chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was erroneously given to someone below 18 with no reported adverse event; Initial information received on 16-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves Adolescent and unknown gender patient where Influenza quadrivalent recombinant vaccine [Flublok] was erroneously given to someone below 18 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immuisation and flublok was erroneously given to someone below 18 with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  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: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Bell's palsy, Dysphagia, Facial paralysis
Clinical narrative: Woke up the next day with trouble swallowing and minor jaw paralysis, diagnosis by Dr as Bell's Palsy
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: accidently gave 2 flu hd to pt (requested flu hd and covid)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy hives erupting, usually late in the day, at various parts of my body.  One of the first episodes was a series of hives around almost my entire waistline but not my back. Right now, under my left arm and other spots on my body and legs.
Age: 72.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pt described extreme swelling of top of arm (almost doubling in size) and extreme itching. Woke up to these effects on Saturday after vaccine given.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: PT RECEIVED 2 COVID SHOTS AND 1 FLUZONE HD SHOT.  PT SHOULD HAVE RECEIVED ONE COVID AND ONE FLU SHOT
Age: 23.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Anxiety, Dizziness
Clinical narrative: At around 11:00 am, patient requested help today at (redacted) team her first Hepatitis A vaccine and her first Jynneos vaccine. PHN, assessed patient and confirmed previous vaccines in the vaccine database. Patient denied history of allergies or adverse reactions to vaccines.  Patient reported only history of Anxiety, untreated. At  11:10 am PHN, administered Jynneos vaccine lot # FDP00015 BUD 9/30/2024 in the right arm, subcutaneously. At 11:12 am patient reported feeling dizzy and anxous. Patient started deep breathing and PHN, gave patient juice box. Patient finished juice box. PHN, walked patient over to lay down in her tent. Patient sat up and consented to vitals being taken at 11:18 am: Blood pressure: 110/60, heart rate 78 BPM, 16 respiratory rate, 100 % SP02. Patient stated she was feeling better. Patient ate a snack, drank water. Patient requested to received Hepatitis A vaccine. PHN called Dr.. Dr. agreed OK to administer Havrix to the patient after dizziness resolved. PHN, administered Havrix lot # 772YT exp 9/23/2025 in the left deltoid while the patient was supine. Patient displayed no signs or symptoms of anxiety and stated she "felt fine." Patient sat up at 11:40 am and gave PHN, permission to take vitals: heart rate was 88 beats per minute, oxygen saturation was 99%, respiratory rate 18 per minute. Patient educated sign and symptoms of emergency. Patient denied dizziness or nausea and walked away with a steady gait at 11:45 am with referral to the local clinic.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Prior to the day vaccine was administered (on Friday) to the pt there was a flu clinic offsite. 2 patients at the clinic refused to receive their pfizer covid vaccine after vaccine was prepared. Pharmacist brought back these 2 vaccines to use for other patients who need the vaccine as long as it is same day (Frida). Vaccines were not used on Friday but they were kept in the fridge. On Saturday, clerk pulled one of the 2 prepared vaccines and gave it to the pharmacist who administered the vaccine. Vaccine was assembled around 4:30 pm on Friday 9/27/24 and was brought back, stored in fridge and administered to the patient mentioned above around 09:38 am on Saturday. The assembled vaccine was kept refrigerated all time.
