chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea; vomiting; headache; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (medically significant), outcome "unknown"; VOMITING (medically significant), outcome "unknown"; HEADACHE (medically significant), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the known safety profile of the drug and available information, the possible contribution of suspect drug BNT162b2 (BNT162B2) cannot be excluded for the reported events. Case will be reassessed should additional information becomes available.  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.
Age: 3.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Patient came in to office for nurse visit for catch up vaccines as patient was not immunized. Patient received Proquad, and Varivax. Medical Assistant called and explained to mom that patient received two varicellas and she needed to watch patient for any fevers over 102 degrees, such as the febrile seizure. Patient parent was called again the next day to follow up to see how he was doing, mom reported a fever of 100.9 the day of vaccination but since no fever just tired.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient DID NOT have any adverse effect from the vaccine that we are aware of. This form is being submitted due to patient receiving the incorrect vaccine. She came in for the Boostrix & received the Spikevax. We have submitted our own report through the company as well. Just reporting on this.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident, Eye excision, Myocardial infarction, Ophthalmic artery thrombosis
Clinical narrative: Mild stroke, heart attack, Retinal Artery Occlusion
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal artery occlusion
Clinical narrative: Mild stroke, heart attack, Retinal Artery Occlusion
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypogeusia, Hyposmia, Influenza like illness, Nasopharyngitis, Pain in extremity
Clinical narrative: pt stated mild flu and cold like system and sore arm for one week. Then after one week arm ok but they said they had constant cold/flu like system that they can not get rid of (its been one month since vaccine administered) - pt stating they currently have little sense of smell and taste as well of on/off cough w/ phlegm  - they stated they took OTC tylenol, mucinex, advil,  benadryl, and certirizine as different alternatives thruought the month thinking it was either a allergy season reaction or a mild flu
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Productive cough
Clinical narrative: pt stated mild flu and cold like system and sore arm for one week. Then after one week arm ok but they said they had constant cold/flu like system that they can not get rid of (its been one month since vaccine administered) - pt stating they currently have little sense of smell and taste as well of on/off cough w/ phlegm  - they stated they took OTC tylenol, mucinex, advil,  benadryl, and certirizine as different alternatives thruought the month thinking it was either a allergy season reaction or a mild flu
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Laboratory test, Seizure
Clinical narrative: I have been suffering from have grand mal seizures ever since 8-10 weeks after being ?fully? vaccinated. I have several hospital records and doctor?s visits with no answers. I do not have epilepsy and I?ve been through testing , everything keeps coming back with no answers. I will fight for my life. Because I have been for 3 years and I am going to make sure everyone knows and sees the damage you have caused my body. I will be posting on social media accounts and all proof I have.
Age: 52.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: area was red, hot and swollen and painful
Age: 65.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy developed the following morning/ within 24 hours. Patient feels this is related to vaccine administration given timing.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the 5 year old dose instead of the 4 year old dose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a Covid Moderna Spikevax that expired on 4/19/2024. Patient reports no adverse effects at this time and was asked to report if there are any in the future.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired Moderna Spikevax Vaccine and showed no signs of adverse effects at time vaccine was given. She has been notified and will watch for any future adverse effects.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: No adverse event, Product selection error
Clinical narrative: No adverse event was reported. The patient is a 20-year-old female who saw a provider. The order was supposed to come from the private vaccines but was given (written) from the state vaccines instead. No symptoms were reported from the patient.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient attended off site vaccine clinic as "walk in" , selected on the form that wants to get RSV vaccine. Forgot to mention to the pharmacist that already got this vaccine in October 2023.
