chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Hives and rashes all over the body, occurring randomly in all places on body, including face and near genitals but never on. Has never appeared on scalp, and in extreme episodes. Often soothed by a Benadryl tablet and hydrocortisone cream on the flare up sites. Both treatments help slightly, but the itching is still pretty severe. Occurs randomly throughout the day with no rhyme or reason, not directly linked to movement or outside exposure. Skin first turns very red, then soon after hives will show up. The skin becomes textured (bumpy) in all surrounding areas that isn't the hive itself. The skin itself, while red, is never sore to the touch or when pressure applied. Itching only.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: started 2 weeks after 2nd shot, shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that he/she had shingles which started occurring 2 weeks after receiving his/her 2nd Shingrix shot. He/She did not want to get shingles. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Been a year since 1st dose, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: 28-SEP-2022 Reporter's Comments: The case was reported via interactive digital media. It was more than a year since the patient received first dose of Shingrix.  The patient asked was there any concerns with getting his/her second dose now. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via media concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 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. It was unspecified if an autopsy was performed. It was reported by consumer that, "My 19 year old friend died from the vaccine, you were lucky. He wasn't." 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 20221003651 and 20221003655.; Sender's Comments: V0: 20221005731-covid-19 vaccine ad26.cov2.s-Death. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) 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 UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    Concomitant medications were not reported. It was reported that patient did not report any adverse events. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654894, US-MODERNATX, INC.-MOD-2022-654906, US-MODERNATX, INC.-MOD-2022-654910 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654894:Patient No-1 US-MODERNATX, INC.-MOD-2022-654906:Patient No -3 US-MODERNATX, INC.-MOD-2022-654910:Patient No-4
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: Within 48 hours after COVID Disease, she had the same vaginal reaction; Vaginal reaction with multiple black lesions on Vulva; COVID Disease; This spontaneous case was reported by a nurse and describes the occurrence of VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction), VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva) and POST-ACUTE COVID-19 SYNDROME (COVID Disease) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 030L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (COVID Disease). On 03-Sep-2022, the patient experienced VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction) and VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva). At the time of the report, VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction), VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva) and POST-ACUTE COVID-19 SYNDROME (COVID Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 13-Nov-2021, the patient received first booster dose.  Patient stated that she did not have any reactions after the first booster.  On 01-Sep-2022, patient had a positive PCR test and COVID Disease. Within 48 hours after COVID Disease, patient had the same vaginal reaction with multiple black lesions on Vulva.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-655011 (E2B Linked Report). This case was linked to MOD-2022-654972, MOD-2022-654969 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655011:other patient case (same reporter)
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vulval disorder, Vulvovaginal discomfort, Vulvovaginal pain
Clinical narrative: Within 48 hours after COVID Disease, she had the same vaginal reaction; Vaginal reaction with multiple black lesions on Vulva; COVID Disease; This spontaneous case was reported by a nurse and describes the occurrence of VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction), VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva) and POST-ACUTE COVID-19 SYNDROME (COVID Disease) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 030L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (COVID Disease). On 03-Sep-2022, the patient experienced VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction) and VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva). At the time of the report, VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction), VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva) and POST-ACUTE COVID-19 SYNDROME (COVID Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 13-Nov-2021, the patient received first booster dose.  Patient stated that she did not have any reactions after the first booster.  On 01-Sep-2022, patient had a positive PCR test and COVID Disease. Within 48 hours after COVID Disease, patient had the same vaginal reaction with multiple black lesions on Vulva.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-655011 (E2B Linked Report). This case was linked to MOD-2022-654972, MOD-2022-654969 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655011:other patient case (same reporter)
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test, Vulval disorder, Vulvovaginal discomfort
Clinical narrative: Within 48 hours after COVID Disease, she had the same vaginal reaction; Vaginal reaction with multiple black lesions on Vulva; COVID Disease; This spontaneous case was reported by a nurse and describes the occurrence of VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction), VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva) and POST-ACUTE COVID-19 SYNDROME (COVID Disease) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 030L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (COVID Disease). On 03-Sep-2022, the patient experienced VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction) and VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva). At the time of the report, VULVOVAGINAL DISCOMFORT (Within 48 hours after COVID Disease, she had the same vaginal reaction), VULVAL DISORDER (Vaginal reaction with multiple black lesions on Vulva) and POST-ACUTE COVID-19 SYNDROME (COVID Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 13-Nov-2021, the patient received first booster dose.  Patient stated that she did not have any reactions after the first booster.  On 01-Sep-2022, patient had a positive PCR test and COVID Disease. Within 48 hours after COVID Disease, patient had the same vaginal reaction with multiple black lesions on Vulva.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-655011 (E2B Linked Report). This case was linked to MOD-2022-654972, MOD-2022-654969 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655011:other patient case (same reporter)
