chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 73-year-old patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The reporter stated that a dose of Twinrix that expired on 1st January 2023, was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the adjuvant; Received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number fb2bh, expiry date 26th January 2024) for prophylaxis.   On 3rd January 2023, the patient received Shingrix. On 3rd January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The pharmacist reported that the patient received only the adjuvant portion of Shingrix one day before reporting (no reconstitution).  The patient had no side effects and physician had been contacted. The registered pharmacist (RPh) declined to provide patient initials and date of birth (DOB) stating she did not thought that they were allowed to share. The reporter consented to follow up.  Additional Supportive Information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 30Dec2019, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th December 2019).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The practice manager reported that the patient never received the second dose of Shingrix.   The reporter did not have the lot number and expiration date information for the first dose. The reporter gave permission for follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Disability, Suspected COVID-19
Clinical narrative: LEGALLY BLIND/ LOST SO MUCH OF HIS EYESIGHT; MULTIPLE STROKES; SUSPECTED COVID-19 INFECTION; PERMANENT DISABILITY; This spontaneous report received from a consumer via a company representative via social media concerned a 48 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. Age at time of vaccination 5 decade old. No concomitant medications were reported.  On an unspecified date, the patient had went through the gauntlet with covid due to his job the patient was fully vaccinated, wore mask and maintained whole 9 yards. The patient had got covid (suspected covid-19 infection) and was hospitalized for unspecified number of days. The patient was put in an induced coma. The patient had multiple strokes and lost so much of his eyesight that he was now legally blind and had been fighting for his permanent disability.  It was reported that "A friend of mine went through the gauntlet with Covid. Due to his job, he was fully vaccinated. Wore masks, the whole 9 yards. Then he got COVID and was hospitalized. I told him before he went in to not let them put him into a coma. They put him in an induced coma. He had multiple strokes and lost so much of his eyesight that he is now legally blind. 48 yrs old and is now fighting for his permanent disability. It breaks my heart for him". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, multiple strokes, legally blind/ lost so much of his eyesight and permanent disability was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20230103381. This report was associated with a product quality complaint: 90000265459 and 90000265460.; Sender's Comments: V0 : 20230103417-  legally blind/ lost so much of his eyesight, multiple strokes,  permanent disability. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230103417-Suspected covid 19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Death, Off label use
Clinical narrative: KILLED; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of 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) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use (dose number in series 3). No concomitant medications were reported.  On an unspecified date, the patient was killed and died from an unknown cause of death (dose number in series 3). It was unknown if an autopsy was performed. It was reported "Johnson & Johnson NON VAXED! Never got Covid or wore a mask unless I absolutely HAD to, used common sense and washed hands and used lots of hand sanitizers! Covid vaccine and boosters killed my friend". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was serious (Death).; Sender's Comments: V0-20230103418-Killed. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEGS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in legs and it was reported as " same here blood clots in my legs " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230103607- Blood clot in legs-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date the patient died from unknown cause of death and It was unknown if an autopsy was performed or not. It was reported as " My father died a week after the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221166018- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients (two male patients) of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patients were healthy prior vaccination. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. It was unspecified whether an autopsy was performed or not. As per reporter, "I have 2 former healthy brothers now dead due to it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230105724.; Sender's Comments: V0: 20230105739- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE TIRED; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients (reporter's family) of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients all received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced little tiredness (dose number in series 1). It was reported that "I've had all the Coved shots and so for no reactions, no Covid. Only a little tired from the first shot. My family has been the same. I'm NOT suggesting anyone take it. I fully support the right to choice in THIS matter. God bless all. Stay safe and be fair". The patients received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. No adverse events were reported following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20230103940.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Skin disorder
Clinical narrative: SICK FOR 3 MONTHS; SPOTS ALL OVER BODY AND PACK, SPOTS STARTED AT THE INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick for 3 months, and spots all over body and pack, spots started at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 3 months, and the outcome of spots all over body and pack, spots started at the injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20230108457. This case, involving the same patient is linked to 20230109456.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: REBOUND COVID; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 rebound covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rebound covid. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Skin disorder, Vomiting
Clinical narrative: SICKNESS; SPOTS ON LEGS,CHEST, AND ASS (NEW SPOTS SHOWING UP EVERY DAY); THREW UP; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The patient experienced sick for 3 months and spots all over body and back, spots started at the injection site (Dose number in series 1). The patient had recovered from sick for 3 months, and the outcome of spots all over body and pack, spots started at the injection site was not reported.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was sick again for 3 months with spots on legs, chest, and ass. Patient states that he is sick forever and new spots are showing up every day. Patient also states that poison was put in his arm. He was sick, and states his life was ruined. (Dose number in series 2) On 04-JAN-2023, on the day of reporting, the patient just threw up in morning (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness, and spots on legs, chest, and ass (new spots showing up every day), and the outcome of threw up was not reported. This report was non-serious. This case, involving the same patient is linked to 20230108455. This case, from the same reporter is linked to 20230108457.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: 12. 4 % PVC after the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VENTRICULAR EXTRASYSTOLES (12. 4 % PVC after the 2nd dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029K20A) for COVID-19 prophylaxis.     No known allergies.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (12. 4 % PVC after the 2nd dose). At the time of the report, VENTRICULAR EXTRASYSTOLES (12. 4 % PVC after the 2nd dose) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 71 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of Ventricular extrasystoles, which occurred after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported 12.4 % Premature ventricular contractions (PVCs) after vaccination. The outcome was reported as recovering. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-694361 (Patient Link).; Sender's Comments: Company Comment: This is a spontaneous case concerning a 71 year-old, male patient with no reported medical history, who experienced the non-serious unexpected, AESI of Ventricular extrasystoles, which occurred after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported 12.4 % Premature ventricular contractions (PVCs) after vaccination. The outcome was reported as recovering. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 Vaccine, Bivalent was given BUD).    Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: He got terrible pain where he got his shot in his arm.; It went through his joints and into his wrists/It settled into his joints; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (He got terrible pain where he got his shot in his arm.) and ARTHRALGIA (It went through his joints and into his wrists/It settled into his joints) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concomitant products included CORTISONE and LIDOCAINE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (He got terrible pain where he got his shot in his arm.) and ARTHRALGIA (It went through his joints and into his wrists/It settled into his joints). At the time of the report, VACCINATION SITE PAIN (He got terrible pain where he got his shot in his arm.) had not resolved and ARTHRALGIA (It went through his joints and into his wrists/It settled into his joints) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It settled into his joints and he's not the only one with the trouble.   No treatment medication was provided by reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Patient received a dose from a vial that was punctured a week ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago) and NO ADVERSE EVENT (No Adverse Event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Concurrent medical conditions included GERD, Dementia and Bradycardia.    On 04-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago).    No concomitant medication details was reported. No other vaccine received 4 weeks prior to COVID-19 vaccine. No treatment medication details was reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Caller is the parent of a 3 year old who received Modern Covid vaccine a few weeks ago on 09De2022 Lot#018C22A but was given the 6 year to 12 year old dose instead of the 6 month to 5 year dose.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Caller is the parent of a 3 year old who received Modern Covid vaccine a few weeks ago on 09De2022 Lot#018C22A but was given the 6 year to 12 year old dose instead of the 6 month to 5 year dose.) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Influenza: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 09-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Caller is the parent of a 3 year old who received Modern Covid vaccine a few weeks ago on 09De2022 Lot#018C22A but was given the 6 year to 12 year old dose instead of the 6 month to 5 year dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Caller is the parent of a 3 year old who received Modern Covid vaccine a few weeks ago on 09De2022 Lot#018C22A but was given the 6 year to 12 year old dose instead of the 6 month to 5 year dose.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Caller is the parent of a 3 year old who received Modern Covid vaccine a few weeks ago on 09De2022 Lot#018C22A but was given the 6 year to 12 year old dose instead of the 6 month to 5 year dose.).    No concomitant medication information was provided. It was reported that patient received Modern Covid vaccine a few weeks ago on 09-Dec-2022 with Lot no 018C22A but was given the 6 year to 12 year old dose instead of the 6 month to 5 year dose. This dose administered was the patient's first dose of primary series. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Urticaria
Clinical narrative: feeling sick; broke out in severe hives; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick) and URTICARIA (broke out in severe hives) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (feeling sick) and URTICARIA (broke out in severe hives). At the time of the report, MALAISE (feeling sick) and URTICARIA (broke out in severe hives) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient took the covid booster Moderna and Dupixent injection on the same day and broke out in severe hives. Patient went to the hospital because of bad hives and feeling sick.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Reached out to patient to gleam more information 1/2/23 left voicemail.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Gait disturbance, Hypersensitivity vasculitis, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Developed hypersensitivity vasculitis as diagnosed by Dr. Red spots on the legs and sometimes on the arms & back. Pain, swelling, bumps. At times could not walk due to the pain. Missed several days of school (10-20 days) and some work. Condition would take several days to resolve. Symptoms seemed to be triggered by periods of standing.  Symptoms started on/about Feb 10, 2022. Had several flareups over the course of 2022 and several periods of missing school and work. Issue finally ended about Sept 2022.  Dr prescribed Prednisone 20mg and Omeprazole 20mg in May 2022 which seemed to help. Had to do a couple treatments of the Prednisone. 2-3 visits with primary care physician, 3-4 visits with specialist Dr, plus the several trips for urine sample and bloodwork.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Pain, Rash, Rash macular, Swelling
Clinical narrative: Developed hypersensitivity vasculitis as diagnosed by Dr. Red spots on the legs and sometimes on the arms & back. Pain, swelling, bumps. At times could not walk due to the pain. Missed several days of school (10-20 days) and some work. Condition would take several days to resolve. Symptoms seemed to be triggered by periods of standing.  Symptoms started on/about Feb 10, 2022. Had several flareups over the course of 2022 and several periods of missing school and work. Issue finally ended about Sept 2022.  Dr prescribed Prednisone 20mg and Omeprazole 20mg in May 2022 which seemed to help. Had to do a couple treatments of the Prednisone. 2-3 visits with primary care physician, 3-4 visits with specialist Dr, plus the several trips for urine sample and bloodwork.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Developed hypersensitivity vasculitis as diagnosed by Dr. Red spots on the legs and sometimes on the arms & back. Pain, swelling, bumps. At times could not walk due to the pain. Missed several days of school (10-20 days) and some work. Condition would take several days to resolve. Symptoms seemed to be triggered by periods of standing.  Symptoms started on/about Feb 10, 2022. Had several flareups over the course of 2022 and several periods of missing school and work. Issue finally ended about Sept 2022.  Dr prescribed Prednisone 20mg and Omeprazole 20mg in May 2022 which seemed to help. Had to do a couple treatments of the Prednisone. 2-3 visits with primary care physician, 3-4 visits with specialist Dr, plus the several trips for urine sample and bloodwork.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Came in and explained that his arm was sore and he was in severe pain, He was going to visit his doctor to seek treatment for the pain
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Henoch-Schonlein purpura, Urine analysis normal
Clinical narrative: Patient developed henoch-schonlein purpura 5-6 days after COVID bivalent booster.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Myalgia, Pyrexia
Clinical narrative: Chills, Slight Fever, Muscle Aches, Upset Stomach - Lasted about 12-16 hours after starting (less than 48 hours after shot).
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given additional Bivalent booster. No adverse events have occurred since vaccination.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Magnetic resonance imaging
Clinical narrative: Patient had 1 tonic clonic (non febrile) seizure on 12/24/22 and 2 tonic clonic seizures on 12/25/2022.  Patient was diagnosed with epilepsy and placed on Keppra. He will remain on Keppra for at least 2 years at which time he can be weaned off if he remains seizure free.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received incorrect formulation for age group. At 5yo patient should've received a bivalent vaccine, not a monovalent primary series.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt RECEIVED IMCORRECT COVID FORMULATION FOR AGE-GROUP.  Pt 5 YO AT TIME OF VACCINATION. SHOULD'VE RECEIVED PFIZER 5-11Y ORAGER CAP.
