chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC20
Symptoms: Pain
Clinical narrative: pain after the vaccination; This is a spontaneous report received from a Physician from a sales representative.  An elderly patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain after the vaccination".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma exercise induced" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacture unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacture unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 25May2024 to 29May2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Feb2021 as dose 1, single), in left arm, on 26Mar2021 as dose 2, single), in left arm, on 01Nov2021 as dose 3 (booster), single), in left arm, on 07Jun2022 as dose 4 (booster) single), in left arm and on 25Oct2023 as dose 6 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 25Aug2023. Past drug history included: Doxycycline, reaction(s): "Allergy"; Hydromorphone, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28May2024 to 01Jun2024.
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Malaise
Clinical narrative: Felt sick; lightheaded; This is a spontaneous report received from an Other HCP from a sales representative.  An adult female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset May2024, outcome "recovered" (May2024), described as "Felt sick"; DIZZINESS (non-serious) with onset May2024, outcome "recovered" (May2024), described as "lightheaded". Therapeutic measures were not taken as a result of malaise, dizziness.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart palpitation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 27May2024 to 01Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Pneumonia; Pneumonia; This is a spontaneous report received from a Consumer or other non HCP .  An 83-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "Pneumonia".  Additional information: Each time patient got a pneumonia vaccine, patient get pneumonia. He know It's impossible, because it doesn't have the live virus, but it does happen. Referred to medication as "Plavix 20", assumed referring to Prevnar 20 and was confused given focus of study/interview was around COVID/ Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: dose of YF-VAX was administered to a patient after it had been diluted with an incorrect diluent with no adverse event; Initial information received on 04-Jun-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves Adult female patient (age in 30s) to whom dose of Yellow fever vaccine-[YF-VAX] was administered after it had been diluted with an incorrect diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-May-2024, the patient received 0.5 ml dose of suspect Yellow Fever vaccine- (single dose vial) Solution for injection of lot UJ966A and expiry: 31-Jan-2025 via subcutaneous route in unknown administration site for immunization; which was administered after it had been diluted with an incorrect diluent with no adverse event (product preparation error) (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: M
Vaccine: RAB
Symptoms: No adverse event, Underdose
Clinical narrative: he received 0.5 mL of IMOVAX for his 2nd and 3rd dose, with no reported adverse event; Initial information received on 05-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who received 0.5 ml of RABIES (HDC) Vaccine [IMOVAX RABIES] for his 2nd and 3rd dose, 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 an unknown date, the patient received a dose of 0.5 ml of suspect RABIES (HDC) Vaccine (Powder and solvent for suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for post-exposure prophylaxis (Immunization) and received 0.5 ml of imovax for his 2nd and 3rd dose, with no reported adverse event (incorrect dose administered) (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.   Reportedly "This is reported to PV as a potential medication error due to the caller reports that he and his family had a bat infestation in their house; they received rabies immune globulin and were initiated on a 4-dose series of IMOVAX. He reports that he is currently looking at his chart, and the chart for his first dose of IMOVAX he received 2.5 IU (1 mL) or IMOVAX for his first dose, which was at the pediatric ER. Then, his subsequent doses were given at the doctors office; his second and third doses of IMOVAX are documented as 0.5 mL doses. The caller was unable to answer questions for the AE questionnaire at the time of the call; he states that he does not have the time right now, but he agrees to receive follow-up. No further information provided by the reporter.This situation is pre-assessed as a medication error/an inappropriate use due to the caller. "  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: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: that an expired dose of IPOL was inadvertently administered with no reported adverse event; Initial information received on 05-Jun-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 1-year-old male patient and is reported that an expired dose of IPV (VERO) [IPOL] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine inact (Havrix); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) for Prophylactic Vaccination.  On an unknown date, the patient received a 0.5 ml dose  Frequency:once of suspect IPV (VERO) Suspension for injection Strength:standard of lot V1B901M expiry date: 02-Jun-2024 via unknown route in unknown administration site for immunisation and is reported that an expired dose of ipol was inadvertently administered with no reported adverse event (expired product administered) 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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: reconstituted ACT-HIB with sterile water instead of the saline solution with no reported adverse event; Initial information was received on 05-Jun-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was given reconstituted HIB (PRP/T) vaccine [ACT-HIB] with sterile water instead of the saline solution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (total, once) of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and reconstituted act-hib with sterile water instead of the saline solution with no reported adverse event (product preparation error) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence 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: 5.0
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 5-year-old got KENRIX and was given the IPOL as well, with no reproted adverse event; Initial information received on 05-Jun-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves 5-year-old with unknown gender got diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid [Kenrix] and was given the and IPV (VERO) [IPOL] as well, with no reproted adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date the 5-year-old got KINRIX not produced by Sanofi Pasteur (strength, form, lot number, expiry date: unknown) not reported via unknown route in unknown administration site as prophylactic vaccination (immunization) and was given the IPV (VERO), Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site prophylactic vaccination (immunization) as well, with no reported adverse event (extra dose administered) (latency) following the administration of IPV (VERO) and (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.
