chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Bilateral Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 (2-3 weeks prior to 15Nov2022) as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug allergies: PCN" (unspecified if ongoing), notes: Drug allergies: PCN; "Drug allergies: Sulfa" (unspecified if ongoing), notes: Drug allergies: Sulfa. The patient had no drug or alcohol abuse. The patient had no related family history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (caused and prolonged hospitalization, disability, medically significant, life threatening, congenital anomaly (as reported)) with onset 15Nov2022, outcome "recovering", described as "Bilateral Pulmonary embolism". The patient was hospitalized and prolonged hospitalization for pulmonary embolism (start date: Nov2022, discharge date: 21Nov2022, hospitalization duration: 6 day(s)). The event "bilateral pulmonary embolism" required physician office visit. Therapeutic measures were taken as a result of pulmonary embolism with anticoagulants.  Patient was low risk for blood clot so BNT162b2, BNT162b2 omi ba.4-5 also suspected. The vaccine may have increased her risk or caused the clots.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event pulmonary embolism with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: I got Immune thrombocytopenia from the Pfizer Covid 19 shoot number 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "I got Immune thrombocytopenia from the Pfizer Covid 19 shoot number 2".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed our 18 yr old daughter.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "killed our 18 yr old daughter.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed our 18 yr old daughter.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: even when I did use to get the flu shot I always ended up with it; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown age and gender who reported even when i did use to get the flu shot always ended up with it after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength; formulation; lot number; expiry date not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date the patient reported even when i did use to get the flu shot i always ended up with it (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was reported by patient "So I choose not to anymore".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; Flu; Initial information received on 05-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced pneumonia and flu after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (route, administration site, form, strength, dose, frequency, expiry date, lot number unknown) for Influenza.  On an unknown date the patient had developed pneumonia and flu (influenza) (unknown latency) following the administration of Influenza vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (pneumonia, Flu).  Outcome: Unknown.  Seriousness criteria: medically significant for pneumonia.; Sender's Comments: Sanofi Company Comment dated 10-Jan-2023: This case involves a Adult and unknown gender patient who experienced pneumonia and flu after receiving Influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any relevant medical history of patient, lab investigation and any concurrent conditions, therapy details precludes comprehensive case assessment.
Sex: U
Vaccine: FLUX
Symptoms: Ageusia, Asthenia, Malaise
Clinical narrative: I've been sick/ very very sick; very weak; no taste at all; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and gender patient and it was reported that he/she have been sick/ very very sick, very weak and had no taste at all after receiving Influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a Booster dose of suspect Influenza vaccine produced by unknown manufacturer(with unknown formulation, strength, route, lot number, expiration and at unknown administration site) for prophylactic vaccination.  On an unknown date, the patient felt very weak (asthenia), I've been sick/ very very sick (sickness) and no taste at all (ageusia) (unknown latency) following the administration of Influenza vaccine.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all events.  Additional information was received on 06-Jan-2023 from consumer/non-HCP: PT for the event I've been sick/ very very sick was updated. Clinical course was updated and text amended accordingly.
Sex: U
Vaccine: FLUX
Symptoms: Eating disorder, Influenza, Mobility decreased
Clinical narrative: eating now; got bad flu 25 Christmas still sick couldn't get out of bed for 5 days; Initial information received on 05-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who received Influenza vaccine and had got bad flu 25 Christmas still sick couldn't get out of bed for 5 days but eating now.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Dec-2022, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site with unknown form, strength, frequency, expiry date for Immunization.  On 25-DEC-2022 the patient got bad flu 25 Christmas still sick couldn't get out of bed for 5 days (influenza) (latency: 8 days) after the administration of Influenza vaccine.  On an unknown date, the patient had eating disorder (unknown latency) after the administration of Influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome : Not Recovered / Not Resolved for influenza and was Recovered / Resolved on an unknown date for eating disorder.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot and have had it twice; Initial information was received on 08-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional via Social Media.  This case involves Adult and unknown gender patient who got the flu shot and have had it twice after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On an unknown date the patient got the flu shot and have had it twice (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: newborn patient mistakenly received a DAPTACEL vaccination at the hospital this morning instead of the intended Hep B vaccination with no reported adverse event; Inappropriate age at vaccine administration with no reported adverse event; Initial information received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 day old male patient who mistakenly received a diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at the hospital this morning instead of the intended hep b vaccination with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Jan-2023, a newborn patient mistakenly received a 0.5 ml dose 1 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength: standard) (expiry date, lot number: not reported) via unknown route in unknown administration site for immunization instead of the intended hep b vaccination with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age).  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the events (newborn patient mistakenly received a daptacel vaccination at the hospital this morning instead of the intended hep b vaccination and inappropriate age at vaccine administration with no reported adverse event.)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.08
