chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: No problems during vaccine in left arm with no reaction on skin or arm other than slight soreness. Evening on date of vaccine, felt  muscle ache, fatigue, chest tightness that continued following days. No fever. 3 days after vaccination, felt very, fatigued, weak and no strength trying to walk a short distance. Before vaccination, normal 3 mile walk 3-5 times week at avg 3 mph with no issues. 4 days after vaccination went to urgent care  with same symptoms. Neg for flu and covid. 6 days after vaccination symptoms better but still evident. Same on day 7. Seeking PCP care on day 8 or ER.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt experienced NO side effects; discovered that 2 doses were administered- both accepted by insurance; 1st on 11/29/23 and 2nd on 10/09/2024 so reporting
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring abnormal, Condition aggravated
Clinical narrative: Patient already has heart condition and sometimes gets arrhythmia. Patient started having more frequent arrhythmia and called MD after 5-6 days. According to patient she started feeling it within 1 hour but she sometimes get arrhythmia so didn't call her doctor straight away. After persistent symptoms doctor gave her ZEO patch to monitor her heart rhythm. She had arrhythmia for almost 40 times within 1.5 weeks.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Spikevax administered (child is 6 and vaccine booster administered was for 12 and above). Child has tolerated it with no issues.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Patient experienced rash that was approximately 4-5 inches in diameter. redness, no pain per patient, worsened over time. Patient referred to seek medical attention if redness continues to develop
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Vomiting
Clinical narrative: Wife states that about 24 hours after the vaccine the patient began to vomitting non-stop for about 12 hours. His stomach symptoms have resolved but the patient is still "run-down"
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lethargy, Nausea, Vomiting
Clinical narrative: Wife states that about 24 hours after the vaccine the patient began to vomitting non-stop for about 12 hours. His stomach symptoms have resolved but the patient is still "run-down"
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Product administered at inappropriate site, Skin warm
Clinical narrative: Significant redness, which is very warm to touch on the upper arm. Appears that this vaccine was inappropriately administered BELOW the deltoid muscle.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Injection site erythema, Injection site swelling
Clinical narrative: I have covid arm. Entire upper arm, deltoid area, is red and swollen.  I read up on it and the article said to report it.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dtap administered to 11 year old and should have been Tdap.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tinnitus
Clinical narrative: Body aches and headache to start and then chills with a low grade fever. Chills were extreme, but has now subsided after lasting about 4 hours. Still have headache and body aches, with ringing in my ears.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, headache. Took to my bed for 18-hours. Lots of Tylenol, water, and sleep. Fever broke around 1 pm.  Still have headache.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RSV, RV5, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error: Nurse called at 4:48pm to apologize for clinic staff miscommunication resulting in my 5 month old being given adult RSV shot  (Abrysvo Lot#HP1193 Exp: 04/2025 Left upper vastus lateralis IM) instead of antibody version for infants. Advised to bring to ER if any adverse symptoms. None presenting at this time. Advised to get correct vaccination at 6 month shots.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster, Hypoaesthesia, Nerve injury, Paraesthesia
Clinical narrative: shingles symptoms, numbness and tingling and left eye dysfunction, due to cervical nerve being affected, so far 35 days no relief of symptoms in spite of prescribed medication Neurontin,  treated 2 times since vaccination at urgent care
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual acuity tests
Clinical narrative: shingles symptoms, numbness and tingling and left eye dysfunction, due to cervical nerve being affected, so far 35 days no relief of symptoms in spite of prescribed medication Neurontin,  treated 2 times since vaccination at urgent care
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No AE; Customer reported an AE for STERILE DILUENT. The caller said they used an expired lot of STERILE DILUENT to reconstitute PROQUAD and then administered the dose to a patient. Confirmed no other AE occurred. Case number provided. No AE/PQC.; Customer reported an AE for STERILE DILUENT. The caller said they used an expired lot of STERILE DILUENT to reconstitute PROQUAD and then administered the dose to a patient. Confirmed no other AE occurred. Case number provided. No AE/PQC.; This spontaneous report was received from a Medical Assistant and refers to a 5-year-old male patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On 30-SEP-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, administered as prophylaxis (Lot No. y009107 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 06-NOV-2025) (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) which was reconstituted with an expired sterile diluent, solution for injection/infusion (Lot No. w000454 has been verified to be a valid lot number for [sterile diluent], expiration date reported and upon internal validation established as 25-JUL-2024) (indication, strength, dose, route of administration and frequency were not provided) (expired product administered and product preparation issue).   Additionally, it was confirmed that no other adverse event (AE) occurred (no adverse event).