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Induration, Peripheral swelling
Clinical narrative: Arm is still swollen; 'Firm' arm; This spontaneous case, initially received on 03-Jun-2024, was reported by a health professional and concerns an adult female patient.  Administration of company suspect drug(s): On 20-Nov-2023, the patient received Flucelvax Quadrivalent (influenza vaccine inact sag 4v) for Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine, Dose regimen: 0.5 ml, Route of Administration and Anatomical Location: Not Reported; Lot number: AU3129B.  No additional suspect drugs.  Adverse reactions/events and outcomes: On and unknown day in Nov-2023, one or two day after taking the vaccine, the patient's arm was swollen (outcome: Not recovered / Not resolved) and 'Firm' (outcome: Not recovered / Not resolved). The patient's pharmacist advised to put topical inflammatory aw well as heat to increase blood-flow, but no further details were provided.  Non-drug treatment/Other action taken:  Flucelvax Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter did not provide a causality assessment. The events were assessed as non-serious.; Reporter's Comments: The events of peripheral swelling and musculosceletal stiffness were assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Age: 65.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Pruritus, Swelling
Clinical narrative: SWELLING, ITCHING. TOOK BENADRYL USED ICE
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: localized swelling to arm x4 days, improved with ice
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Injection site reaction, Rash macular, Somnolence
Clinical narrative: When I got the shot on 6/3/24 I had no reaction at all. Injection site was not red nor sore. I did not feel tired or achy. That is true for subsequent days until 6/9/24. On that morning I found a red splotch on my left arm where at injection site. I was also very tired and my joints were very achy. Hip, knees especially. I just wanted to sleep all day and put heat where the pain was.  That helped a lot. On 6/10/24, the red patch on the arm is smaller but still visible.  I felt somewhat better and was able to walk more comfortably without the knee pain and was strong enough to ride my bike 12 miles. So it was a very brief and mild reaction, but it was a surprise that it  occurred   6 days after the  injection.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Enterovirus infection, Enterovirus test positive, Injected limb mobility decreased, Intensive care, Laboratory test
Clinical narrative: Onset of fever and rash, 5 days after immunizations administered.  Tmax 101.6(ax).  Rash:  faint, red blanching papules mostly on UE and LE.  Pt holding LUE by side and cannot move it.  Will move fingers, but weak grasp.  Pt is not guarding when arm is passively moved.  PCP called peds neuro, who agreed AFM workup. PCP requested enterovirus PCP Because EV-D68 is known to cause AFM in children and pt has s/sx c/w this virus.   Direct admission to PICU on Sunday, 6/9/24.  MRI shows myelitis C3-C6.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Lumbar puncture, Magnetic resonance imaging abnormal, Motor dysfunction, Myelitis, Pallor
Clinical narrative: Onset of fever and rash, 5 days after immunizations administered.  Tmax 101.6(ax).  Rash:  faint, red blanching papules mostly on UE and LE.  Pt holding LUE by side and cannot move it.  Will move fingers, but weak grasp.  Pt is not guarding when arm is passively moved.  PCP called peds neuro, who agreed AFM workup. PCP requested enterovirus PCP Because EV-D68 is known to cause AFM in children and pt has s/sx c/w this virus.   Direct admission to PICU on Sunday, 6/9/24.  MRI shows myelitis C3-C6.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Papule, Pyrexia, Rash
Clinical narrative: Onset of fever and rash, 5 days after immunizations administered.  Tmax 101.6(ax).  Rash:  faint, red blanching papules mostly on UE and LE.  Pt holding LUE by side and cannot move it.  Will move fingers, but weak grasp.  Pt is not guarding when arm is passively moved.  PCP called peds neuro, who agreed AFM workup. PCP requested enterovirus PCP Because EV-D68 is known to cause AFM in children and pt has s/sx c/w this virus.   Direct admission to PICU on Sunday, 6/9/24.  MRI shows myelitis C3-C6.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: pt said after the vaccine started vomiting
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Dyspnoea, Joint range of motion decreased, Lung disorder, Magnetic resonance imaging joint
Clinical narrative: Have lost over 3 inches on my right arm.  Nerve pain from neck down to my hips. Right e!bow will not bend all the way. Now I am on blood pressure pills.  Right lung does not fill up and hard to take a deep breath.   Shingles vaccine
