chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: moderna Dose Number 6; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HF9275), in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, Lot No: 057f22a), administration date: 09May2023, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Lot No: a57145c), administration date: 15Sep2022, for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (10Oct2023) and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2023, outcome "recovered", described as "moderna Dose Number 6". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2023) Negative, notes: Tested negative day 6 and day 8; (12Oct2023) Negative, notes: Tested negative day 6 and day 8; (14Oct2023) Positive, notes: Day 10 started with fever, runny nose, cough and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. COVID 19 Treatment includes Paxlovid from 05Oct2023 to 09Oct2023.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: symptoms of a bad cold with aches and pains, no fever/tested positive on a home test/confirmed as positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 17:15 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: COVID-19 (non-serious) with onset 11Oct2023, outcome "unknown", described as "symptoms of a bad cold with aches and pains, no fever/tested positive on a home test/confirmed as positive for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that he and his wife both received the Comirnaty 2023-2024 Covid 19 vaccine on Monday, 09Oct2023 at 5:15 PM, within minutes of each other. By Wednesday night, 11Oct2023, the patient started developing symptoms of a bad cold with aches and pains, no fever. He tested positive on a home test on Thursday morning, 12Oct2023. He went to an urgent care clinic on Friday morning, 13Oct2023, and they did a nasal swab. Yesterday, 15Oct2023, he got the results from the urgent care test and it was confirmed as positive for COVID. He does work frequently in the hospital so he might have picked it up there. Two days ago on Saturday, 14Oct2023, his wife started developing symptoms and tested positive on a home test that Saturday. She has not had a regular clinic test yet.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331521 same reporter/drug/event, different patient;
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 21Sep2023 at 12:00 as dose 1, single (Lot number: HG4629) at the age of 73 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: GJ6772, Location of injection: Left Arm, Vaccine Administration Time: 11:45 AM), administration date: 26Dec2022, when the patient was 72-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: GH9702, Location of injection: Left Arm, Vaccine Administration Time: 11:00 AM), administration date: 15Sep2022, when the patient was 72-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 4, Batch/Lot No: FJ9943, Location of injection: Left Arm, Vaccine Administration Time: 11:00 AM), administration date: 04Apr2022, when the patient was 71-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: FD8448, Vaccine Administration Time: 03:00 PM), administration date: 17Sep2021, when the patient was 71-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: ER2613, Vaccine Administration Time: 05:00 PM), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 Immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Vaccine Administration Time: 02:00 PM), administration date: 24Feb2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Oct2023 at 12:00, outcome "recovered" (09Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive; (09Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Clinical course:  Anti-viral details, Paxlovid, treatment started on 04Oct2023  and treatment stopped on 08Oct2023 for treatment of COVID-19. On 04Oct2023, positive test for Covid-19 with mild symptoms, no fever. Negative test  on 09Oct2023 9 AM. The patient had no known allergies.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Tachycardia
Clinical narrative: myocarditis; chest pains; tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001244.  A 67-year-old female patient received bnt162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pains"; MYOCARDITIS (medically significant) with onset 2021, outcome "unknown"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown". Clinical course: Patient started treatment with Pfizer BioNTech COVID-19 vaccine dose 1 on 13Mar2021, and dose 2 on 16Aug2021 for COVID-19 immunisation. After the 1st dose, on unreported dates, the patient had chest pains for 9 months, tachycardia, and myocarditis.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300327879 same patient, different dose/event;
Sex: U
Vaccine: RSV
Symptoms: Asthma, Bronchitis, Pneumonia
Clinical narrative: Pneumonia; asthma; bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "Respiratory illness" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; ASTHMA (non-serious), outcome "unknown"; BRONCHITIS (non-serious), outcome "unknown".  Clinical course: Patient suffered a horrible history of respiratory illness. Patient had asthma, bronchitis, and pneumonia.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Therapeutic response unexpected
Clinical narrative: it completely halted one of my autoimmune diseases/Chronic rhinosinusitis with nasal polyps (CRSwNP).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic rhinosinusitis with nasal polyps" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "it completely halted one of my autoimmune diseases/Chronic rhinosinusitis with nasal polyps (CRSwNP).". Additional information: Important: After receiving the Pfizer covid vaccine, it completely halted one of my autoimmune diseases: Chronic rhinosinusitis with nasal polyps (CRSwNP). Daily, I would have rock like polyps forming in my nasal passages that were very painful to remove. This had gone on for a few years. I haven't had one since the vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller and his wife used a Paxlovid prescription back in 19Sep; Caller and his wife used a Paxlovid prescription back in 19Sep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller and his wife used a Paxlovid prescription back in 19Sep". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient and his wife used a Paxlovid prescription back in 19Sep and it worked perfectly with no problems and wanted to know how long to wait before getting the new Pfizer Vaccination for Covid-19.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300172107 same reporter/product/event, different patient;
