chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Myalgia
Clinical narrative: muscle heaviness; muscle soarness and heaviness; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (muscle heaviness) and MYALGIA (muscle soarness and heaviness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (muscle heaviness) and MYALGIA (muscle soarness and heaviness). At the time of the report, MUSCLE DISCOMFORT (muscle heaviness) and MYALGIA (muscle soarness and heaviness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2024-764831 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Your moderna vaccine , the strongest one, killed my father; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Your moderna vaccine , the strongest one, killed my father) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication not reported.  The patient was died in 2024. It was reported that, it was very simple that, the Moderna vaccine, the strongest one, killed the patient. He did not want to take it, but a nurse said if he did not take it they would not treat him, and he would have to leave, and they could no longer treat him because he did not want to take it. Basically, he did not want to take it. He felt trapped and obligated. It was unknown if the patient experienced any additional symptoms/events. The cause of death reported as, the patient did not know which specific Moderna vaccine was received, but the portal required an answer, so they choose to the best of their ability.   Treatment medication not reported. Company comment: This spontaneous case concerns a male patient of an unknown age, with no medical history reported, who died an unknown time after an unspecified dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine (seriousness assessment fatal and medically significant). Cause of death was not reported. Information regarding clinical evaluation, diagnostic tests and autopsy report has not been disclosed. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: Your moderna vaccine , the strongest one, killed my father
Sex: U
Vaccine: MENB, PNC20
Symptoms: Pyrexia
Clinical narrative: had 102 degree fever after taking vaccine; This is a spontaneous report received from a Nurse from a sales representative.  A 2-month-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "had 102 degree fever after taking vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient had other vaccine Bexsero on the same date.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19/ flu-like symptoms; COVID-19/ flu-like symptoms; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1 (toppac), single (Lot number: HG4680) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5, unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Mar2024, outcome "unknown" and all described as "COVID-19/ flu-like symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2024) Positive, notes: Test results were -flu and COVID+. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid for COVID 19 treatment from 25Mar2024 to 29Mar2024).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400080108 same  patient/reporter, different drug/AE;
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Weight
Clinical narrative: vascular blockages/TIA; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6201) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability) with onset 2021, outcome "not recovered", described as "vascular blockages/TIA". The event "vascular blockages/tia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) 145 lbs; (2021) 120 lbs, notes: When got the shot. Therapeutic measures were taken as a result of transient ischaemic attack. Clinical course: Patient had severe adverse reactions to the COVID vaccines that patient was still suffering with the problems caused by the vaccines. It was three years later and patient had to go through speech therapy. It had been hard. Patient had been ended up in five facilities and had blockages vascular blockages. Patient had been through unexplained vascular blockages and they called it a TIA, it was a cerebral problem, left side of body, not work right. Patient used to walk using a walker for months. No vaccine administered on same day. No Prior vaccine (within 4 weeks). Physician was put in the emergency room at, Hospital name withheld. Patient was in hospital, next hospital because that was the event. Patient ended up in the rehabilitation hospital in withheld and then ended up doing outpatient physical therapy and now patient at Neurologist of Speech and Cognitive therapy at hospital name withheld. This was not going away. Patient had been dealing with this for 3 years.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400081198 same patient, different vaccine dose/event;
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Weight
