chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test, SARS-CoV-2 test
Clinical narrative: After having a shot (Pfizer COVID-19 Shot) to prevent covid; I still got it; After having a shot (Pfizer COVID-19 Shot) to prevent covid; I still got it; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had covid 3 times in the past" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing); "prostrate" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; TAMSULOSIN taken for prostatic disorder. The patient also took other concomitant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "After having a shot (Pfizer COVID-19 Shot) to prevent covid; I still got it". The event "after having a shot (pfizer covid-19 shot) to prevent covid; i still got it" required physician office visit. The patient underwent the following laboratory tests and procedures: Lab work: unknown results, notes: wellness check with my doctor, a month ago; SARS-CoV-2 test: negative, notes: not currently diagnosed with COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical curse: Patient took Atorvastatin and had no idea. It was just what his doctor prescribed for him. Patient also took Tamsulosin and thought think that was for his prostrate. The name of the medication that they were currently prescribed was Paxlovid however, they were not currently diagnosed with COVID-19. They had a prescription because they were going on vacation and they wanted it just in case but through their conversation they reported that he had covid 3 times before. Consumer stated, 78, 79 and he just had it few months ago. He went to walk in the last time he had it. His doctor was not open that day and had to go to a walk in. He stayed isolated for 5 days. It will be that first time that he will take paxlovid. If he catch it gain. he wanted to have something that he could take and did not want to wind up in the hospital. They told him after having a shot (Pfizer COVID-19 Shot) to prevent covid and he still got it. They told him to take Vitamin C and Vitamin D. Yes when they first come out, he got one. He was taking other medicine for blood pressure and things like that and he talked to his primary doctor about interaction with the Paxlovid. So, he knew what to do if he ever get it. He got shot over a couple of years. It was when the Pfizer came out with them.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: feeling faint; weak/ got weaker; fall time oxygen/ oxygen level dropped to 49; can't walk; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 2, single (Lot number: FC3181) at the age of 80 for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: FA7484), administration date: 29Jul2021, when the patient was 80-year-old, for Covid-19 Immunization. The following information was reported: DIZZINESS (hospitalization), outcome "unknown", described as "feeling faint"; ASTHENIA (hospitalization), outcome "unknown", described as "weak/ got weaker"; OXYGEN SATURATION DECREASED (hospitalization, medically significant), outcome "unknown", described as "fall time oxygen/ oxygen level dropped to 49"; GAIT DISTURBANCE (hospitalization, medically significant), outcome "unknown", described as "can't walk". The events "feeling faint", "weak/ got weaker", "fall time oxygen/ oxygen level dropped to 49" and "can't walk" required physician office visit. The patient underwent the following laboratory tests and procedures: Oxygen saturation: 49, notes: oxygen level dropped to 49. Therapeutic measures were taken as a result of dizziness, asthenia, oxygen saturation decreased.  Clinical Course: Consumer reported that "Covid-19 shot by Pfizer was administered to me. Shortly there after I started feeling faint/weak. I had to be rushed to the hospital for a stay. Come home, got weaker. Was prescribed many many infusion trying to come back. (text illegible) to house very expensive 2,000 each approx had to have many infusion. Got a little better then oxygen level dropped to 49 had to be taken to hospital stayed better than 1 week sent home within 24 hour oxygen by (text illegible) and portable oxygenated now, predominantly in a wheel chair, can't walk/,fall time oxygen, bedside potty, gallbladder drain to hospital every 60 days for drainage. Say heart not strong enough to remove, many hospital stays, rehab, nurses, Physical therapists, shots and pills."