Age: 12.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Herpes virus test, Viral test, Vulvovaginal ulceration
Clinical narrative: Lipschutz ulcer
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: Pt called on 9/30/24 and stated he has tested his blood sugar and found his fasting levels to be >200 since his shot
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Headache, Neck pain, Pain in jaw
Clinical narrative: posterior head and neck pain, left jaw and shoulder pain started 8 days after vaccination, worse at night. Takes Tylenol with some relief. Will be seen by MD in 2 days
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Measles post vaccine, Morbillivirus test positive, Pyrexia, Rash
Clinical narrative: Rash , fever, headache
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt reported warmth, redness and swelling at the injection site
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a flu shot when she already received a flu shot at another pharmacy a few days prior.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram, Fatigue, Muscular weakness, Pain in extremity, Palpitations
Clinical narrative: Patient stated on 9/27/24 at approximately 1009 she began feeling heart palpitations, fatigue, and weakness in her legs. She also stated her right arm felt sore for two days after Moderna vaccine.  Patient came into Hospital as a walk in patient on 9/30/24 because she was concerned of her palpitations she felt on 9/27/24. The walk in provider saw the patient and ordered an EKG. Provider approved EKG and faxed to patient's cardiologist.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Mom states her son complained of having a rash on his torso that went up his back.  It was noticed Saturday during the day so less than 24 hours after receiving both a flu and a covid vaccination.  He has had both before, however, this was the first time he had the 12 and up formulation for the covid vaccination.  The rash is itchy and raised.  It sounded like she was describing hives.  She has tried triamcinolone which did not help.  She tried benadryl which also did not help.  She plans to give him benadryl and pepcid this evening to help with the itchiness.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Heart rate increased
Clinical narrative: Elevated resting heart rate episodes. Currently pregnant and due March 18 2025
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received two dosages of the flu vaccine. One dose was administered on 08/08/2024 and the second on 09/29/24
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Blood pressure decreased, Dysgeusia, Fatigue, Feeling hot, Nausea
Clinical narrative: About 4-5 minutes after the shot, I got really hot, my blood pressure dropped, my mouth felt like metal, and I felt nauseated. I had to lie down for about 25 minutes, and I feel very tired still.  I had not had a lot to eat prior to the vaccination but was well hydrated.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: About 4-5 minutes after the shot, I got really hot, my blood pressure dropped, my mouth felt like metal, and I felt nauseated. I had to lie down for about 25 minutes, and I feel very tired still.  I had not had a lot to eat prior to the vaccination but was well hydrated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: SpikeVax Moderna with Influenza (unknown name) administered at pharmacy on 09/29/24. Pt developed L arm erythema w/o swelling  same days that didn't improve after taking OTC  Benadryl single dose same day
Age: 69.0
Sex: M
Vaccine: COVID19, FLU3, PNC20, RSV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Pt wanted COVID (Moderna), high dose flu (Fluad) and a Pneumonia shot (Prevnar 20). Pt was accidentally given RSV (Arexvy) which he had already received last year. No adverse events seen when he left today.
