chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discharge, No adverse event
Clinical narrative: FLUZONE QUADRIVALENT (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event.; FLUZONE QUADRIVALENT (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event.; Initial information was received on 10-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 33 years old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event. while receiving vaccine .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Nov-2023, the patient received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (lot U8192CAand expiry 30-06-24) (strength: unknown) via intramuscular route in the left arm for immunization.  On 09-NOV-2023 the patient developed a non-serious fluzone quadrivalent (syringe) was administered to a patient and the vaccine liquid came out of the patient`s arm with no adverse event. (incorrect dose administered and exposure via skin contact) (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.
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper
Clinical narrative: gastric pain that spreads throughout abdominal area, that really a burning pain; burning pain abdomen; Initial information received on 11-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse/patient).  This case involves an unknown age female patient who had gastric pain that spreads throughout abdominal area, that really a burning pain and burning pain abdomen after receiving influenza quadrival A-B Vaccine [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect influenza quadrival A-B Vaccine, Suspension for injection lot U3200BA, expiry- 30-Jun-2024 via unknown route in unknown administration site for immunization (strength: unknown).  On an unknown date the patient had gastric pain that spreads throughout abdominal area, that really a burning pain (abdominal pain upper) and burning pain abdomen (abdominal discomfort) (unknown latency).  Reportedly, patient had the FLUZONE vaccine about two weeks ago and progressively getting worse with gastric pain that spreads throughout abdominal area, that really burning pain. had a vaccine reaction with both COVID shots,  was in pain for months and months after, those shots and now also with Flu shots.  Action taken: not applicable.  The patient took Proton Pump Inhibitors as corrective treatment for the events  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: can't move her arm, she has a hard time putting on clothes; had a flublok wanting the child dose but about a week later her arm got sore and sore and sore and she had difficulty getting dressed that is why she is trying to figure out if she got the senior dose and not the adult dose of flublok; Initial information was received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who can't move her arm, she has a hard time putting on clothes and had a flublok wanting the child dose but about a week later her arm got sore and sore and sore and she had difficulty getting dressed that is why she is trying to figure out if she got the senior dose and not the adult dose of flublok after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (Injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date the patient can't move her arm, she has a hard time putting on clothes (limb discomfort)and had a flublok wanting the child dose but about a week later her arm got sore and sore and sore and she had difficulty getting dressed that is why she is trying to figure out if she got the senior dose and not the adult dose of flublok (pain in extremity) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly, Caller also asked if FLUBLOK contains eggs and preservatives. She stated that she has the paper work at the time of call and wants to know which dose she got, if it is the adult dose or the senior dose.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: We have now given our kid Rabivax after 2 weeks from the date my dog caught her wrist with no reported adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 11 years old male patient and reporter reported we have now given our kid Rabies (Hdc) Vaccine [Imovax Rabies] after 2 weeks from the date my dog caught her wrist with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, reporter reported we have now given our kid Rabies (Hdc) Vaccine after 2 weeks from the date my dog caught her wrist with no reported adverse event (inappropriate schedule of product administration)  (latency: unknown).  It was reported, My kid 11 year was caught by my pet dog 2 weeks ago on the wrist . No bleeding happened but there could have been scratches. We didn't get the anti-rabies shot done at that time . My kid just washed the hand with soap. My pet dog is anti rabies vaccinated and is behaving normally . We have now given our kid Rabivax after 2 weeks from the date my dog caught her wrist which is late. My questions are Could in the above case my kid have got rabies from the pet dog even though he is vaccinated and behaving normally after the bite. Rabivax has been is taken late i.e. after 14 days from the occurrence . But will it still protect my child against rabies in future.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: high flu or high-dose fluzone given to a pregnant person with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age pregnant female patient who was given influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known and occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's previous pregnancies details were not provided.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.7 ml dose of suspect influenza quadrival a-b high dose hv vaccine lot number not reported via unknown route in unknown administration site (route, formulation, strength and expiration date: not provided) for Immunisation (exposure during pregnancy) (latency- same day)  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event and Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 14.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: box was left out and was not refrigerated, duration: 5 days with no reported adverse event; the product administered to a patient with no reported adverse event; Initial information received on 14-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 14 years old unknown gender patient who was administered the vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] whose box was left out and was not refrigerated, duration: 5 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Nov-2023, the patient received a dose of 0.5 ml suspect Influenza Quadrival A-B Vaccine (lot U8200AA and expiry date: 30-Jun-2024) (strength, formulation, expiry date unknown)via unknown route in unknown administration site for prophylactic vaccination(Immunization) (poor quality product administered) (Latency: same day).  