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1 year old was given Ipol twice/has already received the 3 doses as scheduled for his age/dose was too early because the next dose was due at age 4 with no reported adverse event; Initial information received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 months old patient who was given ipv (vero) [ipol] twice/has already received the 3 doses as scheduled for his age/dose was too early because the next dose was due at age 4 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 immunisation; and hib vaccine (hib vaccine) for Immunisation.  On 09-Jan-2023, the patient received a dose of 0.5 ml (dose 4) once of suspect ipv (vero) (Suspension for injection) (strength: standard; lot: V1B891M; expiry date: 01-Jun-2024) via intramuscular route in the left thigh for immunisation.  On 09-Jan-2023 the patient of 1 year old was given ipv (vero) [ipol] twice/has already received the 3 doses as scheduled for his age/dose was too early because the next dose was due at age 4 with no reported adverse event (Inappropriate schedule of product administration) (latency: same day).  It was reported that the wrong child's name was clicked on which indicated that the child need vaccine, but the child had already had vaccine, and was administered again.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Electric shock sensation, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: her eyes were not focusing, and unable to focus to read; things were moving around; dizziness; headaches; reaction as an electric bolt to the brain; visual changes; seeing flashing lights; has not functioned normally since then and has not been able to go to school; still not feeling right; Initial information received on 09-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 16 years old female patient who had reaction as electric bolt to the brain, visual changes, has not functioned normally since then and has not been able to go to school, still not feeling right, her eyes were not focusing, and unable to focus to read, dizziness, headaches and things were moving around while receiving meningococcal A-C-Y-W135 (T Conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), and family history were not provided. Patient had a MCV4-P vaccination in 2017 (Lot#: U5916AA, Exp.date: 23OCT2017 with NO adverse reaction). Concomitant medications included INFLUENZA VACCINE (FLU VACCINE VII) for Immunisation.  On 01-Nov-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, Solution for injection (strength: standard) (lot: U7596AA; expiry date: 14-Mar-2025) via intramuscular route in the right deltoid for immunisation.   On 01-Nov-2022 (same day latency) Within minutes while still at the doctor's office patient began experiencing non-serious adverse reactions as an electric bolt to the brain (electric shock sensation), visual changes (visual impairment), seeing flashing lights (photopsia), has not functioned normally since then and has not been able to go to school (loss of personal independence in daily activities) and still not feeling right (feeling abnormal) following the administration of meningococcal A-C-Y-W135 (T conj) vaccine.  On an unknown date few days later, the patient developed non-serious events her eyes were not focusing, and unable to focus to read (vision blurred), dizziness, headaches (headache) and things were moving around (vertigo) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  Corrective treatment: : IV fluids, unknown medication for Vertigo given in the ED and not reported for other events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.
Sex: F
Vaccine: MNQ
Symptoms: Photopsia, Vertigo, Vision blurred, Visual impairment
Clinical narrative: her eyes were not focusing, and unable to focus to read; things were moving around; dizziness; headaches; reaction as an electric bolt to the brain; visual changes; seeing flashing lights; has not functioned normally since then and has not been able to go to school; still not feeling right; Initial information received on 09-Jan-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 16 years old female patient who had reaction as electric bolt to the brain, visual changes, has not functioned normally since then and has not been able to go to school, still not feeling right, her eyes were not focusing, and unable to focus to read, dizziness, headaches and things were moving around while receiving meningococcal A-C-Y-W135 (T Conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), and family history were not provided. Patient had a MCV4-P vaccination in 2017 (Lot#: U5916AA, Exp.date: 23OCT2017 with NO adverse reaction). Concomitant medications included INFLUENZA VACCINE (FLU VACCINE VII) for Immunisation.  On 01-Nov-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, Solution for injection (strength: standard) (lot: U7596AA; expiry date: 14-Mar-2025) via intramuscular route in the right deltoid for immunisation.   On 01-Nov-2022 (same day latency) Within minutes while still at the doctor's office patient began experiencing non-serious adverse reactions as an electric bolt to the brain (electric shock sensation), visual changes (visual impairment), seeing flashing lights (photopsia), has not functioned normally since then and has not been able to go to school (loss of personal independence in daily activities) and still not feeling right (feeling abnormal) following the administration of meningococcal A-C-Y-W135 (T conj) vaccine.  On an unknown date few days later, the patient developed non-serious events her eyes were not focusing, and unable to focus to read (vision blurred), dizziness, headaches (headache) and things were moving around (vertigo) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  Corrective treatment: : IV fluids, unknown medication for Vertigo given in the ED and not reported for other events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.