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Atrial fibrillation, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Had a lot of symptoms this time. Afib happening daily and longer episodes than usual and more frequent and different times. I also had headaches, fatigue, nausea, chills muscle aches and pain at injection sites. Recovered from all symptoms except the Afib which is continuing daily
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: Had a lot of symptoms this time. Afib happening daily and longer episodes than usual and more frequent and different times. I also had headaches, fatigue, nausea, chills muscle aches and pain at injection sites. Recovered from all symptoms except the Afib which is continuing daily
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Colitis, Computerised tomogram abdomen abnormal
Clinical narrative: severe abdominal pain for 9 hours. No associated symptoms.  patient presented to ED. On CT abdomen, there was concern for possible appendicitis and proctocolitis. Appendicitis ruled out. Proctocolitis was mild and appeared resolving per GI surgeon. Patient's pain resolves after receiving fluids and Pepcid but was admitted overnight due to concern re possible appendicitis.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anion gap increased, Anti-GAD antibody positive, Blood chloride decreased, Blood glucose increased, Glycosylated haemoglobin increased
Clinical narrative: Whether the vaccine is related to the development of T1DM, but this is being reported as there is literature suggesting there could be a relationship. Patient Diagnosed with Type 1 Diabetes in January 2024. Previous fasting blood glucose levels and HgA1C had always been normal. A fasting blood glucose level on 11/1/2023, approximately 3.5 weeks after the covid booster vaccination a fasting blood glucose was abnormal at 181.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Type 1 diabetes mellitus
Clinical narrative: Whether the vaccine is related to the development of T1DM, but this is being reported as there is literature suggesting there could be a relationship. Patient Diagnosed with Type 1 Diabetes in January 2024. Previous fasting blood glucose levels and HgA1C had always been normal. A fasting blood glucose level on 11/1/2023, approximately 3.5 weeks after the covid booster vaccination a fasting blood glucose was abnormal at 181.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache, dizziness, and nausea beginning about 1 hr. after administration of vaccine. Patient laid down and rested and was given water and crackers.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Syncope, Urinary incontinence, Vomiting
Clinical narrative: Syncopal episode with loss of bladder control, arousable after a few minutes, then with nausea and vomiting.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Lymphadenopathy, Peripheral swelling
Clinical narrative: Covid arm, large swollen area, tennis ball diameter, enlarged lymph nodes under left arm
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction, Swelling
Clinical narrative: No reaction immediately at pharmacy. Later that day 9/18/24, patient experienced bleeding/swelling/bruising and sought assessment at an urgent care. By 9/23/24, swelling/bruising had improved. As of 9/26/24, patient still experiencing bruising.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness/swelling and pain at the injection site. There was no sysmptoms of anaplylaxis or rash anywere else on the body. Injection site was iced, and patient was given benadryl. Patient was monitored for an extened period of time. she left pharmacy since she insisted she was feeling fine, and the injection site appeared normal.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine site swollen, hot to touch, red, and itchy. Parent informed to use ice or cool compress to site, apply topical cortisone cream, and use oral motrin. Parent also informed to call back if area gets larger.
