chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received a first dose in 2020, so needs to know what to do in this situation; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: The patient received a first dose in 2020, so needs to know what to do in this situation). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 13-AUG-2024 The pharmacist calls regarding an Inappropriate schedule of vaccine more than 6 months for Shingrix second dose.  The patient received a first dose in 2020, so needs to know what needs to be done in this situation. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: An expired dose of Shingrix was administered to a 61 years old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   On 12-AUG-2024, the patient received Shingrix. On 12-AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: An expired dose of Shingrix was administered to a 61 years old female patient). The outcome of the expired vaccine used was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bilateral headache; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Lot number: FC3183) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (medically significant) with onset 29Jul2021, outcome "not recovered", described as "bilateral headache". The event "bilateral headache" required physician office visit. Therapeutic measures were taken as a result of headache. Clinical course: Patient have had a bilateral headache every single day for over 3 years starting 29Jul2021 that is a direct result of this experimental substance. Patient have been debilitated from his/her healthy vibrant self and lost any trace of the person he/she was 3 years ago. Patient reported had spent a lot of moneys in co-pays and final billing amounts, multiple prescriptions, and have had absolutely no relief.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400105901 same patient, different dose/event;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: Reactivation and dissemination of Herpes Simplex virus 2; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2022 at 10:00 as dose number unknown, single (Lot number: FJ1614) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES SIMPLEX (non-serious) with onset 22Feb2022, outcome "not recovered", described as "Reactivation and dissemination of Herpes Simplex virus 2". Therapeutic measures were taken as a result of herpes simplex.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines on the same date as the  vaccine or any other vaccines within 4 weeks prior to the vaccination. The patient was taking  valaciclovir (VALACYCLOVIR reported as Valcyclovir) within 2 weeks of the event starting (as reported). The patient received Valacyclovir to treat the event.
Sex: M
Vaccine: COVID19
Symptoms: Transplant
Clinical narrative: transplant; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation; Moderna vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation. The following information was reported: TRANSPLANT (medically significant), outcome "unknown". Clinical course: Reporter stated that he was recommended to get a COVID booster because he was in the group who were recommended for an extra booster. He added that the pharmacist told him that a new booster was coming out close to the end of august. Reporter wanted to verify this information and wanted to know when will this new booster be available so he could decide if he should just get the currently available or just wait for the new one. Upon clarifying reporter stated that he had gotten every single booster that was released and he sometimes get the Pfizer COVID vaccine and sometimes, the Moderna vaccine. Reporter stated that the most recent COVID vaccine that he received was on late Jan2023. Call added that he was a part if the at risk group who are recommended to get an extra booster as he had a transplant. Upon clarifying reporter stated that he had gotten every single booster that was released and he sometimes get the Pfizer COVID vaccine and sometimes, the Moderna vaccine. Reporter stated that the most recent COVID vaccine that he received was on late Jan2024. Call added that he was a part if the at risk group who are recommended to get an extra booster as he had a transplant.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: TBE
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: sharp pain in the joint and she could not tell if it was joint or bone in the ankle and pointed to her lateral aspect of the achilles area; This is a spontaneous report received from a Nurse.  A 31-year-old female patient received tick-borne encephalitis vaccine (TICOVAC), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "sharp pain in the joint and she could not tell if it was joint or bone in the ankle and pointed to her lateral aspect of the achilles area". Therapeutic measures were taken as a result of arthralgia.  Additional information: Nurse reported about Ticovac and stated they had someone present to their clinic for the Ticovac 2nd dose and the patient had received the 1st one at a pharmacy. Nurse reported that the patient was not sure if she had a reaction and the pharmacy was not very helpful and word travels and the patient had made an appointment there. They did not give the 2nd dose to the patient and the patient had received the first dose and experienced while sleeping a sharp pain where it woke her up with a sharp pain in the joint and she could not tell if it was joint or bone in the ankle and pointed to her lateral aspect of the achilles area and the next day said she did eventually fall asleep and it was feeling a little better and she could weight bear and carried on with her activities, took some Ibuprofen but it was still a little bit sore and eventually it disappeared.  