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 14 year old received bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 14-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, 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 05-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster).    No concomitant medication were reported. The nurse stated that one of the employees gave a bivalent booster shot to a 14 year old.    No treatment medication was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: tested positive for Covid (home test) - twice; bad cold; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (bad cold) and COVID-19 (tested positive for Covid (home test) - twice) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 045A21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2022, the patient experienced NASOPHARYNGITIS (bad cold). On 05-Oct-2022, the patient experienced COVID-19 (tested positive for Covid (home test) - twice). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (bad cold) and COVID-19 (tested positive for Covid (home test) - twice) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies to medications, food and other products. Patient had no medical history relating to adverse event. Patient had no acute and chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was not provided. No concomitant medications were reported. Patient called HCP for consultation. It was stated that patient tested positive (twice) with a home COVID test. The patient had a bad cold yesterday (04Oct2022) and was feeling worse today (05Oct2022).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose - 10Feb2021; 2nd dose - 11Jul2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 10Feb2021; 2nd dose - 11Jul2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Have been on chemotherapy prior to getting their 1st dose of the Moderna Covid-19 vaccine). Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 10Feb2021; 2nd dose - 11Jul2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 10Feb2021; 2nd dose - 11Jul2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication details were not reported by the reporter.  They have been on chemotherapy prior to getting their 1st dose of the Moderna Covid-19 vaccine and the condition for which they are receiving chemotherapy had been present since then. They also state that the condition remained they same since they got the vaccine.  On 28-Aug-2021, patient received 3rd dose of Moderna COVID-19 Vaccine, Batch number 043B21A. On 04-May-2022, patient received 4th dose of Pfizer COVID-19 Vaccine, Batch number  FK9894. On 05-Oct-2022, patient received bivalent booster dose of Moderna COVID-19  Vaccine, batch number 027E22A.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion with no reported adverse event; temperature excursion involved a low temperature of 29F with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA408679, 2022SA410140, 2022SA409520, 2022SA409928, 2022SA410163, 2022SA410177, 2022SA410116, 2022SA409707 and 2022SA409694.  This case involves an unknown age and unknown gender patient who received  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from pre-filled syringes after a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, temperature excursion occurred and involved a low temperature of 29.0 F (Fahrenheit) and the total excursion time was for 45 minutes with no reported adverse event (product storage error). The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection from pre-filled syringes (dose, strength, expiry date: unknown) lot UT7689LA via unknown route in unknown administration site for prophylactic vaccination after a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day)   Doctor states that 12 patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion occurred on 23-Sep-2022, including 4 pediatric patients and 8 adults.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (healthcare professional).  This case is linked to cases SanofiPVPortal20221006000441, SanofiPVPortal20221006000454, 2022SA410571 and 2022SA400593.  This case involves an unknown age female patient who experienced broke out in hives after 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 (dose, brand name, strength, formulation, route, site and  lot number: unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  The 82-year old caller stated that her 4 sisters have the same/similar reactions to medications that she herself has. As far as the information about herself, she provided that in 2012 and 2013 she took the "regular flu shot" and broke out in hives.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event broke out in hives.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a Healthcare Professional and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, thepatient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023) administered for prophylaxis (strength, and route of administration were not provided). provided) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (lot# S030249, expiration date 06- FEB-2022). According to the reporter, the temperature excursion was 46 degrees Fahrenheit for a time frame of 8 hours on 05-SEP-2022, without any previous temperature excursion.; Sender's Comments:  US-009507513-2209USA002570:02242096 US-009507513-2209USA002469:02242101 US-009507513-2209USA002606:02242106 US-009507513-2209USA002532:02242109 US-009507513-2209USA002532:02242109 US-009507513-2209USA002779: US-009507513-2209USA002722:02242109
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported.; administration of PROQUAD to an 14 year old Patient; This spontaneous report was received from a physician and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 22-AUG-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, 0.5 ml, lot # W012741, expiration date 16-OCT-2023, for prophylaxis (route of administration and anatomical site were not provided) (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Already had both shots, got another one yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date few years back).   On 26th September 2022, the patient received the 3rd dose of Shingrix. On 26th September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient forgot that he/she had already had both Shingrix shots a few years back and got another one yesterday (from the date of reporting) and asked would this have an adverse effect. Additional supportive information: As patient already had both the dose of Shingrix few years back and had 3rd dose of Shingrix vaccine again, which led to extra dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Death, Thrombosis