Sex: F
Vaccine: UNK
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Nausea, Pharyngeal swelling
Clinical narrative: Symptoms of anaphylaxis began occur after injection of the vaccine. The patient had swelling of the throat and difficulty breathing, as well as flushing of the skin. She was taken to the emergency department and was provided with epinephrine and corticosteroids as well as benadryl, famotidine, and nebulized albuterol. Symptoms of nausea, swelling of throat and face resolved after administration of medications in ED.
Sex: F
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: Symptoms of anaphylaxis began occur after injection of the vaccine. The patient had swelling of the throat and difficulty breathing, as well as flushing of the skin. She was taken to the emergency department and was provided with epinephrine and corticosteroids as well as benadryl, famotidine, and nebulized albuterol. Symptoms of nausea, swelling of throat and face resolved after administration of medications in ED.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Arthralgia, Back pain, CSF protein increased
Clinical narrative: Patient went to the ER 10 days post vaccination administration. Complained of injection-site rash and redness. Extremety pain with numbness/ tingling sensation, unsteady gait, pain in the left shoulder, radiating to her back and to shoulder, as well as LE radiating pain, worsening weakness and trouble ambulating, numbness and tingling in the legs and palms. Discharged from ER 06/27/2024 and was given steroids and NSAIDS for treatment. Admitted to hospital again 06/29/2024 progressively worsening weakness. No longer able to ambulate. Also c/o back pain. Received lumbar puncture CSF Proteins elevated to 79. Diagnosed with AIDP and GBS with superimposed CVA.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Cerebellar infarction, Cerebrovascular accident, Chest X-ray normal, Gait disturbance, Gait inability
Clinical narrative: Patient went to the ER 10 days post vaccination administration. Complained of injection-site rash and redness. Extremety pain with numbness/ tingling sensation, unsteady gait, pain in the left shoulder, radiating to her back and to shoulder, as well as LE radiating pain, worsening weakness and trouble ambulating, numbness and tingling in the legs and palms. Discharged from ER 06/27/2024 and was given steroids and NSAIDS for treatment. Admitted to hospital again 06/29/2024 progressively worsening weakness. No longer able to ambulate. Also c/o back pain. Received lumbar puncture CSF Proteins elevated to 79. Diagnosed with AIDP and GBS with superimposed CVA.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Injection site erythema, Injection site rash, Magnetic resonance imaging head abnormal
Clinical narrative: Patient went to the ER 10 days post vaccination administration. Complained of injection-site rash and redness. Extremety pain with numbness/ tingling sensation, unsteady gait, pain in the left shoulder, radiating to her back and to shoulder, as well as LE radiating pain, worsening weakness and trouble ambulating, numbness and tingling in the legs and palms. Discharged from ER 06/27/2024 and was given steroids and NSAIDS for treatment. Admitted to hospital again 06/29/2024 progressively worsening weakness. No longer able to ambulate. Also c/o back pain. Received lumbar puncture CSF Proteins elevated to 79. Diagnosed with AIDP and GBS with superimposed CVA.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Muscular weakness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient went to the ER 10 days post vaccination administration. Complained of injection-site rash and redness. Extremety pain with numbness/ tingling sensation, unsteady gait, pain in the left shoulder, radiating to her back and to shoulder, as well as LE radiating pain, worsening weakness and trouble ambulating, numbness and tingling in the legs and palms. Discharged from ER 06/27/2024 and was given steroids and NSAIDS for treatment. Admitted to hospital again 06/29/2024 progressively worsening weakness. No longer able to ambulate. Also c/o back pain. Received lumbar puncture CSF Proteins elevated to 79. Diagnosed with AIDP and GBS with superimposed CVA.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
Clinical narrative: end up getting COVID in Nov2022 over holiday; end up getting COVID in Nov2022 over holiday; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER6213), in arm and on 26Apr2021 as dose 2, single (Lot number: ER8729) at the age of 52 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I do not smoke, nothing" (unspecified if ongoing), notes: I do not smoke, nothing; "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (2022) and all described as "end up getting COVID in Nov2022 over holiday". Patient actually ended up getting COVID in Nov2022 over holiday and that COVID lasted about 3 to 4 weeks because she remembers deficiency in autoimmune disease and that is why she was put on quarantine. The patient underwent the following laboratory tests and procedures: Lab work: Unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400261975 Same patient, different vaccine dose and event;
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: Scratchy throat, fever
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Chills, Erythema, Fatigue, Injection site pain, Swelling