On an unknown date the box was left out and was not refrigerated, duration: 5 days with no reported adverse event (product storage error) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  It was reported that the box was left out and was not refrigerated. No one knew in the facility, it was delivered. Max/low temperature reached: Unknown since it was in the box. Duration: 5 days Human error- Yes If negative advice, was the product administered to a patient? Yes Does extended stability data cover the excursion- No  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: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone high dose quadrivalent was given to a patient under 65 of age with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient under 65 years of age who was given Influenza Quadrival A-B High Dose HV Vaccine[Fluzone high-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient under 65 years age received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot number, strength, expiry date, dose not reported) via unknown route in unknown administration site as immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 2-month-old baby was administered a hip shot of an expired ACTHIB with no adverse event; Initial information received on 16-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who was administered a hip shot of an expired HIB (PRP/T) Vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UJ836AA, Expiry date: 20-10-2023 with unknown strength) via unknown route in unknown administration site as immunization with no adverse event (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: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Numbness in her finger; Injection site pain; This spontaneous case was received on 07-Nov-2023 from a pharmacist via agency (reference number: SEQW23-04095) and concerned a 65-years-old female patient.  The patient's medical history and concomitant medications were not reported.  On 18-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza immunization for patients over 65 years of age. The batch number reported was 371640 and expiry date was 30-Jun-2024.   On unspecified date in 2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain and some numbness in her fingers. Treatment measures associated with event included Tylenol extra strength (paracetamol).   The outcome of the events of 'vaccination site pain' and 'numbness in fingers' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-years-old patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving the suspect vaccine, the patient experienced hypoaesthesia and vaccination site pain. Causality for event hypoaesthesia is unassessable, due to unclear temporal relationship. Causal role of the suspect vaccine cannot be excluded for event vaccination site pain, due to anatomical plausibility and is assessed as possibly related.; Sender's Comments: A 65-years-old patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving the suspect vaccine, the patient experienced hypoaesthesia and vaccination site pain. Causality for event hypoaesthesia is unassessable, due to unclear temporal relationship. Causal role of the suspect vaccine cannot be excluded for event vaccination site pain, due to anatomical plausibility and is assessed as possibly related.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Body pain; Weakness; Fatigue; Respiratory symptoms (runny nose); Fever of 103 F/temperature is 101 F; This spontaneous case was received on 08-Nov-2023 from a physician (consumer) via Regulatory Authority (reference number: SEQW23-04137) and concerned a 27-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified flu vaccination, administered on an unreported date, after which the patient experienced a low-grade fever.   On 06-Nov-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: 0.5ml; anatomical location: left arm; route of administration: not reported) for influenza prophylaxis. The batch number reported was AU1073A and expiry date 30-Jun-2024.    On 07-Nov-2023, one day after receiving Afluria Quadrivalent, the patient experienced a fever of 103 degrees Fahrenheit (F), body pain and weakness, fatigue, and respiratory symptoms (runny nose).   On 08-Nov-2023, the patient's temperature was 101 F. The patient was worried that she may be developing an infection such as COVID, flu, common cold, or respiratory syncytial virus (RSV).  At the time of the initial reporting, on 08-Nov-2023, the patient had not recovered from all events. As reported, issues have not resolved.  The reporter did not provide a causality assessment. As reported, the patient was unsure if these symptoms were related to receiving the vaccine itself or were due to some type of infection she had developed.  The case was assessed as non-serious.  This case is linked with the case 202306493 (the same patient and the same reporter).  Company comment: A patient was vaccinated with Afluria Quadrivalent. One day following vaccination, the patient experienced fever, body pain, weakness, fatigue, and respiratory symptoms (runny nose). The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified flu vaccination, after which the patient experienced a low-grade fever. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pyrexia, pain, asthenia, fatigue, rhinorrhoea, with the currently available information and chronological plausibility.; Sender's Comments: A patient was vaccinated with Afluria Quadrivalent. One day following vaccination, the patient experienced fever, body pain, weakness, fatigue, and respiratory symptoms (runny nose). The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified flu vaccination, after which the patient experienced a low-grade fever. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pyrexia, pain, asthenia, fatigue, rhinorrhoea, with the currently available information and chronological plausibility.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Low-grade fever; This spontaneous case was received on 08-Nov-2023 from a physician via agency (reference number: SEQW23-04137), reported by a physician (consumer) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.    On an unspecified date, the patient was vaccinated with influenza virus vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient experienced low grade fever.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  Company comment: On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient experienced low grade fever. Causal role of the vaccine is unassessable, due to insufficient information about chronology and alternative aetiology.; Sender's Comments: On an unspecified date, an unknown amount of time after receiving influenza virus vaccine, the patient experienced low grade fever. Causal role of the vaccine is unassessable, due to insufficient information about chronology and alternative aetiology.