Clinical narrative: vascular blockages/TIA; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Lot number: ER8730) at the age of 67 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/ Lot number: EN6201, Route of administration: Intramuscular, Anatomical location: Left arm), administration date: 28Feb2021, when the patient was 67-year-old, for COVID-19 immunisation, reaction(s): "vascular blockages/TIA". The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, disability) with onset 2021, outcome "not recovered", described as "vascular blockages/TIA". The event "vascular blockages/tia" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) 145 lbs; (2021) 120 lbs, notes: when got the shot, weighed 120 pounds. Therapeutic measures were taken as a result of transient ischaemic attack. Clinical course: Patient was still dealing with it. It was three years later and patient had to go through speech therapy. It had been hard. Patient had been ended up in five facilities and had blockages vascular blockages. Patient ended up in 5 facilities. Patient had been through unexplained vascular blockages and they called it a TIA, it was a cerebral problem, left side of body, not work right. Patient used to walk using a walker for months. No vaccine administered on same day. No Prior vaccine (within 4 weeks). Physician was put in the emergency room at, Hospital name withheld in a withheld. Patient was in hospital, next hospital because that was the event. Patient ended up in the rehabilitation hospital in withheld and then ended up doing Outpatient physical therapy and now patient at Neurologist of Speech and Cognitive therapy at hospital name withheld in withheld. This was not going away. Patient had been dealing with this for 3 years.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400081103 Same patient/product, different dose (Dose 1)/events.;
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  An 86-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1 (toppac), single (Lot number: HG4659) at the age of 86 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose 4 (Booster, single), Batch/Lot No: AS7163B, Location of injection: Arm Left), administration date: 28Sep2023, when the patient was 86-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster, Single); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, single; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19 included COVID 19 Treatment from  24Mar2024 to 29Mar2024. NDC number: 00069-5321-30. No known allergies. No other medication in 2weeks. Events did not result in emergency room visit or physician office visit.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Blood glucose normal, Disorientation, Hypotension, Loss of consciousness, Pallor
Clinical narrative: During patients 5th vaccine administration during visit, patient started to turn pale and tilt his head downward. Patient then started to drop his head and leaned forward as if he was going to fall forward out of chair. Patient did not fall. Patients face was cool and pale, while chest and abdomen were warm. Nurses supported patient and attempted sit him back up properly in chair, support his head and neck, and checked if patient was coherent. Patient was slow to respond and not oriented. Nurses then checked for airway, breathing, and circulation. Patient had no signs of respiratory distress, and pluses/circulation was intact. Nurses then checked blood pressure and the initial blood pressure was hypotensive at (55/46) at 3:23pm. Patient then began vomiting and had two small episodes of emesis. Nurses began cooling patient with ice pack, cooling fans, and small sips of water/sprite. Blood pressure was rechecked at 3:23pm: (66/36), 3:25pm: (86/49) and temp of 97.1, 3:27pmm 104/64 and heart rate 73bpm, respirations of 16, 3:29pm: pulse 70bpm and respirations 16, 3:31pm: 108/64 and heart rate 80bpm. Emergency services arrived at 3:30pm and assessed and took over patient care. Patient was taken by EMS to hospital. Patient blood sugar taking by EMS was 88mg/dl at 3:34pm. Mom and brother here during event. Brother disclosed after the incident that patient has fainted before during vaccines or blood draws.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Slow response to stimuli, Vomiting
Clinical narrative: During patients 5th vaccine administration during visit, patient started to turn pale and tilt his head downward. Patient then started to drop his head and leaned forward as if he was going to fall forward out of chair. Patient did not fall. Patients face was cool and pale, while chest and abdomen were warm. Nurses supported patient and attempted sit him back up properly in chair, support his head and neck, and checked if patient was coherent. Patient was slow to respond and not oriented. Nurses then checked for airway, breathing, and circulation. Patient had no signs of respiratory distress, and pluses/circulation was intact. Nurses then checked blood pressure and the initial blood pressure was hypotensive at (55/46) at 3:23pm. Patient then began vomiting and had two small episodes of emesis. Nurses began cooling patient with ice pack, cooling fans, and small sips of water/sprite. Blood pressure was rechecked at 3:23pm: (66/36), 3:25pm: (86/49) and temp of 97.1, 3:27pmm 104/64 and heart rate 73bpm, respirations of 16, 3:29pm: pulse 70bpm and respirations 16, 3:31pm: 108/64 and heart rate 80bpm. Emergency services arrived at 3:30pm and assessed and took over patient care. Patient was taken by EMS to hospital. Patient blood sugar taking by EMS was 88mg/dl at 3:34pm. Mom and brother here during event. Brother disclosed after the incident that patient has fainted before during vaccines or blood draws.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered Pfizer +12 years Covid vaccine, patient is 9 years old
