chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram, Deep vein thrombosis, Echocardiogram, Electrocardiogram
Clinical narrative: RIGHT LEG DVT AND PULMONARY EMBOLISM REQUIRING HOSPITALIZATION, ANTICOAGULATION, AND SUPPLEMENTAL OXYGEN WORSENED PULMONARY FAILURE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pulmonary embolism, Respiratory failure, Ultrasound scan
Clinical narrative: RIGHT LEG DVT AND PULMONARY EMBOLISM REQUIRING HOSPITALIZATION, ANTICOAGULATION, AND SUPPLEMENTAL OXYGEN WORSENED PULMONARY FAILURE
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: A lady where I live went blind after the vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: BLINDNESS (medically significant), outcome "unknown", described as "A lady where I live went blind after the vaccine".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101732606 same reporter/product, different patient/events;US-PFIZER INC-202200902372 same reporter/product, different patient/events;
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: She got her vaccine, the lady pharmacist gave her the vaccine, it hurt a lot when she gave it, and she noticed that she was not giving it in the top of her arm in the front (triangle area).  It was given in the back of her arm, pretty far down and not in the meat part of her arm.  She took a big hunk area to give the shot in before the infinity shot in the back of the arm, 6" down from the shoulder, she is 5'1" or 5'2" so she has short arms, and felt it was given subcutaneously.  She left and went to her next doctor appointment that day and she mentioned it to them.  She does remember when she had an apt on the nurses said that the injection area did not look right.   It may have been at the HD where she mentioned to them, and they all said that it did not feel right, and not like any type of flu shot in the front of the arm.  Then she started to try and find out about it.  She went to the HD to check on it, and she saw one of the nurses and was told that they do not give RSV shots so they could not tell her for sure, but she said that it looked like it was not give in the right area.  Then the nurse gave her some #'s to call and she started to that.  She then called her regular PCP's office and they asked why was she calling and telling them about it that they could not help her with that.  She was told to call the manufacturer who could possibly give her some information.  They told her that she would need to get her PCP to take over and order a titer to see if there were any neutralizing antibodies in her body.  She Emailed her PCP and she said she did not want to do anything until she saw her in person.  She saw the doctor on 1/17/24, she gave her all the information and phone #'s, and got a report from her nurse today that they said that GSK did not have any information about this case, and they gave her the information to get the titer.  (They did file 2 reports on her ).   So she is in a dilemma if the vaccine will work as there is no data to tell if it was given in the wrong place because it's too new and it's not happened before, or if she has any protection from RSV if it's given subcutaneously instead of IM.
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immediate post-injection reaction, Injection site pain, Product administered at inappropriate site
Clinical narrative: She got her vaccine, the lady pharmacist gave her the vaccine, it hurt a lot when she gave it, and she noticed that she was not giving it in the top of her arm in the front (triangle area).  It was given in the back of her arm, pretty far down and not in the meat part of her arm.  She took a big hunk area to give the shot in before the infinity shot in the back of the arm, 6" down from the shoulder, she is 5'1" or 5'2" so she has short arms, and felt it was given subcutaneously.  She left and went to her next doctor appointment that day and she mentioned it to them.  She does remember when she had an apt on the nurses said that the injection area did not look right.   It may have been at the HD where she mentioned to them, and they all said that it did not feel right, and not like any type of flu shot in the front of the arm.  Then she started to try and find out about it.  She went to the HD to check on it, and she saw one of the nurses and was told that they do not give RSV shots so they could not tell her for sure, but she said that it looked like it was not give in the right area.  Then the nurse gave her some #'s to call and she started to that.  She then called her regular PCP's office and they asked why was she calling and telling them about it that they could not help her with that.  She was told to call the manufacturer who could possibly give her some information.  They told her that she would need to get her PCP to take over and order a titer to see if there were any neutralizing antibodies in her body.  She Emailed her PCP and she said she did not want to do anything until she saw her in person.  She saw the doctor on 1/17/24, she gave her all the information and phone #'s, and got a report from her nurse today that they said that GSK did not have any information about this case, and they gave her the information to get the titer.  (They did file 2 reports on her ).   So she is in a dilemma if the vaccine will work as there is no data to tell if it was given in the wrong place because it's too new and it's not happened before, or if she has any protection from RSV if it's given subcutaneously instead of IM.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait disturbance, Seizure