The information on the batch/lot number for tick-borne encephalitis vaccine will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (not pregnant) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "recovered", described as "hives". It was unknown if therapeutic measures were taken as a result of urticaria.  Additional information: The patient developed hives following one of her initial COVID-19 vaccines (the patient believed it was the Pfizer vaccine, but was not sure) several years ago.  She did not remember if she had received the influenza vaccine at the same visit.  The patient has not received any subsequent COVID-19 vaccines since this event.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: Patient received swelling in the leg of injection - the entire leg swelled up after injection; This is a spontaneous report received from a Nurse from a sales representative.  An infant patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines on the same date as the vaccine(s) reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine(s) reported. It was unknown if the patient was taking any other medications within 2 weeks of the event starting.  The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Patient received swelling in the leg of injection - the entire leg swelled up after injection". It was unknown if therapeutic measures were taken as a result of vaccination site swelling.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Menstruation irregular, Premature menopause
Clinical narrative: hashimoto disease; period never came back; diagnosed prematurely post- menopause; Irregular menstrual bleeding with IUD; This is a spontaneous report received from an Other HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (disability) with onset 17Aug2021 at 14:00, outcome "not recovered", described as "Irregular menstrual bleeding with IUD"; PREMATURE MENOPAUSE (disability) with onset 2023, outcome "not recovered", described as "period never came back; diagnosed prematurely post- menopause"; AUTOIMMUNE THYROIDITIS (disability) with onset 2024, outcome "not recovered", described as "hashimoto disease". Therapeutic measures were taken as a result of menstruation irregular. It was unknown if therapeutic measures were taken as a result of premature menopause, autoimmune thyroiditis. Clinical Course: Patient received vaccine on Shoulder. Patient had Irregular menstrual bleeding with IUD and had IUD removed about 8 months later because of the irregular bleeding, period never came back. She was now diagnosed with prematurely post- menopause at 38, now she was 39. Patient now also had Hashimoto disease, her thyroid was holding up for now but eventually she would need to take thyroid meds- didn't have this before the vaccine. No other medical history before the shot. Patient did not receive other vaccine same date, no other vaccine in four weeks, no other medications in two weeks.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Gastritis, Gastrooesophageal reflux disease, Oropharyngeal discomfort
Clinical narrative: gastritis; acid reflux issues; My throat is ruined; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, lot number unknown), for COVID-19 immunisation. The following information was reported: GASTRITIS (non-serious), outcome "unknown"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "acid reflux issues"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "My throat is ruined".  Additional information: Patient reported "There is no category for why I have to say to this company. I had your Covid vaccines. I have never been the same since. Days after my second shot I developed gastritis and long term acid reflux issues. My throat is ruined. No one will tell me your vaccine didn't cause this. I have tracked everything, everyday and everything goes back to your vaccine. I can barely work. I'm financially destroyed. Pfizer's Covid vaccine wasn't safe. You ruined my health and life."
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, Drug ineffective
Clinical narrative: covid; covid; diabetes; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid"; DIABETES MELLITUS (medically significant), outcome "not recovered", described as "diabetes". Clinical course: Caller stated that her sister had covid/diabetes. Received all shots. Wanted to know how to get paxlovid for her sister because she heard it was good. Caller also mentioned that her sister got Covid for the second time even though her sister had all the covid shots.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: DF
Symptoms: Breakthrough dengue fever
Clinical narrative: dengue; SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT  Initial unsolicited social media report received from consumer (patient's mother) on 14 Dec 2017.  This case involves a female patient (Age was not reported) who was vaccinated with a dose of TETRAVALENT (CHIMERIC) DENGUE VACCINE (DENGVAXIA) (batch number, expiry date, route and site of administration were not reported) on an unspecified date.  The patient's medical history and concomitant medication were not reported.  On an unspecified date, post vaccination, the patient experienced dengue.  Laboratory investigation and corrective treatment were not reported.  Outcome of event was unknown.  Upon internal review the case was considered as serious because of important medical event: dengue.  List of documents held by sender: none.; Sender's Comments: This is a poorly documented case where patient experienced dengue post Dengvaxia vaccine. Further information on time to onset, vaccination details, sign of severity, patient immune status, medical history and PCR test result are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received another menquadfi injection after she received menquadfI a year ago already with no reported adverse event; Initial information received on 15-Aug-2024 regarding an unsolicited valid non-serious case received from Health Authorities.  