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: caller stated that her nephew died due to the vaccine.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male 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 and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "caller stated that her nephew died due to the vaccine.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter expressed deep concern and frustration about the safety and efficacy of the Pfizer COVID-19 vaccine, alleging that it contains cancer-causing ingredients and has resulted in numerous deaths. They questioned why Pfizer continues to distribute the vaccine despite reports of adverse effects, including deaths allegedly linked to cancer and other serious illnesses. stated that her baby died due to the vaccine.  Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: caller stated that her nephew died due to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller stated that her baby died due to the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DEATH (death, medically significant), outcome "fatal", described as "Caller stated that her baby died due to the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter expressed deep concern and frustration about the safety and efficacy of the Pfizer COVID-19 vaccine, alleging that it contains cancer-causing ingredients and has resulted in numerous deaths. They questioned why Pfizer continues to distribute the vaccine despite reports of adverse effects, including deaths allegedly linked to cancer and other serious illnesses. stated that her baby died due to the vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: Caller stated that her baby died due to the vaccine
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: didn't feel well until 3/15/2024; Initial information received on 17-Apr-2024 regarding an unsolicited valid non-serious case received via consumer/non-healthcare professional.  This case involves a 76-year-old female patient who experienced didn't feel well until 3/15/2024 after receiving influenza vaccine.  The patient's past medical history included UTI (urinary tract infection) with 1 in 12/2023 & 1 03/2024. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Peripheral neuropathy in 01/2024 in in the front of my legs.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for flu (influenza). Information on batch number was requested.  On an unknown date the patient had an event of didn't feel well until 3/15/2024 (malaise) (unknown latency) following the administration of influenza vaccine.  Reportedly, Patient hadn't had the flu in years, but not only did she get it  It was unknown if any lab data/test results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction to the vaccine; Initial information received on 18-Apr-2024 regarding an unsolicited valid  serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age female patient who experienced anaphylactic reaction to the Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone].  The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided   On an unknown date, the patient received an unknwon dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed event of anaphylactic reaction to the vaccine (anaphylactic reaction) (unknown latency). This event was assessed as medically significant.  Reportedly, Caller stated that she is starting a new job and is required to take the flu vaccine but when she took the vaccine last year she had an anaphylactic reaction to the vaccine. Caller wanted to know the ingredients of the vaccine to make sure she does not have another anaphylactic reaction. Caller stated that she is allergic to corn and does not remember if she took the vaccine with or without the preservative.  Agent did provide information regarding product composition, animal component, egg and chicken protein allergies, preservatives and thimerosal.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event anaphylactic reaction to the vaccine.; Sender's Comments: Sanofi company comment dated 23-Apr-2024: This case involves an unknown age female patient who experienced anaphylactic reaction to the Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone]. Furthermore, information regarding condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUA4
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope; Dizziness; This spontaneous case initially received on 19-Apr-2024, was reported by a health authority and concerns a male patient.  Administration of company suspect drug(s): It was reported that on 05-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular; anatomical location: left arm; dose and indication: not reported). The batch number reported was 346363. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 05-Oct-2022, the patient experienced Syncope (Medically Significant, outcome: Not Reported), and dizziness (outcome: Not Reported).  Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter assessed the events as non-serious and did not provide causality assessment. The event of syncope was considered medically significant.; Reporter's Comments: Causality: Based on chronological plausibility, causality for dizziness and syncope is assessed as possibly related.