Sex: M
Vaccine: FLUC3
Symptoms: Autopsy, Death, Immunisation reaction, Necrotising fasciitis
Clinical narrative: Intramuscular influenza vaccination; Necrotizing fasciitis; This spontaneous case was received on 10-Nov-2023 from other non-health professional (reference number SEQW23-04188) and concerned a male patient of unreported age.  The patient's medical history and concomitant medications were not reported. The patient's historical procedures included dyalisis.  On 22-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (Influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date, following the vaccination, as reported, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced necrotizing fasciitis.   On 23-Oct-2022, a year and a day later, as reported, the patient purportedly died from intramuscular influenza vaccination as allegedly determined by the Coroner. The further information about the autopsy was not provided.  The reporter assessed the event of 'vaccination adverse reaction' to be related to Flucelvax Quadrivalent.  This case was assessed as serious due to the fatal outcome. Additionally, the event of necrotizing fasciitis was considered to be medically significant by a Physician.  Company comment: A patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unspecified time after vaccination the patient experienced necrotizing fasciitis. A year and a day later, as reported, the patient purportedly died from intramuscular influenza vaccination. Autopsy report was not provided. Cause of death was not specified. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to limited information provided and unclear temporal relationship causality for the events immunisation reaction and necrotising fasciitis is unassessable.; Sender's Comments: A patient was vaccinated with the suspect product Flucelvax Quadrivalent. An unspecified time after vaccination the patient experienced necrotizing fasciitis. A year and a day later, as reported, the patient purportedly died from intramuscular influenza vaccination. Autopsy report was not provided. Cause of death was not specified. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to limited information provided and unclear temporal relationship causality for the events immunisation reaction and necrotising fasciitis is unassessable.; Reported Cause(s) of Death: Intramuscular influenza vaccination
Age: 15.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received two flu vaccines in a flu season.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Pneumovax23 given at 12mo well child appt; mom today reported fever but unsure if due to this vaccine, other vaccines given or if child is sick (attend daycare).
Age: 1.42
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: I accidentally gave Proquad and Varivax. instead of MMR and Varivax.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is a 30yo G1 at 15'0 when she received the first dose of Heplisav-B.  She is being followed by high-risk OB for history of myomectomy, 4 prior LEEP procedures, and hemoglobin C trait. She is a health care worker. She was found to be Heb B susceptible on her new OB labs and accepted Hep B vaccination.  She was given one dose of Heplisav-B before it was discovered that this was not recommended in pregnancy due to paucity of safety data.  6 days after the vaccination, was noted to have normal fetal heart tones and patient denies any pelvic pain or vaginal bleeding, feeling well.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered the high dose fluzone instead of fluzone quad.  Discovered immediately.  Patient has not had any adverse reactions
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Dyspnoea, Fatigue, Heart rate increased, Myocarditis
Clinical narrative: Myocarditis: increased heart rate , shortness of breath, chest pain, fatigue. Pt went to PCP. Lasted about six weeks before some improvement. pt still has some sx.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: nsaids (aspirin) and heating pads, but no resolve
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted upon injection.  Held patient up until regained consciousness (less than 1 minute.   Had patient lay on back with legs elevated for about 5 minutes .  Patient drank water and was fully recovered after 10 minutes and received another immunization.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient complains of redness, hard knot, swelling and warmth at injection site, was instructed when to seek medical attention
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Posture abnormal
Clinical narrative: Patient presented for 5 vaccines for travel. Administered Spikevax and VAQTA intramuscularly into left arm,  Fluzone Quad and Boostrix intramuscularly into right arm. After 4th shot, patient began to feel light headed and stated that they did not eat anything for the day. Patient's head began to nod off 10 seconds later and patient began to sway back. Patient slumped over and black-outed for 2 seconds and became alert right after. Pt monitored till better.