Clinical narrative: Swelling; Bright redness; Fatigue; Chills; Site soreness; Fluad Quadrivalent and Arexvy vaccines were administered in the same arm on the same date; This spontaneous case was retrieved 10-Jan-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2720866-1) reported by other healthcare professional and concerned an elderly female patient.    The patient's concurrent condition included rheumatoid arthritis, allergic rhinitis, GERD, edema, nutcracker esophagus, hypothyroidism, bladder spasms, hypercholesteremia, low thyroid, neuropathy, vaginal infections, and allergies to Septra (sulfamethoxazole and trimethoprim), Lipitor (atorvastatin), lisinopril, phenothiazines, Reglan (metoclopramide), methotrexate, Imuran (azathioprine), gabapentin, and Intravenous Pyelogram (IPV) dye allergy. The patient's concomitant medications included Allegra (fexofenadine hydrochloride), Corlanor (ivabradine hydrochloride), Cosentyx (secukinumab), diltiazem ER (extended release), famotidine, Cytomel (liothyronine sodium), Myrbetriq (mirabegron), progesterone, Crestor (rosuvastatin calcium), Tirosint (levothyroxine sodium), trazodone, Trelegy (fluticasone furoate, umeclidinium bromide, vilanterol trifenatate), Yuvafem (estradiol), Voltaren (diclofenac epolamine) and tramadol, all used for unspecified indications.    On 01-Dec-2023, the patient was vaccinated with a non-company, co-suspect Arexvy vaccine (RSV vaccine prot. subunit PreF3; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number was not reported.  On the same date, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number was not reported.  On 02-Dec-2023, reported as 'on day two', one day after receiving the Fluad Quadrivalent vaccine and non-company, co-suspect Arexvy vaccine, the patient experienced fatigue, chills, and site soreness.   On an unspecified date in Dec-2023, reported as 'by day four', the patient had recovered from the events of fatigue, chills, and 'vaccination site pain'.  On 04-Dec-2023, reported as 'on day four', the patient noticed bright redness and swelling.  At the time of the initial reporting, the patient had not recovered from the events of redness and swelling.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Case Correction (10-Jan-2024): After internal review of information, Product administration error LLT was amended to Product use issue" Fields updated accordingly.; Reporter's Comments: The events considered as related due to chronological and anatomical plausibility. Product use issue error is assessed as not related.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Placental disorder, Premature delivery
Clinical narrative: Exposure during pregnancy; Due date was 28Feb2024 and baby girl was born; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2749519-1 (VAERS ID).  A neonate female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), administration details for the mother: on 05Jan2024 at 15:45 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal immunisation. The mother of the patient was 32 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother's relevant medical history included: "Latex allergy" (unspecified if ongoing). The mother is expected to deliver a baby(s) on 28Feb2024. The mother took concomitant medications (Pre-natal vitamins). The mother's vaccination history included: Influenza vaccine (Vaccine: 1176 Influenza (seasonal) (Flublok Quadrivalent), Manufacturer: Protein Sciences Corporation, Route: Intramuscular-IM, Site: Left Arm, Dose number: 1), for Immunization. The following information was reported: PREMATURE BABY (medically significant) with onset Jan2024, outcome "unknown", described as "Due date was 28Feb2024 and baby girl was born"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Exposure during pregnancy". Clinical course: The mother never had an adverse event following any previous vaccine. The mother's pregnancy was uncomplicated, other than marginal placenta. Due date was 28Feb2024 and baby girl was born. Baby was born 5 pounds and 4 ounces. Both mom and baby are doing well. No reason for late premature birth identified.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated age as neonate, updated indication of immunization to maternal immunization & updated event description.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from a consumer (mother) via FDA (2749519-1).  Updated information: reporter information, parent data, suspect vaccine details, mother's concomitant medications.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received. Follow-up (01Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400047113 Mother case;
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Exposure during pregnancy; Due date was 28Feb2024 and baby girl was born; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2749519-1 (VAERS ID).  A neonate female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), administration details for the mother: on 05Jan2024 at 15:45 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal immunisation. The mother of the patient was 32 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother's relevant medical history included: "Latex allergy" (unspecified if ongoing). The mother is expected to deliver a baby(s) on 28Feb2024. The mother took concomitant medications (Pre-natal vitamins). The mother's vaccination history included: Influenza vaccine (Vaccine: 1176 Influenza (seasonal) (Flublok Quadrivalent), Manufacturer: Protein Sciences Corporation, Route: Intramuscular-IM, Site: Left Arm, Dose number: 1), for Immunization. The following information was reported: PREMATURE BABY (medically significant) with onset Jan2024, outcome "unknown", described as "Due date was 28Feb2024 and baby girl was born"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Exposure during pregnancy". Clinical course: The mother never had an adverse event following any previous vaccine. The mother's pregnancy was uncomplicated, other than marginal placenta. Due date was 28Feb2024 and baby girl was born. Baby was born 5 pounds and 4 ounces. Both mom and baby are doing well. No reason for late premature birth identified.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated age as neonate, updated indication of immunization to maternal immunization & updated event description.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from a consumer (mother) via FDA (2749519-1).  Updated information: reporter information, parent data, suspect vaccine details, mother's concomitant medications.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received. Follow-up (01Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400047113 Mother case;
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Placenta praevia, Premature delivery