This case involves a 12 years old female patient who received another MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] injection after she received menquadfi a year ago already with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 08-Jun-2023, the patient received a Dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (dose, strength, lot, expiry and route: unknown) in unknown administration site for prophylactic Vaccination.   On 14-Aug-2024 she also received a Dose 2, 0.5 ml total (1X) of Menquadfi (U8259AA) via intramuscular route in unknown administration site for prophylactic Vaccination (inappropriate schedule of product administration) (latency same day).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 58.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated that a medical assistant administered the expired vaccine with no reported adverse event; Initial information received on 15-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient who was stated that a medical assistant administered the expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 15-Aug-2024, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) (lot U7183AA, Expiry date: 24-Sep-2023, Frequency : Once, strength was unknown) via intramuscular route in the right deltoid for Immunization and stated that a medical assistant administered the expired vaccine with no reported adverse event (expired product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering an expired vaccine to a patient. Practice supervisor said she was informed that an expired TENIVAC was given to a patient today."   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: chicken pox like rash; Rash; This non-serious case was reported by a consumer and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-JUL-2024, the patient received Shingrix 50 mcg/mg. On 01-AUG-2024, 3 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash). On an unknown date, the patient experienced varicella-like rash (Verbatim: chicken pox like rash). The outcome of the rash was not resolved and the outcome of the varicella-like rash was not reported.   It was unknown if the reporter considered the rash and varicella-like rash to be related to Shingrix.     It was unknown if the company considered the rash and varicella-like rash to be related to Shingrix.   Additional Information: GSK receipt date: 05-AUG-2024 The patient had broken out in a chicken pox like rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: the first dose of the vaccine was given Subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number TS9HE, expiry date 19-JUN-2026) for prophylaxis.   On 09-AUG-2024, the patient received the 1st dose of Shingrix (subcutaneous). On 09-AUG-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: the first dose of the vaccine was given Subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2024 The other health professional (clinical medical assistant) reported that, a patient came in early morning of the reporting day, the Shingrix vaccine was given subcutaneously (the site of injection was not proactively confirmed), which led to intramuscular formulation administered by other route.  The other health professional wanted to know what to expect. The other health professional asked do they need to repeat the dose, what´s the advise in this situation.  Both complete demographics and vaccine details were retrieved and collected in the corresponding sections above. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just had Covid; I just had Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Compromised immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jul2024, outcome "unknown" and all described as "I just had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2024) Unknown results; (06Jul2024) Unknown results; (07Jul2024) Unknown results; (08Jul2024) Unknown results; (09Jul2024) Unknown results; (10Jul2024) Unknown results; (11Jul2024) Unknown results; (12Jul2024) Unknown results; (13Jul2024) Unknown results; (13Jul2024) Positive; (14Jul2024) Unknown results; (15Jul2024) Unknown results; (16Jul2024) Unknown results; (17Jul2024) Unknown results; (18Jul2024) Unknown results; (19Jul2024) Unknown results; (20Jul2024) Unknown results; (21Jul2024) Unknown results; (22Jul2024) Unknown results; (23Jul2024) Unknown results; (24Jul2024) Unknown results; (25Jul2024) Unknown results; (26Jul2024) Unknown results; (27Jul2024) Unknown results; (28Jul2024) Unknown results; (29Jul2024) Negative.  Clinical course: Patient just had Covid- Flirt - for 16 days from the time the patient officially tested positive to negative (13Jul-29Jul). Patient believe to having it for 8 days before (05Jul-13Jul - tested negative 2x) not knowing these symptoms. Ended up in ER 2x - could not breathe. Have had 5 Pfizer covid shots. Last was Sep2023. 73 yrs. old. Compromised immune system. Asked if how long should patiet wait for new shot.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site pain
Clinical narrative: Patient reported pain from injection site to left shoulder to top of head felt like headache.  No swelling, hives or redness.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient had a vasovagal syncopal episode shortly after receiving the meningococcal vaccine. He was caught by mother and the nurse who administered vaccine, and was laid on the exam table, with legs elevated, ice applied to his face, and monitored closely. No head trauma. He regained consciousness within 1 minute, and was alert, awake and oriented x 3. Vitals repeated and wnl.
