i got the flu.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, COVID-19, Epstein-Barr virus test negative, Genital blister, Genital pain
Clinical narrative: I got what appeared to be my first ever herpetic outbreak in my genitals. I?ve never in my life had herpes. I got the Moderna vaccine on 4/30 and the rash appeared on my labor on 5/2, so 2 days later. I had no reason to believe it was an STD because I?ve been monogamous for 20 years and never had it before so I went to the ER. The rash started out as little blood blisters that grew in size, scabbed over, fell off, became ulcerated, then eventually healed. It was a little itchy at first when the scabs were forming. The ulcers were extremely painful. It all lasted about a week.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Genital rash, Genital ulceration, Herpes simplex test negative, Scab, Varicella virus test negative
Clinical narrative: I got what appeared to be my first ever herpetic outbreak in my genitals. I?ve never in my life had herpes. I got the Moderna vaccine on 4/30 and the rash appeared on my labor on 5/2, so 2 days later. I had no reason to believe it was an STD because I?ve been monogamous for 20 years and never had it before so I went to the ER. The rash started out as little blood blisters that grew in size, scabbed over, fell off, became ulcerated, then eventually healed. It was a little itchy at first when the scabs were forming. The ulcers were extremely painful. It all lasted about a week.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Pharmacist monitored patient. Patient was give orange juice after experincing small seizure and vomiting twice. Color came back into skin shortly after. Patient came to pharmacy day after to report incident.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tremor, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Pharmacist monitored patient. Patient was give orange juice after experincing small seizure and vomiting twice. Color came back into skin shortly after. Patient came to pharmacy day after to report incident.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Additional Details: Patient was anxious prior to vaccination/hyperventilating. Allowed 5-10 minutes for her to calm herself.  Injection given left arm. Patient allowed to sit in chair with RN and mother for several minutes-drank water. She stated she felt dizzy and wanted to go out to the waiting area. Mother assisted her to chair in waiting area. Patient unable to stand/syncopal episode. Patient alert after incident, and transferred to chair. VS: BP: 98/56, O2 sat: 99% and HR: 60. Gave patient a sugary drink. Approximately 5 minutes later repeat B/P: 124/64.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt didnt need any epinephrine . she was responsive within couple of minutes and then parametics took over and took her to hospital
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Malaise, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Unable to Sleep-Severe, Additional Details: PATIENT STATED SYMPTOMS STARTED LATER THAT DAY OF THE VACCINATION. SYMPTOMS INCLUDED "NOT FEELING WELL, TINGLING SENSATION AND TOSSING AND TURNING WHEN TRYING TO SLEEP". PT ALSO COMPLAINED OF A SORE ARM BUT IT WAS GETTING BETTER. PT ON 01/26 COMPLAINED OF BODY ACHES WHICH SHE DID NOT PREVIOUSLY MENTION.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Unable to Sleep-Severe, Additional Details: PATIENT STATED SYMPTOMS STARTED LATER THAT DAY OF THE VACCINATION. SYMPTOMS INCLUDED "NOT FEELING WELL, TINGLING SENSATION AND TOSSING AND TURNING WHEN TRYING TO SLEEP". PT ALSO COMPLAINED OF A SORE ARM BUT IT WAS GETTING BETTER. PT ON 01/26 COMPLAINED OF BODY ACHES WHICH SHE DID NOT PREVIOUSLY MENTION.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out about 7 min after getting both COVID and flu shot. He stated after passing out that he was anxious/nervous about getting the COVID vaccine/side effects. He was checked out by paramedics. He called his roommate to pick him up. He was feeling normal, apologetic, and appreciative of the time and care I provided to him.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Systemic: Nausea-Medium
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, COVID-19, Chest discomfort, Electrocardiogram