Age: 87.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Extra dose administered
Clinical narrative: After receiving vaccination resident, patient stated "I had three shots last month." 6:00 pm patient denies pain. no redness noted.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dyspnoea, Headache, Pain in extremity, Toothache
Clinical narrative: Chest pressure and hard to take a deep breath a minute after the shot. It resolved while sitting down for 10 minutes. Headache and teeth pain later in the day that lasted for 3 days. Left arm pain down to my fingers from the night of the shot until 5 days later.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt is 64 at time of visit and given Fluzone HD, a vaccine for individuals 65 and older. No reports adverse events, but incorrect vaccine given.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: patient felt faint after immunizations and very pale at 3:50pm
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Swelling face, Syncope
Clinical narrative: Patient received vaccine and was standing behind me while I administered a vaccine to her mother.  The patient then fainted while my back was turned, falling on the floor and hitting her head.  This resulted in a bump on her forehead, but no blood.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site mass
Clinical narrative: After injection, small amount of blood came to surface of skin and small lump /nodule formed..  Patient iced and massaged area.  Swelling went down but bruise developed at site.   Patient stated that still bruised on 11/21/23.   iced and massaged area
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Electroencephalogram, Gait disturbance, Headache, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: Loss of consciousness. Screaming his head was exploding, high pitched scream. Ran into walls, seizures and memory issues. Would wonder in a circle.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Memory impairment, Screaming, Seizure
Clinical narrative: Loss of consciousness. Screaming his head was exploding, high pitched scream. Ran into walls, seizures and memory issues. Would wonder in a circle.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Flushing, Injection site bruising, Injection site pain
Clinical narrative: patient states she had a painful injection site shortly after the injection that lasted a few days then resolved. on 11/20/23 she states she had a bruise appear at injection site and felted flushed. the bruise was still there on 11/21/23 and is sore.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rash, Urticaria
Clinical narrative: Patient received vaccine on Thursday 11/16/23 and started feeling ill on Friday. She had rash/hives over abdomen and legs beginning Saturday 11/18/23 which she treated with oral loratadine and hydrocortisone cream. Rash had resolved by time of reporting Tuesday 11/21/23.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Sarcoma, Scrotal pain, Scrotal swelling
Clinical narrative: Pt started to have scrotum pain and swelling.  Work up showed sarcoma
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Patient started displaying symptoms of anaphylaxis (difficulty breathing) approx. 5 minutes after administration of vaccination. Administered Epipen jr, while calling EMS. Breathing normalized after epinephrine was given. Monitored patient until paramedics arrived. She was take to ED as a precaution and discharged with steroid rx.
Age: 43.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was given Flucelvax instead of Spikevax on accident. Patient stated he had already received flu vaccine in October of this month
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cyanosis, Nausea
Clinical narrative: Cold chills, blue fingers both hands, with dark blue dots under skin, nausea. Did not seek medical opinion.  Symptoms subsided within  an hour.  No fever.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site infection, Skin warm, Swelling
Clinical narrative: ACCORDING TO THE PATIENT, THE VACCINE ADMINISTERED SHOULDER APPEARED SWOLLEN, RED, AND WARM TO THE TOUCH AFTER APPROXIMATELY 6 DAYS FROMTHE VACCINATION DATE. THE PATIENT REPORTED THAT SHE WAS SEEN BY HER PRACTIONER AND WAS EVALUATED. THE PRACTITIONER DETERMINED THE SITE WAS INFECTED AND THE PATIENT WAS GIVEN APPROPRIATE ANTIBIOTIC THERAPY. THE PATIENT REPORTED THAT SHE HAS SINCE RECOVERED FROM THE INCIDENT WITH NO OTHER COMPLAINTS.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: the patient received a covid shot instead of a scheduled flu vaccine.