Age: 49.0
Sex: M
Vaccine: FLUR4, PNC20
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient got 2 vaccines in left deltoid Thursday 8/15/24. He came into the pharmacy on Saturday 8/17/24 and stated that he started experiencing redness, itching, some discomfort and he said it's warm to the touch. I told him that injection site irritation was not uncommon and to try Tylenol orally and hydrocortisone topically and to let me know if that helped his symptoms. He came back into the pharmacy Monday 8/19/24 to no relief.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Mom noticed the next day right thigh was red and swollen at injection site. Over the next couple days, the redness started all over her body and become hive-like. Mom took her to urgent care and they gave her a 5-day dose of prednisolone. Mom concerned as the rash continues to come and go. Does not bother patient
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: swelling  itching and redness  starting  on Friday night after getting shot
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Double dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer. Patient states worse covid vaccine--fatigue, body aches. Pt reports okay after a day  or two
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered outside the timeframe recommended by the manufacturer
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope.  Provided water and cold compress to patient.  Instructed patient to hold knees to elevate legs while sitting on the chair.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was administered outside the timeframe recommended by the manufacturer.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Migraine, Oropharyngeal pain, Palpitations, Tremor
Clinical narrative: Heart palpitations (2 hours and counting), migraine, sore throat, whole body shakiness
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given outside the timeframe recommended by the manufacturer.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Sore throat, congestion, body aches, cold
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: had significant redness and swelling at the injection site; had significant redness and swelling at the injection site; This spontaneous report was received from a medical assistant and referred to 2 patients (both age and gender unknown). Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 14-MAY-2024, 2 patients received the dose with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, lot #X023559, expiration date: 24-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 14-MAY-2024, the 2 patients experienced had significant redness and swelling at the vaccination site. The patient had sought a medical attention. It was unknown if the patient received the treatment or performed any lab diagnostics/studies. On unknown dates in 2024, the 2 patients recovered from the events. The causal relationship between pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and both events was not reported.  Follow-up information has been received from a PCP office manager on 14-AUG-2024.  It was reported that the patient was a 75-year-old male patient.   On 14-MAY-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered intramuscularly in the right arm.  On the same date, the patient experienced red, swollen arm, right (also reported as right arm swelling) (vaccination site swelling and vaccination site erythema). The patient was given scopolamine as treatment for the event.  On 01-JUN-2024, the patient recovered from the events.  The causal relationship between the events and the suspect therapy was reported as related.  The reporter considered the events as medically significant.  This case was previously considered non-valid because patient identifiers were missing.
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No side effect or symptoms reported; Physician called and reported GARDASIL 9 was inadvertently administered to 9-month-old on 08/09/2024.  No side effects or symptoms reported.  HCP granted permission to follow up.  No further information provided.  No additional AE/no PQC.; This spontaneous report has been received by a physician, regarding a 9-months-old baby patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 09-AUG-2024, the patient was inadvertently vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, vaccination scheme, site of administration, lot #, and expiration date were not provided) as a prophylaxis (product administered to patient of inappropriate age). No side effect or symptoms reported.   Lot # were being requested and will be submitted if received.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: had significant redness and swelling at the injection site; had significant redness and swelling at the injection site; This spontaneous report was received from a medical assistant and referred to a 73-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 14-MAY-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, at a dose of 0.5 milliliter, administered intramuscularly in the right deltoid (lot #X023559, expiration date: 24-NOV-2024) as prophylaxis (strength was not reported).  On 15-MAY-2024, the patient experienced red, swollen arm, left (also reported as arm swelling) (vaccination site swelling and vaccination site erythema).  