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging neck, Neck pain, Neuralgia
Clinical narrative: Have lost over 3 inches on my right arm.  Nerve pain from neck down to my hips. Right e!bow will not bend all the way. Now I am on blood pressure pills.  Right lung does not fill up and hard to take a deep breath.   Shingles vaccine
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: This vaccine was not authorized to be administered after 9/12/2023.  Administration error;  no physical symptoms
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: Vaccine administration error;  vaccine not authorized to be administered after 9/12/2023
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: NO ADVERSE EVENT. IMMUNIZATION ADMINISTERED OUTSIDE OF CDC GUIDELINES. PHYSICIAN RECOMMENDED VACCINE
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Vaccination administered outside of CDC guidelines.  no adverse effects seen. Physician recommend vaccination for pregnant female
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test, Pain in extremity, Tenderness, Varicose vein
Clinical narrative: Developed severe pain left lateral calf and later pain and tenderness both lower extremities and chest. Developed varicose veins of both lower extremities.  Treated conservatively with steroid taper, support hose, massage, ice.  Has gradually improved  over last  20 months.  Still some residual quad and calf tenderness.  Varicose veins still present.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Exposure during pregnancy, Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient stated she wanted to receive the TDap vaccine as suggested by her Doctor as she is 33 weeks pregnant.  Approximately 20 minutes after leaving, patient returns stating she feels numbness and tingling in her left arm and thinks she is having a panic attack.  She also stated having numb feeling in her left ear lobe that appeared flushed.  Patient used the machine to check her blood pressure which was below 120/80 and normal but her heart rate was 104.  Patient stated she believed she was having the attack because she was anxious about the numb feeling in her arm.  Patient calmed down and called her Ob office.  After communicating with the on call ObGyn she stated she gets many panic attacks but usually on both sides and around her head usually feels numb and tingly but this time only on the left arm where she got the vaccine and left side of her ear.  Doctor was on speaker as her husband had arrived.  Dr told her he does not think there is anything wrong and she would be fine.  Patient calmed down and stated she will go home and lie down and will call the on call Doctor back if needed.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Administered Spikevax.  Date of vaccination normal. Patient complained on Sunday the beginning of redness, swollen, and "heat generating".  As a follow-up on Monday 6-10-2024, patient said area not as red, size has not changed, but still warm to touch.  Sounds like "typical" vaccination response, but told pt to follow up with MD
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Cough, Fatigue, Headache
Clinical narrative: Vaccinated on Tues. Chills and headache started midday Wednesday; fatigue and mild stomach pain in evening Wed. Headache still lingering Thu; took Nurtec in evening, subsided. Then on Saturday, became fatigued again with slight nausea. Fever & cough Sunday morning. Unable to perform daily activities on Sunday. Vomiting mid-day Sunday. Treated fever with acetaminophen.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pyrexia, Vomiting
Clinical narrative: Vaccinated on Tues. Chills and headache started midday Wednesday; fatigue and mild stomach pain in evening Wed. Headache still lingering Thu; took Nurtec in evening, subsided. Then on Saturday, became fatigued again with slight nausea. Fever & cough Sunday morning. Unable to perform daily activities on Sunday. Vomiting mid-day Sunday. Treated fever with acetaminophen.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Haemangioma of bone, Hepatic steatosis, Laboratory test, Magnetic resonance imaging
Clinical narrative: 15 days post-vaccination woke up with both arms stuck behind my back, soon after seeing my doctor by video (we were all still in lockdown then), muscle spasms from the chin down and nerve pain throughout the body. Treatments have been all wrong. Not fibromyalgia (as my 2nd surgical consultation Dx - onset doesn't match), They did put the cage in my neck but it didn't help, made it worse.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Muscle spasms, Musculoskeletal disorder, Neuralgia, Psychogenic blindness, Spinal fusion surgery