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; HCP called to report a patient who received PROQUAD instead of separate MMR-II and VARIVAX for a second dose in a dosing regimen. Patient received their first dose of MMR-II and first dose of VARIVAX on 05SEP2024 and was given PROQUAD on 10OCT2024.; This spontaneous report was received from a physician and referred to a 16-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-SEP-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, administered as prophylaxis (Lot No., expiration date, strength, dose number, exact dose quantity volume, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) and with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered as prophylaxis (Lot No., expiration date, strength, dose number, exact dose quantity volume, route of administration, anatomical location of administration and vaccination scheme frequency were not provided). On 10-OCT-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered as prophylaxis (Lot No., expiration date, strength, dose number, exact dose quantity volume, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) instead of separate dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and separate dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for a second dose in a dosing regimen (wrong product administered).  No additional information was provided. No adverse event (no adverse event).
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Blood urea increased, Expired product administered, Full blood count normal, Metabolic function test normal, N-terminal prohormone brain natriuretic peptide increased
Clinical narrative: has a staff member that has given Prevnar 13 past the expiration date; had NT-proBNP, 737 and it was high; BUN was elevated to 29; This is a spontaneous report received from a Nurse from medical information team.  A 66-year-old male patient received pneumococcal 13-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 13), on 07Oct2024 at 14:00 as dose number unknown, single (Lot number: FL4126, Expiration Date: Jun2024) at the age of 66 years intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Pulmonary arterial hypertension" (unspecified if ongoing). Concomitant medication(s) included: REVATIO oral taken for pulmonary arterial hypertension; ORENITRAM oral taken for pulmonary arterial hypertension. Vaccination history included: Prevnar 20 (dose number unknown), administration date: Apr2023, for immunization. The following information was reported: BLOOD UREA INCREASED (non-serious) with onset 07Oct2024, outcome "unknown", described as "BUN was elevated to 29"; N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (medically significant) with onset 07Oct2024, outcome "unknown", described as "had NT-proBNP, 737 and it was high"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 07Oct2024 at 14:00, outcome "unknown", described as "has a staff member that has given Prevnar 13 past the expiration date". The patient underwent the following laboratory tests and procedures: Blood urea: (07Oct2024) 29; Full blood count: (07Oct2024) everything was normal on that; Metabolic function test: (07Oct2024) everything was within the normal range, notes: with the exception of this BUN was elevated to 29; N-terminal prohormone brain natriuretic peptide: (07Oct2024) 737. Therapeutic measures were not taken as a result of n-terminal prohormone brain natriuretic peptide increased, blood urea increased.; Sender's Comments: Based on the close temporal relationship, the association between the event "had NT-proBNP, 737 and it was high" with PREVNAR 13 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Dizziness, Dysphonia, Oropharyngeal pain, Throat irritation
Clinical narrative: Allergic reaction; Sore throat; Hoarseness in my voice; Throat started itching a little bit; Lightheadedness; Initial information received on 21-Sep-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-health care professional.  This case involves an unknown age female patient who had allergic reaction after receiving Prevnar 20 and Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Head injury with disabled.  On an unknown date, the patient received 0.5ml (dose 1) of suspect Prevnar 20 not produced by Sanofi Pasteur (lot-HP7365) (unknown expiry date, formulation, strength and route) via intramuscular route in the right deltoid for pneumonia.  On an unknown date, the patient received 2 doses of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot-UT8408KA, expiry date: 30-Jun-2025) (unknown strength) via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date the patient developed sore throat (oropharyngeal pain), hoarseness in my voice (dysphonia), throat started itching a little bit (throat irritation), lightheadedness (dizziness) and allergic reaction (hypersensitivity) (latency-same day) following the first dose intake of Diphenhydramine hydrochloride, Influenza Usp Trival A-B Subvirion No Preservative Vaccine and Prevnar 20.  Reportedly patient mentioned it was about 10 minutes to her house. Patient walk into her house and immediately she was already feeling light headed then all of the sudden her throat was sore and she  thought, and she got a flu shot at the same time but she had flu shot, many flu shots but never had an issue. This was her first Pneumonia shot (Prevnar 20) and that was pretty fast to have a sore throat from the shot is like an illness type thing like you could get a sore throat and it is really sore and she was like hoarse like hoarseness in my voice and she lived alone no so she immediately started and did not get a handout on Prevnar 20 so she started googling, is that like a reaction. Well, then my throat started itching a little bit, it was not closing off but it was started to itch so then she needed to contact , patient could not call the pharmacy because now you get an answering machine. she could not call the because there was no direct line to, she called the store and the manager said he would immediately have the pharmacist or the nurse practitioner call her, they called her right back. She said yes, your are having an allergic reaction. Do you have any Benadryl. She took 225 milligram of liquid cap. patient have taken 50 milligram doses 3 times.  Action taken was not applicable.  The patient was treated with Diphenhydramine hydrochloride (Benadryl) for Hypersensitivity.  At time of reporting, the outcome was Unknown for the event allergic reaction.