On 19-MAY-2024, the patient recovered from the events.  The causal relationship between the events and the suspect therapy was reported as related.  The reporter considered the events as medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported.; HBP calling to report inadvertently administering a dose of VARIVAX after experiencing a temperature excursion. Temperature excursion assessment was supported.; This spontaneous report was received from other reporter and a consumer regarding to a patient of unknown age and gender. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported.  On 15-AUG-2024, the patient was inadvertent vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot number Y004553 (lot number Y004553 had been verified to be valid lot number for varicella virus vaccine live [Oka/Merck] [VARIVAX]), expiration date 20-FEB-2026, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical injection site were not provided), after experiencing a temperature excursion of 8.2 Fahrenheit (F), with a time frame of 0 hours 15 minutes 0 seconds. Without previous temperature excursion (product storage error).   No additional information provided. No additional adverse event (AE)/product quality complaint (PQC) reported.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Patient's grandmother reported that the following day (08/14/2024) the patient developed a rash all over his body/Patient's grandmother reported that the following two days (08/15/2024 and 08/16/2024) the rash has gotten worse.; Patient's grandmother reported that the patient developed a fever of 102.5 on 08/13/2024.; This spontaneous report was received from other reporter and a consumer regarding to a 15-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 05-AUG-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) injection, at a dose of 0.5 milliliter (mL), administered via intramuscular (strength, frequency, anatomical injection site, lot number and expiration date were not provided) for measles, mumps and rubella (prophylaxis).   On 13-AUG-2024, the patient developed a fever of 102.5 (units not provided) (pyrexia). On 14-AUG-2024 (also reported as "the following day"), the patient developed a rash all over his body. The patient's grandmother reported that the following two days (15-AUG-2024 and 16-AUG-2024), the rash had gotten worse. At the time of reporting, the outcome of the events was not recovered/not resolved.  The causal relationship between the vaccination with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and the events was not provided.  No other symptoms or side effects were reported. No other information reported by patient's grandmother. Consent to contact patient's health care professional (HCP) was not given. No additional adverse event (AE)/no product quality complaint (PQC).  Additional information is not expected.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination falure; Shingles; got three vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination falure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: got three vaccination). The outcome of the vaccination failure, shingles and extra dose administered were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 12-AUG-2024 This case was reported by patient via interactive digital media. The patient reported that he or she got three vaccination and still had shingles this year which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine (3 doses).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 2 more times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 2 more times). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-AUG-2024 The case was received from the patient via interactive digital media. The patient self reported this case for himself/herself. The reporter reported that, he/she had shingles, got the shot, the patient had shingles 2 more times. At the time of reporting the reporter was taking Valtrex 2 times a day. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Injection site vesicles, Scab
Clinical narrative: Blister at site of Hep A day after. got bigger, crusted, dime size. no fever. not painful. treated cephalexin. MD 8/19/24
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Confusional state, Death, Dyspnoea, Generalised oedema
Clinical narrative: Reported Symptoms: 10011906:DEATH;  Narrative: Patient was admitted to the ER on 12/26/20 with worsening shortness of breath and was admitted to acute care services. On 12/29/20, a  hospice consult was placed for end stage CHF, EF 20%.  On 12/30/20 he transferred to the CLC and was a DNR.  On 1/7/21, he was noted to have increased secretions in throat and was given atropine gtts sublingual and ondansetron for nausea.  He also had issues with insomnia and was given trials of hydroxyzine, trazodone and melatonin. Lorazepam remained on profile as well as part of hospice care.  On 1/9/21, he was noted to be more confused, tachypneic and had anasarca (furosemide was ordered).  Later on that same day he began to decline rapidly to the point of unresponsiveness other than to verbal stimuli and was determined to be imminent.  On 1/10/21, he remained unresponsive and not able to tolerate oral meds.  That same day at 1020 when nursing did rounds, he was found to be pulseless and without respirations.  An autopsy was declined.  Other Relevant HX:  Other: death