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Chronic moderate to severe tinnitus bilaterally since vaccinations. Tried Vit B12 supplements, wearing noise protection when mowing lawn or anything that is noisy, increasing fluid intake and  avoiding aspirin or any product that might worsen the loud high pitched ringing in my ears.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Autonomic nervous system imbalance, Balance disorder, Brain fog, Brain stem syndrome
Clinical narrative: Two weeks and 1 day (15 days) post vaccination, I started having the following symptoms:  Aphasia, full body tremors, brain fog,  inability to write, poor concentration, poor memory, garbled speech, quiet speech, inability to walk, fatigue, black outs, dizziness, balance issues, stuttering, urinary tract infection. All of these events continued to happen over the course of several months. To this day I am still struggling with some of them.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis interstitial, Cystoscopy abnormal, Disturbance in attention, Dizziness, Dysarthria
Clinical narrative: Two weeks and 1 day (15 days) post vaccination, I started having the following symptoms:  Aphasia, full body tremors, brain fog,  inability to write, poor concentration, poor memory, garbled speech, quiet speech, inability to walk, fatigue, black outs, dizziness, balance issues, stuttering, urinary tract infection. All of these events continued to happen over the course of several months. To this day I am still struggling with some of them.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgraphia, Dysphemia, Fatigue, Gait inability, Loss of consciousness
Clinical narrative: Two weeks and 1 day (15 days) post vaccination, I started having the following symptoms:  Aphasia, full body tremors, brain fog,  inability to write, poor concentration, poor memory, garbled speech, quiet speech, inability to walk, fatigue, black outs, dizziness, balance issues, stuttering, urinary tract infection. All of these events continued to happen over the course of several months. To this day I am still struggling with some of them.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Speech sound disorder, Tremor, Urinary tract infection
Clinical narrative: Two weeks and 1 day (15 days) post vaccination, I started having the following symptoms:  Aphasia, full body tremors, brain fog,  inability to write, poor concentration, poor memory, garbled speech, quiet speech, inability to walk, fatigue, black outs, dizziness, balance issues, stuttering, urinary tract infection. All of these events continued to happen over the course of several months. To this day I am still struggling with some of them.
Age: 65.0
Sex: F
Vaccine: HEPAB
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: SWOLLEN ARM, RASH, ITCHING
Age: 1.67
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine mistake, healthcare personnel that administered vaccine failed to dilute the vaccine. They do not recall how much was drawn up from the vial, it is assumed that it may have been the whole vial but we are not certain.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: Per patient, sick to the stomach, sore arm, increased heart rate that lasted for 3 days, headache, chills, pain, fevers, dizziness, shakiness that is still present
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Per patient, sick to the stomach, sore arm, increased heart rate that lasted for 3 days, headache, chills, pain, fevers, dizziness, shakiness that is still present
Age: 48.0
Sex: F
Vaccine: FLU4, MMR, TDAP, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no known reaction.  waiting to confirm with patient and have her get appropriately scheduled 2nd dose of shingrix.   I was made aware that pt received 2nd dose of shingrix too early (3 weeks apart). 1st dose received 3/14/24, 2nd dose was unintentionally given early on 4/4/24. pt did also receive inappropriate RSV vaccine  (arexvy) on 3/14/24. Patient is not of age (60 years or over), she is 48 years old
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: The patient's husband called to report that his wife experienced itching and a lump at the injection site.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: COVID-19, Cough, Gait disturbance, Neurological symptom, Pain
Clinical narrative: Had COVID in September a few weeks ago. Lingering dry cough.  Had urine Ct in September treated with Doxycycline x 7 days. Symptoms persisted. Received Bactim for suspected UTI.  Subsequently had neurological symptoms including difficulty walking. Any movement was agony per pt. Stopped taking all ABX and symptoms resolved. Possible that the combination of COVID, STI, and antibiotic treatment put his immune system in over-drive resulting in a severe inflammatory response. Patient also completed an adjuvanted vaccine series of HeplisavB last visit on 9/1. Many other explanations are also possible including medication adverse reaction to Doxycycline or Bactrim, an underlying undiagnosed neurologic condition, or Guillain-Barré syndrome. Informed patient that this is outside pharmacist scope to diagnose and he should work to establish additional care.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Blood test, Computerised tomogram, Dizziness, Heart rate increased