Age: 67.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient was meant to be given HD flu shot, was given standard dose (Flucelvax) in error. Error was caught and patient was given Fluzone HD as well.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: Upon administering both vaccines, patient stated her arm was itching already. Patient agreed to only 25mg of benadryl instead of 50mg. She was given 25mg of benadryl at 2:57pm.  Blood pressure was 157/85. Pulse was 68 at 3:06pm. Blood pressure was 146/83 with a PR of 73 at 3:20pm. Patient had no other symptoms and felt well enough to leave. Upon speaking with the patient at 7:28pm, she had taken another 25mg of benadryl when she got home to make sure it didn't progress any further. She was doing fine by 7:28pm.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Bone pain, Condition aggravated, Fatigue, Pain
Clinical narrative: Since covid shot has been tired all the time and hands hurt worse, ankles hurt and breast bone too. Not like her usual pain
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Since covid shot has been tired all the time and hands hurt worse, ankles hurt and breast bone too. Not like her usual pain
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Cough, Myalgia, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cold, i.e. viral infection - muscle aches, sore throat, runny nose, coughing Rest, keep warm, wash nasal passages, sudafed
Age: 72.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Viral infection
Clinical narrative: Cold, i.e. viral infection - muscle aches, sore throat, runny nose, coughing Rest, keep warm, wash nasal passages, sudafed
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Discomfort, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: PAIN AND RANGE OF MOTION LIMITED. UNABLE TO LIFT ARM COMFORTABLY ABOVE HEAD, LOSS OF STRENGTH, INABILITY TO GET COMFORTABLE LYING ON SIDE
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray normal
Clinical narrative: PAIN AND RANGE OF MOTION LIMITED. UNABLE TO LIFT ARM COMFORTABLY ABOVE HEAD, LOSS OF STRENGTH, INABILITY TO GET COMFORTABLE LYING ON SIDE
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Product administered at inappropriate site
Clinical narrative: PATIENT STATES VACCINE WAS GIVEN TOO HIGH
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal abscess, Cardiomegaly, Colectomy, Computerised tomogram abnormal, Coronary arterial stent insertion
Clinical narrative: A few months after getting the first shot I developed diverticulitis for the first time in my life. Now in 2023 I have had to have one major surgery to fix it and part of my colon removed. That survey took place Oct 4th 2023. I recently had a heart attacked and was told my heart was enlarged. I needed surgery to remove a blood clot in my heart November 13th 2023. I had two stents put in and have continuous issues with digestion. My bladder has also been infected on and off since receiving the vaccine.  To try to fix my diverticulitis I have been on several antibiotics and nothing worked.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Diverticulitis, Dyspepsia, Echocardiogram, Intracardiac thrombus
Clinical narrative: A few months after getting the first shot I developed diverticulitis for the first time in my life. Now in 2023 I have had to have one major surgery to fix it and part of my colon removed. That survey took place Oct 4th 2023. I recently had a heart attacked and was told my heart was enlarged. I needed surgery to remove a blood clot in my heart November 13th 2023. I had two stents put in and have continuous issues with digestion. My bladder has also been infected on and off since receiving the vaccine.  To try to fix my diverticulitis I have been on several antibiotics and nothing worked.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombectomy, Ultrasound abdomen abnormal
Clinical narrative: A few months after getting the first shot I developed diverticulitis for the first time in my life. Now in 2023 I have had to have one major surgery to fix it and part of my colon removed. That survey took place Oct 4th 2023. I recently had a heart attacked and was told my heart was enlarged. I needed surgery to remove a blood clot in my heart November 13th 2023. I had two stents put in and have continuous issues with digestion. My bladder has also been infected on and off since receiving the vaccine.  To try to fix my diverticulitis I have been on several antibiotics and nothing worked.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Received Spikevax on 11/21/23 that was not expired but was past the BUD  of 11/19/23
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Ataxia, Balance disorder, Blood test, Chest X-ray