Clinical narrative: DEATH; CLOTS; HEART ISSUES; This spontaneous report received from a consumer from company representative via media concerned multiple patients. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total 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. No concomitant medications were reported.  On an unspecified date, the patients had clots, heart issues and died. On an unspecified date, the patients died from unknown cause of death. It was unknown whether the autopsy was performed. It was reported that, "What about all the young men who took it and now have clots, heart issues and death." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of clots and heart issues was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20221003651 and 20221005731.; Sender's Comments: V0- 20221003655-covid-19 vaccine ad26.cov2.s-Death. The event(s) 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(s). Therefore, this event(s) is considered unassessable. 20221003655-covid-19 vaccine ad26.cov2.s-Clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Product administered to patient of inappropriate age
Clinical narrative: Swelled up arm; Red arm; 13 years old administered with the bivalent booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (Swelled up arm), ERYTHEMA (Red arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old administered with the bivalent booster dose) in a 13-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, lot number EW0179) on 06-Aug-2021, Pfizer (2nd dose and lot number FL3197) on 27-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 30-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old administered with the bivalent booster dose). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelled up arm) and ERYTHEMA (Red arm). At the time of the report, PERIPHERAL SWELLING (Swelled up arm), ERYTHEMA (Red arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old administered with the bivalent booster dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 30-Sep-2022, the patient received first booster dose.  Patient currently has no adverse effects except for a swelled up and red arm. The patient handled it better than the previous two doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654904:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Pain in extremity
Clinical narrative: arm was sore for all 4; The lymph node under arm was a little irritated; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore for all 4) and LYMPHADENITIS (The lymph node under arm was a little irritated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In May 2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (arm was sore for all 4) and LYMPHADENITIS (The lymph node under arm was a little irritated). At the time of the report, PAIN IN EXTREMITY (arm was sore for all 4) and LYMPHADENITIS (The lymph node under arm was a little irritated) outcome was unknown. No concomitant information were reported by the reporter.  Patient received the first and second dose in May of this year. Patient was thinking about getting the new bivalent vaccine. The second dose, how does that differ from the bivalent vaccine? Would it be to patient advantage to get the newest vaccine? was this vaccine approved?.  Patient received 4 doses of the Moderna Vaccine.  No treatment information were reported by the reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves an unknown age female patient who experienced pain in her arm after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route, frequency: unknown) (lot number and expiry date: not reported) in unknown administration site prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of pain in her arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, reporter attempted to transfer the caller to Medical, however the caller was very adamant she was not helping with our experiment. Reporter tried to explain all adverse reactions need to be reported (I hope I got that right) but the caller stating that is only going to help us and not her. She disconnected the call. Reporter know this needs to be reported, but do not have any information.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (pain in her arm).  At time of reporting, the outcome was Unknown for the event pain in her arm.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Arthropathy, Asthenia, Cough, Malaise
Clinical narrative: he has been coughing; had weakness in his joints; has felt sick; Initial information received from 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 65 years old male patient who has been coughing, had weakness in his joints and has felt sick while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Had flu shot and pneumonia shots last year and he was healthier before he got the flu shot. He spoke with the doctor and had a hard time convincing them it was not COVID. Wanted to know if it was a bad batch?  Concomitant medications included SALBUTAMOL (ALBUTEROL HFA).  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.  On 29-SEP-2022 the patient has felt sick (malaise) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date the patient has been coughing (cough) and had weakness in his joints (asthenia)  (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  He stated he was going to schedule an appointment for a chest x-ray to make sure everything was clear.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (he has been coughing, had weakness in his joints, has felt sick).  At time of reporting, the outcome was Unknown for all.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blepharitis, Eyelid margin crusting, Eyelid pain, Hordeolum, Lacrimation increased
Clinical narrative: Day 2 after injection right eye lid in right corner became painful and watery like a stye.  That night it woke me up through the night. It continued to get worse throughout the 3rd day after shot. That night it was crusted over and swollen over the entire lid.  Still painful, watery and inflamed
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep disorder, Swelling of eyelid
Clinical narrative: Day 2 after injection right eye lid in right corner became painful and watery like a stye.  That night it woke me up through the night. It continued to get worse throughout the 3rd day after shot. That night it was crusted over and swollen over the entire lid.  Still painful, watery and inflamed
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Electromyogram, Magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Deep Soar and bruise in arm for 3 months. Severe pain in arm, tingling from elbow to finger tips for 5 months. Taking 6-8 tylenol daily. pain rating 1-10 pain level is 13