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLUA4, HEP
Symptoms: Syncope
Clinical narrative: Following vaccination, patient fainted as he was exiting the store and immediately fainted within minutes following vaccine.  Did not hit his head and came to quickly.  Pt  was A&O x3.  He stated he has never fainted in the past. Observed pt for any other reactions for 20 minutes. Pt denied medical treatment and felt fine after resting.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient was inadvertently administered an expired vaccination. The vaccine expired on 04/16/2024, and this was administered on 04/18/2024. This was reported to Moderna and their lab responded with the following, "The vaccines administered [on April 17, 2024 and April 18, 2024] from lot number 206E23A maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration." Have attempted to reach patient multiple times, but patient has not answered phone calls. Patient has not called complaining of any additional adverse effects.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Atrial fibrillation, Brain scan normal, Computerised tomogram head, Condition aggravated
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/1/2021 MODERNA #3 11/17/2021  SUFFERS ACUTE HYPERTENSIVE EPISODE ASSOCIATED WITH CONFUSION AND MEMORY LOSS.   HE HAS 3 DAYS OF PERMANENT MEMORY LOSS.    INFARCTION WAS NOT SEEN ON BRAIN IMAGING.  PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME.  SYNDROME INCLUDED PARTIAL SEIZURES.  ALSO DEVELOPED A LEFT KIDNEY STONE REQURING URETERAL STENTING FOR OBSTRUCTIVE UROPATHY.  ALONG WITH PRESCRIPTION MEDICATIONS HE WAS TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Confusional state, Detoxification, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/1/2021 MODERNA #3 11/17/2021  SUFFERS ACUTE HYPERTENSIVE EPISODE ASSOCIATED WITH CONFUSION AND MEMORY LOSS.   HE HAS 3 DAYS OF PERMANENT MEMORY LOSS.    INFARCTION WAS NOT SEEN ON BRAIN IMAGING.  PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME.  SYNDROME INCLUDED PARTIAL SEIZURES.  ALSO DEVELOPED A LEFT KIDNEY STONE REQURING URETERAL STENTING FOR OBSTRUCTIVE UROPATHY.  ALONG WITH PRESCRIPTION MEDICATIONS HE WAS TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Laboratory test, Magnetic resonance imaging head, Nephrolithiasis, Partial seizures
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/1/2021 MODERNA #3 11/17/2021  SUFFERS ACUTE HYPERTENSIVE EPISODE ASSOCIATED WITH CONFUSION AND MEMORY LOSS.   HE HAS 3 DAYS OF PERMANENT MEMORY LOSS.    INFARCTION WAS NOT SEEN ON BRAIN IMAGING.  PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME.  SYNDROME INCLUDED PARTIAL SEIZURES.  ALSO DEVELOPED A LEFT KIDNEY STONE REQURING URETERAL STENTING FOR OBSTRUCTIVE UROPATHY.  ALONG WITH PRESCRIPTION MEDICATIONS HE WAS TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ureteral stent insertion, Urinary tract obstruction
Clinical narrative: MODERNA #1 1/5/2021 MODERNA #2 2/1/2021 MODERNA #3 11/17/2021  SUFFERS ACUTE HYPERTENSIVE EPISODE ASSOCIATED WITH CONFUSION AND MEMORY LOSS.   HE HAS 3 DAYS OF PERMANENT MEMORY LOSS.    INFARCTION WAS NOT SEEN ON BRAIN IMAGING.  PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME.  SYNDROME INCLUDED PARTIAL SEIZURES.  ALSO DEVELOPED A LEFT KIDNEY STONE REQURING URETERAL STENTING FOR OBSTRUCTIVE UROPATHY.  ALONG WITH PRESCRIPTION MEDICATIONS HE WAS TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Colitis ulcerative, Colonoscopy, Condition aggravated, Detoxification
Clinical narrative: PFIZER #1 9/3/2021 PFIZER #2 9/24/2021  DEVELOPED WORSENED ULCERATIVE COLITIS REQUIRING IV REMICADE, EFFORT INTOLERANCE, POST-EXERTIONAL MALAISE, ATYPICAL CHEST DISCOMFORT.  DIAGNOSED WITH COVID 19 VACCINE INDUCED POTS AND PERICARDITIS.  TREATED WITH NADOLOL, COLCHICINE, AND PROTOCOL
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Exercise tolerance decreased, Laboratory test, Malaise
Clinical narrative: PFIZER #1 9/3/2021 PFIZER #2 9/24/2021  DEVELOPED WORSENED ULCERATIVE COLITIS REQUIRING IV REMICADE, EFFORT INTOLERANCE, POST-EXERTIONAL MALAISE, ATYPICAL CHEST DISCOMFORT.  DIAGNOSED WITH COVID 19 VACCINE INDUCED POTS AND PERICARDITIS.  TREATED WITH NADOLOL, COLCHICINE, AND PROTOCOL
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Postural orthostatic tachycardia syndrome
Clinical narrative: PFIZER #1 9/3/2021 PFIZER #2 9/24/2021  DEVELOPED WORSENED ULCERATIVE COLITIS REQUIRING IV REMICADE, EFFORT INTOLERANCE, POST-EXERTIONAL MALAISE, ATYPICAL CHEST DISCOMFORT.  DIAGNOSED WITH COVID 19 VACCINE INDUCED POTS AND PERICARDITIS.  TREATED WITH NADOLOL, COLCHICINE, AND PROTOCOL