Age: 42.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Cardiac stress test normal, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Chest pain, increased heart beat, chest tightness, light headed, arm pain, shortness of breath, can feel heart beating in chest
Age: 42.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Electrocardiogram normal, Heart rate increased, Laboratory test normal, Pain in extremity, Palpitations
Clinical narrative: Chest pain, increased heart beat, chest tightness, light headed, arm pain, shortness of breath, can feel heart beating in chest
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Abdominal pain upper, Anxiety, Arthralgia, Aura
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Constipation, Dizziness
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry eye, Ear discomfort, Endoscopy, Fatigue, Feeling abnormal
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Head discomfort, Hot flush, Hypoaesthesia, Insomnia
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Muscle spasms, Muscle tightness, Muscle twitching
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Nervous system disorder, Neuralgia, Palpitations
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Photophobia, Throat tightness, Tinnitus, Tremor
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vestibular function test
Clinical narrative: Neurological issues, migraines, fatigue, muscle twitching, numbness and tingling in limbs, vertigo, muscle weakness, nausea, Gi issues, heart palpitations, shaking limbs, hot flashes, tinnitus, head pressure, ear pressure. Throat tightness, muscle tightness in neck back and shoulders. Muscle spasms throughout body,  dry eyes, lightheadedness, brain fog, anxiety, insomnia. Seeing auras, light sensitivity, constipation, stomach cramping, nerve pain, joint pain.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: 1. Moderate frontal  head ache started 6 hours post vaccination and lasted for 24 hours , relieved by advil  400 mg 2. Mild Chills began at 20:00 day of vaccination and continued intermittently at night for 2 days 3. Mild injection site tenderness began  immediately after administration and continued for two days
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client received Janssen COVID vaccine lot #: 211D21A on 04/16/22/22 and Pfizer COVID Booster lot #: FP7138 on 08/07/22 at local Public Health Center. Client denied any chronic conditions, medications, or any known allergies. Lead PHN submitted a medical consult via text message to the doctor because client came on 10.02.22 local Testing Vaccine Site Team requesting to receive Pfizer COVID Bivalent booster five days earlier than the recommended timeframe of two months apart from the last Pfizer COVID booster per CDC guideline. Medical consult sent to the doctor at 0951. The doctor approved Pfizer COVID Bivalent booster at 0953. Client received a Pfizer COVID Bivalent booster Lot# GJ3277 exp. 12.05.22 IM by a nurse at 1010 today. Client stayed the recommended time frame in the observation area and client was educated on when to seek emergency care. Client tolerated the vaccine well and left the facility at 1025.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Injection site erythema, Product administration error
Clinical narrative: A trained employee and a employee in training were administering the vaccines to this patient. The employee in training injected all the ones in the left thigh listed above. The MMR was administered correctly, but the Hep A and HiB were not. One of these IM injections was administered in an area of the leg lateral to the cleansed region, and the other was administered at a 45 degree angle. Patient's parents were concerned when an erythematous area appeared 24 hours after injections in left leg. Uncertain which vaccine was administered in site of erythema noted by parents. Parents took infant to physician for evaluation today and monitoring was recommended.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: numbness of fingers right hand, ever tingling, right hand. Arm swelling, swelling of fingers and hand rt. Itching.
Sex: U
Vaccine: PNC15
Symptoms: Poor quality product administered, Syringe issue
Clinical narrative: The medical assistant noticed that vaxneuvance syringes were not as "smooth" when giving injection to patients compared to other company's prefilled syringes/ Other company's syringes were somoother and need less efforts to give the injections; Adverse event was also filled as precaution since 2 patients received the vaccines from possibly defctive syringes; This spontaneous report was received from a company representative and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, 2 patients was vaccinated with possibly defective syringes of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot number W027250, had been verified to be a valid number; expiration date 09-JUL-2024, and upon internal validation established as the same date, administered for prophylaxis (strength, and route of administration were not provided) (poor quality product administration).   On an unknown date, a medical assistant reported that when she used pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for the first two times, she noticed that syringes were not as smooth and need less effort when giving injections to patients compared to other company's prefilled syringes (unspecified names of the other company's syringes) (syringe issue). I t was reported that the medical assistant would not compare with other pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringes because it was her first time using it.  This is a non-valid case due to the lack of patient's identifiers.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Patient was administered Expired STERILE DILUENT reconstituted MMRII on 01/04/2023.; Patient was administered Expired STERILE DILUENT reconstituted MMRII on 01/04/2023.; This spontaneous report was received from a medical assistant and refers to a unspecified age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot #W001518, expiration date: 13-JAN-2024, had been verified to be a valid number, and upon internal validation established as the same date, administered for prophylaxis (strength, dose, and route of administration were not provided) who was reconstituted with an expired sterile diluent, lot #T014300, expiration date: 03-DEC-2022 had been verified to be a valid number, and upon internal validation established as the same date (strength, dose, route of administration, and indication were not provided) (expired product administration). No additional adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles twice, had shingles shot / suspected Vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter suggested to go to the doctor immediately and get a drug called Valtrex and if doctor said there would nothing that would help, find a another doctor. The patient stated that, he/she had shingles twice and had his/her shingles shot. Follow-up would not possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Near death experience