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Eye irritation, Product administered to patient of inappropriate age, Syringe issue, Underdose
Clinical narrative: vaccine came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms; 49-year old female patient received fluzone hd qiv; vaccine came out of the crack in the barrel and sprayed into the patient's eyes; Initial information received on 05-Oct-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 49 years old female patient to whom when the nurse administered the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2023, the 49 years old female patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength: standard/0.7 ml, frequency: once, expiry date: not reported and lot number: U8132BA) via unknown route in unknown administration site as immunization (product administered to patient of inappropriate age), vaccine came out of the crack in the barrel of the syringe and sprayed out into the patient's eye experience minimal irritative eye symptoms (eye irritation) and (accidental exposure to product) (same day latency).  Action taken: not applicable.  An unknown corrective treatment was received for the event (eye irritation). It was not reported if the patient received a corrective treatment for other events.  At time of reporting, the outcome was Unknown for other events and was Recovering / Resolving for the event eye irritation.  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.  A Product Technical Complaint (PTC) was initiated on 05-Oct-2023 for FLUZONE HD QIV (lot/batch number: unknown) (Expiration date: unknown).  The sample status of the PTC was Not Applicable and the complaint was set in process.  Additional information was received on 05-OCT-2023 from quality department: Batch number and  PTC details added, text amended accordingly.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of ACTHIB to a patient with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3-years-old male patient who was administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On an unknown date in Oct-2023,  the patient received expired 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ801AA; expiry date: 05-Oct-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 4.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered , with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient whom  expired vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] administered , with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 09-Oct-2023, the patient received a dose 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ807AA expiry date: 01-Oct-2023 via intramuscular route in the left deltoid for immunization.  On 09-OCT-2023 the patient developed expired vaccine administered , with no reported adverse event (expired product administered) on the same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Reportedly, :Nurse mentioned that nurse misread the expiration date on a PENTACEL vaccine, nurse though the expiration date was 10Oct2023, but it was 01Oct2023, nurse was asking if they should repeat the dose  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired vaccine administered , with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: the injection site was raised after injection; Initial information was received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2023SA315554(CLUSTER) and 2023SA315006(CLUSTER).  This case involves an unknown age and gender patient who experienced the injection site was raised after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (Injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be available.  On an unknown date the patient had the injection site was raised after injection (vaccination site swelling) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 2 patients were given an expired FLUZONE QUAD (prefilled) vaccine with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender 2 patients who were given an expired influenza quadrival A-B vaccine [Fluzone QIV] 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 2 patients were given an expired dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT7731NA, expiry date- 30-JUN-2023) (strength, dose unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Caller read online that the current shot needs to be administered, is that how we proceed? Are there any adverse reactions we need to look out for? No patient information is available, caller states that she can callback if needed.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 and Regulatory Authority 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: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received two doses of Fluad Quadrivalent on the same day; This spontaneous case was received on 12-Oct-2023 from other healthcare professional (pharmacist) via digital communications (reference number SEQW23-03323) and concerned a 74-year-old, male patient.  The patient's concurrent conditions included high blood pressure and chronic obstructive pulmonary disease (COPD). The patient's concomitant medications included metoprolol tartrate, venlafaxine, losartan, omeprazole, diclofenac, Crestor (rosuvastatin calcium), trazodone, Norvasc (amlodipine besilate), Lovaza (omega-3-acid ethyl ester), Singulair (montelukast sodium), clonidine and azathioprine, all used for unreported indication.   On 12-Oct-2023, the patient received two doses of Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) at two different locations, as reported, for immunisation against influenza disease (explicitly coded as 'Extra dose administered'). The batch number reported was 371630 and the expiry date was 30-Jun-2024.  At the time of initial reporting, the patient did not experience any adverse events after the administration of Fluad Quadrivalent.  The case was assessed as non-serious.  Company comment: A 74-year-old male patient received two doses of Fluad Quadrivalent at two different locations, as reported (explicitly coded as: 'Extra dose administered'). Reportedly, patient did not experience any adverse events following vaccination. Extra dose administered is assessed as not related as per company specific conventions.; Sender's Comments: A 74-year-old male patient received two doses of Fluad Quadrivalent at two different locations, as reported (explicitly coded as: 'Extra dose administered'). Reportedly, patient did not experience any adverse events following vaccination. Extra dose administered is assessed as not related as per company specific conventions.