Clinical narrative: Comirnaty (, mRNA, 2023-2024 Formula),HN0427, pharmacy - Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula)  I felt a little woozy in am.  Dr. detected high heart rate of 130bpm and atrial fibrillation. Went to ER.   My initial acute symptoms resolved but I need to follow up with cardiologist because of this event. Because of the timing of my symptoms the morning after the vaccination, I am reporting this event. I have not had any reactions to previous COVID 19 vaccinations. I was prescribed Apixaban and metoprolol succinate XL
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Haemorrhage in pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: Premature Delivery; Premature rupture of membranes; Haemorrhage in pregnancy; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2725878-1 (VAERS ID).  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Nov2023 as dose 1, single (Lot number: HF5024) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "gestational diabetes" (unspecified if ongoing); "previous pregnancy" (unspecified if ongoing), notes: induced at 38 weeks due to insulin controlled gestational diabetes. The patient was 3 trimester pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 3 trimester pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Dec2023. Concomitant medication(s) included: MAGNESIUM taken for supplementation therapy; DHA taken for supplementation therapy; VALACYCLOVIR [VALACICLOVIR]; INSULIN taken for gestational diabetes; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: HAEMORRHAGE IN PREGNANCY (medically significant) with onset 30Nov2023 at 13:00, outcome "recovered"; PREMATURE RUPTURE OF MEMBRANES (non-serious) with onset 01Dec2023 at 04:00, outcome "recovered"; PREMATURE DELIVERY (non-serious) with onset at 15:15, outcome "recovered". The baby was delivered premature, via vaginal route, delivery date. The baby weighed 2635.968 grams. Additional information: Patient age reported as 40.00. Patient was 36+5 weeks pregnant, due date 22Dec2023. Had no bleeding or any sign of being close to labor prior to the vaccine. Patient did have gestational diabetes controlled with insulin. She had the vaccine Wednesday afternoon and the next day she had bloody show at 13:00, water broke 04:00 Friday morning, and gave birth through vaginal delivery 15:15 afternoon. Baby was 5 lb 13 oz at birth with no other issues. To me, the timing is suspicious for the vaccine possibly being the cause of early delivery, especially since patient had no signs of being close to labor before the vaccine and her previous pregnancy she was induced at 38 weeks due to insulin controlled gestational diabetes. Symptom reported as Delivery, Exposure during pregnancy, Haemorrhage in pregnancy, Premature Delivery and Premature rupture of membranes. Seriousness assessed as no by FDA.  No follow-up attempts are possible.  Amendment: This follow-up report is being submitted to amend previously reported information: event Premature Delivery added.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-202400013572 baby case;
Sex: F
Vaccine: RSV
Symptoms: Caesarean section, Exposure during pregnancy, Premature delivery
Clinical narrative: The twins were born at 36 weeks by c-section at 4'9" and 4'13" lbs; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority, Program ID. Regulatory number: 2741926-1 (VAERS ID).  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver two baby(s). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE DELIVERY (non-serious), outcome "unknown", described as "The twins were born at 36 weeks by c-section at 4'9" and 4'13" lbs". The first baby was delivered premature, via cesarean route, delivery date unknown. The baby weighed 2222.6 grams. The second baby was delivered premature, via cesarean route, delivery date unknown. The baby weighed 1873.33 grams.  Additional information: patient received the Abrysvo vaccine on 17Nov2023 at 35 weeks and 2 days gestation of twins. The twins were born at 36 weeks by c-section at 4'9" and 4'13" lbs. Two questions: 1) would they have benefitted from the vaccine the mother received or should they receive a separate dose? 2) should the dose be a decreased quantity since they were preemies?  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.  Follow-up (04Mar2024): This is a spontaneous follow-up report received by Pfizer via US FDA (Regulatory number: 2741926-1).   Updated information includes: delivery type, vaccination date, weight of the neonates were added.  Follow-up (24Mar2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previous information: Event term  "Maternal exposure during pregnancy" was updated to "Premature Delivery".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400024433 mother/fetus case;US-PFIZER INC-202400024432 mother/fetus case;