Age: 40.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Cough, Paranasal sinus discomfort, Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: I had a cough, runny nose, fever, and sinus pressure. This went on for about 8 days before I went to the doctor. I was prescribed Albuterol, Azithromycin, and a cough syrup with Codeine. I am feeling much better now.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 3/3/21, 4/2/21, 11/11/21, 5/12/22. Positive on 1/5/23
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/5/21, 5/3/21, 11/4/22. Positive on 12/29/22
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a COVID vaccine that had been out of the refrigerator for longer than 12 hours. No adverse reaction reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Patient began experiencing intermittent tinnitus in both ears after the second dose of the Pfizer COVID-19 mRNA based vaccine. This tinnitus has continued to affect her for almost two years, and is not a condition that affected her before her COVID-19 vaccine. As a pharmacist myself, I am aware that vaccines (especially the COVID vaccine) are often blamed for almost every adverse event that has ever occurred to a patient in our population, however I just don't see that there could be any other possible cause of this patient's tinnitus due to the timing of when it started. The patient in question is my wife and I know it has affected her day to day functioning and is a serious problem. We have mentioned it to her primary care provider but the provider has not seemed to take the issue seriously at all, and told her that he doesn't even know how to complete a VAERS form.   She has yet to see an ear, nose and throat specialist, due to the fact that these providers have been so booked up, but she has obtained a referral.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: no adverse events
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bronchitis, COVID-19, Cardiac monitoring, Chest X-ray abnormal
Clinical narrative: I had a very sore arm and did not feel great for a few days. On 04/11/2021, I started not feeling well with aches all over my body, not able to mover, no energy, nauseated and congestion. On 04/15/2021, I tested positive for COVID-19 with a home test, and I went to a walk-in clinic, and I got prescription for PAXLOVID. I also went to the emergency room because I was having difficulty breathing. I had a chest x-ray, put on oxygen and wore a heart monitor. It was determined that I had severe bronchitis secondary to COVID-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Mobility decreased, Nausea, Pain
Clinical narrative: I had a very sore arm and did not feel great for a few days. On 04/11/2021, I started not feeling well with aches all over my body, not able to mover, no energy, nauseated and congestion. On 04/15/2021, I tested positive for COVID-19 with a home test, and I went to a walk-in clinic, and I got prescription for PAXLOVID. I also went to the emergency room because I was having difficulty breathing. I had a chest x-ray, put on oxygen and wore a heart monitor. It was determined that I had severe bronchitis secondary to COVID-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had a very sore arm and did not feel great for a few days. On 04/11/2021, I started not feeling well with aches all over my body, not able to mover, no energy, nauseated and congestion. On 04/15/2021, I tested positive for COVID-19 with a home test, and I went to a walk-in clinic, and I got prescription for PAXLOVID. I also went to the emergency room because I was having difficulty breathing. I had a chest x-ray, put on oxygen and wore a heart monitor. It was determined that I had severe bronchitis secondary to COVID-19.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Angiogram abnormal, Cardiac arrest, Cardiac tamponade, Cardio-respiratory arrest, Chest X-ray abnormal
Clinical narrative: Patient was admitted with shortness of breath and had to go to ICU. Patient was found to have cardiac tamponade in the ICu and they had to put in a drain to drain his pericardium. confirmed with tests on 12/26. Patient then transferred to ICU floor and then cardiac arrested on 1/6/2023
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Haemothorax, Intensive care, Lung opacity
Clinical narrative: Patient was admitted with shortness of breath and had to go to ICU. Patient was found to have cardiac tamponade in the ICu and they had to put in a drain to drain his pericardium. confirmed with tests on 12/26. Patient then transferred to ICU floor and then cardiac arrested on 1/6/2023
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Pericardial drainage, Pericardial effusion
Clinical narrative: Patient was admitted with shortness of breath and had to go to ICU. Patient was found to have cardiac tamponade in the ICu and they had to put in a drain to drain his pericardium. confirmed with tests on 12/26. Patient then transferred to ICU floor and then cardiac arrested on 1/6/2023
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram abnormal, Epilepsy, Magnetic resonance imaging abnormal, Swollen tongue, Tongue biting
Clinical narrative: EPILEPTIC SEIZRE. BIT TONGUE. HOSPITALIZED ON 8/19/21 AFTER EMS TRANSFERRED FROM HOME TO HOSPITAL. TREATED SWOLLEN TONGUE AND PERFORMED DIAGNOSTIC TESTING. SEIZURES RE-OCCURED AGAIN ON 12/24/21, 01/09/22 AND 5/22/2022. NO HOSPITALIZATION FOR THOSE 3 TIMES. BIT TONGUE AGAIN ON ALL OCCASIONS. TONGUE IS NOW ENLARGED &  WAS DIAGNOSED WITH EPILEPSY AND PUT ON LAMOTRIGINE MEDICATION TO CONTROL SEIZURES.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: About 3 inches below injection site, a red spot in a rectangular shape approximately two inches long with the feeling of a knot below the skin