Clinical narrative: 15 days post-vaccination woke up with both arms stuck behind my back, soon after seeing my doctor by video (we were all still in lockdown then), muscle spasms from the chin down and nerve pain throughout the body. Treatments have been all wrong. Not fibromyalgia (as my 2nd surgical consultation Dx - onset doesn't match), They did put the cage in my neck but it didn't help, made it worse.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site bruising, Injection site erythema, Local reaction
Clinical narrative: local reaction on left thigh at site of DTaP administration of bruise with mild erythema (approx 4cm x 6cm) that started the day after receiving vaccine, seen on third day after receiving and no progression of symptoms, does not appear to be causing child discomfort
Age: 0.67
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report T/E case for VAXNEUVANCE (PFS). VAXNEUVANCE was administered to 4 patients.  No side effects or any other information was known by HCP. AE filed for VAXNEUVANCE see case# 02609847, 02609922, 02609923. No additional AE reported. N; HCP called to report T/E case for VAXNEUVANCE (PFS). VAXNEUVANCE was administered to 4 patients.  No side effects or any other information was known by HCP. AE filed for VAXNEUVANCE see case# 02609847, 02609922, 02609923. No additional AE reported. N; This spontaneous report was received from a medical assistant concerning to an 8-month-old patient of unspecified gender.  The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 29-FEB-2024, the patient was vaccinated with a dose of  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe (PFS), lot #X022475, expiration date: 23-JAN-2026, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) that went though a temperature excursion (T/E) of 53.0 degree Fahrenheit (F) during 4 hours and 30 minutes. Thought, the reporter expressed that the reason for this report had not been due to a ''data logger'' and that a previous T/E had not occurred. Furthermore, it was stated that there were no side effects and that there was no further information available (Improper storage of product in use).  This is one of 4 reports received from the same medical assistant. ; Sender's Comments:  US-009507513-2405USA009558:02609847 US-009507513-2405USA009246:02609922 US-009507513-2405USA010079:02609923
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Gait disturbance, Pain, Pyrexia, Tenderness
Clinical narrative: Erythema, fever, pain, tender to the touch, Limping. Area of erythema that is fading at the periphery central induration with no fluctuance, mildly ttp. 6-4-24- Treatment: cephalexin (Keflex) 250 mg/5ml suspension take 8mls by mouth 2 times a day for 10 days  Benadryl Ibuprofen
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP called to report inadvertent administration of PNEUMOVAX 23 to a patient on 28MAY2024 after a temperature excursion.; This spontaneous report was received from an unspecified reporter (other) and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date, pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (expiration date: 30-NOV-2024, strength, lot # were not provided) experienced temperature excursion with 0.5 degree Celsius for 6 hours. There was no previous temperature excursion. On 28-MAY-2024, the patient was vaccinated with improper stored pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (expiration date: 30-NOV-2024, administered for prophylaxis, strength, dose, lot #, anatomical site of administration and route of administration were not provided) (Product storage error). No additional adverse event (AE) (no AE).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported PROQUAD was administered to a patient on an unspecified date during a temperature excursion; no additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).    On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # X011981, expiration date: 19-JUL-2024 (strength, dose, route and anatomical location were not provided) for prophylaxis.  On unspecified date, the vaccines of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered during a temperature excursion. No additional adverse event reported. The temperature excursión was in 12°F and the time frame was 1 hour 0 minutes, 0 seconds. There was no previous temperature excursión.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HBP calling. GARDASIL 9 was administered following a TE. See TE case 02614509. No additional AE/No PQC.; This spontaneous report as received from a customer (reported also as ''other'') refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 29-MAY-2024, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, lot # 1957405, expiration date: 11-NOV-2025 (exact dose, route od administration and anatomical location were not provided) for prophylaxis.   Administered doses of vaccine was exposed to the temperature excursion (product storage error). There was no additional adverse event reported (no adverse event).