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient complains of a hard painful lump at injection site that is still there 1 week after injection.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was initially administered the pediatric/adolescent formulation dose of 10mcg/0.5mL. After error noted, GSK and local pharmacy notified and advised to administer subsequent pediatric/adolescent formulation dose of 10mcg/0.5 mL to achieve the total adult dose of 20mcg/1mL. Patient tolerated vaccination well
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Dysphonia, Dyspnoea, Hot flush, Nausea
Clinical narrative: Patient received her Prevnar 20 vaccine and was advised to wait for 15 to 20mins after injection for allergic reaction precautions. The patient notified staff of urgent symptoms (shortness of breath, coughing, hot flash, nausea, stridor, ardor). Staff activated emergency response plan and 25mg IM Benadryl given. Patient quickly improved and was monitored for 1 hour. Patient returned to clinic later in day and received a second dose of 25mg IM Benadryl for hoarseness/sore throat.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Oropharyngeal pain, Stridor
Clinical narrative: Patient received her Prevnar 20 vaccine and was advised to wait for 15 to 20mins after injection for allergic reaction precautions. The patient notified staff of urgent symptoms (shortness of breath, coughing, hot flash, nausea, stridor, ardor). Staff activated emergency response plan and 25mg IM Benadryl given. Patient quickly improved and was monitored for 1 hour. Patient returned to clinic later in day and received a second dose of 25mg IM Benadryl for hoarseness/sore throat.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: The Pfizer COVID-19 2023-24 vaccine (6 months-4 years) was not diluted prior to administration. The authorized dose is 3 mcg; the patient received a higher than authorized dose (9 mcg) because the vaccine was not diluted. The patient's mother reported that the patient has experienced no side effects since the day of the vaccine.
Age: 7.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None to date. We have made multiple phone attempts and sent a letter explaining that we needed to follow up on the vaccines with no response.  Vaccines given past age recommendation. Both manufacturers were contacted and indicated that because these were catch up doses there should not be any effects, though there was a potential for headaches or pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Medication  administered  had expired.
Age: 38.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: raised welt and itchiness at injection site, exdending 4 inches distally, 2 inches in width. No additional treatment.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Blood creatinine normal, Brain natriuretic peptide increased, Cardiac failure acute, Condition aggravated, Death
Clinical narrative: Patient had unwitnessed collapse and subsequently passed away in the early morning of 4/21/24.  patient was being treated at the time for acute on chronic systolic heart failure with increase in his diuretic medication
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Diuretic therapy, Full blood count normal, Left ventricular failure, Syncope
Clinical narrative: Patient had unwitnessed collapse and subsequently passed away in the early morning of 4/21/24.  patient was being treated at the time for acute on chronic systolic heart failure with increase in his diuretic medication
Age: 31.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Urticaria
Clinical narrative: urticaria 2 days after vaccine.  still with rash 6 days post injection.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Face oedema, Fatigue, Urticaria
Clinical narrative: within 2 hours of vaccine administration, generalized urticaria, dizziness, and fatigue were noted. Mild facial edema. No respiratory distress or decrease in vital signs. not erythema noted at injection sites. 25mg benadryl and 40mg prednisone given. Symptoms resolved within 2 hours
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fatigue
Clinical narrative: Became very fatigued within 24 hours, went Er, sent home,  went back next day,  admitted.  died on Oct 17.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Cellulitis localized to injection area, Augmentin 875-125 twice daily x 10 days, warm compresses, stable.  (warm, erythematous rash, firm, tender, localized starting several hours post-vaccination.)
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash erythematous
Clinical narrative: Cellulitis localized to injection area, Augmentin 875-125 twice daily x 10 days, warm compresses, stable.  (warm, erythematous rash, firm, tender, localized starting several hours post-vaccination.)
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Feeling hot, Immediate post-injection reaction, Pallor, Peripheral coldness
Clinical narrative: At 302pm a 17-year-old male was vaccinated in the right deltoid with HPV vaccine (Lot#1965079)About 30 seconds later patient began to feel hot, leaned back in the chair and closed his eyes with paleness to his face. Pt. Not responding to verbal questions. Attempted to get vitals but unsuccessful. I then Called for help and Nurse came in room with patient and attempted to feel for a pulse but could not find one. Pt then lost all control of upper body and fell forward in front of nurse. Provider was called in to assist. Provider attempted to feel for a pulse but could not find one. EMS was activated. Nurse came in to assist patient to the floor. Patient was turned on his side and his skin color began to come back slowly. Several attempts were made to get vitals but not successful. Patient remained on the floor until he was awake. About 315 pm patient was assisted into chair as he was somewhat alert. Vitals signs was taken BP 74/42 p-116, hands extremely cold and unable to obtain oxygen saturations. EMS has arrived and patient was alert but still pale in face. Vitals signs taken by EMS at 320pm 104/60 p-96, BS@90, o2 sats 88-91. Vitals retaken again 5 minutes later BP 110/78 p-91. Mother was asked if patient had eaten anything today and she said no. Patient was given a snack. Mother also remembered that he had a previous reaction to HPV. Mother stated she forgot to let us know when the question was asked. Patient mother refused patient to be transported to hospital. Mother signed Refusal to transport consent. Patient moved to another examining room where he remained with EMS and Nurse.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Pulse absent
Clinical narrative: At 302pm a 17-year-old male was vaccinated in the right deltoid with HPV vaccine (Lot#1965079)About 30 seconds later patient began to feel hot, leaned back in the chair and closed his eyes with paleness to his face. Pt. Not responding to verbal questions. Attempted to get vitals but unsuccessful. I then Called for help and Nurse came in room with patient and attempted to feel for a pulse but could not find one. Pt then lost all control of upper body and fell forward in front of nurse. Provider was called in to assist. Provider attempted to feel for a pulse but could not find one. EMS was activated. Nurse came in to assist patient to the floor. Patient was turned on his side and his skin color began to come back slowly. Several attempts were made to get vitals but not successful. Patient remained on the floor until he was awake. About 315 pm patient was assisted into chair as he was somewhat alert. Vitals signs was taken BP 74/42 p-116, hands extremely cold and unable to obtain oxygen saturations. EMS has arrived and patient was alert but still pale in face. Vitals signs taken by EMS at 320pm 104/60 p-96, BS@90, o2 sats 88-91. Vitals retaken again 5 minutes later BP 110/78 p-91. Mother was asked if patient had eaten anything today and she said no. Patient was given a snack. Mother also remembered that he had a previous reaction to HPV. Mother stated she forgot to let us know when the question was asked. Patient mother refused patient to be transported to hospital. Mother signed Refusal to transport consent. Patient moved to another examining room where he remained with EMS and Nurse.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Gestational diabetes; Gestational diabetes; premature delivery; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gestational diabetes" (unspecified if ongoing), notes: previous pregnancy, the diabetes resolved after birth. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). Concomitant medication(s) included: PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; VITAMIN D [VITAMIN D NOS]; ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The patient also took other concomitant therapy. The following information was reported: GESTATIONAL DIABETES (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Gestational diabetes"; PREMATURE DELIVERY (medically significant), outcome "unknown". The baby was delivered premature. The patient underwent the following laboratory tests and procedures: Blood glucose: gestational diabetes. Clinical course: Respondent reported after receiving Abrysvo at 33 weeks 2 days, she was asked to repeat glucose tests due to concerns about her child's size, which revealed gestational diabetes, a condition she also experienced in her previous pregnancy. Like her previous pregnancy, the diabetes resolved after birth.  And exactly a week later (34 weeks 2 days), she experienced a pre-term birth.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400054332 same reporter/drug, different patient (baby);
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Blood glucose abnormal, Disease recurrence, Exposure during pregnancy, Gestational diabetes, Premature delivery