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Paranasal sinus hypersecretion, Pyrexia, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: I woke up the morning of December 5th, I had sinus drainage, on Tuesday I developed a fever (99.5) and then other times when I had a sinus infection it lasted 3 days, but on Wednesday fever went to 100.5. I had a home COVID-19 test, and it was positive. I went to Urgent Care facility, and I had another test, and it was also Positive, they recommended prescription, on Wednesday I started taking Paxlovid.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Hep A given instead of Hep B No treatment, no symptoms
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Dyspnoea
Clinical narrative: patient was administered covid pfizer bivalent booster vaccine and within minutes she had trouble breathing and holding her throat. pharmacist administered epinephrine and 911 was contacted. patient immediately improved after administration, her throat felt better and breathing improved. local county sheriff was in close proximity to pharmacy and came in while awaiting local ems and police to arrive. pt was stable and was assessed by local ems. she had elevated blood pressure due to epinephrine. mother opted not to transport to ER by ems. Patient and mother left the pharmacy about 7pm. Pharmacist followed up with parent next day 1/6 about 930am and mother stated she did take daughter local ER for further evaluation where she was given rx for benadryl, prednisone, and epinephrine
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Dyspnoea, Malaise, SARS-CoV-2 test positive
Clinical narrative: I was positive for Covid-19; having trouble breathing and feeling very sick and I had a cough.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: I had cold like symptoms. Sore throat, stuffed head, coughing and fatigue. I also lost taste and smell. I took TYLENOL and ROBITUSSIN DM to treat the symptoms. The doctor did not prescribe anything else but after 3 days I felt better but the fatigue lasted several weeks. I feel like I am currently recovered compared to how I felt. I also reached out to my allergy doctor who prescribed me prednisone which I did not end up taking.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I had cold like symptoms. Sore throat, stuffed head, coughing and fatigue. I also lost taste and smell. I took TYLENOL and ROBITUSSIN DM to treat the symptoms. The doctor did not prescribe anything else but after 3 days I felt better but the fatigue lasted several weeks. I feel like I am currently recovered compared to how I felt. I also reached out to my allergy doctor who prescribed me prednisone which I did not end up taking.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Moderna Monovalent was charted in patient's chart. Patient should have received Moderna Bivalent vaccine. Patient received monovalent moderna vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: local reaction resulted in redness/swelling from injection site in right thigh to knee
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy, Computerised tomogram abnormal, Lymphadenopathy, Lymphoma, Pharyngeal mass
Clinical narrative: Lymph nodes in right side of neck had accute swelling
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Positron emission tomogram abnormal, Throat cancer
Clinical narrative: Lymph nodes in right side of neck had accute swelling
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: COVID-19, Chills, Cough, Headache, Myalgia
Clinical narrative: Congestion, fever, chills, muscle/body aches, headaches, severe nausea, cough, runny nose, sore throat
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Congestion, fever, chills, muscle/body aches, headaches, severe nausea, cough, runny nose, sore throat
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Congestion, fever, chills, muscle/body aches, headaches, severe nausea, cough, runny nose, sore throat
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I received my Covid-19 vaccine on 10/06/2022. On the morning of 12/14/202 I woke up with a runny stuffy nose and headache. I took an at home Covid-19 test and tested positive. After testing positive I reached out to my doctor and was prescribed PAXLOVID. Symptoms lasted about 9 days.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal, Painful respiration, Pericarditis
Clinical narrative: Chest pain. Chest pain when breathing. Chest pain that coincided with heart beat. Pressure in chest. Chest pain when laying down.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in shoulder that vaccine was given. Pain still continues
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Cough, Influenza like illness, Migraine
Clinical narrative: On 05/10/2021, I woke up with chills and body aches and Migraine. I felt like I had the flu. Shortly after, congestion and coughing began. The coughing lasted for months. I did a telehealth visit. I was prescribed medication for cough and an antibiotic and steroids.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: On 05/10/2021, I woke up with chills and body aches and Migraine. I felt like I had the flu. Shortly after, congestion and coughing began. The coughing lasted for months. I did a telehealth visit. I was prescribed medication for cough and an antibiotic and steroids.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bronchitis, Cough, Fatigue, Influenza virus test negative, Pyrexia
Clinical narrative: He had a rash on the cheek and then a week later he was tired, coughing. He goes to the day care and on Dec 29, a day care center called that he was too tired, with mild fever we took him to the doctor, and he was diagnosed with bronchitis, On Dec 29 he vomited and Dec 30. Doctor prescribed medication. For information: Pneumonia is a condition that he has suffered before and was hospitalized in August 2022.