Age: 89.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidently administered the fluzone hd quad that were expired with no reported adverse event; Initial information received on 26-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 89 years old female patient who accidently administered the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] that were expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2024, the patient's Health care professional accidently administered expired dose of a 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT8057CA, Expiry date: 30-Jun-2024, strength: standard) in the right arm as immunization (expired product administered) (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: 2.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered, Product distribution issue
Clinical narrative: received on friday that are no longer good with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient that received influenza USP trival A-B subvirion NO preservative vaccine [fluzone] on friday that are no longer good with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 27-Sep-2024, the patient received 0.5 ml of suspect IN influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection (unknwon strength) with lot UT8506A and expiry date 30-Jun-2025 via intramuscular route in unknown administration site for influenza.  On 27-SEP-2024 the patient received influenza USP trival A-B subvirion NO preservative vaccine on friday that are no longer good with no reported adverse event (poor quality product administered) (Latency same day).  Reportedly, Clinical supervisor stated they received a notification from Vaccine Shoppe for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024.  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.; Sender's Comments:  US-SA-2024SA295848:02243791 US-SA-2024SA295436:02243842 US-SA-2024SA295434:02243875 US-SA-2024SA295324:02243780 US-SA-2024SA295520:02243804 US-SA-2024SA295994:02243824 US-SA-2024SA295596:02243829 US-SA-2024SA295462:02243859 US-SA-2024SA296042:02243867
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Flublok that that were transit for too long, and was administered to patient, with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA296034 (Cluster case).  This case involves a 49 years old female patient to whom had received Influenza Trivalent Recombinant Vaccine [Flublok TIV]that that were transit for too long, and was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Sep-2024, the patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (Frequency: once, strength: standard, expiry date: 30-Jun-2025 and lot TFAA2431) via unknown route in unknown administration site as immunization (poor quality product administered) (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: 49.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 49 years old patient received a fluzone hd tiv dose with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 49 years old female patient who experienced 49 years old patient received a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] dose 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 49 years old patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (strength: not reported), with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (lot: UT8425CA, Expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  No lab data reported.  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.  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: 11.0
Sex: M
Vaccine: DTAPIPV, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received adacel and kinrix with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to US-SA-2024SA295751  This case involves a 11 years old male patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid [Kinrix] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2023, the patient received a 0.5 ml dose of suspect Suspension for injection of diphtheria-2/tetanus/5 ac pertussis vaccine (lot 3CA22C1, expiry date: 28-Feb-2026, strength: standard) via intramuscular route in the deltoid nos and on an unknown date, the patient received Kinrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (dose, strength, route, form, frequency, lot number, expiry date was unknown) for Immunisation (extra dose administered) (unknown latency).  Reportedly, They wanted to know if there are any serious adverse event they should look out for.  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.; Sender's Comments:  US-SA-2024SA295751:
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to ipol being given after excursion with no reported adverse event; Punctured ipol exposed to 10.1 C upto 39 minutes due to human error with no reported adverse event; Initial information received on 01-Oct-2024 regarding an unsolicited valid non-serious case received from Other Health Care Professional.  This case involves a 7 year old female patient received punctured IPV (VERO) [IPOL] exposed to 10.1 (degree Celsius) upto 39 minutes due to human error with no reported adverse event and inappropriate use due to IPOL being given after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List of concomitant: ''no other vaccines''.  On 23-Sep-2024, the patient received 2 doses of suspect 0.5ml (once) Standard IPV (VERO) Suspension for injection (lot W1C741M, expiry date: 17-Nov-2025) via subcutaneous route in the right arm for prophylactic vaccination reportedly, punctured IPOL exposed to 10.1 c upto 39 minutes due to human error with no reported adverse event (product storage error) (latency unknown) and inappropriate use due to IPOL being given after excursion with no reported adverse event (poor quality product administered) (latency-same day) following the administration of IPV (VERO).  Reportedly, Human error has occurred, and product was administered post excursion. 2 doses of IPOL vaccine were administered but none of the Adacel.  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.; Sender's Comments:  US-SA-2024SA296031:02245279
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Exposure via eye contact, Eye irritation, Ocular discomfort
Clinical narrative: eye is burning, and she feels pressure on the right side of her eye consistently; dry eye with no lubrication; pharmacist was removing the bubbles from barrel of FLUBLOK pfs and she pulled the plunger up and two drops of the vaccine went into her right eye; Initial information received on 01-Oct-2024 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 39 years old female patient who had burning in her eyes, and she feels pressure on the right side of her eye consistently, dry eye with no lubrication and pharmacist was removing the bubbles from barrel of Influenza quadrivalent recombinant vaccine [Flublok] pfs (abbreviation not known) and she pulled the plunger up and two drops of the vaccine went into her right eye.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2024, 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 Immunisation and pharmacist was removing the bubbles from barrel of flublok pfs and she pulled the plunger up and two drops of the vaccine went into her right eye (accidental exposure to product) (latency- same day).  On 27-Sep-2024, the patient eye is burning, and she feels pressure on the right side of her eye consistently (eye irritation) and dry eye with no lubrication (dry eye) (latency- same day).  Reportedly, pharmacist came in to hospital with suspected injury to eye. On 27SEP2024 the pharmacist was removing the bubbles from barrel of FLUBLOK pfs and she pulled the plunger up and two drops of the vaccine went into her right eye. She flushed her eye with water. Today her eye is burning and she feels pressure on the right side of her eye consistently. She has been washing eye frequently. HCP  did physical exam of eye and she said patient had dry eye with no lubrication.  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: 68.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: they received fluzone hd outside of the shipping window went to go pull the syringes out of the refrigerator they noticed one had already been administered with no ae; they received fluzone hd outside of the shipping window went to go pull the syringes out of the refrigerator they noticed one had already been administered with no ae; Initial information received on 01-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 69 years old male patient and it was reported that they received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] outside of the shipping window went to go pull the syringes out of the refrigerator they noticed one had already been administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Oct-2024, the patient received an unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) (lot: U8519BA; expiry date: 30-Jun-2025; frequency: once) outside of the shipping window went to go pull the syringes out of the refrigerator they noticed one had already been administered with no ae (poor quality product administered) (latency: same day) via unknown route in the left deltoid for Immunization.   On an unknown date in 2024, Fluzone HD was shipped outside of the shipping window with no adverse event (product storage error) (unknown latency).  Reportedly, it was shipped out on 28-Sep-2024 and was not received until 1-Oct-2024. She was already directed not to use the products  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: 64.0
Sex: F
Vaccine: UNK
Symptoms: Joint range of motion decreased, Migraine, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: neck became so stiff following the administration that couldn't turn her head either way; pain experienced when turning her head in either direction and the migraine; Initial information received on 01-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 64 year old female patient who had neck became so stiff following the administration that couldn't turn her head either way and pain experienced when turning her head in either direction and the migraine after receiving influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Migraine.   On 30-Sep-2024, the patient received standard dose of 0.5 ml of suspect influenza trivalent recombinant vaccine Solution for injection once with lot TFAA2420 and expiry date 31-May-2025 via intramuscular route in left arm for Immunization.  On 30-Sep-2024 the patient neck became so stiff following the administration that couldn't turn her head either way (musculoskeletal stiffness) and pain experienced when turning her head in either direction and the migraine (neck pain) (Latency same day) following the administration of influenza trivalent recombinant vaccine.  Reportedly, The patients neck became so stiff following the administration that she couldn't turn her head either way. She also developed a migraine. Reporter noted she has never had a reaction to a flu product in the past.Caller also indicated that the administering pharmacy technician administered FLUBLOK "pretty low" on her arm per patient's request to avoid any shoulder discomfort.   Action taken was not applicable.  The patient was treated with naproxen sodium (Aleve) for pain, nabumetone (Relafen) for pain, menthol (Biofreeze pain relieving) and heat for Pain.  