Clinical narrative: Given Rsv vaccine on Friday afternoon.  No side effects but a little soreness at injection site.  Next day (Saturday) I was doing errands, driving, I noticed a strange feeling in my head as I turned corners.  No other problems.  finished my errands and came home.  Ate dinner, watched tv.  Told my husband I had some feelings of vertigo.  Went to bed but became nauseous, vomited a little bit, fell asleep.  Slept all night.  Husband awakened me and turning my head while flat in bed caused me to feel vertigo.  I slept all day except for being helped to bathroom and drinking a little water.  Slept all night Sunday,  Still vertigo and unsteady, ate a little on Monday.  Drank more water and felt a little better when in bed when I moved my head.  Still weak and dizzy when up.  Better each day as vertigo cleared but then weak and unsteady on my feet due to not eating or drinking much for days.  Went to ER on Friday, Nov. 17, 2023.  Tests, exam for vertigo.  Determined I was dehydrated and weak from being in bed and not eating or drinking enough.  I am much better today, walking better, eating well and drinking some Pedalyte as directed by Dr.  I do not know if it is from the vaccine but seemed to me to be. My doctor thinks it might be a situation of something else causing the vertigo at the same time as I got the vaccine.  Will never know but I think you should know in case other old people develop this.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Computerised tomogram head, Dehydration, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Given Rsv vaccine on Friday afternoon.  No side effects but a little soreness at injection site.  Next day (Saturday) I was doing errands, driving, I noticed a strange feeling in my head as I turned corners.  No other problems.  finished my errands and came home.  Ate dinner, watched tv.  Told my husband I had some feelings of vertigo.  Went to bed but became nauseous, vomited a little bit, fell asleep.  Slept all night.  Husband awakened me and turning my head while flat in bed caused me to feel vertigo.  I slept all day except for being helped to bathroom and drinking a little water.  Slept all night Sunday,  Still vertigo and unsteady, ate a little on Monday.  Drank more water and felt a little better when in bed when I moved my head.  Still weak and dizzy when up.  Better each day as vertigo cleared but then weak and unsteady on my feet due to not eating or drinking much for days.  Went to ER on Friday, Nov. 17, 2023.  Tests, exam for vertigo.  Determined I was dehydrated and weak from being in bed and not eating or drinking enough.  I am much better today, walking better, eating well and drinking some Pedalyte as directed by Dr.  I do not know if it is from the vaccine but seemed to me to be. My doctor thinks it might be a situation of something else causing the vertigo at the same time as I got the vaccine.  Will never know but I think you should know in case other old people develop this.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Hypersomnia, Injection site pain, Nausea, Vertigo, Vomiting
Clinical narrative: Given Rsv vaccine on Friday afternoon.  No side effects but a little soreness at injection site.  Next day (Saturday) I was doing errands, driving, I noticed a strange feeling in my head as I turned corners.  No other problems.  finished my errands and came home.  Ate dinner, watched tv.  Told my husband I had some feelings of vertigo.  Went to bed but became nauseous, vomited a little bit, fell asleep.  Slept all night.  Husband awakened me and turning my head while flat in bed caused me to feel vertigo.  I slept all day except for being helped to bathroom and drinking a little water.  Slept all night Sunday,  Still vertigo and unsteady, ate a little on Monday.  Drank more water and felt a little better when in bed when I moved my head.  Still weak and dizzy when up.  Better each day as vertigo cleared but then weak and unsteady on my feet due to not eating or drinking much for days.  Went to ER on Friday, Nov. 17, 2023.  Tests, exam for vertigo.  Determined I was dehydrated and weak from being in bed and not eating or drinking enough.  I am much better today, walking better, eating well and drinking some Pedalyte as directed by Dr.  I do not know if it is from the vaccine but seemed to me to be. My doctor thinks it might be a situation of something else causing the vertigo at the same time as I got the vaccine.  Will never know but I think you should know in case other old people develop this.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Pt got Spikevax 1 day after the BUD 11/19/2023 . Vaccine was not expired. No adverse event was reported
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Got vaccine 1 day past the BUD of 11/19/23. Vaccine was not expired yet. No adverse event reported
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Electric shock sensation, Facial pain, Gait inability
Clinical narrative: Patient got the last dose of bactrim DS and got Covid vaccine on 10/29/23. She had developed the minor rash on chest, back that night. It spread to arms, legs, felt like electric shock entire body the next day, she came to urgent care and got prednisone on 10/30/23. The pain got worse and spread to face, neck, so she came to ER on morning of 11/1/23. They discharged her after a few hours with pain meds. She got back to ER that night due to stomach contraction ( like labor). Then the contraction spread to whole body, so much pain on skin (like sun burn) , joints, muscle, arms, fingers, bottom of feet became sensitive that she could not walk along with  the collapsing hip,  knee. Steroid was helpful for contraction but not the pain and headache. The doctor concluded the Covid 19 Pfizer and Bactrim DS triggered the reaction. She was able to sleep for 1 to 3 hours per night, got discharged on 11/10/23, and remained home care up to now.