Clinical narrative: Gestational diabetes; Gestational diabetes; premature delivery; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gestational diabetes" (unspecified if ongoing), notes: previous pregnancy, the diabetes resolved after birth. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). Concomitant medication(s) included: PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; VITAMIN D [VITAMIN D NOS]; ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The patient also took other concomitant therapy. The following information was reported: GESTATIONAL DIABETES (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Gestational diabetes"; PREMATURE DELIVERY (medically significant), outcome "unknown". The baby was delivered premature. The patient underwent the following laboratory tests and procedures: Blood glucose: gestational diabetes. Clinical course: Respondent reported after receiving Abrysvo at 33 weeks 2 days, she was asked to repeat glucose tests due to concerns about her child's size, which revealed gestational diabetes, a condition she also experienced in her previous pregnancy. Like her previous pregnancy, the diabetes resolved after birth.  And exactly a week later (34 weeks 2 days), she experienced a pre-term birth.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400054332 same reporter/drug, different patient (baby);
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Biopsy skin abnormal, Blister, Dry skin, Eczema, Psoriasis
Clinical narrative: biopsy of her neck and results came as spongiotic dermatitis/dermatitis spread to her legs and feet/ 2nd biopsy of her leg and results were spongiotic dermatitis; doctor said it might be psoriasis; dots all over her body which were itchy/ started on her hip and lower back/ went to her lefthand and the back of her neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of spongiotic dermatitis in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On 20-OCT-2023, the patient received Arexvy. In OCT-2023, less than 2 weeks after receiving Arexvy, the patient experienced spongiotic dermatitis (Verbatim: biopsy of her neck and results came as spongiotic dermatitis/dermatitis spread to her legs and feet/ 2nd biopsy of her leg and results were spongiotic dermatitis), psoriasis (Verbatim: doctor said it might be psoriasis) and itchy rash (Verbatim: dots all over her body which were itchy/ started on her hip and lower back/ went to her lefthand and the back of her neck). The patient was treated with triamcinolone acetonide. The outcome of the spongiotic dermatitis, psoriasis and itchy rash were not resolved.   It was unknown if the reporter considered the spongiotic dermatitis, psoriasis and itchy rash to be related to Arexvy.     It was unknown if the company considered the spongiotic dermatitis, psoriasis and itchy rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-APR-2024 and 16-APR-2024 The patient self-reported this case. The patient had received a Arexvy vaccine. she stated that at the end of October after her dose, she started getting dots all over her body which were itchy. It started on her hip and lower back and then it went to her left hand and the back of her neck. The patient's doctor said it might be psoriasis and referred her to a dermatologist. On 14-DEC-2023, she got a biopsy of her neck, and the results came back as spongiotic dermatitis. The dermatitis spread to her legs and feet. On 22-FEB-2024 she got her second biopsy which was of her leg and the results were again spongiotic dermatitis. The patient was currently using a steroid ointment to treat the dermatitis which was Triamcinolone acetonide ointment 0.1 percent. The GlaxoSmithKline sales representative was very patient with reporter, and he asked her questions about the symptoms that she had with the RSV vaccine and had taken some information and he was going to report it and he was very you know calm about asking the questions. The patient was willing to give it to him because of all the symptoms that she had and it was surprised to her getting a reaction from one of the shots and that was she thought that was what that was and so he was very good and very easy to you know give him her questions and he was taking any questions that she may had so that was very helpful. The reporter consented to the follow up.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Rash, Rash macular, Rash papular, Skin wound
Clinical narrative: biopsy of her neck and results came as spongiotic dermatitis/dermatitis spread to her legs and feet/ 2nd biopsy of her leg and results were spongiotic dermatitis; doctor said it might be psoriasis; dots all over her body which were itchy/ started on her hip and lower back/ went to her lefthand and the back of her neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of spongiotic dermatitis in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On 20-OCT-2023, the patient received Arexvy. In OCT-2023, less than 2 weeks after receiving Arexvy, the patient experienced spongiotic dermatitis (Verbatim: biopsy of her neck and results came as spongiotic dermatitis/dermatitis spread to her legs and feet/ 2nd biopsy of her leg and results were spongiotic dermatitis), psoriasis (Verbatim: doctor said it might be psoriasis) and itchy rash (Verbatim: dots all over her body which were itchy/ started on her hip and lower back/ went to her lefthand and the back of her neck). The patient was treated with triamcinolone acetonide. The outcome of the spongiotic dermatitis, psoriasis and itchy rash were not resolved.   It was unknown if the reporter considered the spongiotic dermatitis, psoriasis and itchy rash to be related to Arexvy.     