At time of reporting, the outcome was Recovering / Resolving for all the events.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: administration of menquadfi to a female that was pregnant with no adverse event; Initial information received on 01-Oct-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old female patient who was pregnant and received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported administration of Menquadfi to a female that was pregnant with no adverse event occurred at 13 weeks and of pregnancy, during first pregnancy trimester.  The date of last menstrual period was reported as 11-Jul-2024. The estimated due date is 27-Apr-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine BrfHbp/NadA/NHBA OMV (Bexsero) for immunization.  On 30-Sep-2024, the patient received 0.5ml dose of suspect standard Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U8193AA, expiry date: 30-Sep-2027) via intramuscular route in the right deltoid for immunization was administration to a female that was pregnant with no adverse event (exposure during pregnancy) (latency-same day).  Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to administration of Menquadfi to a female patient that was 10 weeks and 2 days pregnant.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Nurse stated that a patient received half dose of the FLUZONE T with no reported adverse event; Initial information received on 02-Oct-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves an unknown age male patient and reporter stated that a patient received half dose of the influenza USP trival A-B subvirion vaccine [fluzone] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date nurse stated that a patient received half dose of the unknown dose of suspect influenza USP trival A-B subvirion vaccine (unknown strength) with lot U8500CA and expiry date 30-Jun-2025 via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (incorrect dose administered) (latency same day).  Reportedly, Nurse stated that patient received half dose of the Fluzone.   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: 0.33
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: menquadfi was administered to a 4- month old with no ae; Initial information received on 02-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no 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, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) for Immunisation; and Hepatitis b vaccine rHBsAg (yeast) (Engerix b) for Immunisation.  On 02-Oct-2024, the patient received a  dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) Frequency : 1x, lot U8271AB, Expiry date: 31-Jan-2028, strength was unknown via intramuscular route in the left thigh for Immunization and menquadfi was administered to a 4- month old with no ae (product administered to patient of inappropriate age) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to Menquadfi was administered to a 4-month old. "  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: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: Pharmacist was administering a Fluzone Hd vaccine when the product ran down the patient's arm and some went onto the armchair with no reported adverse event; Pharmacist was administering a Fluzone Hd vaccine when the product ran down the patient's arm and some went onto the armchair with no reported adverse event; Initial information received on 02-Oct-2024 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 75 years old female patient where pharmacist was administering influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] vaccine when the product ran down the patient's arm and some went onto the armchair with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2024, the patient received 0.5 ml dose of suspect Influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot- 8080750 and expiry date- 30-JUN-2025) via unknown route in Left Deltoid (strength- not provided) for Immunisation and pharmacist was administering a fluzone hd vaccine when the product ran down the patient's arm and some went onto the armchair with no reported adverse event (exposure via skin contact) and (accidental exposure to product) (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: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Vomiting
Clinical narrative: Have always received high dose with no reaction. Nausea, intense vomiting, and incredible lethargy . this is second day of symptoms.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lethargy, Nausea, Vomiting
Clinical narrative: Have always received high dose with no reaction. Nausea, intense vomiting, and incredible lethargy . this is second day of symptoms.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RSV, RV5, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient received the RSV (Abrysvo vaccine) in error. The patient should had received monoclonal antibodies for RSV. Wrong vaccine/medication administered.  The patient stayed in the clinic for about 30 minutes after administration and no noted side effects reported. Informed the patient's mother of incident/error after 5pm (over 3 hours later) and no side effects reported at this time either. Report made with manufacturer of incident as well.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms noted.  Patient was given accidently adult and pediatric dose of moderna on same day instead of flu vaccines.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: I received the RSV IMMUNIZATION ON September 20, 2024. 10 days after I received the COVID and flu shots. I had no reaction to the COVID of flu shots, but I started having a reaction to the RSV shot within the hour. I felt dizzy and had to lay down. When I woke up I had trouble breathing even with my oxygen. I had to turn oxygen up another unit. I was weak and couldn't walk to the kitchen without getting out of breath. I was hoping it would clear up, but never did .  I went to the ER and to my doctor.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neuralgia, Tooth extraction, Trigeminal neuralgia