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspnoea, Muscle spasms, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient had shortness of breath upon standing she sat back down and started having lower back spasms. after a few minutes these issues subsided. Her blood pressure was 127/84 with a pulse of 78. After 15 minutes she felt better and was able  to stand and walk around without issue. After she returned home she broke out in hives and took benadryl.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Patient presented with some slight redness and raised area on her injection site on 10/6/22. Slight pain to the touch. Later evening on 10/6/22 patient reported the site is warm to the touch and redness is increasing. Patient describes a reaction similar to this 2 years ago.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: sore arm-Severe, Additional Details: pt reported a sore arm after injection and friday thru weekend she felt unable to more arm without difficulty. pt called her md who advised her "to give it a few days" and check back with office if still bothering her
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Palpitations, Tachycardia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tachycardia-Medium, Additional Details: aBOUT 26 HOURS AFTER GETTING THE VACCINE PATIENT HAS CHEST PAIN, PRESSURE, PALPITATIONS, HARD TO TAKE DEEP BREATH. pATIENT DOES NOT HAVE HISTORY FOR HEART DISEASE, ONLY HAS ANXIETY. 4 DAYS LATER SHE STILL HAS MILD SYMPTOMS. aCCORDING TO PATIENT THIS HAPPENED WITH ALL OF HER COVID DOSES, BOTH PFIZER AND MODERNA.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cold sweat, Dizziness, Flushing, Hyperhidrosis, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient passed out after administration and was cold and clammy blood pressure checked 112/84 patient regained consciousness after a couple of minutes and said she felt light headed
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient passed out after administration and was cold and clammy blood pressure checked 112/84 patient regained consciousness after a couple of minutes and said she felt light headed
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Confusional state, Dizziness, Feeling abnormal, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tinnitus-Severe, Systemic: Vomiting-Severe, Additional Details: EMS was called. EMS arrived on scene in under 5 minutes. BP was too low for EMS to get a clear reading. He may have lost consciousness briefly. He was much better and talking when they left to take him to the hospital. Still very dazed and confused. Spoke with family member later in the day and he was able to go home the same day.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Hypotension, Nausea, Syncope, Tinnitus, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tinnitus-Severe, Systemic: Vomiting-Severe, Additional Details: EMS was called. EMS arrived on scene in under 5 minutes. BP was too low for EMS to get a clear reading. He may have lost consciousness briefly. He was much better and talking when they left to take him to the hospital. Still very dazed and confused. Spoke with family member later in the day and he was able to go home the same day.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Vomiting
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tinnitus-Severe, Systemic: Vomiting-Severe, Additional Details: EMS was called. EMS arrived on scene in under 5 minutes. BP was too low for EMS to get a clear reading. He may have lost consciousness briefly. He was much better and talking when they left to take him to the hospital. Still very dazed and confused. Spoke with family member later in the day and he was able to go home the same day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate increased, Pain
Clinical narrative: I had COVID in early September, very short lived at 48 hours symptom free except cough. I had the latest recommended booster on 29 September. The next day 100 degree temp, mild body/head ache, cough worsened, elevated HR to 100-115. After 48 hours symptoms gone except for cough, which is lessining as of t his report.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis allergic, Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient called on 10/3 informing that she has allergy allover her body after getting the flu shot on 9/30. no doctor is needed, she is improving.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Bump at vaccination site and pain,treated with pain creams ,not improved-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Spouse states that her husband finds it difficult to sleep on his left side,and still has pain on that site. Patient spoke another lanuage  and was comminicting through a pharmacy technician.Spouse left before i could see the bump.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient called this morning to report that the area of the vaccination injection was hard "like a knot" and red
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menstruation irregular, Ovulation disorder, Progesterone decreased, Weight increased
Clinical narrative: Significant unexplained weight gain (over 15 lbs in 2-3 months) in extremely active individual (workout 5-6 days/week) with no change in prior habits. Removal of ovulation and alteration in menstrual cycle and unexplained sudden issue with low progesterone.  Vaccination series dates: 7/21/21, 8/11/21, 1/27/22
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 10.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Ten year old female was given Pfizer Bivalent 12 and up vaccine in error. Only adverse effect was a sore arm after injection.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Nasopharyngitis, Pain
Clinical narrative: I did not have an adverse reaction to the vaccine. I received the vaccine on 09/13/2022 and tested positive via a home test for COVID-19 14 days later on 09/27/2022. I contacted my primary care doctor via the patient portal and was given the prescription on 09/27/2022. I retested and was negative on 10/04/2022 and 10/05/2022. I tested again today, 10/07/2022, and I was positive again. I have cold like symptoms with congestion, cough, chills and body aches.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I received the vaccine on 09/13/2022 and tested positive via a home test for COVID-19 14 days later on 09/27/2022. I contacted my primary care doctor via the patient portal and was given the prescription on 09/27/2022. I retested and was negative on 10/04/2022 and 10/05/2022. I tested again today, 10/07/2022, and I was positive again. I have cold like symptoms with congestion, cough, chills and body aches.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, unable to vomit due to previous esophagus procedure.  Fever: 101.3
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: generalized intense itching within 10 minutes of vaccine- treated medically in Emergency Dept