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Heart failure with reduced ejection fraction, Increased upper airway secretion, Insomnia, Nausea, Pulse absent
Clinical narrative: Reported Symptoms: 10011906:DEATH;  Narrative: Patient was admitted to the ER on 12/26/20 with worsening shortness of breath and was admitted to acute care services. On 12/29/20, a  hospice consult was placed for end stage CHF, EF 20%.  On 12/30/20 he transferred to the CLC and was a DNR.  On 1/7/21, he was noted to have increased secretions in throat and was given atropine gtts sublingual and ondansetron for nausea.  He also had issues with insomnia and was given trials of hydroxyzine, trazodone and melatonin. Lorazepam remained on profile as well as part of hospice care.  On 1/9/21, he was noted to be more confused, tachypneic and had anasarca (furosemide was ordered).  Later on that same day he began to decline rapidly to the point of unresponsiveness other than to verbal stimuli and was determined to be imminent.  On 1/10/21, he remained unresponsive and not able to tolerate oral meds.  That same day at 1020 when nursing did rounds, he was found to be pulseless and without respirations.  An autopsy was declined.  Other Relevant HX:  Other: death
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure, Tachypnoea, Unresponsive to stimuli
Clinical narrative: Reported Symptoms: 10011906:DEATH;  Narrative: Patient was admitted to the ER on 12/26/20 with worsening shortness of breath and was admitted to acute care services. On 12/29/20, a  hospice consult was placed for end stage CHF, EF 20%.  On 12/30/20 he transferred to the CLC and was a DNR.  On 1/7/21, he was noted to have increased secretions in throat and was given atropine gtts sublingual and ondansetron for nausea.  He also had issues with insomnia and was given trials of hydroxyzine, trazodone and melatonin. Lorazepam remained on profile as well as part of hospice care.  On 1/9/21, he was noted to be more confused, tachypneic and had anasarca (furosemide was ordered).  Later on that same day he began to decline rapidly to the point of unresponsiveness other than to verbal stimuli and was determined to be imminent.  On 1/10/21, he remained unresponsive and not able to tolerate oral meds.  That same day at 1020 when nursing did rounds, he was found to be pulseless and without respirations.  An autopsy was declined.  Other Relevant HX:  Other: death
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Impaired work ability, Insomnia, Neck mass
Clinical narrative: 2021 11/02 received COVID 19 vaccine at 1:30 PM 11/03 went to work customer service agent 11/04 awakeneed to a slight headache -went to work -nose running become unbearable -left work with a headache -difficulty sleeping 11/5 woke up with a throbbing headache -did not go to work -By evening headache became worse Noticed some bump on my left side of neck and fist that were painful to the slightest touch Began taking Tylenol for it appeared to be a migraine 11/06 awakened by headache -Tylenol not working Anything touching my nose was felt like fire! 11/07 went to Emergency room given pain pills The following 3 weeks not able to go to work
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tenderness
Clinical narrative: 2021 11/02 received COVID 19 vaccine at 1:30 PM 11/03 went to work customer service agent 11/04 awakeneed to a slight headache -went to work -nose running become unbearable -left work with a headache -difficulty sleeping 11/5 woke up with a throbbing headache -did not go to work -By evening headache became worse Noticed some bump on my left side of neck and fist that were painful to the slightest touch Began taking Tylenol for it appeared to be a migraine 11/06 awakened by headache -Tylenol not working Anything touching my nose was felt like fire! 11/07 went to Emergency room given pain pills The following 3 weeks not able to go to work
Age: 77.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Arthralgia, Fatigue, Headache, Laboratory test, Myalgia
Clinical narrative: Left arm hurt very bad for several days. Pharmacist told me to ice it. Pain radiated down my arm into my hand. By July 10 it was still hurting so I called my doctor. July 17 I woke up with severe headache, pain in all joints, muscles hurt & fatigue.
Age: 77.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm hurt very bad for several days. Pharmacist told me to ice it. Pain radiated down my arm into my hand. By July 10 it was still hurting so I called my doctor. July 17 I woke up with severe headache, pain in all joints, muscles hurt & fatigue.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Received vaccines listed on 08/05/24. The following day, parent noticed "a few red dots" on his torso. On 08/07/24 he had blotchy, red hives mostly concentrated under both arms, on chest and abdomen. Parent applied hydrocortisone 1% cream and rash quickly faded then resolved.
Age: 17.0
Sex: M
Vaccine: MNP
Symptoms: Dyskinesia, Electrocardiogram, Full blood count, Metabolic function test, Nausea
Clinical narrative: Vaccinated at 10:41 am, parent refers that the teenager had involuntary movements, neck pain and nauseas at 11:30 am
Age: 17.0
Sex: M
Vaccine: MNP
Symptoms: Neck pain
Clinical narrative: Vaccinated at 10:41 am, parent refers that the teenager had involuntary movements, neck pain and nauseas at 11:30 am