Age: 74.0
Sex: M
Vaccine: SMALL
Symptoms: Full blood count, Immunisation reaction, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient just established with me, but I reviewed his chart, and found this probably vaccine related side effect that I do not believe has been reported.  From his previous provider's note dated 3/3/2022:  "Patient is a 74 y.o. male with history of sigmoid adenocarcinoma s/p sigmoid colectomy and subsequent chemotherapy in October 2002, with no known recent thrombocytopenia noted to have an incidental platelet count of 1 40,000 in October 2021 and then 58,000 in November 2021.  No known change in medications or recent vaccinations.  He had received the first dose of Moderna COVID-19 vaccination on January 24, 2021 and the second dose February 26, 2021.  Repeat platelet count done December 13, 2021  within normal limit at 1 95,000 with a normal WBC ,RBC count and hemoglobin.  Received Moderna booster January 11, 2022. Platelet count dropped again to 86,000 on January 17, 2022 and 69,000 March 3, 2022. "
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Needle issue
Clinical narrative: After the nurse administered the injection and withdrew the syringe from the infant's thigh, the needle remained in the pt's leg. The needle does not screw on to the syringe tightly.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired immunization:  Kinrix: Lot: G9N2M Exp: 4-14-24.  No adverse effects noted at time of administration.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Impaired driving ability, Oral herpes, Paraesthesia oral
Clinical narrative: Two days after vaccination, patient developed a cold sore on lip with tingling.  By day 6 or 7 after vaccination, she sought medical care because she was also dizzy, had a headache and couldn't drive; she was prescribed acyclovir cream and an oral antiviral which she did not fill at this pharmacy.  Today, Day 9, her cold sore has scabbed over but she still has a headache, light sensitivity, and trouble focusing her vision.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Photophobia, Scab, Vision blurred
Clinical narrative: Two days after vaccination, patient developed a cold sore on lip with tingling.  By day 6 or 7 after vaccination, she sought medical care because she was also dizzy, had a headache and couldn't drive; she was prescribed acyclovir cream and an oral antiviral which she did not fill at this pharmacy.  Today, Day 9, her cold sore has scabbed over but she still has a headache, light sensitivity, and trouble focusing her vision.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Gait disturbance, Pain, Swelling
Clinical narrative: She got her vaccine, her shoulder puffed up pretty badly, worse than seh has ever had.  Two days after that she woke up in the morning feeling like she had fallen down 4 flights of stairs.  Her muscles, tendons and ligaments felt all screwed up, and stayed that way for 6 weeks, and is not totally over it yet.  She had extreme pain, and had to take a lot of Ibuprofen and aspirin to stop it enough to get some sleep.  It affected her gluteal muscles, which she had never had before.  It also gave her sciatica that went to her knee which made her knee buckle.  Her shin bones was bad, knees were horrible especially the left one, shoulders bad.  She sat in a chair and bent over to tie a show and horizontally across her abdomen it cramped up, which she had never had before. The foot from the big toe to her heel also cramped up tieing her shoe.  She would get brief jabbing pains in random spots, her right upper arm, the middle of her right thigh, her big toe on the right foot, the top of her left foot.  So much went wrong with her it is hard to describe what was going on.  It was difficult to get in and out of a car, she had to use her arm to lift her leg to get in. she would always have to lead with her right foot to go down the stairs due to her knee being so bad, and having to go one step at a time to go up steps.  She still gets occasional jabs of pain.  She does not feel that her left knee is ever going to recover, and not able to walk quite right.  She has not fallen yet, but does stagger around.  She eliminated everything else that she could think of that could cause this.  She has not slipped, fallen or step in a hole or lift anything or anything unusual other than get this vaccine.  She has had all her COVID shots, 2 pnuemonia vaccines, her flu shot and the shingles vaccines without any problems.   Her groin muscles were horrible.  She did not go to her doctor for her symptoms as there is no test that he can do that can show pain.  She was not going to have him prescribe her some high powered prescription pain medications as she did not want that.  She did call the county health department and they told her to report it to us.  The pain and swelling in the shoulder went down, and can live with the problems that she is still having, and what is really bad is her left knee.   She initially used ice packs on her knee, and would use a heating pad which seemed to help, but only temporary.  She eventually phased that out, and relies on the OTC medications.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Abdominal pain, Arthralgia, Gait disturbance, Ligament pain, Mobility decreased
Clinical narrative: She got her vaccine, her shoulder puffed up pretty badly, worse than seh has ever had.  Two days after that she woke up in the morning feeling like she had fallen down 4 flights of stairs.  Her muscles, tendons and ligaments felt all screwed up, and stayed that way for 6 weeks, and is not totally over it yet.  She had extreme pain, and had to take a lot of Ibuprofen and aspirin to stop it enough to get some sleep.  It affected her gluteal muscles, which she had never had before.  It also gave her sciatica that went to her knee which made her knee buckle.  Her shin bones was bad, knees were horrible especially the left one, shoulders bad.  She sat in a chair and bent over to tie a show and horizontally across her abdomen it cramped up, which she had never had before. The foot from the big toe to her heel also cramped up tieing her shoe.  She would get brief jabbing pains in random spots, her right upper arm, the middle of her right thigh, her big toe on the right foot, the top of her left foot.  So much went wrong with her it is hard to describe what was going on.  It was difficult to get in and out of a car, she had to use her arm to lift her leg to get in. she would always have to lead with her right foot to go down the stairs due to her knee being so bad, and having to go one step at a time to go up steps.  She still gets occasional jabs of pain.  She does not feel that her left knee is ever going to recover, and not able to walk quite right.  She has not fallen yet, but does stagger around.  She eliminated everything else that she could think of that could cause this.  She has not slipped, fallen or step in a hole or lift anything or anything unusual other than get this vaccine.  She has had all her COVID shots, 2 pnuemonia vaccines, her flu shot and the shingles vaccines without any problems.   Her groin muscles were horrible.  She did not go to her doctor for her symptoms as there is no test that he can do that can show pain.  She was not going to have him prescribe her some high powered prescription pain medications as she did not want that.  She did call the county health department and they told her to report it to us.  The pain and swelling in the shoulder went down, and can live with the problems that she is still having, and what is really bad is her left knee.   She initially used ice packs on her knee, and would use a heating pad which seemed to help, but only temporary.  She eventually phased that out, and relies on the OTC medications.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscle spasms, Myalgia, Pain, Pain in extremity, Sciatica
Clinical narrative: She got her vaccine, her shoulder puffed up pretty badly, worse than seh has ever had.  Two days after that she woke up in the morning feeling like she had fallen down 4 flights of stairs.  Her muscles, tendons and ligaments felt all screwed up, and stayed that way for 6 weeks, and is not totally over it yet.  She had extreme pain, and had to take a lot of Ibuprofen and aspirin to stop it enough to get some sleep.  It affected her gluteal muscles, which she had never had before.  It also gave her sciatica that went to her knee which made her knee buckle.  Her shin bones was bad, knees were horrible especially the left one, shoulders bad.  She sat in a chair and bent over to tie a show and horizontally across her abdomen it cramped up, which she had never had before. The foot from the big toe to her heel also cramped up tieing her shoe.  She would get brief jabbing pains in random spots, her right upper arm, the middle of her right thigh, her big toe on the right foot, the top of her left foot.  So much went wrong with her it is hard to describe what was going on.  It was difficult to get in and out of a car, she had to use her arm to lift her leg to get in. she would always have to lead with her right foot to go down the stairs due to her knee being so bad, and having to go one step at a time to go up steps.  She still gets occasional jabs of pain.  She does not feel that her left knee is ever going to recover, and not able to walk quite right.  She has not fallen yet, but does stagger around.  She eliminated everything else that she could think of that could cause this.  She has not slipped, fallen or step in a hole or lift anything or anything unusual other than get this vaccine.  She has had all her COVID shots, 2 pnuemonia vaccines, her flu shot and the shingles vaccines without any problems.   Her groin muscles were horrible.  She did not go to her doctor for her symptoms as there is no test that he can do that can show pain.  She was not going to have him prescribe her some high powered prescription pain medications as she did not want that.  She did call the county health department and they told her to report it to us.  The pain and swelling in the shoulder went down, and can live with the problems that she is still having, and what is really bad is her left knee.   She initially used ice packs on her knee, and would use a heating pad which seemed to help, but only temporary.  She eventually phased that out, and relies on the OTC medications.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Swelling, Tendon pain
Clinical narrative: She got her vaccine, her shoulder puffed up pretty badly, worse than seh has ever had.  Two days after that she woke up in the morning feeling like she had fallen down 4 flights of stairs.  Her muscles, tendons and ligaments felt all screwed up, and stayed that way for 6 weeks, and is not totally over it yet.  She had extreme pain, and had to take a lot of Ibuprofen and aspirin to stop it enough to get some sleep.  It affected her gluteal muscles, which she had never had before.  It also gave her sciatica that went to her knee which made her knee buckle.  Her shin bones was bad, knees were horrible especially the left one, shoulders bad.  She sat in a chair and bent over to tie a show and horizontally across her abdomen it cramped up, which she had never had before. The foot from the big toe to her heel also cramped up tieing her shoe.  She would get brief jabbing pains in random spots, her right upper arm, the middle of her right thigh, her big toe on the right foot, the top of her left foot.  So much went wrong with her it is hard to describe what was going on.  It was difficult to get in and out of a car, she had to use her arm to lift her leg to get in. she would always have to lead with her right foot to go down the stairs due to her knee being so bad, and having to go one step at a time to go up steps.  She still gets occasional jabs of pain.  She does not feel that her left knee is ever going to recover, and not able to walk quite right.  She has not fallen yet, but does stagger around.  She eliminated everything else that she could think of that could cause this.  