Age: 77.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Ear discomfort, Paranasal sinus discomfort, Tinnitus
Clinical narrative: Ear ringing; Ear pressure; Sinus pressure; Slightly dizzy; This spontaneous case was received on 13-Oct-2023 from other non-health professional (consumer) via Company (reference number SEQW23-03360) and concerned a 77-year-old, female patient.   The patient's past medical history included some allergies. The patient's concomitant medications included unspecified allergy medicine.   On 12-Oct-2023, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as she takes flu shot every year, as reported. The batch number reported was 370270.   On the same date, after receiving Fluad Quadrivalent, the patient experienced ear pressure and ringing, sinus pressure and felt slightly dizzy. The patient started taking Flonase (fluticasone propionate) and loratadine.  At the time of initial reporting, the patient had not recovered from the events. As it was reported that she still had ringing and some pressure and that symptoms were still ongoing  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 77-year-old patient was vaccinated with Fluad Quadrivalent vaccine. On the same day after receiving the suspect vaccine, the patient experienced tinnitus, ear discomfort, paranasal sinus discomfort and dizziness.  Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to chronological plausibility.; Sender's Comments: A 77-year-old patient was vaccinated with Fluad Quadrivalent vaccine. On the same day after receiving the suspect vaccine, the patient experienced tinnitus, ear discomfort, paranasal sinus discomfort and dizziness.  Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to chronological plausibility.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Erythema, Inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received the Prevnar vaccine 9/14. She then noticed a red bump on her right arm the following Sunday, 9/17. Over the next days, it extended to wrap around her right upper arm. It was itchy and swollen, not painful. She was having some chills on Monday 9/18, but didn't take her temperature. Did not persist into Tuesday. No body aches. No shortness of breath. She has tried topical hydrocortisone without help. She was taking Tylenol and Advil to help reduce inflammation. No known allergies to vaccinations or their ingredients. Patient was started on cefadroxil and reported improvement in symptoms. Has since resolved.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: Patient received the Prevnar vaccine 9/14. She then noticed a red bump on her right arm the following Sunday, 9/17. Over the next days, it extended to wrap around her right upper arm. It was itchy and swollen, not painful. She was having some chills on Monday 9/18, but didn't take her temperature. Did not persist into Tuesday. No body aches. No shortness of breath. She has tried topical hydrocortisone without help. She was taking Tylenol and Advil to help reduce inflammation. No known allergies to vaccinations or their ingredients. Patient was started on cefadroxil and reported improvement in symptoms. Has since resolved.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Our vaccinating pharmacy technician accidentally administered a fluzone high dose flu shot to a 59 year old patient at an off-site vaccine clinic.  I am submitting this report to document the incident. The patient has not reported any adverse events. I contacted the assisted living facility where we were when the vaccine was administered to inform them of the error since the patient has memory problems.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Influenza like illness, Myalgia, Taste disorder, Temperature regulation disorder
Clinical narrative: Aside from already reported s8de effects such as muscle aching, feeling flu like, inability to regulate temperature, their is a terrible taste I. My mouth that started about 24 hours after getting the shots.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Heart rate increased, Pain
Clinical narrative: Full body aches, chills, headaches, ear pain,  low fever, high resting heart (>120) for 12+ hours
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Full body aches, chills, headaches, ear pain,  low fever, high resting heart (>120) for 12+ hours
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VARIVAX was administered outside of the prescribing guidelines, 2nd dose was given at 18 months; No additional AE; This spontaneous report was received from a registered nurse referring to an 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapy were not reported.   On an unknown date (reported as 12 months of age), the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (both dose, lot#, expiration date, anatomical location and route of administration not reported) as prophylaxis. On an unknown date (reported as 18 months of age), the patient was vaccinated with the second dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (both dose, lot#, expiration date, anatomical location and route of administration not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered outside of the primary investigator (PI) guidelines (product administered to patient of inappropriate age). No additional adverse event (AE) was reported (no adverse event).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shingles about a month after the second shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles about a month after the second shot).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 12-OCT-2023 This case was reported by a patient via interactive digital media. The patient got the shot and then second shot and got the shingles about a month after the second shot. The patient said he was done with vaccines. Follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: did not eat anything; She could barely walk; she started having rigors where her teeth were chattering; fever of 103.5; nausea; splitting headache; fatigue; lymph node swelling; disequilibrium; tinnitus in her ears; redness; swelling; warm to the touch in the arm where she received the vaccine.; lightheadedness; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears) and ERYTHEMA (redness) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2022. Previously administered products included for Product used for unknown indication: Pfizer Vaccine in March 2021, Pfizer Vaccine in April 2021 and Pfizer Vaccine in December 2021; for COVID-19 prophylaxis: Moderna Covid-19 Vaccine in July 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine, Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.    On 07-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever of 103.5). On 07-Oct-2023 at 10:00 AM, the patient experienced CHILLS (she started having rigors where her teeth were chattering). On 08-Oct-2023, the patient experienced FEEDING DISORDER (did not eat anything) and GAIT INABILITY (She could barely walk). In October 2023, the patient experienced BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.), DIZZINESS (lightheadedness), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), DIZZINESS (lightheadedness), PYREXIA (fever of 103.5), CHILLS (she started having rigors where her teeth were chattering), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling) had not resolved and INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5.         The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.   No treatment information was reported.
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Headache, Injection site warmth, Lymphadenopathy, Nausea
Clinical narrative: did not eat anything; She could barely walk; she started having rigors where her teeth were chattering; fever of 103.5; nausea; splitting headache; fatigue; lymph node swelling; disequilibrium; tinnitus in her ears; redness; swelling; warm to the touch in the arm where she received the vaccine.; lightheadedness; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears) and ERYTHEMA (redness) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2022. Previously administered products included for Product used for unknown indication: Pfizer Vaccine in March 2021, Pfizer Vaccine in April 2021 and Pfizer Vaccine in December 2021; for COVID-19 prophylaxis: Moderna Covid-19 Vaccine in July 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine, Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.    On 07-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever of 103.5). On 07-Oct-2023 at 10:00 AM, the patient experienced CHILLS (she started having rigors where her teeth were chattering). On 08-Oct-2023, the patient experienced FEEDING DISORDER (did not eat anything) and GAIT INABILITY (She could barely walk). In October 2023, the patient experienced BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.), DIZZINESS (lightheadedness), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), DIZZINESS (lightheadedness), PYREXIA (fever of 103.5), CHILLS (she started having rigors where her teeth were chattering), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling) had not resolved and INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5.         The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.   No treatment information was reported.
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Swelling, Tinnitus
Clinical narrative: did not eat anything; She could barely walk; she started having rigors where her teeth were chattering; fever of 103.5; nausea; splitting headache; fatigue; lymph node swelling; disequilibrium; tinnitus in her ears; redness; swelling; warm to the touch in the arm where she received the vaccine.; lightheadedness; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears) and ERYTHEMA (redness) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2022. Previously administered products included for Product used for unknown indication: Pfizer Vaccine in March 2021, Pfizer Vaccine in April 2021 and Pfizer Vaccine in December 2021; for COVID-19 prophylaxis: Moderna Covid-19 Vaccine in July 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine, Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.    On 07-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever of 103.5). On 07-Oct-2023 at 10:00 AM, the patient experienced CHILLS (she started having rigors where her teeth were chattering). On 08-Oct-2023, the patient experienced FEEDING DISORDER (did not eat anything) and GAIT INABILITY (She could barely walk). In October 2023, the patient experienced BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.), DIZZINESS (lightheadedness), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, FEEDING DISORDER (did not eat anything), GAIT INABILITY (She could barely walk), BALANCE DISORDER (disequilibrium), TINNITUS (tinnitus in her ears), ERYTHEMA (redness), SWELLING (swelling), DIZZINESS (lightheadedness), PYREXIA (fever of 103.5), CHILLS (she started having rigors where her teeth were chattering), NAUSEA (nausea), HEADACHE (splitting headache), FATIGUE (fatigue) and LYMPHADENOPATHY (lymph node swelling) had not resolved and INJECTION SITE WARMTH (warm to the touch in the arm where she received the vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5.         The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.   No treatment information was reported.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Erythema of eyelid, Rash, Rash erythematous, Swelling of eyelid, Urticaria
Clinical narrative: I received the flu shot last Wednesday evening 10/11. On 10/14 Saturday afternoon I woke up with slightly red, slightly swollen eyelids. (I work night shift). On Sunday early morning before going to sleep I developed a red rash with some hives, and smaller bumps on my knees and my buttocks. That same afternoon when I woke up my eyelids were even more swollen than the day before. I haven?t been exposed to anything new other than the flu shot that I know of, haven?t changed any skin products, haven?t eaten anything different, or taken any new medications. I put hydrocortisone cream on the rash and it cleared up by afternoon, I also took Benadryl but it didn?t help the swollen eyelids. They were close to normal by Monday morning.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain, Tenderness
Clinical narrative: I am still having significant left shoulder pain one month after the administration. The injection was given very high, and I believe was administered into the bursa instead of the muscle. The pain is worse with palpating and lifting my arm up. I can do most activities, but have to take ibuprofen if I know I will be using my arms for a lot of physical activity. I know this will probably heal and recover eventually, but it is impacting my life  for now.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Ear discomfort, Eye movement disorder, Hypoacusis
Clinical narrative: Ear felt plugged like I had gotten water in it. It did not subside, so I went to my PCP after a week. My balance was off, eyes seemed to have a control issue with movement and brain to follow, My hearing has been impaired, so I was fast tracked ENT for examination. No liquid in ear, given an audiology consult with hearing being significantly diminished. Prescribed Prednisone 20MG for 10 days for possible inflammation of the ear gland with a follow up on October25th and another audiol ogy test.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10/3/23 - An area of warm, swollen redness appeared on her right upper arm, painful to move arm. 10/4/23 - Fever, chills, headache with ongoing warm, swollen and red right upper arm, pain with arm movement. 10/6/23 - right arm still warm and red, redness larger in size, but now itchy and still painful to move arm. 10/9/23 - redness decreased, no more pain with arm movement, arm still itchy.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: 10/3/23 - An area of warm, swollen redness appeared on her right upper arm, painful to move arm. 10/4/23 - Fever, chills, headache with ongoing warm, swollen and red right upper arm, pain with arm movement. 10/6/23 - right arm still warm and red, redness larger in size, but now itchy and still painful to move arm. 10/9/23 - redness decreased, no more pain with arm movement, arm still itchy.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED AFTER VIABILITY DATE
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Began as typical injection site soreness, but it never resolved. One month later i continue to have pain in that muscle , along with limited range of motion of the arm.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: possible adm . of only vial  1 was given to pt. not discovered until all 5 dose were administration from box. unable to determine which patient  did not get unmixed dose.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Possible adm. of only vial 1 was given to pt. not discovered until all 5 doses were adm. from the box. Unable to determine which patient did not get unmixed dose
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Possible adm of vial 1 was given to pt. , not discovered until after 5 doses were administered from box. unable to determine which pt. did not get mixed dose
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Possible adm. of only vial 1 was given to pt. not discovered until all 5 doses were adm. from the box. Unable to determine what pt. did not get unmixed dose
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Body temperature increased, Dysgeusia, SARS-CoV-2 test negative, Toothache
Clinical narrative: All joints hurt really really hurt, Temp ranged between 100.5 and 100.7 for appox 24 hours. I couldn't hold my urine. Food tastes bad, metallic. Took home COVID test, it was negative. Took Tylenol for fever. I felt like I did when I had Swine flu 30 years ago. Teeth hurt.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Urinary incontinence
Clinical narrative: All joints hurt really really hurt, Temp ranged between 100.5 and 100.7 for appox 24 hours. I couldn't hold my urine. Food tastes bad, metallic. Took home COVID test, it was negative. Took Tylenol for fever. I felt like I did when I had Swine flu 30 years ago. Teeth hurt.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Discomfort, Rash erythematous, Rash pruritic
Clinical narrative: Uticarial dermatitis on front torso, arms, and upper legs. Slightly red rash with some itchiness/discomfort. Most of rash had faded after six days. No treatment except for aloe vera for comfort.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling cold, Headache, Pain
Clinical narrative: Within 24 hours, he developed extreme fatigue, body aches, bitemporal headache and constant feeling of being cold.  These symptoms still remain.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Enlarged uvula, Fear, Oral mucosal erythema, Oral pain
Clinical narrative: She got her vaccine, had the listed reactions on the paperwork.  She has had all the Pfizer vaccines and the listed normal reactions.  She woke up out of her sleep this morning with a sensation of feeling where she could not breath, she was blocked in the back of her throat with severe soreness of her uvula, and it was red when she checked it.  The uvula was very swollen and red.  It was scary, she was thinking that this was happening to her again.  She is watching, and now she has a sore throat.  This kind of feels like a reaction that she had when taking generic medications of anaphylaxis.  She is breathing a little easier but sill has the swollen, red sore throat.  She has not called her doctor, but left word with one of them and she has not called her PCP yet.