chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Head injury, Swelling, Syncope
Clinical narrative: Syncope; Fall; bump on her head; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 30May2024 as dose number unknown, 0.5ml single (Lot number: HJ1516, Expiration Date: Jun2026) at the age of 16 years intramuscular, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (medically significant) with onset 30May2024, outcome "recovered with sequelae" (30May2024); SYNCOPE (medically significant) with onset 30May2024, outcome "unknown"; HEAD INJURY (medically significant) with onset 30May2024, outcome "not recovered", described as "bump on her head". It was unknown if therapeutic measures were taken as a result of syncope, fall, head injury. Clinical course: Caller stated that she called from (Institute name withheld) for Meningitis B. Clarified as Trumenba, a Pfizer product. Had a patient in the office that after the patient had received Trumenba experienced syncope. Later provided that this patient also experienced a fall from the syncope and a bump on the head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400184249 Same reporter and product, different patient;
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 30May2024 as dose number unknown, 0.5ml single (Lot number: HJ1516, Expiration Date: Jun2026) at the age of 16 years intramuscular, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 30May2024, outcome "recovered". Therapeutic measures were not taken as a result of syncope. Additional information: Caller stated that she called from (Institute name withheld) for Meningitis B. Clarified as Trumenba, a Pfizer product. Had four patients in the office after they had received Trumenba that all experienced syncope and one of those patients also complained of chest pain, arm pain and headache. This report is for one of those patients that experienced syncope only.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400184242 Same reporter and product, similar events, different patient;US-PFIZER INC-202400184261 Same reporter and product, similar events, different patient;US-PFIZER INC-202400184251 Same reporter and product, similar events, different patient;US-PFIZER INC-202400184261 Same reporter and product, similar events, different patient;
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Chest pain, Headache, Pain in extremity, Syncope
Clinical narrative: Syncope; Chest pain; arm pain (right); Headache; This is a spontaneous report received from a Consumer or other non HCP.  A 17-year-old patient received meningococcal group b Rlp2086 (TRUMENBA), on 30May2024 as dose number unknown, 0.5ml single (Lot number: HJ1516, Expiration Date: Jun2026) at the age of 17 years intramuscular, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 30May2024, outcome "unknown"; HEADACHE (non-serious) with onset 30May2024, outcome "unknown"; SYNCOPE (medically significant) with onset 30May2024, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 30May2024, outcome "unknown", described as "arm pain (right)". The events "syncope", "chest pain", "arm pain (right)" and "headache" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: 116 pounds, 12.8 ounces, notes: Weight is 116 pounds, 12.8 ounces. Therapeutic measures were taken as a result of syncope. It was unknown if therapeutic measures were taken as a result of chest pain, pain in extremity, headache.  Clinical course: Had a patient in the office that after the patient had received Trumenba experienced syncope. Later provided that this patient also experienced chest pain, right arm pain and headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400184249 Same reporter and product, different patient;
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Syncope; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 30May2024 as dose number unknown, 0.5ml single (Lot number: HJ1516, Expiration Date: Jun2026) at the age of 16 years intramuscular, in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SYNCOPE (medically significant) with onset 30May2024, outcome "recovered". Therapeutic measures were not taken as a result of syncope.  Clinical course: It was reported that they had a patient in the office that after the patient had received Trumenba experienced syncope. Stated that the patient's last visit was on last visit 06Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400184249 Same reporter and product, similar events, different patient;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies: Codeine". Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 22May2024 to 27May2024.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: IPOL was exposed to excursion for 21 minutes on fridge, temp. was 34.31° C  and was administered to patient with no adverse event; Initial information received on 24-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old male patient (126 cm and 23 kg) who was administered IPV (VERO) [IPOL] which was exposed to excursion for 21 minutes on fridge, temp. was 34.31° C.  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 Booster dose of suspect IPV (VERO) (Suspension for injection) (lot: WIC751M) (strength; expiry date unknown) which was exposed to excursion for 21 minutes on fridge, temp. was 34.31° c via intramuscular route in the left deltoid for immunization (poor quality product administered) (latency: same day).  Reportedly, the excursion occurred on 18-Mar-2024.  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: 21.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: receive the acthib, but it was diluted with sterile water verses the 0.4 saline diluent that it comes with no reported adverse event; Initial information received on 24-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 years old male patient who receive the HIB (PRP/T) vaccine [ACT-HIB], but it was diluted with sterile water verses the 0.4 saline diluent that it comes 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization)  On 23-May-2024, the patient received a 0.5 ml dose (dose 4) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection Frequency: once, Strength: standard, of lot UK009AA expiry date: 28-Feb-2025 via intramuscular route in the right thigh for immunization but it was diluted with sterile water verses the 0.4 saline diluent that it comes with no reported adverse event (product preparation error) latency; on 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: 70.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 70 year old patient was administered the ADACEL with no reported adverse event; Initial information received on 29-May-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 70 years old female patient who was administered the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-May-2024, the patient received a standard dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml total (lot 2CA69C1, expiry date-20-Jul-2025) via unknown route in the left arm for Immunization.  On 29-MAY-2024, the 70 year old patient was administered the diphtheria-2/tetanus/5 AC pertussis vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-VAX was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 29-May-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered Yellow Fever Vaccine [YF-VAX] which was reconstituted with sterile water 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 (dose and units unspecified) (frequency: Once) of suspect Yellow Fever Vaccine (Solution for injection) which was reconstituted with sterile water (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (product preparation error) (latency-same day). Batch number was requested for this case.  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: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: DTAP-IPV portion was not mixed with the HIB portion prior to being administered to the consumer/did not receive the HIB portion, with no reported adverse event; Initial information received on 30-May-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient and it was reported DTAP-IPV portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was not mixed with the HIB portion prior to being administered to the consumer/did not receive the HIB portion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-May-2024, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UK026AA; expiry date: 30-Jun-2025; frequency: once; strength: standard) of which dtap-ipv portion was not mixed with the hib portion prior to being administered to the consumer/did not receive the hib portion, with no reported adverse event (single component of a two-component product administered) (latency: same day) via intramuscular route in the right thigh for Immunization.  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: MMR
Symptoms: Expired product administered
Clinical narrative: patient has not reported any medical concerns or symptoms; HBP reporting that a dose of MMR II was administered beyond it's expiration date of 5/10/2024 today, 5/28/2024.  HBP stated that the expired dose was inadvertently administered during the patient; This spontaneous report as received from a health business professional (HPB) referring to  a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On an unknown date, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection (dose, route, lot # and expiration date were not reported) for prophylaxis  It was reported on 28-MAY-2024, the patient was vaccinated inadvertently with  an expired  second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)rHA, injection, dose : 0.5 milliliter, lot # W034592, expiration date: 10-MAY-2024(route  was not reported) for prophylaxis during the patient's routine visit and confirmed that the patient has not reported any medical concerns or symptoms after being administered the expired.
Age: 0.17
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; VAXNEUVANCE was administered to 4 patients after temperature excursion.; This spontaneous report was received from medical assistant and refers to a 10-week-old patient of unknown age. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 05-MAR-2024, the patient was vaccinated with an improper storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X022475, expiration date: 23-JAN-2026 (who had been verified to be a valid number) administered for prophylaxis (strength, dose, frequency, and anatomical route of administration were not provided). The vaccine was administered at temperature of 53.0F with a time frame of 4 hours 30 minutes and 0 seconds. There was no information about previous temperature excursion (product storage error).   No additional adverse event.  This is one of the 4 cases received from same reporter.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: just fell apart (tip on the syringe part of it just broke off, then the diluent just leaked out); The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 23May2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "just fell apart (tip on the syringe part of it just broke off, then the diluent just leaked out)".  Causality for "just fell apart (tip on the syringe part of it just broke off, then the diluent just leaked out)" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The reporter was mixing an RSV shot, the Abrysvo and it just fell apart, the tip on the syringe part of it just broke off, it was defective and then the diluent just leaked out.  Batch/lot number is not provided, and it cannot be obtained.
Age: 22.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness postural
Clinical narrative: 5:15 pm vaccines adm both vaccines in left arm. the patient indicates dizziness when getting up. We wait until the patient indicates she feel better
Age: 78.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse even occurred to patient. Client was mistakenly given a pediatric dose of Moderna.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The 10-year-old patient received a 12+ year-old dose of Moderna (2023-2024 formula COVID-19). No known adverse events at the time of this report.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Patient has 2-3 small pocks exactly on top of the injection site where the vaccine was administered. There is also a red ring around the area. Patient said they appeared within a week of receiving the injection. They are not currently nor have they ever been itchy.
Age: 50.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Rash
Clinical narrative: RASH ON ARM
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5 year old received Tdap instead of a Dtap
Age: 31.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dyspnoea, Mobility decreased, Muscle disorder, Pain, Paraesthesia
Clinical narrative: Patient reported generalize pain, lock muscles, unable to move arms and leg, tingling sensation, and difficulty breathing. Patient was able to communicate verbally. 911 was called, and patient was admitted to hospital.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Spontaneous itchiness. Rashes all over body. Extreme itchiness on hands and feet. Has not stopped for 3 years.
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 YEAR OLD RECEIVED DTAP INSTEAD OF TDAP
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, White blood cell count increased
Clinical narrative: Rash, swelling in legs, elevated WBC
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bursitis, Dyspnoea, Magnetic resonance imaging joint, Mobility decreased
Clinical narrative: Patient underwent second Shingrix vaccination in left deltoid on 30Jan2024. Soon afterwards she started to develop pain and mild loss or ROM in her left shoulder. Patient was referred to PT with improvement in ROM but still has some mild pain at times. MRI was obtained (see below), and had discussed orthopedics evaluation for which patient declined.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tendon disorder, Tendon injury
Clinical narrative: Patient underwent second Shingrix vaccination in left deltoid on 30Jan2024. Soon afterwards she started to develop pain and mild loss or ROM in her left shoulder. Patient was referred to PT with improvement in ROM but still has some mild pain at times. MRI was obtained (see below), and had discussed orthopedics evaluation for which patient declined.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: Noted on 6/3/2024 pt received MMR and and Pro quad Vaccines on 5/7th. No Adverse invent. Father told to the nurse that did not have any reaction or any adverse event.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received 12-year-old dose of Pfizer COVID vaccine and the patient was 6 years old at the time of administration. At the time of writing, no adverse events have been noted.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm, Tendonitis
Clinical narrative: PATIENT STATES THAT 3 DAYS AFTER RECEIVING VACCINE, HER LEFT ARM BEGAN TO HURT AND WAS WARM TO THE TOUCH. SHE WENT TO AN EXPRESS CARE & WAS DIAGNOSED WITH TENDONITIS OF THE LEFT ARM, GIVEN BACLOFEN TO TREAT.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Erythema, Headache, Myalgia, Peripheral swelling
Clinical narrative: Swelling and redness on left arm. Headache, achy joints and muscles.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Hemiparesis, Magnetic resonance imaging, Paraesthesia, Peripheral swelling
Clinical narrative: Left side weakness, bilateral lower extremity and upper left extremity swelling and paresthesias.  First: Swollen left leg which turned in.  could not walk.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Left side weakness, bilateral lower extremity and upper left extremity swelling and paresthesias.  First: Swollen left leg which turned in.  could not walk.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Two years of uncontrollable itching.   I never take any meds, never use lotion, never use anything.  During these two years I spent hundreds on itching cream to try and find something that would work and nothing worked.  My head arms and legs were itching out of control beginning within a month after getting the jab.  I never experienced anything like it in my life. I was so itchy it was out of control. Mostly where hair grew.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Headache, chills, achy, stomach pain, and nausea
Age: 11.0
Sex: M
Vaccine: HPV9, UNK, UNK
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Gait disturbance, Metabolic function test normal, Muscle swelling
Clinical narrative: Bilateral quadriceps pain and swelling progressively worsening within 6 hours after administration of vaccines above. Difficulyt with ambulation. Prompted ED visit  for IV fluids and Toradol with some improvement.
Age: 11.0
Sex: M
Vaccine: HPV9, UNK, UNK
Symptoms: Myalgia, Urine analysis normal
Clinical narrative: Bilateral quadriceps pain and swelling progressively worsening within 6 hours after administration of vaccines above. Difficulyt with ambulation. Prompted ED visit  for IV fluids and Toradol with some improvement.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired MMRII administration on 30MAY2024. Vaccine expired on 25MAY2024; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 30-MAY-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, lot number W039699 that was verified to be a valid lot number (expiration date reported and validated 25-MAY-2024) as prophylaxis (dose, scheme, route and anatomical location of administration were not provided) (expired product administered). It was confirmed that the patient had no side effects, and no previous temperature excursions were reported. The operator of device was a healthcare professional. No other medical information was known. No additional adverse event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION TO THE COVID VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced allergic reaction to the covid vaccine (Dose number in series 1). Patient reports that she is currently taking XARELTO. Patient explained she had an allergic reaction to the COVID vaccine. Did not clarify if this was prior to or after taking XARELTO The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction to the covid vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: MMRV
Symptoms: Device connection issue, No adverse event
Clinical narrative: No additional adverse event; needle stayed in the patients thigh with the luer lock attached to it/nothing broke, the luer lock just detached from the syringe; "loose" luer lock; the syringe was pulled out after the injection the needle stayed in the patients thigh with the luer lock attached to it.; poor quality device used; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-MAY-2024, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, first dose, lot #1950652, expiration date: 27-JAN-2026 (strength, route of administration, and indication were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X027623, expiration date: 28-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided). It was reported that they had issue with thightening the needle on prefiled sterile diluent (BAXTER STERILE DILUENT) syringes ad recently had a neeadle deatached from the prefiled syringe after being administered to a patient (Device connection issue). It was also reported to had a loose luer lock (Syringe issue). The reporter stated that when syringe was pulled out after te injection the needle stayed in the patients thigh with the leuer lock attached to it (Complication of device removal). Nothing broke the leuer lock just deatached from the syringe (Poor quality device used). No additional adverse event was reported.
Age: 0.75
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 9-month-old patient mistakenly received a vaccine too early, with no reported advers event; Initial information received on 28-May-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 months old male patient who was mistakenly administered Typhoid VI Polysaccharide Vaccine [Typhim VI] too early, with no reported advers event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-May-2024, the patient had mistakenly received (dose and units unspecified) of suspect Typhoid VI Polysaccharide Vaccine (Solution for injection) (lot VZA501M, expiry date: 08-Nov-2025; strength not reported) too early, with no reported adverse event (product administered to patient of inappropriate age) (latency-same day) via intramuscular route in unknown administration site for Immunization.  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: 50.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given wrong Vaccine , MA was supposed to give Hep B. Patient has not reported any adverse Symptoms
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, PNC15
Symptoms: Pyrexia, Seizure
Clinical narrative: High fever and seizure
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Injection site erythema, Injection site hypoaesthesia, Injection site swelling
Clinical narrative: Patient received SpikeVax Moderna IM L  deltoid on 5/29/24.  Then received RSVPreF3 Vac on 5/30  R arm at around 11:00 am.  Then on 5/30 at around 21:34, patient started to have SOB, weakness, L arm numbness, swelling, warmth, and redness over the L arm where he received the COVID vaccine.  Patient was sent out to ER for further evaluation and management.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Patient received SpikeVax Moderna IM L  deltoid on 5/29/24.  Then received RSVPreF3 Vac on 5/30  R arm at around 11:00 am.  Then on 5/30 at around 21:34, patient started to have SOB, weakness, L arm numbness, swelling, warmth, and redness over the L arm where he received the COVID vaccine.  Patient was sent out to ER for further evaluation and management.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling, Rash, Tenderness
Clinical narrative: Per the patient's message:  "I wanted to share with you my first reaction to a vaccine, ever.  Perhaps there are reports that go back to the pharmaceutical company to keep them informed as to reactions to a version of a vaccine.  Within hours after the shot I had the usual side effects, my upper arm became tender and I had pain (to be expected).  What I did not expect was the swelling and rash that developed on my upper arm and was still significant five days  later.  The swelling of the upper arm grew and traveled to the front of the upper arm along with swelling of the front upper arm.   I developed a rash on my upper abdomen that disappeared after 72 hours.  I also experienced a fever that lasted 36 hours."
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Patient returned to pharmacy within 24-48h with red, swollen arm from injection site. Patient reports pain upon palpation and skin was tender. Pharmacist on duty recommended patient to take Benadryl and go to Urgent Care for further treatment.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received a third dose of Heplisav-B. Patient completed series with two doses on 02/15/2024 and 03/14/2024
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysstasia, Fall, Fear
Clinical narrative: Approximately an hour after returning home from receiving the vaccine booster, I began experiencing extreme dizziness, unable to stand without falling, the room was constantly spinning, I had to crawl to restroom and have family never in home navigate where restroom was. This persisted in varying degrees of severity for approximately 4 days. Since this episode, I have intermittent ringing in my ear at varying degrees of volume that continue to date - it is now 6/2024. I also now have an adverse reaction to the flu vaccine with similar but far less degree of severity parting only a day or two. I no longer take the flu shot as a result. I am now terrified to receive a pneumonia or shingles injection vaccines for fear of similar reactions.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Tinnitus, Vertigo
Clinical narrative: Approximately an hour after returning home from receiving the vaccine booster, I began experiencing extreme dizziness, unable to stand without falling, the room was constantly spinning, I had to crawl to restroom and have family never in home navigate where restroom was. This persisted in varying degrees of severity for approximately 4 days. Since this episode, I have intermittent ringing in my ear at varying degrees of volume that continue to date - it is now 6/2024. I also now have an adverse reaction to the flu vaccine with similar but far less degree of severity parting only a day or two. I no longer take the flu shot as a result. I am now terrified to receive a pneumonia or shingles injection vaccines for fear of similar reactions.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine.   No reported adverse reactions
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Gaze palsy, Lethargy, Rash
Clinical narrative: I have a lingering small rash on my left hip. I also had a headache and lethargy the first few days after the vaccine, but those are more typical side effects.
Age: 0.67
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of polio in the same vaccine visit. One was in the combination Pentacel
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Tinnitus, Vision blurred
Clinical narrative: Pt states that this morning after she woke up around 7am she went to the kitchen to get something to eat. She began to feel lightheaded, nauseous, had blurred vision, and ringing in her ears. She was on her way to the bathroom and she felt that she had to sit down or she would pass out. Mom states pt sat down in the hallway and crawled to the bathroom. She did not have emesis or pass out. Mom states she looked pale. Pt drank water and ate dry cereal and began to feel better. Mom reports the whole event lasted 5-10 minutes. Mom reports pt took a nap after the event. Pt now presents to Clinic feeling back to baseline at 11am HR 118 and BP 102/62
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a covid vaccine that was taken from the freezer and given a 30 day expire date. Patient was given the vaccine on 5/29/2024 and the expired date was 5/24/2024.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Migraine
Clinical narrative: Patient received Engerix Hep B vaccination ~1200  (6/03) and started to feel a migraine progress around 7 pm the same day. Patient does not have a history of migraines. Only difference in the day was receiving the Hep B vaccination. Patient took OTC medication (ibuprofen). 6/04 symptoms were relieved with OTC medications.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Client received a third HPV vaccine that was not necessary, as client completed 2 dose series at age 9 - client tolerated vaccination well. No nausea, fatigue, dizziness, or fainting observed by this nurse during client visit nor upon client leaving the clinic.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Pain in arm, shoulder, and neck lasting through the date of this form submission.    So far, the pain is tolerable, but I wanted to report it because I have never had arm/shoulder pain of this intensity and lasting this long after a vaccination.   I will mention it the next time I visit a doctor, but I will not make an appointment specifically for this unless the pain gets worse or other symptoms develop.    Problem may have resulted from the injection process and not the vaccine.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Pt reports having a rash on bilateral arms and back of neck that started 1 day after 2nd dose of Hep B vaccine. he reports the rash was itchy and bumpy like little pimples. He reports the rash has lasted 2 months and it is starting to improve
Age: 21.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Patient came in for her 2nd Meningococcal B vaccine and she was also due for Tdap (last one 10/14/2014) I took the patient temperature, went over questions, ask if the patient felt ill, drew up the immunization, had a coworker confirm/verify . I gave the Tdap in the right deltoid, then went over to the left side and gave her meningococcal B in the right side, I administered it in the Left deltoid and patient said oh.. and fainted, I laid her down on the bed, called for help , Dr. and PA all were present and took over, did vitals, gave patient some water, put a cool cloth on her forehead, and gave her some skittles to eat. I checked on the patient every 5 minutes. She wanted us to call her brother to come and get her as she said she felt "fuzzy". Her brother came and picked her up and left. I told her to call office if she has any symptoms.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Neck pain, Pain
Clinical narrative: Patient describes of sore joint in shoulder, not associated with injection site, starting 1 day after vaccine and increasingly getting worse . She saw family physician and has had 2 rounds of steriods without relief, after last round she recalled the physician since if  started radiating further from your shoulder up through her neck, doctor started her on muscle relaxant  (tizanidine) and patient stating getting some relief now.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Bipolar disorder, Confusional state, Hallucination, Laboratory test, Mental disorder
Clinical narrative: Psychotic break, mental disorders, confusion, gain weight, seizures, bipolar and hallucinations
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Psychotic disorder, Seizure, Weight increased
Clinical narrative: Psychotic break, mental disorders, confusion, gain weight, seizures, bipolar and hallucinations
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Angiogram cerebral, Arteriogram carotid, Magnetic resonance imaging head, Pyrexia, Seizure
Clinical narrative: Seizure, fever,
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown at this time. patient has not answered at this time.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: hives/rash within minutes of vaccination. Given Benadryl in office with improvement. Pending result
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Product preparation error
Clinical narrative: LPN administered Hib vaccine diluent only.  It was noted when performing inventory.  Mother of child was notified, and child is scheduled for revaccination.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: patient has not experienced an adverse reaction/effect at this time. patient feels fine.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 9 month old administered 2 doeses of HIB (one single does and one group does with Dtap , IPV, Hib), no treatments at this time, partents notifed and baby is fine.
Age: 7.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Polio given 3 months early r/t it should have been full 6 months from 2nd to 3rd dose
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient requested two vaccinations, Prevnar 20 and Spikevax, on 6/1/24. Prevnar20 was given in the left arm and spikevax in the right. Patient came today 6/4/24 and reported that her left arm developed redness from her elbow to her shoulder. She reports developing rash on Sunday on her elbow and then to her bicep. It was painful starting Saturday going into Sunday. She reported that the redness and pain did go down and when I looked at it, it did look like it was red. Patient states that it is a lot better today, however still a little sore.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Arthralgia, myalgia, localized swelling/redness at injection site.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: PT HAD A RASH THAT TURNED OUT TO  BE ACTIVE SHINGLES WHEN HE WENT TO DR 5/16/24 A MONTH AFTER THE VACCINATION
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Staff member gave half the required dose.  Staff member only gave the DTAP-IPV components, therefore resulting in the patient not receiving the Hib component. Had this error not been found, this patient would have been missing  a dose in the series.  Staff member called and notified parents of this error. Patient is scheduled to come into the clinic so that staff may remedy this error by administering the missing Hib.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Extreme fatigue began on evening of day one and lasted for the next 3 days with chills on day 2. Watery diarrhea, abdominal cramps, pain at injection point, fever of 103 , headache, began on day 2 and continued for 4 days with fever breaking on day 4 but remained low 99-101 until day 5.  Diarrhea stopped after one week with use of pepto bismol.  Went to my doctor after one week to discuss the symptoms as the symptoms were quite severe in my opinion.  He noted that hopefully with fluids and pepto bismol, the symptoms would subside. I still have some fatigue going into the second week.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Extreme fatigue began on evening of day one and lasted for the next 3 days with chills on day 2. Watery diarrhea, abdominal cramps, pain at injection point, fever of 103 , headache, began on day 2 and continued for 4 days with fever breaking on day 4 but remained low 99-101 until day 5.  Diarrhea stopped after one week with use of pepto bismol.  Went to my doctor after one week to discuss the symptoms as the symptoms were quite severe in my opinion.  He noted that hopefully with fluids and pepto bismol, the symptoms would subside. I still have some fatigue going into the second week.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chest discomfort, Fatigue, Feeling cold, Limb discomfort
Clinical narrative: Patient reports tightness sensation to left arm, and sleepiness immediately after vaccination.  Patient reports palpitations and anxiety in the evening of vaccination. 06/04/2024 upon MD assessment patient reports "something pulling on left side of chest,"  sleepiness, feeling cold and fatigue. MD prescribed loratadine 10 mg x1 tablet daily.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Sleep disorder, Somnolence
Clinical narrative: Patient reports tightness sensation to left arm, and sleepiness immediately after vaccination.  Patient reports palpitations and anxiety in the evening of vaccination. 06/04/2024 upon MD assessment patient reports "something pulling on left side of chest,"  sleepiness, feeling cold and fatigue. MD prescribed loratadine 10 mg x1 tablet daily.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site rash, Rash, Rash erythematous, Rash papular
Clinical narrative: 1 day after receiving the Moderna Spikevax, pt experienced a red lumpy skin rash that began at the site of injection and wrapped up around the front of her neck. The rash resolved on its own after 3 days
Age: 18.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Nausea, Pain
Clinical narrative: Pt was given the MMR vaccine and immediately upon entry into the arm felt pain. "Worst pain I've ever felt from a vaccine."  Her arm became numb and immobile and radiated up her shoulder to her neck.  The Menveo vaccine had not been given yet.  The technician administering the vaccine immediately came and got the pharmacist.   The patient was complaining of numbness, pain and nausea.  No shortness of breath.  Gave the pt some orange juice and checked her blood pressure which was 118/89. Upon examination it appeared the administration site was a little too high.  The numbness and pain subsided over a little time but still bothersome. Advised the patient to see a doctor if the pain or side effects continue and to alert me if they continue. Since pt was feeling better, patient elected  and we did proceed to give the patient the Menveo vaccine in the other arm and had no issues with this shot.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Extra dose administered
Clinical narrative: MA had given rotavirus when patient already received 3 rotateq vaccinations.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Deafness, Fall
Clinical narrative: Patient fell slowly to floor in hallway, without losing consciousness or hitting her head.  She reported unable to hear for a short period.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Angiogram pulmonary, Blood folate, Blood homocysteine, C-reactive protein
Clinical narrative: Acute deep vein thrombosis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac telemetry, Chest X-ray, Deep vein thrombosis, Differential white blood cell count, Echocardiogram
Clinical narrative: Acute deep vein thrombosis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Factor II mutation, Full blood count, Hepatitis C antibody, International normalised ratio
Clinical narrative: Acute deep vein thrombosis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Iron binding capacity total, Lipids, Metabolic function test, Occult blood, Prostatic specific antigen
Clinical narrative: Acute deep vein thrombosis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Protein C, Protein S, Prothrombin level, Red blood cell sedimentation rate, Reticulocyte count
Clinical narrative: Acute deep vein thrombosis