She has not slipped, fallen or step in a hole or lift anything or anything unusual other than get this vaccine.  She has had all her COVID shots, 2 pnuemonia vaccines, her flu shot and the shingles vaccines without any problems.   Her groin muscles were horrible.  She did not go to her doctor for her symptoms as there is no test that he can do that can show pain.  She was not going to have him prescribe her some high powered prescription pain medications as she did not want that.  She did call the county health department and they told her to report it to us.  The pain and swelling in the shoulder went down, and can live with the problems that she is still having, and what is really bad is her left knee.   She initially used ice packs on her knee, and would use a heating pad which seemed to help, but only temporary.  She eventually phased that out, and relies on the OTC medications.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/no PQC.; HCP calling to report a patient was inadvertently administered an expired dose of VARIVAX. HCP reports the vaccine had not experienced any temperature excursions previously. No side effects/symptoms reported. No additional information/clarification p; This spontaneous report was received from a medical assistant concerning a 34-year-old female patient. The patient's medical history, and concurrent conditions. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 11-APR-2024, the patient was inadvertently vaccinated with an expired dose of with varicella virus vaccine live (oka/merck) (VARIVAX) injection (Expired product administered), 0.5 milliliter, lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (strength, anatomical location and route of administration were not provided). It was reported that the vaccine had not experienced any temperature excursions previously. No side effects/symptoms were reported.
Sex: M
Vaccine: HPV9
Symptoms: Fall, Jaw fracture, Loss of consciousness
Clinical narrative: passed out; broke his jaw; fall; This spontaneous report has been received from a registered nurse, referring to an adolescent male patient of unknown age. The patient's pertinent medical history included syncopal episodes after getting blood drawn. The patient's drug reactions or allergies and concomitant medications were unknown by reporter.  On unknown dates, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, dose, strength and expiration date were unknown) for prophylaxis and other multiple adolescent vaccinations (indication, route, dose, strength and expiration date were unknown).         On an unknown date, the patient developed passed out and broke his jaw as a result of the fall after receiving multiple adolescent vaccinations and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the events was unknown. It was unknown if the patient had sought medical attention or treatment given for the events. The causality assessment between the events and suspect vaccines was not reported. The reporter did not feel comfortable providing any additional information because the practice was doing an internal review on the situation.   Upon internal review, the events of broke his jaw and passed out were determined to be medically significant.  Lot# unknown, additional information is not expected.
Age: 67.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: daptacel was administered to an adult patient instead of the intended tdap vaccine with no reported adverse event; administration of daptacel to a patient older than 7 years with no reported adverse event; Initial information received on 15-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 67 years old female patient and diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] was administered to an adult patient older than 7 years  instead of the intended Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (cho) (shingrix) for Immunisation.  On 11-Apr-2024, the patient received 0.5 ml total of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C6013AA) (Expiry date: 05-Jul-2024) (Frequency: once) (Strength: Standard) via intramuscular route in the arm nos (not otherwise specified) for immunisation.  On 11-APR-2024, the diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] was administered to an adult patient older than 7 years  instead of the intended Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) vaccine with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  It was reported, Caller would like to know how to proceed and whether there are any safety and/or adverse reactions to monitor the patient for. This situation is reported to PV as a medication error due to the administration of DAPTACEL to a patient older than 7 years.  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: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: only received the DTAP-IPV liquid portion during administration, they did not receive the ACTHIB portion with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who was only  administered the dtap-ipv liquid portion, they did not receive the acthib portion of  Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumonia 15.  On 15-Apr-2024, the patient received the dtap-ipv liquid portion, they did not receive the acthib portion 0.5 ml (Dose  1) of suspect  Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) with no reported adverse event (single component of a two-component product administered) (latency: same day) (lot UJ974AC, expiry: 25-Nov-2024, strength: standard, frequency: once) via intramuscular route in the thigh nos (not otherwise specified) for Prophylactic Vaccination (Immunisation).  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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: received the dtap-ipv liquid portion during administration. they did not receive the acthib portion with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 1 years old male patient who had received the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] liquid portion during administration, they did not receive the acthib portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Apr-2024, the patient received a 0.5 ml (dose 1) dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 25-Nov-2024 and lot UJ974AC) via intramuscular route in the thigh Nos (Not otherwise specified) as Immunization and received the dtap-ipv liquid portion during administration. they did not receive the acthib portion with no reported adverse event (single component of a two-component 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 and Module of the 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: IPV
Symptoms: Medication error, No adverse event, Routine immunisation schedule incomplete
Clinical narrative: patient who received ipol doses off schedule. caller reporting the patient is new to their practice and the former pediatrician administered 4 doses by 2 years old with no ae; Initial information received on 16-Apr-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 years old patient of an unknown gender who had received IPV (Vero) [IPOL] doses off schedule caller reporting the patient is new to their practice and the former pediatrician administered 4 doses by 2 years old 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 a dose 1 Primary dose of suspect IPV (Vero) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site and 3 other doses were administered on unknown dates for suspect IPV (Vero) as Immunization and received ipol doses off schedule. caller reporting the patient is new to their practice and the former pediatrician administered 4 doses by 2 years old with no ae (routine immunisation schedule incomplete) (same day latency). Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: received dtap-ipv portion only of pentacel vaccine with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 weeks old male patient who was administered with dtap-ipv portion only of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] 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 in February 2024, the patient had received only dtap-ipv portion 0.5 ml (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ870AA, strength: standard, frequency: once; expiry date not reported) via intramuscular route in the leg for Immunization with no reported adverse event (single component of a two-component 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: doses of menactra in which the second dose was administered early with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient who received doses of Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] in which the second dose was administered early with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 24-Jun-2014 , the patient received a dose 1 of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine  (Solution for injection) lot number not reported via unknown route in unknown administration site. On 14-Jun-2018 she also received a dose 2 of vaccine  with an unknown batch number via unknown route in unknown administration site for prophylactic vaccination (Immunization)  (strength, expiry date was unknown) and doses of menactra in which the second dose was administered early with no reported adverse event (inappropriate schedule of product administration) (unknown latency). The information on batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 18 month-old patient received a daptacel dose that was later noted to have recently expired with no reported adverse event; Initial information received on 16-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 months old female patient who was administered with Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] that was later noted to have recently expired with no reported adverse event.  The patient's past vaccination(s) included Vaxelis. The patient's past medical history, medical treatment(s) and family history were not provided.  On 16-Apr-2024, the patient had received expired (dose and units unknown) (dose: 1) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot C5980AB, expiry date: 06-Apr-2024, strength: standard, frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (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.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Herpes zoster ophthalmicus; This serious case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes zoster in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2024, the patient received the 1st dose of Shingrix (unknown deltoid). On 04-APR-2024, 3 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: Herpes zoster ophthalmicus) (serious criteria GSK medically significant and other: Other medically imp. condition). The outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.     It was unknown if the company considered the ophthalmic herpes zoster to be related to Shingrix.   Additional Information: GSK receipt date: 16-APR-2024 The reporter reported that a patient received Shingrix vaccine and experienced ophthalmic herpes zoster, which was impacted on right eye. The vaccine was administered at a pharmacy, not in the physicians practice. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: given a patient the vaccine intramuscular instead of subcutaneously with no adverse event; Initial information received on 17-Apr-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 73 years old male patient who was given the Yellow fever Vaccine - [YF-VAX] intramuscular instead of subcutaneously with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Apr-2024, the patient received a 0.5 ml dose of suspect Yellow fever Vaccine - Solution for injection (lot UK033AA, expiry: 31-Mar-2025 with unknown strength) via intramuscular route in the right deltoid as Immunization instead of subcutaneously with no adverse event (incorrect route of product administration) (latency: same day).  It was reported "Pharmacist wanted to know what are the next steps if YF-VAX was given to patient intramuscularly? She asked if the patient is going to be covered by the vaccine? Will it be effective? Does she need to re-vaccinate the patient? What will be the side effects to 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.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Redness, pain, swelling on injection site; fever of 101.8; bad headache; nausea; on day 4 arm began itching
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Redness, pain, swelling on injection site; fever of 101.8; bad headache; nausea; on day 4 arm began itching
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Very sore arm and not getting better; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Very sore arm and not getting better). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient received Arexvy and experienced very sore arm and not getting better. The follow-up could not be possible as no contact details were available. This was 1 of the 5 cases, reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Limb discomfort, Muscle twitching, Paraesthesia, Pyrexia
Clinical narrative: Approximately 10 hours after receiving the vaccine, patient developed tingles down her spine.  She also developed some heaviness to her left shoulder and some twitching.  She felt as through she would pass out.  She was febrile at 102 F.  She took ibuprofen 400 mg at home and came to the ER.  She was treated with acetaminophen, diphenhydramine and ibuprofen.  She was reassessed after these interventions and noted to be markedly improved.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site induration
Clinical narrative: Both (R) and (L) outer thigh with 1cm induration and 1cm induration
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, tenderness, warmth and swelling on right upper arm near site of IPV + VARIVAX injection. Symptoms began about 48 hrs after injections. Patient was started on Amoxicillin by a family friend and has had 2 dose with improvement. Area of inflammation is about the size of a half dollar.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired, no symptoms
Age: 14.0
Sex: M
Vaccine: RAB
Symptoms: Bell's palsy
Clinical narrative: Patient developed a Bell's Palsy after receiving his third rabies vaccine
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired, no symptoms
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired, no symptoms
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral thrombosis, Computerised tomogram, Hypoaesthesia, Thalamic stroke
Clinical narrative: 5 months later Left side went numb--Stroke of the Thalmus caused by a blood clot
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, COVID-19, Cardiac failure congestive, Chronic kidney disease, End stage renal disease
Clinical narrative: Hospitalization for CHF, COVID-19, hypoxemia, hypothyroid, pleural effusion, uncontrolled hypertension, anemia, CKD, ESRD, pneumonia  on dates 4/8/2024- 4/22/2024. Treated with dexamethasone and Remdesivir.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Hypothyroidism, Hypoxia, Pleural effusion, Pneumonia
Clinical narrative: Hospitalization for CHF, COVID-19, hypoxemia, hypothyroid, pleural effusion, uncontrolled hypertension, anemia, CKD, ESRD, pneumonia  on dates 4/8/2024- 4/22/2024. Treated with dexamethasone and Remdesivir.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Gingival swelling, Mouth ulceration, Pyrexia
Clinical narrative: The patient had the Covid vaccine on 4/18/24. The patient experienced fever after the shot, which has been subsidized. On 4/20/24, the patient started experiencing swelling and soreness in her gums and oral ulcerations of the roof of her mouth. Resolving on its own. No difficulty swallowing, SOB, chest pain, gum bleeding, skin rash, itching, and any other symptoms. The patient has had the vaccine before but never experienced similar reactions. (2023-2024) Moderna Spikevax Vaccine 12+
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, Benign prostatic hyperplasia, COVID-19 pneumonia, Cardiac failure acute
Clinical narrative: Hospitalization for shortness of breath and pneumonia likely due to COVID-19 (positive), acute hypoxic respiratory failure, COPD, obstructive sleep apnea, Afib, Acute on chronic diastolic heart failure, CKD stage 3, microcytic anemia, hypertension, hyperlipidemia, GERD, BPH, depression/anxiety on dates 4/12/24- 4/22/24.  Treated with dexamethasone, baricitinib, and Remdesivir.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease, Chronic obstructive pulmonary disease, Depression, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: Hospitalization for shortness of breath and pneumonia likely due to COVID-19 (positive), acute hypoxic respiratory failure, COPD, obstructive sleep apnea, Afib, Acute on chronic diastolic heart failure, CKD stage 3, microcytic anemia, hypertension, hyperlipidemia, GERD, BPH, depression/anxiety on dates 4/12/24- 4/22/24.  Treated with dexamethasone, baricitinib, and Remdesivir.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperlipidaemia, Hypertension, Left ventricular failure, Microcytic anaemia, Obstructive sleep apnoea syndrome
Clinical narrative: Hospitalization for shortness of breath and pneumonia likely due to COVID-19 (positive), acute hypoxic respiratory failure, COPD, obstructive sleep apnea, Afib, Acute on chronic diastolic heart failure, CKD stage 3, microcytic anemia, hypertension, hyperlipidemia, GERD, BPH, depression/anxiety on dates 4/12/24- 4/22/24.  Treated with dexamethasone, baricitinib, and Remdesivir.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Hospitalization for shortness of breath and pneumonia likely due to COVID-19 (positive), acute hypoxic respiratory failure, COPD, obstructive sleep apnea, Afib, Acute on chronic diastolic heart failure, CKD stage 3, microcytic anemia, hypertension, hyperlipidemia, GERD, BPH, depression/anxiety on dates 4/12/24- 4/22/24.  Treated with dexamethasone, baricitinib, and Remdesivir.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Respiratory arrest
Clinical narrative: Per newspaper article the pt was not breathing when mom presented to ER with him at 0607 on 4/19/24. .