It was unknown if the company considered the spongiotic dermatitis, psoriasis and itchy rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-APR-2024 and 16-APR-2024 The patient self-reported this case. The patient had received a Arexvy vaccine. she stated that at the end of October after her dose, she started getting dots all over her body which were itchy. It started on her hip and lower back and then it went to her left hand and the back of her neck. The patient's doctor said it might be psoriasis and referred her to a dermatologist. On 14-DEC-2023, she got a biopsy of her neck, and the results came back as spongiotic dermatitis. The dermatitis spread to her legs and feet. On 22-FEB-2024 she got her second biopsy which was of her leg and the results were again spongiotic dermatitis. The patient was currently using a steroid ointment to treat the dermatitis which was Triamcinolone acetonide ointment 0.1 percent. The GlaxoSmithKline sales representative was very patient with reporter, and he asked her questions about the symptoms that she had with the RSV vaccine and had taken some information and he was going to report it and he was very you know calm about asking the questions. The patient was willing to give it to him because of all the symptoms that she had and it was surprised to her getting a reaction from one of the shots and that was she thought that was what that was and so he was very good and very easy to you know give him her questions and he was taking any questions that she may had so that was very helpful. The reporter consented to the follow up.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Biopsy, Biopsy skin abnormal, Eczema, Rash, Rash pruritic
Clinical narrative: biopsy of her neck and results came as spongiotic dermatitis/dermatitis spread to her legs and feet/ 2nd biopsy of her leg and results were spongiotic dermatitis; doctor said it might be psoriasis; dots all over her body which were itchy/ started on her hip and lower back/ went to her lefthand and the back of her neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of spongiotic dermatitis in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma.   On 20-OCT-2023, the patient received Arexvy. In OCT-2023, less than 2 weeks after receiving Arexvy, the patient experienced spongiotic dermatitis (Verbatim: biopsy of her neck and results came as spongiotic dermatitis/dermatitis spread to her legs and feet/ 2nd biopsy of her leg and results were spongiotic dermatitis), psoriasis (Verbatim: doctor said it might be psoriasis) and itchy rash (Verbatim: dots all over her body which were itchy/ started on her hip and lower back/ went to her lefthand and the back of her neck). The patient was treated with triamcinolone acetonide. The outcome of the spongiotic dermatitis, psoriasis and itchy rash were not resolved.   It was unknown if the reporter considered the spongiotic dermatitis, psoriasis and itchy rash to be related to Arexvy.     It was unknown if the company considered the spongiotic dermatitis, psoriasis and itchy rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-APR-2024 and 16-APR-2024 The patient self-reported this case. The patient had received a Arexvy vaccine. she stated that at the end of October after her dose, she started getting dots all over her body which were itchy. It started on her hip and lower back and then it went to her left hand and the back of her neck. The patient's doctor said it might be psoriasis and referred her to a dermatologist. On 14-DEC-2023, she got a biopsy of her neck, and the results came back as spongiotic dermatitis. The dermatitis spread to her legs and feet. On 22-FEB-2024 she got her second biopsy which was of her leg and the results were again spongiotic dermatitis. The patient was currently using a steroid ointment to treat the dermatitis which was Triamcinolone acetonide ointment 0.1 percent. The GlaxoSmithKline sales representative was very patient with reporter, and he asked her questions about the symptoms that she had with the RSV vaccine and had taken some information and he was going to report it and he was very you know calm about asking the questions. The patient was willing to give it to him because of all the symptoms that she had and it was surprised to her getting a reaction from one of the shots and that was she thought that was what that was and so he was very good and very easy to you know give him her questions and he was taking any questions that she may had so that was very helpful. The reporter consented to the follow up.
Age: 16.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported. No PQC.; AE is being filed for misuse related to PROQUAD being administered to 16 year old male; PROQUAD being concomitantly administered with VARIVAX.; This spontaneous report was received from medical assistant and refers to a 16-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 03-APR-2024 in the evening, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X018954, expiration date: 13-JUL-2025, (upon internal review it was determined to be a valid number) (strength, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot #X019302, expiration date: 14-JAN-2025 (upon internal review it was determined to be a valid number) (strength, and route of administration were not provided). Both vaccines were administered in right arm for prophylaxis (vaccination) (Product administered to patient of inappropriate age, accidental overdose). The patient had not reported any adverse events or had any emergency room visits due to being administered both vaccines (no adverse event). As of 04-APR-2024, it was unknown if the patient would receive another dose of both vaccines.