Clinical narrative: Exposure during pregnancy; Due date was 28Feb2024 and baby girl was born; This is a spontaneous report and received from Consumer or other non HCPs from Regulatory Authority. Regulatory number: 2749519-1 (VAERS ID).  A neonate female patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), administration details for the mother: on 05Jan2024 at 15:45 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal immunisation. The mother of the patient was 32 years old at the time of vaccination. The patient's relevant medical history was not reported. The mother's relevant medical history included: "Latex allergy" (unspecified if ongoing). The mother is expected to deliver a baby(s) on 28Feb2024. The mother took concomitant medications (Pre-natal vitamins). The mother's vaccination history included: Influenza vaccine (Vaccine: 1176 Influenza (seasonal) (Flublok Quadrivalent), Manufacturer: Protein Sciences Corporation, Route: Intramuscular-IM, Site: Left Arm, Dose number: 1), for Immunization. The following information was reported: PREMATURE BABY (medically significant) with onset Jan2024, outcome "unknown", described as "Due date was 28Feb2024 and baby girl was born"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Exposure during pregnancy". Clinical course: The mother never had an adverse event following any previous vaccine. The mother's pregnancy was uncomplicated, other than marginal placenta. Due date was 28Feb2024 and baby girl was born. Baby was born 5 pounds and 4 ounces. Both mom and baby are doing well. No reason for late premature birth identified.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated age as neonate, updated indication of immunization to maternal immunization & updated event description.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from a consumer (mother) via FDA (2749519-1).  Updated information: reporter information, parent data, suspect vaccine details, mother's concomitant medications.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received. Follow-up (01Oct2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400047113 Mother case;
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: it was supposed to be Varicella to be administered but they have given the VAXELIS instead/ An inappropriate use due to PENTACEL and VAXELIS being administered at the same day/time resulting to patient receiving DTAP-IPV-HIB components; Nurse also confirmed that it was supposed to be Varicella to be administered but they have given the VAXELIS instead; patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel; patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel; This non-serious spontaneous safety report, with reference number 2024SA252910, was received by partner on 29-AUG-2024 and forwarded on 30-AUG-2024 from other health professional.  Due to the nature of the event, the causality between the event 'it was supposed to be Varicella to be administered but they have given the VAXELIS instead/ An inappropriate use due to PENTACEL and VAXELIS being administered at the same day/time resulting to patient receiving DTAP-IPV-HIB components', 'patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: it was supposed to be Varicella to be administered but they have given the VAXELIS instead/ An inappropriate use due to PENTACEL and VAXELIS being administered at the same day/time resulting to patient receiving DTAP-IPV-HIB components; Nurse also confirmed that it was supposed to be Varicella to be administered but they have given the VAXELIS instead; patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel; patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel; This non-serious spontaneous safety report, with reference number 2024SA252910, was received by partner on 29-AUG-2024 and forwarded on 30-AUG-2024 from other health professional.  Due to the nature of the event, the causality between the event 'it was supposed to be Varicella to be administered but they have given the VAXELIS instead/ An inappropriate use due to PENTACEL and VAXELIS being administered at the same day/time resulting to patient receiving DTAP-IPV-HIB components', 'patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel' and Vaxelis was not applicable.  Further information is expected.
Age: 8.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: HCP called to report that a patient received PROQUAD and MENVEO mixed together and injected intramuscularly. Caller states the intent was to administer PROQUAD mixed with sterile diluent as indicated, but the product was accidentally mixed with MENVE; product was accidentally mixed with MENVEO and administered; product was accidentally mixed with MENVEO and administered; Inappropriate reconstitution technique; No side effects or symptoms reported; This spontaneous report as received from a Certified Medical Assistant (C.M.A) concerning an 8-year-old male patient with prophylaxis. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 12-SEP-2024, the health care professional (HCP) called to report that the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X025094, expiration date: 16-APR-2024, 0.5 milliliter, for prophylaxis and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) 0.5 ml, E4A39, expiration date: 30-JUN-2024 for prophylaxis mixed together and injected intramuscularly (Incorrect route of product administration).   Caller stated the intent was to administer measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) mixed with sterile diluent as indicated, but the product was accidentally mixed with meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) and administered (Wrong product administered, product administration error and product preparation issue). Caller stated this administration was a "catch up" administration as the patient was unsure if they had ever received any doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), the facility treated this as the initial dose. No side effects or symptoms reported.   No further information provided. No Additional AE/ No PQC (No adverse event).