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait inability, Nervous system disorder, Seizure
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Fatigue, Gait inability, Magnetic resonance imaging
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Malaise, Pain, Paraesthesia, Scan brain, Seizure
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Biopsy brain abnormal, Death, Demyelination, Laboratory test, Neurological symptom
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Acute kidney injury, Altered state of consciousness, Asthenia, Atrial fibrillation, Biopsy brain abnormal
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Blood immunoglobulin G increased, CSF protein increased, Cerebral disorder, Depressed level of consciousness, Electroencephalogram normal
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Endotracheal intubation, Fatigue, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Partial seizures
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis, Pneumonia staphylococcal, Positron emission tomogram, Rash erythematous, Respiratory failure
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Spinal cord disorder, Splenomegaly, Unresponsive to stimuli
Clinical narrative: Patient had neurological symptoms and eventually ended up passing away in the hospital 2/6/24. He was treated for a demylinating disorder with a brain biopsy and plasma exchange.
Sex: F
Vaccine: MMR
Symptoms: Illness, Viral infection
Clinical narrative: AE is being filed as patient received an initial dose of MMR II and is now reported to be sick./ Patient was sick with viral infection; This spontaneous report was received from a medical assistant referring to a 4 month old female patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 16-NOV-2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter, Lot Number reported as: X020160 (invalid lot number) and expiration date reported as: 30-JUN-2021 (strength, route and anatomical location were not provided) for prophylaxis.  The reporter requested a replacement for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) that was drawn up but not used due to patient canceling appointment as the patient was reported to be sick with viral infection on unspecified date. Medical assistant reported the patient was supposed to receive a second dose of MMR II at the appointment that was canceled. It was reported that the patient would receive the second dose at a later date. The outcome of viral infection was unknown.  The causal relationship between viral infection and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.  Follow up information was received from medical assistant on 19-JAN-2014.  It was reported that on 16-NOV-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the valid lot number reported was W025567 and expiration date was not reported, but upon internal validation was established as 14-AUG-2024.
Age: 48.0
Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No additional AE. No Additional PQC.; leaked out onto the patient's skin due to a crack in the syringe tip; leaked out onto the patient's skin due to a crack in the syringe tip.; during administration when plunger was pushed, VAXNEUVANCE leaked out onto the patient's skin due to a crack in the syringe tip; This spontaneous report was received from a healthcare business professional (HBP) and refers to 48-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 30-JAN-2024, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL, 1 dosage form, intramuscularly, lot number X022028 with expiration date 22-OCT-2025 (anatomical location was not reported) indication reported as vaccine.  On the same date, during administration when plunger was pushed, pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) leaked out onto the patient's skin due to a crack in the syringe tip (syringe issue, poor quality device used and exposure via skin contact). It was reported that the needle was attached securely. The patient did not receive any of the product (also reported that the vaccine was administered, discrepant information), and no injury to either administrator or patient was reported. No adverse reactions were reported. The patient no sought medical attention and not received any treatment. The reporter was not able to take pictures or return product as it was thrown away. The caller also confirmed that the only place that the vaccine was leaking was from the hub base/tip area.  Notes for DPOC:  Please provide a detailed description of the defect using the questions below: o Is there a crack? YES o If yes, describe the size, shape & depth of the crack: "SMALL CRACK MAYBE A MILLIMETER OR 2" o Provide the exact location of the crack on the syringe: "AT THE BASE WHERE THE NEEDLE CONNECTS" o Is the syringe broken into 2 or more pieces? NO Was anyone injured as a result of the breakage? NO Was there difficulty trying to attach the syringe needle to the syringe? NO Under what situation was this defect noticed: (select one) during administration o While the syringe was still in the tray? NO Is there any broken glass or other separated component in the tray? (if yes specify) NO o After removing the syringe from the tray? NO o While trying to attach the needle to the syringe? NO o While giving the injection? YES o Immediately after giving the injection? NO o Was the syringe tip cap attached properly prior to use? YES o Was the syringe tray intact and undamaged on receipt? YES o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? "YES ADMINISTERED BUT NOT EXPOSED TO BODILY FLUIDS" If complaint sample is not/cannot be returned, please provide reason: ALREADY THROWN AWAY
Age: 3.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; HCP intended to administer MMR II and VARIVAX to a patient, but inadvertently grabbed VARIVAX  and PROQUAD; This spontaneous report as received from a registered nurse refers to a 3 year old patient of unknown gender.     No pertinent medical history, concurrent conditions, drug reactions, or allergies were provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT)   On 31-JAN-2024, the Healthcare professional (HCP) intended to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and  varicella virus vaccine live (oka/merck) (VARIVAX)  to the patient, but inadvertently grabbed  varicella virus vaccine live (oka/merck) (VARIVAX)  injection, 0.5 milliliter, once, lot #W008711 has been verified to be a valid lot number, expiration date: 14-MAR-2024, administered for prophylaxis (route of administration were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) injection, 0.5 milliliter, once, lot #W024548 has been verified to be a valid lot number, expiration date: 31-JAN-2024, administered for prophylaxis (route of administration were not provided), which were then concomitantly administered to the patient (wrong product administered).  The patient did not experience any adverse issues or side effects from the administered doses  of  varicella virus vaccine live (oka/merck) (VARIVAX)  and measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Temp Excursion; Initial report received on 03-Jan-2024.  A lab services manager reported that a patient (gender, age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a possible temperature excursion.  Medical history, allergies, and concomitant medications at the time of vaccination were unknown.   On an unknown date between 26-Dec-2023 to 29-Dec-2023, the patient received a dose of HEPLISAV-B (Lot # 944608, expiration date 27-Jan-2026, and NDC # 43528-003-01; route and injection site not reported). The HEPLISAV-B that was given had a possible temperature excursion with an unknown exact temperature. The product was ordered on 18 Dec-2023, shipped on the 19-Dec-2023, and due to a delay in shipment, it was received on the 26 Dec-2023. The HEPLISAV-B was promptly put in the refrigerator. It was cold to the touch but not frozen, and the ice pack on the top in the box was cold. No adverse side effects were reported by the patient.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temp Excursion; Initial report received on 03-Jan-2024.  A lab services manager in the reported that a patient (gender, age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a possible temperature excursion.  Medical history, allergies, and concomitant medications at the time of vaccination were unknown.   On an unknown date between 26-Dec-2023 to 29-Dec-2023, the patient received a dose of HEPLISAV-B (Lot # 944608, expiration date 27-Jan-2026, and NDC # 43528-003-01; route and injection site not reported). The HEPLISAV-B that was given had a possible temperature excursion with an unknown exact temperature. The product was ordered on 18 Dec-2023, shipped on the 19-Dec-2023, and due to a delay in shipment, it was received on the 26 Dec-2023. The HEPLISAV-B was promptly put in the refrigerator. It was cold to the touch but not frozen, and the ice pack on the top in the box was cold. No adverse side effects were reported by the patient.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temp Excursion; Initial report received on 03-Jan-2024.  A lab services manager reported that a patient (gender, age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a possible temperature excursion.  Medical history, allergies, and concomitant medications at the time of vaccination were unknown.   On an unknown date between 26-Dec-2023 to 29-Dec-2023, the patient received a dose of HEPLISAV-B (Lot # 944608, expiration date 27-Jan-2026, and NDC # 43528-003-01; route and injection site not reported). The HEPLISAV-B that was given had a possible temperature excursion with an unknown exact temperature. The product was ordered on 18 Dec-2023, shipped on the 19-Dec-2023, and due to a delay in shipment, it was received on the 26 Dec-2023. The HEPLISAV-B was promptly put in the refrigerator. It was cold to the touch but not frozen, and the ice pack on the top in the box was cold. No adverse side effects were reported by the patient.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Hypertension, Nasal congestion, Respiratory disorder
Clinical narrative: high blood pressure; increased cholesterol; nasal congestion; can't breathe correctly; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "increased cholesterol"; NASAL CONGESTION (non-serious), outcome "unknown"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "can't breathe correctly". Therapeutic measures were taken as a result of blood cholesterol increased. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Additional information: Age reported as 70-74 years old. The patient reported values of "one thirties, one forties", reported as little bit higher than it probably should be. Doctor commented it crept up a little bit from last year. When asked if still taking the Crestor (Rosuvastatin), patient answered yes and is also taking unspecified allergy pills.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, Head injury, Headache, Pain
Clinical narrative: fluid around heart/heart fluid buildup/got a little filled with fluid; shortness of breath/out of breath; headache/frequent headaches; pain/sore and aching; fall; hit her head; This is a spontaneous report received from a Consumer or other non HCP.  A female patient in her 70's received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (batch/lot number: unknown) for covid-19 immunization; furosemide (FUROSEMIDE); metoprolol tartrate (METOPROLOL TARTRATE); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); alprazolam (ALPRAZOLAM); atorvastatin (ATORVASTATIN). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious) with onset 2023, outcome "unknown"; HEAD INJURY (non-serious) with onset 2023, outcome "unknown", described as "hit her head"; PERICARDIAL EFFUSION (hospitalization), outcome "unknown", described as "fluid around heart/heart fluid buildup/got a little filled with fluid"; DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath/out of breath"; HEADACHE (non-serious), outcome "not recovered", described as "headache/frequent headaches"; PAIN (non-serious), outcome "not recovered", described as "pain/sore and aching". The action taken for furosemide, metoprolol tartrate, hydrochlorothiazide, alprazolam and atorvastatin was unknown. Clinical course: The reporter informed that the patient was recently hospitalized for fluid around heart and was currently experiencing shortness of breath, headache, pain. She had a fall in Sep2023 or Oct2023. The patient has heart fluid buildup. She got a little filled with fluid and was out of breath. She had a fall in Sep2023 or Oct2023 and hit her head. Now, she thought that the frequent headaches have can only come from that. The patient informed that she was sore and aching. She has pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion
Clinical narrative: fluid around heart/heart fluid buildup/got a little filled with fluid; shortness of breath/out of breath; headache/frequent headaches; pain/sore and aching; fall; hit her head; This is a spontaneous report received from a Consumer or other non HCP.  A female patient in her 70's received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (batch/lot number: unknown) for covid-19 immunization; furosemide (FUROSEMIDE); metoprolol tartrate (METOPROLOL TARTRATE); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); alprazolam (ALPRAZOLAM); atorvastatin (ATORVASTATIN). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious) with onset 2023, outcome "unknown"; HEAD INJURY (non-serious) with onset 2023, outcome "unknown", described as "hit her head"; PERICARDIAL EFFUSION (hospitalization), outcome "unknown", described as "fluid around heart/heart fluid buildup/got a little filled with fluid"; DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath/out of breath"; HEADACHE (non-serious), outcome "not recovered", described as "headache/frequent headaches"; PAIN (non-serious), outcome "not recovered", described as "pain/sore and aching". The action taken for furosemide, metoprolol tartrate, hydrochlorothiazide, alprazolam and atorvastatin was unknown. Clinical course: The reporter informed that the patient was recently hospitalized for fluid around heart and was currently experiencing shortness of breath, headache, pain. She had a fall in Sep2023 or Oct2023. The patient has heart fluid buildup. She got a little filled with fluid and was out of breath. She had a fall in Sep2023 or Oct2023 and hit her head. Now, she thought that the frequent headaches have can only come from that. The patient informed that she was sore and aching. She has pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound case about COVID shots and Paxlovid; Rebound case about COVID shots and Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound case about COVID shots and Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: my son had the Covid shot and was sick for like 2 days; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ILLNESS (non-serious), outcome "unknown", described as "my son had the Covid shot and was sick for like 2 days".  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound case about COVID shots and Paxlovid; Rebound case about COVID shots and Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound case about COVID shots and Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound; Rebound; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Leukaemia, Lymphadenopathy
Clinical narrative: Leukemia; Swollen lymph nodes; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-746956 (MODERNA).  A male patient received BNT162b2 (BNT162B2), in 2020 as dose 1, 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: LEUKAEMIA (medically significant), outcome "unknown", described as "Leukemia"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Swollen lymph nodes". Additional information: Shared with me that a bad outcome after receiving first Covid vaccine in 2020. Received Pfizer's vaccine. Then had swollen lymph nodes that did not resolve. Then was diagnosed with Leukemia. Attributed Covid vaccine to cancer diagnosis.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: sore arm; By mistake when went to pharmacy, got the Pfizer updated vaccine; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-OCCC-CINT0007055 (OCCC), US-MODERNATX-MOC20230926000028 (MODERNATX).  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, since the epidemic started), for COVID-19 immunisation; Moderna (DOSE 2), for COVID-19 immunisation; Moderna (DOSE 3), for COVID-19 immunisation; Moderna (DOSE 4), for COVID-19 immunisation; Moderna (DOSE 5), for COVID-19 immunisation; Moderna (DOSE 6), for COVID-19 immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset Jan2024, outcome "unknown", described as "By mistake when went to Walgreens, got the Pfizer updated vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient did not report any medical history or condition. He was user of Moderna for his COVID-19 vaccine since the epidemic started. had the updated vaccine recently 3 or 4 days ago. By mistake when went to Walgreens, he got the Pfizer updated vaccine. He wanted to know if that is okay. He had Moderna the last several years a total of 6 doses, ended up getting the Pfizer update. He stated did not have side effects except just a sore arm. He wanted to know which one to take in the future.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myelin oligodendrocyte glycoprotein antibody-associated disease
Clinical narrative: New-onset MOGAD after first-dose SARS-CoV-2 mRNA vaccination; This is a literature report for the following literature source(s).  A 45-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, 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: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (medically significant), outcome "unknown", described as "New-onset MOGAD after first-dose SARS-CoV-2 mRNA vaccination". The vaccine may non-specifically activate occult anti-MOG antibodies, as reported in a 45-year-old woman with relapsing MOGAD following mRNA booster vaccination. No follow-up attempts are possible.; Sender's Comments: The event myelin oligodendrocyte glycoprotein antibody-associated disease is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing); "smoked like a freight train" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN, SINGLE), for influenza immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (death, hospitalization) with onset 2022, outcome "fatal", described as "stroke". The patient date of death was 24Oct2022. Reported cause of death: "stroke". It was not reported if an autopsy was performed. Clinical course: 2 Patients were involved. During the call while collecting Patient adverse event details, realized that both had previously received all Pfizer doses. Patient also received last covid shot in Sep2022 and Flu shot, while in rehab in nursing home. Around 6:30 PM, reporter received a call informing that was acting really strange and also had a stroke. Patient was hospitalized and passed away 24Oct2022. Patient mentioned that had a past medical history of Emphysema, COPD history, and smoked like a freight train.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Reported Cause(s) of Death: stroke
Sex: U
Vaccine: HPV4, MEN, TDAP
Symptoms: Dizziness, Headache
Clinical narrative: dizziness/feeling dizzy; headaches; Initial information received on 25-Jan-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves Adolescent and unknown gender patient who experienced dizziness/feeling dizzy and headaches after receiving gardasil, diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] and meningococcal a-c-y-w135 (t conj) vaccine [menquadfi].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On 23-Jan-2024, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, expiry date and lot number) via intramuscular route in unknown administration site for routine immunization.  On 23-Jan-2024, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for routine immunization.  On 23-Jan-2024, the patient received an unknown dose of suspect GARDASIL not produced by Sanofi Pasteur (with an unknown strength, expiry date, formulation and lot number) via unknown route in unknown administration site for routine immunization.  On 23-Jan-2024, the patient developed events of headaches (headache) and dizziness/feeling dizzy (dizziness) (latency: same day).  Patient did not experience any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported, Dr. called to report and AE for a patient who received MenQuadFi, Adacel and Gardasil at their routine visit on Tuesday the 23rd. The patient said they started feeling dizzy with in minutes of receiving the vaccines. The patient is reporting continued dizziness and headaches since. As of today, the symptoms are still ongoing.   Action taken with meningococcal vaccine (menquadfi), diphtheria, tetanus and acellular pertussis vaccine (adacel) and hpv vaccine vlp rl1 4v (yeast) (gardasil) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event dizziness/feeling dizzy and was Not Recovered / Not Resolved for the event headaches.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired ADACEL was mistakenly administered to a patient with no reported adverse event; Initial information received from Regulatory Authority on 24-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who was mistakenly administered an expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hpv vaccine vlp rl1 4v (yeast) (gardasil) for prophylactic vaccination; and meningococcal vaccine a/c/y/w conj (dip tox) (menactra) for Prophylactic vaccination.  On 23-Jan-2024, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5963AA) (Expiry date: 18-Jan-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left arm for immunization.  On 23-Jan-2024, the patient was mistakenly administered an expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Medical assistant calling on behalf of physician. Phone given to physician. Physician states that an expired ADACEL was mistakenly administered to a patient and is inquiring for guidance. This situation is pre-assessed as a medication error/an inappropriate use due to administration of an expired product.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: only the liquid portion (DTaP-IPV) of pentacel was injected to the patient with no reported adverse event; Initial information was received on 24-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient to whom only the liquid portion (dtap-ipv) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was injected to the patient 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 13V (CRM197) (Prevenar 13) for prophylactic vaccination.  On 22-Dec-2023, the patient received a 0.5 ml, once (dose 1) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ865AA, expiry date: unknown, strength: standard) via intramuscular route in unknown administration site for Immunisation and only the liquid portion (dtap-ipv) of pentacel was injected to the patient with no reported adverse event (single component of a two-component product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature reached 9.3 C for 13 mins 10 C for 10 C was administered to patient with no reported adverse event; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 11 years old male patient where IPV (VERO) [Ipol] temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine, meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 12-Dec-2023, the patient received a 0.5 ml, once dose of suspect IPV (VERO) (Suspension for injection) (lot W1C751M, expiry date: 18-Nov-2025, Strength: standard) via intramuscular route in the left deltoid for Immunisation and ipol temperature reached: 9.3 c for 13 mins 10 c for 10 c was administered to patients with no reported adverse event (poor quality product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins/punctured IPOL was administered to patient with no reported AE; Max/low temperature reached: 9.3 C for 13 mins/punctured IPOL was administered to patient with no reported AE; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 years old male patient who received punctured Poliomyelitis Vaccine (Inactivated) IPV (VERO) (Ipol) reporter reported previously was administered to 50 patients/ max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a vaccine) for Prophylactic vaccination.  On 28-Dec-2023, the patient received 0.5 ml total of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1C751M) (Expiry date: 18-Nov-2025) (Strength: standard) (Frequency: once) via intramuscular route in the left deltoid for immunization.  On 28-Dec-2023, the patient received punctured Poliomyelitis Vaccine (Inactivated) IPV (VERO) (Ipol) reporter reported previously was administered to 50 patients/ max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event (product storage error, latency: unknown) (poor quality product administered; latency: same day).  It was reported, Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error: Unknown Administered: Yes, it was administered to 50 patients. Does extended stability data cover the excursion :No. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  This situation is pre-assessed as a medication error/an inappropriate use due to administration of punctured IPOL that is not suitable for use.   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.