Clinical narrative: Patient is fully vaccinated. Patient is COVID + at ED visit on 12/30/2021. 49-year-old female presents to the ED due to substernal chest pain/abdominal burning sensation that radiates to the back as well as left shoulder spasms ongoing for the past 2 days but worsened today and became unbearable so came to ED for pain relief and further workup. Patient denies any fever, chills, nausea, vomiting, shortness of breath, diarrhea, constipation, urinary symptoms. BP 135/82  | Pulse 73  | Temp 98 °F (36.7 °C) | Resp 13  | Ht 157.5 cm (5' 2")  | Wt 77.1 kg (170 lb)  | SpO2 97%  | BMI 31.09 kg/m² CXR: No evidence of an acute process. Normal EKG. Treatment: fluid, toradol, decadron.  Discharged from ED stable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Patient is fully vaccinated. Patient is COVID + at ED visit on 12/30/2021. 49-year-old female presents to the ED due to substernal chest pain/abdominal burning sensation that radiates to the back as well as left shoulder spasms ongoing for the past 2 days but worsened today and became unbearable so came to ED for pain relief and further workup. Patient denies any fever, chills, nausea, vomiting, shortness of breath, diarrhea, constipation, urinary symptoms. BP 135/82  | Pulse 73  | Temp 98 °F (36.7 °C) | Resp 13  | Ht 157.5 cm (5' 2")  | Wt 77.1 kg (170 lb)  | SpO2 97%  | BMI 31.09 kg/m² CXR: No evidence of an acute process. Normal EKG. Treatment: fluid, toradol, decadron.  Discharged from ED stable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore weak thumb joints with a popping sensation (this also occured after initial vaccine doses). Swollen sore armpit (lymp nodes?) only on left side side of vaccination (this was a new symptom with just this booster dose).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscle rigidity, Nausea, Seizure, Syncope
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: patient had 3 episodes. 1st: she had severe nausea that morning.2nd : nausea then vomited. 3rd. same say couple hours later, she fainted, unconscious and turned rigid. as she woke up she vomited. f/u with md awaits results
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: patient had 3 episodes. 1st: she had severe nausea that morning.2nd : nausea then vomited. 3rd. same say couple hours later, she fainted, unconscious and turned rigid. as she woke up she vomited. f/u with md awaits results
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Hypertension, Vertigo
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: high blood pressure, glucose and dizziness/vertigo
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness, Ear, nose and throat examination abnormal, Tinnitus
Clinical narrative: Received initial dose of Moderna on 1/29/21 (LOT # 039K20A) and second dose on 2/26/21 (LOT 3 028L20A).  Noticed  ringing in ears (Tinitus) sometime in March.  Went to an audiologist in June and another in August for this because I thought is was odd because of the sudden onset of symptoms, literally overnight.  Both times I was told it's just hearing loss.  Received my booster on  12/29/21 and on 1/14/22 I noticed a significant increase in the ringing in my ears. Only then did I notice the sudden onset of symptoms are approximately 2 weeks after receiving the vaccine.   Now it's very, very  bad.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest X-ray normal, Deafness, Dizziness
Clinical narrative: Patient is fully vaccinate.  COVID + on 12/29/2021 at ED visit. Chief compaint, dizziness. Had bodyaches, ST yesterday. Associated symptoms: hearing loss (resolved), nausea, shortness of breath, syncope, vision changes and weakness, sore throat. BP 119/70  | Pulse 82  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 17  | Ht 154.9 cm (5' 1")  | Wt 65.8 kg (145 lb)  | SpO2 99%  | BMI 27.40 kg/m²   Labd negative.  CXR neg.  DC home
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Laboratory test normal, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Patient is fully vaccinate.  COVID + on 12/29/2021 at ED visit. Chief compaint, dizziness. Had bodyaches, ST yesterday. Associated symptoms: hearing loss (resolved), nausea, shortness of breath, syncope, vision changes and weakness, sore throat. BP 119/70  | Pulse 82  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 17  | Ht 154.9 cm (5' 1")  | Wt 65.8 kg (145 lb)  | SpO2 99%  | BMI 27.40 kg/m²   Labd negative.  CXR neg.  DC home
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: Patient is fully vaccinate.  COVID + on 12/29/2021 at ED visit. Chief compaint, dizziness. Had bodyaches, ST yesterday. Associated symptoms: hearing loss (resolved), nausea, shortness of breath, syncope, vision changes and weakness, sore throat. BP 119/70  | Pulse 82  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 17  | Ht 154.9 cm (5' 1")  | Wt 65.8 kg (145 lb)  | SpO2 99%  | BMI 27.40 kg/m²   Labd negative.  CXR neg.  DC home
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Pain