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Angiocardiogram, Atrial fibrillation, Cardiac ablation, Coronary arterial stent insertion, Echocardiogram
Clinical narrative: PFIZER #1 10/15/2021 PFIZER BIVALENT #2 10/14/2022 MODERNA BIVALENT #3 9/25/2023  PATIENT DEVELOPS PAROXYSMAL ATRIAL FIBRILLATION REQUIRING ABLATION THEN SUFFERS A RCA INFERIOR MYOCARDIAL INFARCTION REQUIRING THROMBECTOMY AND STENTING.  LVEF = 35%  SMALL PERICARDIAL EFFUSION.  DIAGNOSED WITH MILD PERICARDITIS.  ALL CARDIAC EVENTS CLINICALLY DETERMINED TO BE CAUSED BY MRNA COVID VACCINATION.  FINALLY, HE UNDERWENT A WATCHMAN DEVICE LAA OCCLUDER FOR STROKE PREVENTION.  TREATED WITH ASA CLOPIDOGREL LOSARTAN UPGRADED TO ENTRESTO METOPROLOL UPGRADED TO CARVEDILOL AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Ejection fraction decreased, Electrocardiogram, Immunisation reaction, Laboratory test, Left atrial appendage closure implant
Clinical narrative: PFIZER #1 10/15/2021 PFIZER BIVALENT #2 10/14/2022 MODERNA BIVALENT #3 9/25/2023  PATIENT DEVELOPS PAROXYSMAL ATRIAL FIBRILLATION REQUIRING ABLATION THEN SUFFERS A RCA INFERIOR MYOCARDIAL INFARCTION REQUIRING THROMBECTOMY AND STENTING.  LVEF = 35%  SMALL PERICARDIAL EFFUSION.  DIAGNOSED WITH MILD PERICARDITIS.  ALL CARDIAC EVENTS CLINICALLY DETERMINED TO BE CAUSED BY MRNA COVID VACCINATION.  FINALLY, HE UNDERWENT A WATCHMAN DEVICE LAA OCCLUDER FOR STROKE PREVENTION.  TREATED WITH ASA CLOPIDOGREL LOSARTAN UPGRADED TO ENTRESTO METOPROLOL UPGRADED TO CARVEDILOL AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Myocardial infarction, Percutaneous coronary intervention, Pericardial effusion, Pericarditis, Thrombectomy
Clinical narrative: PFIZER #1 10/15/2021 PFIZER BIVALENT #2 10/14/2022 MODERNA BIVALENT #3 9/25/2023  PATIENT DEVELOPS PAROXYSMAL ATRIAL FIBRILLATION REQUIRING ABLATION THEN SUFFERS A RCA INFERIOR MYOCARDIAL INFARCTION REQUIRING THROMBECTOMY AND STENTING.  LVEF = 35%  SMALL PERICARDIAL EFFUSION.  DIAGNOSED WITH MILD PERICARDITIS.  ALL CARDIAC EVENTS CLINICALLY DETERMINED TO BE CAUSED BY MRNA COVID VACCINATION.  FINALLY, HE UNDERWENT A WATCHMAN DEVICE LAA OCCLUDER FOR STROKE PREVENTION.  TREATED WITH ASA CLOPIDOGREL LOSARTAN UPGRADED TO ENTRESTO METOPROLOL UPGRADED TO CARVEDILOL AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient presented to vaccination clinic inside homeless resource center and received influenza vaccine without incident.  After doing data entry, we noticed that this person had received the influenza vaccine on 3/20/24.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Neoplasm malignant
Clinical narrative: Headaches within 1 year, joint pain within 5 years, cancer after 30 years