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: PCV was administered an expired Hep B vaccine. another unexpired dose was administered 1 week later.
Age: 65.0
Sex: F
Vaccine: IPV, YF
Symptoms: Paraesthesia, Rash
Clinical narrative: Developed rash on the left arm that worsened was associated with tingling as well.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not have a reaction from these vaccinations. The vaccinations weren't documented in the state record and the child's PCP office gave additional vaccines 6/10/24 (unsure if also reported by the PCP office.)
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Headache
Clinical narrative: Pt developed headaches and intermittent chest pain 2-3 days after receiving Bexsero. Headaches were constant and improved with ibuprofen but returned when medication was wearing off. Intermittent chest pains started a day or so after the headaches, pt describes the pain as deep and in the center of her chest. they last about 10 minutes or so, no shortness of breath when they happen. they do go away on their own but have happened several times a day since they started.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Wrong product administered
Clinical narrative: Patient was intended to receive Prevnar 20 vaccine but Pfizer COVID-19 2023-2024 vaccine erroneously given. No local or systemic reactions noted; however, patient did have a panic attack as she had adamantly declined the COVID vaccine just prior to administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Vaccines administered after counseling with physician and consent obtained from parent(s). URTICARIAL RASH NOTED ABOUT 30 MINS POST IMMUNIZATION, TREATED WITH DIPHENHYDRAMINE 10 mL PO X1 IN OFFICE. NO SWELLING OF THE THROAT OR FACE, NO RESPIRATORY DISTRESS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed painful rash on 5/30/24 on right abdomen.
Age: 83.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient reports pain in the left arm since vaccine administration of 1st dose of Menveo on 06/05/24, he states that it continues to today and didn't have any issues with Bexsero administration dose 1 or 2 and associates this pain with Menveo first dose. He reports no other symptoms or concerns. I instructed patient to call 911 however he refused stating this wasn't necessary and would like to speak with a nurse or pharmacist today. I informed him that Facility will reach out the RN and pharmacist and ask the pharmacist to reach out to his MDO and inform office and find out how to proceed with final dose of Menveo .  Upper management will also request pharmacist to reach out to the patient and call the patient to discuss outcome of that conversation.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adverse reaction, Feeling abnormal, Seizure
Clinical narrative: Patient was feeling off a few hours after vaccination and ended up in the ER and having a seizure episode. ER department attributed this to the vaccination. Patient had no prior history of seizures.
Age: 29.0
Sex: F
Vaccine: TYP, YF
Symptoms: Chest pain, Dizziness, Headache, Paraesthesia, Tremor
Clinical narrative: Patient became light-headed with a headache after 10 minutes. Stated having pain in the center right of chest. Her arms felt tingly and shaky for a few minutes. She said it felt like an anxiety attack coming on and off. She felt better after having a snack and after being checked on by a doctor around 10:00 am
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Local reaction
Clinical narrative: Per MD note from 06/06/2024: By hx and timing, parent describing local vaccine reaction after DtaP, HAV vaccines given 2 days prior.  Prior hx possible local reaction also given after 15 mo WCC, w/ different vaccines.  Presumably currently having local reaction to tetanus compoment of DtaP, as local reactions to tetanus vaccines can be common, though not generally an indication to withhold future vaccines (UTD).  Next routine immunizations not due til 2026.  Reviewed s/s  local vs systemic reactions.  Reassurance provided re:  current sx; parent education provided re: role of antipyretics/anti-inflammatories and immune response.  Parent would like option of ibuprofen if needed.  Advised, and parent agreeable to:  -  Apply local cool compresses q 3-4 hours and prn  -  may give Tylenol for pain, fever if needed -   ibuprofen (Ibuprofen 100) 100 MG/5ML suspension; Take 15 mL (300 mg) by mouth every 6 (six) hours if needed for mild pain, moderate pain or fever for up to 4 days--if sx of discomfort not alleviated by above; - to call for any decrease in PO intake, new breathing difficulties or swelling, fevers, malaise - ED precautions reviewed -  given prior h/o local reaction, will schedule f/u w/ PCP re:  further considerations for vaccine mgt, eg, Allergy referral -  will ask Nursing to call parent in f/u and to file VAERS report   Parent expressed understanding of/agreement w/ plan, had no additional questions.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient described fever, chills, and aches that onset the night after receiving the vaccine