Clinical narrative: Patient is fully vaccinated.  COVID + on 12/30/2021 at ED visit. 27-year-old male with history of asthma presents to ED due to possible covid concern. Patient states that his coworker who has close contact with tested positive for covid 19 2 days ago. Patient states was asymptomatic then but patient now having cough, fever, chills, body aches, fatigue and wants to be tested for COVID 19. He denies any lightheadedness, dizziness, nausea, vomiting, shortness of breath, chest pain, abdominal pain, diarrhea or constipation, urinary symptoms.BP 163/72  | Pulse 94  | Temp 98.1 °F (36.7 °C) (Oral)  | Resp 17  | Wt 104 kg (230 lb)  | SpO2 96%  | BMI 31.19 kg/m² CXR: no acute process. Patient given Decadron, Robitussin-AC, Toradol and Robaxin for pain control and pelvic control.given information for monoclonal antibody clinic.  Discharged.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient is fully vaccinated.  COVID + on 12/30/2021 at ED visit. 27-year-old male with history of asthma presents to ED due to possible covid concern. Patient states that his coworker who has close contact with tested positive for covid 19 2 days ago. Patient states was asymptomatic then but patient now having cough, fever, chills, body aches, fatigue and wants to be tested for COVID 19. He denies any lightheadedness, dizziness, nausea, vomiting, shortness of breath, chest pain, abdominal pain, diarrhea or constipation, urinary symptoms.BP 163/72  | Pulse 94  | Temp 98.1 °F (36.7 °C) (Oral)  | Resp 17  | Wt 104 kg (230 lb)  | SpO2 96%  | BMI 31.19 kg/m² CXR: no acute process. Patient given Decadron, Robitussin-AC, Toradol and Robaxin for pain control and pelvic control.given information for monoclonal antibody clinic.  Discharged.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Anticoagulant therapy, Bradycardia, COVID-19, Dyspnoea at rest
Clinical narrative: Patient is fully vaccinated. COVID + 12/29/2021 on admission to hospital. DX shortness of breath, COVID. States she has been feeling more short of breath at rest and with exertion over the last couple of days. She was diagnosed with COVID-19 on 11/17/21 and was hospitalized 11/22-12/8/2021, during which time she was treated with Decadron and baricitinib but did not tolerate remdesivir due to bradycardia.In the ED, vital signs were stable. She remains on 3L O2 NC saturating well 94-99%. CTA chest was negative for PE. Labs were largely unremarkable. Patient placed on steroids and ab with improved symptoms.  Discharged in stable condition. (D-dimer 1094) Lovenox
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fibrin D dimer increased, Laboratory test normal, SARS-CoV-2 test positive
Clinical narrative: Patient is fully vaccinated. COVID + 12/29/2021 on admission to hospital. DX shortness of breath, COVID. States she has been feeling more short of breath at rest and with exertion over the last couple of days. She was diagnosed with COVID-19 on 11/17/21 and was hospitalized 11/22-12/8/2021, during which time she was treated with Decadron and baricitinib but did not tolerate remdesivir due to bradycardia.In the ED, vital signs were stable. She remains on 3L O2 NC saturating well 94-99%. CTA chest was negative for PE. Labs were largely unremarkable. Patient placed on steroids and ab with improved symptoms.  Discharged in stable condition. (D-dimer 1094) Lovenox
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased
Clinical narrative: Patient developed temperature of 103 degrees 3 days after vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient began experiencing bilateral tinnitus about 16 hours after vaccine; Bil ear ringing has been constant and unchanged.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment
Clinical narrative: On Sept 9, 2021 after the first vaccination about 7 minutes after the shot I got a bad pain on the left side of my head from my eye to the top of my head. The second dose was on Oct 5, 2021 & I have had issue still today with brain fog & forgetfulness, I am suffering
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Confusional state, Loss of consciousness
Clinical narrative: Patient had a loss consciousness for some few seconds and after regain of consciousness he was confused. Follow up to ED reports Non hemorrhagic CVA.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy soft tissue, Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: moderna vaccine November  Pt developed severe itching and pain at injections site immediately following injection  Pt noted edema and tissue growth with central recurrent bleeding at the injection site after injection this progressed until seen on 1/10/22 at which time it was evident that the pt had need for tissue resection and biopsy.  biopsy positive for proliferation of squamous cells consistent with SCC