Clinical narrative: Neuropathic pain that initially manifested in the teeth but then spread to other parts of the left side of my face. After seeing dental specialists and getting teeth extracted with no relief, I was eventually referred to a neurologist and diagnosed with trigeminal neuralgia
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Culture urine, Differential white blood cell count, Dizziness, Electrocardiogram, Feeling abnormal
Clinical narrative: 10/15/24 Feeling weird. Swelling to arm + itching to arm. Legs felt like 50lb. Instructed to take Benadryl 50 mg po. Sent to ED 10/15/24 Reports 1 hr after injection feeling dizzy + throat swelling. ER aware that took Benadryl 50 mg at home. Labs ordered: CBC with differential, urinalysis, urine culture, ABO Rh with RHIG caused, CMP hcG, quantitative, CBC. No shortness of breath, no chest pain, denies abdominal pain or urinary symptoms. Sent home to take Benadryl Q 6 - 8 hrs as needed since EKG, heart rate, vital signs stable + no signs of anaphylaxis. 10/16/24 @ 1716 c/o Facial swelling in am. Sent home from work had (R) sided migraines - slept. Woke up with facial swelling, lips + mouth "kinda swollen". Instructed to take Benadryl 50 mg po now. Have someone take her to ER. Slept since didn't take any Benadryl all day.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Human chorionic gonadotropin, Impaired work ability, Limb discomfort, Lip swelling
Clinical narrative: 10/15/24 Feeling weird. Swelling to arm + itching to arm. Legs felt like 50lb. Instructed to take Benadryl 50 mg po. Sent to ED 10/15/24 Reports 1 hr after injection feeling dizzy + throat swelling. ER aware that took Benadryl 50 mg at home. Labs ordered: CBC with differential, urinalysis, urine culture, ABO Rh with RHIG caused, CMP hcG, quantitative, CBC. No shortness of breath, no chest pain, denies abdominal pain or urinary symptoms. Sent home to take Benadryl Q 6 - 8 hrs as needed since EKG, heart rate, vital signs stable + no signs of anaphylaxis. 10/16/24 @ 1716 c/o Facial swelling in am. Sent home from work had (R) sided migraines - slept. Woke up with facial swelling, lips + mouth "kinda swollen". Instructed to take Benadryl 50 mg po now. Have someone take her to ER. Slept since didn't take any Benadryl all day.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth swelling, Peripheral swelling, Pharyngeal swelling, Pruritus, Swelling face
Clinical narrative: 10/15/24 Feeling weird. Swelling to arm + itching to arm. Legs felt like 50lb. Instructed to take Benadryl 50 mg po. Sent to ED 10/15/24 Reports 1 hr after injection feeling dizzy + throat swelling. ER aware that took Benadryl 50 mg at home. Labs ordered: CBC with differential, urinalysis, urine culture, ABO Rh with RHIG caused, CMP hcG, quantitative, CBC. No shortness of breath, no chest pain, denies abdominal pain or urinary symptoms. Sent home to take Benadryl Q 6 - 8 hrs as needed since EKG, heart rate, vital signs stable + no signs of anaphylaxis. 10/16/24 @ 1716 c/o Facial swelling in am. Sent home from work had (R) sided migraines - slept. Woke up with facial swelling, lips + mouth "kinda swollen". Instructed to take Benadryl 50 mg po now. Have someone take her to ER. Slept since didn't take any Benadryl all day.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: 10/15/24 Feeling weird. Swelling to arm + itching to arm. Legs felt like 50lb. Instructed to take Benadryl 50 mg po. Sent to ED 10/15/24 Reports 1 hr after injection feeling dizzy + throat swelling. ER aware that took Benadryl 50 mg at home. Labs ordered: CBC with differential, urinalysis, urine culture, ABO Rh with RHIG caused, CMP hcG, quantitative, CBC. No shortness of breath, no chest pain, denies abdominal pain or urinary symptoms. Sent home to take Benadryl Q 6 - 8 hrs as needed since EKG, heart rate, vital signs stable + no signs of anaphylaxis. 10/16/24 @ 1716 c/o Facial swelling in am. Sent home from work had (R) sided migraines - slept. Woke up with facial swelling, lips + mouth "kinda swollen". Instructed to take Benadryl 50 mg po now. Have someone take her to ER. Slept since didn't take any Benadryl all day.
Age: 0.58
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Approximately 2 hours after receiving the flu vaccine family noted a hive on her R arm No problem breathing or swallowing - continued to be alert and happy In office hive like rash (R)elbow & (R)cheek and fine light red rash on trunk - smiling, alert and active stopped Amoxicillin & recommended benadryl rash from influenza vaccine vs Amoxicillin
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Otitis media, Upper respiratory tract infection
Clinical narrative: Patient developed URI infection and subsequent bilateral OM requiring systemic anti-biotics
Age: 28.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: After administering the vaccine to the patient, she was notified she had to wait 15 minutes. I had proceeded to room my next patient, once in the room with another pt I could hear yelling next door. I had excused myself and while coming into the other room patient was already passed out laying on the table, another MA and the phlebotomist was already in the room stating pt had a seizure while she fainted.