Age: 1.25
Sex: F
Vaccine: PNC15
Symptoms: Pain, Peripheral swelling, Vaccination site swelling, Weight bearing difficulty
Clinical narrative: Caller stated after injecting to a 15 month old female in right thigh, both of her legs swelled, and she was not baring weigh on legs.; Caller stated after injecting to a 15 month old female in right thigh, both of her legs swelled, and she was not baring weigh on legs.; This spontaneous report was received from Other Health Professional and refers to a 15-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (in her left tight during the events).   On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (strength, and route of administration were not provided) injection, one dose in her right tight, lot #X022479, expiration date reported as 23-JAN-2026, administered for prophylaxis.  On an unknown date, after vaccination, her both legs were swelled, and she was not baring weigh in her legs. The patient was placed on Diphenhydramine (BENADRYL) and use for pain. The patient's mother took the patient to the emergency room (ER); there, the patient was placed on prednisone. On an unknown date, the patient was admitted into the hospital due to the events. On an unknow date, the patient recovered from the event.   The causality assessment between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse called to report an adverse event for MMR-II. The MMR-II expired on 4/15/2024 and was administered to a patient on 4/22/2024. The MMR-II experienced no temperature excursions through date of administration. No additional AE reported. No PQC rep; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.   On 22-APR-2024, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, as prophylaxis (lot number: W022640, which was determined to be valid, with an expiration date on 15-APR-2024. Therapy type: rHA) (strength, dose, scheme, route and anatomical location f administration were not reported) (Expired product administered).  It was reported that the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced no temperature excursions through date of administration, no additional adverse event was reported.
Age: 0.33
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient that was given the Varivax (PF) varicella vaccine in place of the Vaxelis vaccine; This spontaneous report was received from a other health professional concerning a 4-month-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection administered for prophylaxis (strength, dose, scheme, anatomical location, route of administration, lot # and expiration date were not provided) in place of administering diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection as prophylaxis  (strength, dose, scheme, anatomical location, route of administration, lot # and expiration date were not provided) (wrong vaccine administered).
Sex: U
Vaccine: HEP
Symptoms: Immunisation reaction
Clinical narrative: Hepatitis B Vaccine Causes More Problems Than It Solves; Initial report received on 17-Apr-2024.  This report was received from a social media post.  A patient reported that a male (race and ethnicity and age unknown) received HEPLISAV-B and it "causes more problems than it solves."  No medical history at the time of vaccination was reported.  No concomitant medications at the time of vaccination were reported.  On an unknown date, a male patient received an unknown dose of a hepatitis b vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route and site of administration was not reported)].   The reporter stated that HEPLISAV-B "causes more problems than it solves."  No further information was provided.  The outcome of the event was not reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dysphagia, Gastritis, Heavy metal increased, Magnetic resonance imaging
Clinical narrative: multiple system inflammation/atrophy, multiple er visits, severe abdominal pain, scans, mris, gastritis, pots, dementia symptoms, difficulty swallowing, vocal cord paralysis, suicidal ideation, 40 lb weight loss multiple visits to neurology, gastroenterologists, urologists, speech, pulmonologist, psychiatrists,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple system atrophy, Multisystem inflammatory syndrome in adults, Postural orthostatic tachycardia syndrome, Psychiatric symptom, Scan
Clinical narrative: multiple system inflammation/atrophy, multiple er visits, severe abdominal pain, scans, mris, gastritis, pots, dementia symptoms, difficulty swallowing, vocal cord paralysis, suicidal ideation, 40 lb weight loss multiple visits to neurology, gastroenterologists, urologists, speech, pulmonologist, psychiatrists,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation, Vocal cord paralysis, Weight decreased
Clinical narrative: multiple system inflammation/atrophy, multiple er visits, severe abdominal pain, scans, mris, gastritis, pots, dementia symptoms, difficulty swallowing, vocal cord paralysis, suicidal ideation, 40 lb weight loss multiple visits to neurology, gastroenterologists, urologists, speech, pulmonologist, psychiatrists,
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: 18 y/o m patient presents to medical for HEP B , Staff administered the wrong dose of HEP B - 1ml for 20 y/o and older instead of the 18 y/o and younger. While documenting the immunization, Staff checked patient's  powerchart  that HEP B titer was positive. Notified provider right away regarding the error. Recalled the patient to check his vital signs and explained the two errors that was made by Staff. Patient's vital signs were taken and within normal limits. Patient was aware of the vaccine error that he has the right to know what happened and was instructed to report to medical if worsening symptoms arise.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Localized left arm erythema on left deltoid with induration on vaccine site. No fevers, patient is active and eating well.