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Preterm premature rupture of membranes
Clinical narrative: pre-term delivery; pre-term delivery-contractions began at 2 am and water broke; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2745098-1 (VAERS ID).  A 40-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The patient's relevant medical history included: "Class 3 obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anemia in 3rd trimester" (unspecified if ongoing); "B12 deficiency" (unspecified if ongoing); "geriatric pregnancy" (ongoing). Concomitant medication(s) included: CALCIUM + VIT D; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID]; FLUOXETIN.  The following information was reported: PREMATURE DELIVERY (hospitalization) all with onset 31Jan2024, outcome "unknown" and all described as "pre-term delivery"; PRETERM PREMATURE RUPTURE OF MEMBRANES (hospitalization) with onset 31Jan2024, outcome "unknown", described as "pre-term delivery-contractions began at 2 am and water broke". The patient was hospitalized for  premature delivery, preterm premature rupture of membranes (hospitalization duration: 2 day(s)). The baby was delivered premature, delivery date. The baby weighed 2579.508 grams. Additional information: Pre-term delivery- contraction began at 2 am and water broke at approximately 3:45 am. ESTM delivery date of 23Feb2024. Birth weight was 5 lbs 11 oz. Geriatric pregnancy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow up report is being submitted to amend previously reported information: updated patient age and added geriatric pregnancy as ongoing medical history.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400056748 baby case;
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received expired and improperly stored vaccine.; The medical assistant is reporting that a patient received expired and improperly stored vaccine.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 16-MAR-2024, the patient was vaccinated with expired and improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose, Lot # reported as v029623, but upon internal verification stablished as U029623, expiration date: 26-OCT-2023 (strength, dose number, route and anatomical location were not provided) for prophylaxis.    The temperature excursión was for 20 hours in -21°F. No previous temperature excursión reported. No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects or symptoms reported; Nurse called to report temperature excursion and noted one PROQUAD vaccine had been administered to a patient on 26-MAR-2024 following the excursion below which occurred on  21-MAR-2024; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 21-MAR-2024, the measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X024656, expiration date: 09-APR-2025 underwent a temperature excursion at -10.4 degrees Celsius for 1 hour and 31 minutes.  It was noted that there were no previous temperature excursions.  On 26-MAR-2024, the patient was vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X024656, expiration date: 09-APR-2025, administered for prophylaxis (strength and route of administration were not provided). No side effects or symptoms were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 24Mar2024 to 28Mar2024.  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: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had 2 episodes of shingles; Herpes Zoster keratitis/eye issue/eye problem; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In AUG-2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant and other: serious as per reporter), shingles (Verbatim: had 2 episodes of shingles) (serious criteria other: serious as per reporter) and herpes zoster keratitis (Verbatim: Herpes Zoster keratitis/eye issue/eye problem) (serious criteria GSK medically significant). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles and herpes zoster keratitis were not resolved.   The reporter considered the vaccination failure, shingles and herpes zoster keratitis to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, shingles and herpes zoster keratitis to be related to Shingles vaccine and Shingles vaccine.   Additional Information: Additional Information: GSK Receipt date: 03-APR-2024 A reporter reported that a patient receiving 2 dose of Herpes zoster vaccine 2 months apart in 2020, there are no documented vaccine administrations. Subsequently the patient had 2 episodes of shingles and a case of Herpes Zoster keratitis. The herpes zoster was started from 2022 to ongoing. In 2024, he continued to see an eye specialist for ongoing eye issues.  Patient may have underlying eye problems, herpes keratitis was treated with valacyclovir and the patient may also had neuralgia after Herpes zoster episode. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Gait disturbance, Influenza like illness, Mobility decreased