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm skin, Oedema, Squamous cell carcinoma
Clinical narrative: moderna vaccine November  Pt developed severe itching and pain at injections site immediately following injection  Pt noted edema and tissue growth with central recurrent bleeding at the injection site after injection this progressed until seen on 1/10/22 at which time it was evident that the pt had need for tissue resection and biopsy.  biopsy positive for proliferation of squamous cells consistent with SCC
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: patient was passed out for 10-20 seconds. after regained conscious, some water was given and then patient started vomiting. We decided to call EMS at that moment. EMT checked BP, oxygen level, and HR and everything was normal, after 20-30 minutes mother took her home. Mother said she will take her to PCP.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Dyspnoea, Musculoskeletal pain, Oxygen saturation decreased
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/04/2021.  74 y/o PMHx of sacral ducubitus ulcer, HTN, CHF, HLD, Prostate CA, Afib, Pacermaker, DM type 2, Covid PNA presents to ED with c/o increasing SOB, low O2sats, fevers, and severe buttock pain.  Pt states was diagnosed with Covid19 2 weeks ago and was doing well on his usual 2L NC until yesterday when O2 sats dropped and oxygen increased to 5L NC.  Pt febrile.  CXR no acute findings.  Started on IV Abx.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/04/2021.  74 y/o PMHx of sacral ducubitus ulcer, HTN, CHF, HLD, Prostate CA, Afib, Pacermaker, DM type 2, Covid PNA presents to ED with c/o increasing SOB, low O2sats, fevers, and severe buttock pain.  Pt states was diagnosed with Covid19 2 weeks ago and was doing well on his usual 2L NC until yesterday when O2 sats dropped and oxygen increased to 5L NC.  Pt febrile.  CXR no acute findings.  Started on IV Abx.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose given to early.  Did not meet the correct spacing
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Catheterisation cardiac, Chest pain, Coronary artery bypass
Clinical narrative: Triple bypass heart surgery following catherization after tiredness and chest pain.    One week hospitalization. Home care, cardio rehabilitation.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Fatigue, X-ray
Clinical narrative: Triple bypass heart surgery following catherization after tiredness and chest pain.    One week hospitalization. Home care, cardio rehabilitation.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Extremely high frequency noise in my ears. Visited my family doctor who prescribed a steroid; however, high frequency noise continued after medication. Immediately visited with an ENT who basically said that I had an adverse reaction to the vaccine known as tinnitus and their is no cure. ENT scheduled a hearing test that day to start monitoring my hearing loss from my tinnitus. On a level of 1 to 10, my condition remains anywhere from 8 to 10 with no relief. After months of suffering , I visited with an audiologists for advise on how to live with this condition, which has ruined my life. This high pitch sound is 24-7 and unbearable.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea
Clinical narrative: Reported fleeting pain right shoulder upper r chest.  Also reported shortness of breath.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: There was confusion regarding the expiration date of the Vaccine.  The vaccine was given on 01/24/2022 and the expiration date of the product was 1/23/2022
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Meningitis aseptic, SARS-CoV-2 test positive
Clinical narrative: recurrence of Mollaret's meningitis, positive COVID
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Runny nose, body aches.Fully vax no booster.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: FATIGUE, SORENESS, SWOLLEN LYMPH NODE UNDER ARM.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Fever, muscle aches, fatigue , soreness in the arm and swollen lymph node under armpit about the size of a golf ball.  Insomnia the next of the injection.  Still experience symptoms 3 days after vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, muscle aches, fatigue , soreness in the arm and swollen lymph node under armpit about the size of a golf ball.  Insomnia the next of the injection.  Still experience symptoms 3 days after vaccine.