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/ PQC reported.; Mother stated that her son has received the first and second doses of the ROTATEQ vaccine in April and May 2024/  will be 8 months tomorrow /is already 35 weeks old /she has paused a lot of vaccines.; This spontaneous report was received from a Consumer and refers to a male patient of 35-week-old.   The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On an unknown day in April 2024, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, administered orally as prophylaxis (lot#, expiration date, strength, exact dose quantity volume, and vaccination scheme frequency were not provided). On an unspecified day in May 2024, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, administered orally as prophylaxis (lot#, expiration date, strength, exact dose quantity volume, and vaccination scheme frequency were not provided).   On an unknown day in 2024, patient's mother stated that her son has not received the third dose of ROTATEQ vaccine and it would be "8 months tomorrow". Additionally, it was stated that she decided to pause a lot of vaccines for her son because she did not want to give all the vaccines at once (Inappropriate schedule of product administration).  The patient received the rabies vaccine but did not state the date of administrations and disconnected the phone call abruptly. Also, she provided limited pertinent information, demographic data, had no further clarifications and permission to contact the HCP for a follow-up was unspecified and a letter could not be sent.   No additional AE/PQC reported. (No adverse event)
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to administration for patient younger than indicated population with no reported adverse event; Initial information received on 16-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 64 years old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] and had inappropriate use due to administration for patient younger than indicated population with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2024, the patient received once a high dose of 0.5 ml suspect influenza USP trival A-B high dose subvirion vaccine suspension for injection in pre filled syringe with lot UT8454FA (unknown expiry date) via intramuscular route in the left deltoid for immunization and had inappropriate use due to administration for patient younger than indicated population with no reported adverse event (product administered to patient of inappropriate age) (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: 41.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Extremely itchy face rash spreading to neck
Age: 0.5
Sex: M
Vaccine: COVID19, DTAPHEPBIP, FLU3, HIBV, PNC20, RV5
Symptoms: Breath holding, Crying, Erythema, Infant irritability, Periorbital oedema
Clinical narrative: The evening following immunization, infant developed near constant fussiness with frequent crying, congestion, and fever to 103F. 2-3 days later, also developed edema and erythema of the periorbital skin. Periorbital erythema and edema improved with PO Cetirizine. +Breath holding spells x3-4.
Age: 0.5
Sex: M
Vaccine: COVID19, DTAPHEPBIP, FLU3, HIBV, PNC20, RV5
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: The evening following immunization, infant developed near constant fussiness with frequent crying, congestion, and fever to 103F. 2-3 days later, also developed edema and erythema of the periorbital skin. Periorbital erythema and edema improved with PO Cetirizine. +Breath holding spells x3-4.
Age: 71.0
Sex: M
Vaccine: COVID19, PNC20, TDAP
Symptoms: Asthenia, Erythema, Fatigue, Gait disturbance, Impaired work ability
Clinical narrative: Pt came in Sep 30th to inform us of a reaction that he had developed from the vaccine (Tdap/Prevnar20 vaccine is his first time receiving it). 1st day of vaccination he was ok with no symptoms.  Sat AM, he had flu-like Sx and was bed-bound, in which  he couldn't get up out of bed (+) Low grade fever (+ ) Weakness/Fatigue (+) pt also claimed that he wet his pants as he could not get out of bed.  Sunday he was home all day and could not go to work due to sustained weakness. Monday morning he was better but needed a cane to stay stable. He noticed a minor rash Monday morning.  Per pt he administered the following meds: IBU 800mg x 1 dose, APAP 1000 mg x 1 dose.] I told the pt to take Diphenhydramine 50 mg at bedtime to help with the redness/itchiness. He will follow up with provider to make sure he is ok.
Age: 71.0
Sex: M
Vaccine: COVID19, PNC20, TDAP
Symptoms: Influenza like illness, Mobility decreased, Pruritus, Pyrexia, Rash
Clinical narrative: Pt came in Sep 30th to inform us of a reaction that he had developed from the vaccine (Tdap/Prevnar20 vaccine is his first time receiving it). 1st day of vaccination he was ok with no symptoms.  Sat AM, he had flu-like Sx and was bed-bound, in which  he couldn't get up out of bed (+) Low grade fever (+ ) Weakness/Fatigue (+) pt also claimed that he wet his pants as he could not get out of bed.  Sunday he was home all day and could not go to work due to sustained weakness. Monday morning he was better but needed a cane to stay stable. He noticed a minor rash Monday morning.  Per pt he administered the following meds: IBU 800mg x 1 dose, APAP 1000 mg x 1 dose.] I told the pt to take Diphenhydramine 50 mg at bedtime to help with the redness/itchiness. He will follow up with provider to make sure he is ok.