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle contracture, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Patient got the last dose of bactrim DS and got Covid vaccine on 10/29/23. She had developed the minor rash on chest, back that night. It spread to arms, legs, felt like electric shock entire body the next day, she came to urgent care and got prednisone on 10/30/23. The pain got worse and spread to face, neck, so she came to ER on morning of 11/1/23. They discharged her after a few hours with pain meds. She got back to ER that night due to stomach contraction ( like labor). Then the contraction spread to whole body, so much pain on skin (like sun burn) , joints, muscle, arms, fingers, bottom of feet became sensitive that she could not walk along with  the collapsing hip,  knee. Steroid was helpful for contraction but not the pain and headache. The doctor concluded the Covid 19 Pfizer and Bactrim DS triggered the reaction. She was able to sleep for 1 to 3 hours per night, got discharged on 11/10/23, and remained home care up to now.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Rash, Sensitive skin
Clinical narrative: Patient got the last dose of bactrim DS and got Covid vaccine on 10/29/23. She had developed the minor rash on chest, back that night. It spread to arms, legs, felt like electric shock entire body the next day, she came to urgent care and got prednisone on 10/30/23. The pain got worse and spread to face, neck, so she came to ER on morning of 11/1/23. They discharged her after a few hours with pain meds. She got back to ER that night due to stomach contraction ( like labor). Then the contraction spread to whole body, so much pain on skin (like sun burn) , joints, muscle, arms, fingers, bottom of feet became sensitive that she could not walk along with  the collapsing hip,  knee. Steroid was helpful for contraction but not the pain and headache. The doctor concluded the Covid 19 Pfizer and Bactrim DS triggered the reaction. She was able to sleep for 1 to 3 hours per night, got discharged on 11/10/23, and remained home care up to now.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Joint swelling, Pain in extremity, Peripheral coldness, Tremor
Clinical narrative: very sore right arm. Joint swelling, right ankle, leg, and right wrist. Heavy chills today, the second day after the vaccine. In bed under normally too warm comforter, with extra blanket under it over my body, warm shawl over shoulders and neck, wearing an outdoor jacket in bed- and I am still trembling with chill, hands like icicles. I'm hoping it lets up soon it on the record
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Full blood count normal, Laboratory test normal, Neurological examination normal, Slow response to stimuli, Thinking abnormal
Clinical narrative: Patient stated she has clouded thinking, Decreased processing of thoughts and slow responses starting one day after injections.
Age: 25.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Thyroid function test normal
Clinical narrative: Patient stated she has clouded thinking, Decreased processing of thoughts and slow responses starting one day after injections.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Reported Symptoms:  10016256:FATIGUE;  10016558:FEVER; 10028813:NAUSEA;  10047700:VOMITING;  Narrative:  Other
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Mobility decreased, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Reported Symptoms:  10028813:NAUSEA;  10037087:PRURITUS;  10047700:VOMITING;   Narrative:  Other Relevant HX:  Patient called nurse 8/2/23 reporting:  Pt is calling to report that since receiving the shingle vaccine on Friday he has had a stiff neck, muscle pain, vomiting and calmly skin. Pt states is is unable to hold down food or fluids  He did has toast today and has kept it in but is unable to keep in fluids still.  Pt states neck is stiff and locking up.  Pt used ginger candy for nausea but it was not effective.  Pt was advised to go to ER for eval and TX of s/s and to check for dehydration.  Pt v/u.  Pt did not say which ER he would go to, he states the both suck and the wait time will be 12 hours.  Pt was given the ER notification number.  Patient went to outside facility ER.  8/3/23 the report sent over stated patient seen with:  Rash and other Nonspecific Skin Eruption  Nothing else follows.  Other:  NAUSEA AND VOMITING;  PRURITUS
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Reported Symptoms:  10028813:NAUSEA;  10037087:PRURITUS;  10047700:VOMITING;   Narrative:  Other Relevant HX:  Patient called nurse 8/2/23 reporting:  Pt is calling to report that since receiving the shingle vaccine on Friday he has had a stiff neck, muscle pain, vomiting and calmly skin. Pt states is is unable to hold down food or fluids  He did has toast today and has kept it in but is unable to keep in fluids still.  Pt states neck is stiff and locking up.  Pt used ginger candy for nausea but it was not effective.  Pt was advised to go to ER for eval and TX of s/s and to check for dehydration.  Pt v/u.  Pt did not say which ER he would go to, he states the both suck and the wait time will be 12 hours.  Pt was given the ER notification number.  Patient went to outside facility ER.  8/3/23 the report sent over stated patient seen with:  Rash and other Nonspecific Skin Eruption  Nothing else follows.  Other:  NAUSEA AND VOMITING;  PRURITUS