Clinical narrative: extremely weak; developed light fever; flu like symptoms; he is hardly walking now and needs assistance sitting up; hardly walking now; entire right arm is hurting/fingers that changed to bad pain; severe pain at the wrist; very thirsty; tingling in the fingers that changed to really bad pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAR-2024, the patient received the 1st dose of Shingrix (right arm). In MAR-2024, less than 2 weeks after receiving Shingrix, the patient experienced activities of daily living impaired (Verbatim: he is hardly walking now and needs assistance sitting up), walking difficulty (Verbatim: hardly walking now), pain in arm (Verbatim: entire right arm is hurting/fingers that changed to bad pain), wrist pain (Verbatim: severe pain at the wrist), thirst (Verbatim: very thirsty) and tingling feet/hands (Verbatim: tingling in the fingers that changed to really bad pain). On 19-MAR-2024, the patient experienced fever (Verbatim: developed light fever) and influenza-like symptoms (Verbatim: flu like symptoms). On 20-MAR-2024, the patient experienced weakness (Verbatim: extremely weak). The outcome of the fever, influenza-like symptoms, weakness, activities of daily living impaired, walking difficulty, pain in arm, wrist pain, thirst and tingling feet/hands were unknown.   It was unknown if the reporter considered the fever, influenza-like symptoms, weakness, activities of daily living impaired, walking difficulty, pain in arm, wrist pain, thirst and tingling feet/hands to be related to Shingrix.     It was unknown if the company considered the fever, influenza-like symptoms, weakness, activities of daily living impaired, walking difficulty, pain in arm, wrist pain, thirst and tingling feet/hands to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAR-2024 The patient was the reporter he had received the first dose of Shingrix vaccine in his right arm.  The reporter mentioned that he experienced light fever and flu like symptoms on the evening of Tuesday. The reporter stated that the next day he was extremely weak. he was hardly walking now and needs assistance sitting up. His entire right arm was hurting and was most severe pain at the wrist. he felt extremely thirsty and experiencing tingling in his fingers, which turn to really bad pain. The reporter consent the follow up. The case is linked with US2024039361, same reporter.; Sender's Comments:  US-GSK-US2024039361:Same reporter
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Thirst
Clinical narrative: extremely weak; developed light fever; flu like symptoms; he is hardly walking now and needs assistance sitting up; hardly walking now; entire right arm is hurting/fingers that changed to bad pain; severe pain at the wrist; very thirsty; tingling in the fingers that changed to really bad pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAR-2024, the patient received the 1st dose of Shingrix (right arm). In MAR-2024, less than 2 weeks after receiving Shingrix, the patient experienced activities of daily living impaired (Verbatim: he is hardly walking now and needs assistance sitting up), walking difficulty (Verbatim: hardly walking now), pain in arm (Verbatim: entire right arm is hurting/fingers that changed to bad pain), wrist pain (Verbatim: severe pain at the wrist), thirst (Verbatim: very thirsty) and tingling feet/hands (Verbatim: tingling in the fingers that changed to really bad pain). On 19-MAR-2024, the patient experienced fever (Verbatim: developed light fever) and influenza-like symptoms (Verbatim: flu like symptoms). On 20-MAR-2024, the patient experienced weakness (Verbatim: extremely weak). The outcome of the fever, influenza-like symptoms, weakness, activities of daily living impaired, walking difficulty, pain in arm, wrist pain, thirst and tingling feet/hands were unknown.   It was unknown if the reporter considered the fever, influenza-like symptoms, weakness, activities of daily living impaired, walking difficulty, pain in arm, wrist pain, thirst and tingling feet/hands to be related to Shingrix.     It was unknown if the company considered the fever, influenza-like symptoms, weakness, activities of daily living impaired, walking difficulty, pain in arm, wrist pain, thirst and tingling feet/hands to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAR-2024 The patient was the reporter he had received the first dose of Shingrix vaccine in his right arm.  The reporter mentioned that he experienced light fever and flu like symptoms on the evening of Tuesday. The reporter stated that the next day he was extremely weak. he was hardly walking now and needs assistance sitting up. His entire right arm was hurting and was most severe pain at the wrist. he felt extremely thirsty and experiencing tingling in his fingers, which turn to really bad pain. The reporter consent the follow up. The case is linked with US2024039361, same reporter.; Sender's Comments:  US-GSK-US2024039361:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered/did not reconstitute this medication; Only diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA982A, expiry date 31-OCT-2024) for prophylaxis.   