Age: 71.0
Sex: M
Vaccine: COVID19, PNC20, TDAP
Symptoms: Walking aid user
Clinical narrative: Pt came in Sep 30th to inform us of a reaction that he had developed from the vaccine (Tdap/Prevnar20 vaccine is his first time receiving it). 1st day of vaccination he was ok with no symptoms.  Sat AM, he had flu-like Sx and was bed-bound, in which  he couldn't get up out of bed (+) Low grade fever (+ ) Weakness/Fatigue (+) pt also claimed that he wet his pants as he could not get out of bed.  Sunday he was home all day and could not go to work due to sustained weakness. Monday morning he was better but needed a cane to stay stable. He noticed a minor rash Monday morning.  Per pt he administered the following meds: IBU 800mg x 1 dose, APAP 1000 mg x 1 dose.] I told the pt to take Diphenhydramine 50 mg at bedtime to help with the redness/itchiness. He will follow up with provider to make sure he is ok.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Twinrix in October 2023 and 2nd in July 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on October 2023).   In JUL-2024, the patient received the 2nd dose of Twinrix. In JUL-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose of Twinrix in October 2023 and 2nd in July 2024.). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-SEP-2024 Pharmacist stated a patient received the 1st dose of Twinrix in October 2023 and 2nd in July 2024, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had COVID when I came back.; I had COVID when I came back.; This is a spontaneous report received from a Physician. Other Case identifier(s): MOC20240920000014 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unknown if ongoing); "Phlebitis" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Paxlovid, reaction(s): "phlebitis", notes: I had a phlebitis, it activated and went up my leg. It's usually just at the ankle.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I had COVID when I came back from travel.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient has an ongoing phlebitis. The patient had COVID-19 when the patient came back from travel. The patient had all the series with Pfizer and will get Moderna vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Bone pain, Diarrhoea, Headache, Pyrexia
Clinical narrative: Fever 101.5 now resolved.  Belly pain and diarrhea since 9/28/24 not resolved. Bone pain, resolved. Headache, resolved.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Shortly after vaccination patient reported feeling faint. Patient appeared pale and clammy. Patient was observed in a seated position for approximately 20 minutes. Symptoms resolved on their own without intervention. Patient did not losee consciousness but did report feeling dizzy and faint for several minutes. Patient left in company of a family member upon the resolution of symptoms. Phone follow-up completed a few hours after event and patient reported feeling normal. Patient was instructed to follow up with primary care.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in 45-year-old male EUA medical countermeasure recipient. Dose#1 date 04/26/21 LOT# UNK, pharmacy number unavailable. Unable to obtain any information on subsequent doses, pre-death adverse events and pre-existing medical conditions, victim may be high BMI and or obese,
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Technician gave 2 different covid shots to the same patient. 2 were ready one Comirnaty and the other Novavax. No adverse event was noted by the patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Fatigue, Headache, Hunger
Clinical narrative: Fatigue, chest pain, major anxiety, panic attacks, poor sleep, hunger, headache, low immune system
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Panic attack, Poor quality sleep
Clinical narrative: Fatigue, chest pain, major anxiety, panic attacks, poor sleep, hunger, headache, low immune system
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell?s Palsy on right side of the face
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Immunisation reaction, Urticaria
Clinical narrative: Hives on cheeks, legs. Reaction to the flu vaccine per MD.  Recommended Benadryl as needed
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pt got vaccine on 08/20/2024.  On 09/27-24  Friday about 5:30 while she was picking up her prescription she said I want to talk to you.  Then she said you know that 2nd shingles shot you gave me about 3 weeks ago? (I said I would take her word for it until I looked it up) She then said it is causing a shooting pain in her neck.  I told her this is not a normal reaction but she believes it is vaccine related. I told her I would need to call her to get additional details. When I called her it went to voice mail and asked her to call me back with details required to fill this out.  She has yet to respond - I will call again.  The vaccine was over a month when she notified the pharmacy of her reaction -she said 3 weeks.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disturbance in attention, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: JANSSEN #1 01/12/2022 DEVELOPED VACCINE INDUCED POTS, PALPITATIONS, POST-EXERTIONAL MALAISE, LOSS OF MENTAL CLARITY, AND ANA POSITIVE LIVEDO RETICULARIS PATTERN WITH ARTHRALGIA.   TREATED WITH PROPRANOLOL, HYDROXY CHLOROQUINE, COLCICINE, AND PROTOCOL BASE SPIKE DETOXIFICATION. Clinical Approach to Post-acute Sequelae After COVID-19 Infection and Vaccination.