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Noted at 6:30 pm by patient's father of patient complaining of rash/hives all over body.  Benadryl was administered by parent and relieved symptoms after an hour.  No relapse reported.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered in error 0.25 ml of Moderna Covid vaccine ages 12 and up to a 10 year old patient. No adverse effects noted.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine Error - gave 1 extra dose of HPV - no adverse reactions noted at this time.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Patient felt dizzy right after immunization , remained sitting then fainted. Placed patient on floor help access and prevent injury. Patient breathing not conscious. Responded to her name after few seconds. Asked to remain on the floor abit longer. Asked if she had someone I could call or I could call EMS. Pt declined. So we waited a few minutes longer. Pt was able to stand and walk to wait area. I offered her something to drink , she declined. About 10 to 15 minutes mom of patient came by and gave her electrolyte water and cookies. Mom mentioned her other daughter faints with shot too, now they know pt does also. Pt was able to walk out ok with mother.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Expired product administered
Clinical narrative: Pt was given vaccine that had previously expired per the Beyond Use Date.  Dose BUD was 5/10/24, dose was administered 5/17/24, discovered 6/5/24.  Pt had joint aches for a few days after dose, same side effects as she has had w/ previous doses.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; an expired MMR II vaccine was administered to a patient today; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-JUN-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot #W039972, expiration date: 02-JUN-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired product administered). No additional adverse events (AEs) were reported (No adverse event). No further information provided. No product quality complaint (PQC).
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nurse vaccinated patient with a does of Tdap at approximately 9:00am on 6/10/2024. Vaccination Site was left Deltoid. Patient should have received a third does of DTap. Site coordinator, Department of health, and parent was informed right away. Department of health advised if Tdap was inadvertently administered to a child under age 7 years, it should not be counted as either the first, second, or third dose of DTaP and that the dose should be repeated with DTaP then continue vaccinating on schedule. Patient was scheduled to come back in for Thursday 6/13/2024.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Musculoskeletal discomfort
Clinical narrative: Patient states she started having shoulder discomfort around two weeks post-vaccination. This pain is at rest Patient states. She is currently under a doctor's care. Patient states she is scheduled for shoulder surgery. This event was previously reported through the online portal.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Anger, Blood test, Crying, Immunisation reaction, Injected limb mobility decreased
Clinical narrative: Patient states she started having shoulder discomfort around two weeks post-vaccination. This pain is at rest Patient states. She is currently under a doctor's care. Patient states she is scheduled for shoulder surgery. This event was previously reported through the online portal.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Magnetic resonance imaging abnormal, Neck pain, Orthopaedic procedure, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Patient states she started having shoulder discomfort around two weeks post-vaccination. This pain is at rest Patient states. She is currently under a doctor's care. Patient states she is scheduled for shoulder surgery. This event was previously reported through the online portal.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, FLU4, PNC20, RSV
Symptoms: Sensory disturbance, Sleep disorder, Spinal X-ray abnormal, X-ray limb normal
Clinical narrative: Patient states she started having shoulder discomfort around two weeks post-vaccination. This pain is at rest Patient states. She is currently under a doctor's care. Patient states she is scheduled for shoulder surgery. This event was previously reported through the online portal.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Diarrhoea, Injection site induration, Pyrexia, Vomiting
Clinical narrative: 2x3cm induration left thigh, 3x3cm induration right thigh, fever 105, vomiting, diarrhea
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash on forehead 10 min's after shot.  Rash on Front of throat after 24 hrs.  Took about 2 weeks to go away.  Not itchy, just rough and thick feeling.
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: Patient was given the boostrix (tdap) on 06/05/2024, she was fine, waited for 15 minutes at the pharmacy and left. She came back to the pharmacy on 06/10 /2024 and reported that after the shot when she went home, she started experiencing palpitation in the night and ended up at the ER. She said she feels fine now.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered, Skin warm
Clinical narrative: Received additional DTaP vaccine at the same time she received Vaxelis (DTaP-HBV-Hib-IPV) vaccine. Mom reports that patient had a tactile fever for about 3 days. Tmax unknown. Fully resolved after application of cool compress. No antipyretics given. No additional symptoms.
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Condition aggravated, Headache, Injection site rash, Pyrexia, Rash
Clinical narrative: PT REPORTED SHE HAD HEADACHE AT THE TIME OF ADMINISTRATION, IT LATER GOT WORSE (PT REPORTED HER HEADACHE WAS WORSE THAN HEADACHE WITH CEREBRAL MALARIA), RASH AT INJECTION SITE, RASH ON OTHER ARM, CHEST, FOREHEAD, FEVER
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms
Clinical narrative: Reports cramping to bilateral legs for approximately 1 minute, cramping has resolved.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring
Clinical narrative: Afib, increase in my Diltiazem to 300 mg
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: NO SIGNS OF A REACTION OR COMPLAINTS.   NURSE GAVE DILUENT ONLY BY ERROR.   WE HAVE CALLED THE PATIENT'S PARENT TO PLEASE BRING PATIENT BACK INTO CLINIC IN ORDER TO ACCURATELY ADMIN  GIVEN PENTACEL.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Erythema
Clinical narrative: Child received  all 4 vaccines and was being comforted through breastfeeding by mother. Approximately  6 to 10 minutes after vaccine mother called my attention to redness across child's forehead and trunk. Mother stated redness had not been there prior to vaccine. Health authority notified, child given 5ml of Benadryl child's weight (27lbs). Child observed in clinic, rash improved. Mother was sent home with instructions for out of clinic care and instructions to contact emergency services should condition worsen.
Age: 0.5
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child is 20 days new to the country.  Mom brought vaccine records.  Childs date was in wrong order on the forms and his birthday was entered into the system as this, instead of what his correct birthday which is this.  Mother did not catch it was wrong when she reviewed patient information sheet before we administered.  So the child who is really only 6 months was given 1 yr old immunizations.  Child tolerated vaccines well and I stayed in contact with mom to make sure he was okay.  She was made aware that at 1 yr old we would repeat the doses to make sure he got proper coverage of protection.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Expired product administered, Injection site pain
Clinical narrative: Pt was given vaccine that had previously expired per the Beyond Use Date.  Dose BUD was 5/10/24, dose was administered 5/24/24, discovered 6/5/24.  pt had some chills and soreness at injection site but states similar side effects to all previous doses.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administration error -- was stored incorrectly. Specifically, was moved from freezer to refrigerator more than 30 days prior to admin. Date moved to refrigeration: April 29, 2024 Manufacturer expiration date: July 2, 2024 Date of administration: June 6, 2024 Lot: AU7070D
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, very weak, tired, dizzy, headache, hives around feet. All but hives lasted a full 5 days.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Fever, very weak, tired, dizzy, headache, hives around feet. All but hives lasted a full 5 days.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Wrong dose given.  10ug/mL dose given instead of 3ug/mL dose.   No reported adverse effects based on follow-up 4 days after vaccine administration.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Confusional state, Depressed level of consciousness, Injected limb mobility decreased, Mental impairment
Clinical narrative: The day of the shot my left arm hurt worse than any other shot in my entire life. By evening, I could not move the arm at all. The morning after the shot at 6am, I woke with nausea and crawled to the kitchen for a nausea pill. I felt like my body had been run over by a truck. I had aches and pains throughout my body, I was scattered, cloudy, and could not think straight. I was confused, I had a severe pain in my neck on the left side that kept me awake the next 4 nights. It was so painful that there was no position in bed that didn't hurt to the point of keeping me up. I doubled a sleeping pill on night 3, and it didn't matter, I was still woken up from the pain. It is now 11 days since the shot, and my pains are not gone. The neck pain is the worse. Other pains show up down my right leg, in my lower back on the left side, and body aches here and there. NONE of this was here before I got that shot.!