On 26-MAR-2024, the patient received Menveo. On 26-MAR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered/did not reconstitute this medication) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-MAR-2024 The clinic manager informed that for Menveo they had the two-vial version, and they had a recent new graduate who accidentally gave only vial one, and not vial two, so he did not reconstitute this medication, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: patient received 3 Shingrix doses; patient received dose1 on 26 July 2018 and dose 2 on 07 Aug 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date) and Shingrix (on 26th July 2018 received 1st dose.). Concurrent medical conditions included dementia.   On 19-MAR-2024, the patient received the 3rd dose of Shingrix. On 07-AUG-2023, the patient received the 2nd dose of Shingrix. On 07-AUG-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received dose1 on 26 July 2018 and dose 2 on 07 Aug 2023). On 19-MAR-2024, the patient experienced extra dose administered (Verbatim: patient received 3 Shingrix doses). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt date: 02-APR-2024 The reporter was the daughter of the patient.  She reported that her mother received Zostavax prior to Shingrix coming out.  The patient received 3 Shingrix doses which led to extra dose administered. The reporter asked the pharmacy why this could happen being given all at the same pharmacy and they said because the pharmacy only keeps records for 2-3 years.  The department of health was notified and confirmed Shingrix doses/dates.  She also called insurance but they only will pay for 2 Shingrix but dose 1 did not show up in their system because it had a 720-day retention then falls off.  The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: product was administered to a patient after experiencing a unknown temperature excursion which was not covered by the extended stability data with no reported adverse event; Initial information received on 02-Apr-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] after a unknown temperature excursion which was not covered by the extended stability data 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 administered unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) after a unknown temperature excursion which was not covered by the extended stability data with no reported adverse event (poor quality product administered) (latency: same day) (lot: U7928AA, expiry: 23-Nov-2025) (lot: U7948BA, expiry: 29-Nov-2025) via unknown route in unknown administration site for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given after expiration date of 3/31/24.  No adverse reactions.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event, Product substitution error
Clinical narrative: No adverse event. Gave state vaccine to adult as I grabbed it from the wrong shelf. Patient received correct vaccine and dose.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Respiratory rate increased
Clinical narrative: Child passed out immediately after her third vaccine was administered (HPV). Child fell from chair to the floor (about 18 inches) which was carpeted. Nurse responded immediately. Rapid respirations which slowed down after child relaxed. Color was good. Skin dry, pupils equal and reactive.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Earlier in the day another doctor's office had transferred vaccines over to our clinic after asking if we could use 5 doses of Pentacel by 04/21/24. After reviewing our schedule for the next week it was determined that we could use those, so the transfer was accepted. They were put in the system by the other office with the expiration date as 04/21/24. The vaccines were dropped off while I was out of the office and were accepted by another staff member and put in the vaccines fridge. On the outside of the box the date (04/21/24) was written in sharpie. After I had returned to the office yesterday afternoon I administered a dose to this patient and after administering the dose it was noted that the expiration date on the vial was 04/01/24 and this vaccine had already expired. PCP was notified as well as office manager and the state. I was informed that child is safe, no harm was done to the child but he does need to get another dose if the vaccine. Mother was called and is aware of incident and will be bringing child in to repeat vaccine at his next wellness check in 3 months.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Tolerated injection well.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Resident developed redness/soreness/warmth to R deltoid injection site one day after receiving the updated 2023-2024 Moderna Covid vaccine on 4/4/24.  Compress applied to area and Tylenol received per order. Then, on Monday 4/8, resident's arm became more reddened and hotter to touch and itchy. Order received for Keflex and Hydrocortisone cream.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Tolerated treatment well
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: A nickel size knot at injection site is present today 4/10/24. No redness or warmth to touch. Pt stated her EMT instructor had already informed pt to use cool compression to area. Pt stated swelling has already began to go down since 4/07/24.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 3/31/2024 and was administered on 4/4/2024. No adverse reaction at time of entry.