Clinical narrative: Got that shot, is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was not recovered/not resolved.   The reporter considered the near death experience to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and now it was killing him/her. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, hadn´t received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: A pharmacist reported that a patient had not received the second dose of Shingrix.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. VAERS details pertains to 1st dose of Shingrix in product tab.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: our fridge being out of range on 12/02/22 for one hour; No adverse event; patient vaccinated with Moderna vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with Moderna vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour).    No concomitant medications were provided by the reporter.  HCP reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on 16-Dec-2022. Excursion happened on 02-Dec-2022 during 1 hour and minimum temperature reached was 1.2 A degree C.   No adverse events were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-695843 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695843:Same reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: our fridge being out of range on 02Dec2022 for one hour; No adverse event; 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 02Dec2022 for one hour).    No concomitant medications were provided by the reporter.  HCP  reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on 16-Dec-2022. Excursion happened on 02-Dec-2022 during 1 hour and minimum temperature reached was 1.2 A degree C.  No adverse events were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-695843, US-MODERNATX, INC.-MOD-2023-695862 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Non-significant follow-up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695843:Same reporter US-MODERNATX, INC.-MOD-2023-695862:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were reported.  Patient got the flu shot with no reaction. The flu Vax and Covid vac were not made using the same technique. Patient also received all the Covid boosters. Had Pfizer last time and no reaction like with Moderna fatigue.  No treatment medications were reported.
Age: 13.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: no additional AEs; PROQUAD administered to 13 year old patient; PROQUAD and VARIVAX were both administered to 13 year old patient on 1/4/23; This spontaneous report was received from a registered nurse and refers to a 13-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided. The patient had no vaccination record and vaccine dose history was unknown.  On 04-JAN-2023, the 13-year-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, once, lot #W005206 has been verified to be valid, expiration date was reported as 14-FEB-2024; and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status has been verified as recombinant human albumin (rHA), 0.5 ml, once, lot #W024548 has been verified to be valid, expiration date was reported as 31-JAN-2024, both administered for prophylaxis into same extremity (strengths, exact anatomical locations, and routes of administration were not provided) (product administered to patient of inappropriate age) (overdose).
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 42-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 30th December 2022, the patient received the 1st dose of Engerix B pediatric. On 30th December 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 02-JAN-2023 and 03-JAN-2023 Reporter's Comments: Pharmacist reported pediatric Engerix-B was administered to an adult over 20 years old for a 1st shot, they were given the pediatric dose instead of adult dose. The following inquiry came in via voicemail during non-business hours. No lot or expiration date available. The reporter consented to follow up. Additional Supportive Information: The pediatric Engerix-B was administered to an adult instead of adult dose, which led to underdose and adult use of a child product.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fall, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: PT GOT VACCINE NO ISSUES AT THE TIME.  STOOD UP TO WALK DOWN AISEL, FELT  LIGHT HEADED AND DIZZY.  SAT BACK AND FELL TO KNEES, DIDNT HIT HEAD.  SAT PT UP SLOWLY, GAVE WATER AND GATORADE AND COOL TOWEL,.  OT REMAINED IN PHARMACY FOR 15 MIN. FELT OK TO GET UP.. PARENTS TOOK PT TO MD TO CHECK. HAD VERY LOW BP AND WAS STARTING TO FEEL BETTER.. SPOKE WITH MOM, SHE WAS DUE TO FOLLOW UP WITH MD.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: PT GOT VACCINE NO ISSUES AT THE TIME.  STOOD UP TO WALK DOWN AISEL, FELT  LIGHT HEADED AND DIZZY.  SAT BACK AND FELL TO KNEES, DIDNT HIT HEAD.  SAT PT UP SLOWLY, GAVE WATER AND GATORADE AND COOL TOWEL,.  OT REMAINED IN PHARMACY FOR 15 MIN. FELT OK TO GET UP.. PARENTS TOOK PT TO MD TO CHECK. HAD VERY LOW BP AND WAS STARTING TO FEEL BETTER.. SPOKE WITH MOM, SHE WAS DUE TO FOLLOW UP WITH MD.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient came in 01/08/23 and described a rash that had developed after admsinstartion of the 1st shingrix dose which lasted for 4 days and went away.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient came in 01/08/23 and described a rash that had developed after admsinstartion of the 1st shingrix dose which lasted for 4 days and went away.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium