chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. 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; Covid-19 vaccine (Dose 6 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 7 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 8 unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was administered from 24Dec2023 to 28Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse from product quality group.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 12:30 as dose 1, single (Lot number: HH7595) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN (Hypertension)" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). The patient did not have known allergies. Concomitant medication(s) included: METOPROLOL, start date: 13Jun2011; LISINOPRIL, start date: 16Sep2014; CHLORTHALIDONE, start date: 15Apr2022; SINGULAIR, start date: 12Oct2017; LORATADINE, start date: 05Oct2016. Vaccination history included: moderna (Dose 1 , Batch/Lot No: 013L20A , Location of injection: Arm Right , Vaccine Administration Time: 09:30 AM), administration date: 14Jan2021, when the patient was 69-year-old, for COVID-19 immunization; moderna (Dose 2 , Batch/Lot No: Unknown. , Location of injection: Arm Right , Vaccine Administration Time: 09:00 AM), administration date: 22Feb2021, when the patient was 69-year-old, for COVID-19 immunization; moderna (Dose 3 , Batch/Lot No: 001JZ1-2A , Location of injection: Arm Right , Vaccine Administration Time: 03:00 PM), administration date: 11Apr2022, when the patient was 71-year-old, for COVID-19 immunization; moderna bivalent (Dose 4 , Batch/Lot No: 060f22A , Location of injection: Arm Right , Vaccine Administration Time: 12:00 PM), administration date: 12Oct2022, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures including Paxlovid from 23Dec2023 to 28Dec2023 were taken as a result of vaccination failure, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Vaccination Failure and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 44-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 included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid from 25Dec2023 to 29Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Dysphonia, Headache, Nasal congestion
Clinical narrative: moderate sx Headache; stuffy nose; raspy throat; whole body soreness; nausea; sleeping unwell; dry cough; GI upset; This is a spontaneous report received from a Nurse.  A 29-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HF9275) at the age of 29 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCIN, on 13Sep2023 as unk unk, single. 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, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 31Dec2023, outcome "recovering", described as "GI upset"; COUGH (non-serious) with onset 31Dec2023, outcome "recovering", described as "dry cough"; HEADACHE (non-serious) with onset 31Dec2023, outcome "recovering", described as "moderate sx Headache"; NAUSEA (non-serious) with onset 31Dec2023, outcome "recovering"; DYSPHONIA (non-serious) with onset 31Dec2023, outcome "recovering", described as "raspy throat"; POOR QUALITY SLEEP (non-serious) with onset 31Dec2023, outcome "recovering", described as "sleeping unwell"; NASAL CONGESTION (non-serious) with onset 31Dec2023, outcome "recovering", described as "stuffy nose"; PAIN (non-serious) with onset 31Dec2023, outcome "recovering", described as "whole body soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nasal congestion, dysphonia, pain, nausea, poor quality sleep, cough, abdominal discomfort. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003728 same patient/vaccine, different events;
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Poor quality sleep, SARS-CoV-2 test
Clinical narrative: moderate sx Headache; stuffy nose; raspy throat; whole body soreness; nausea; sleeping unwell; dry cough; GI upset; This is a spontaneous report received from a Nurse.  A 29-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HF9275) at the age of 29 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCIN, on 13Sep2023 as unk unk, single. 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, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 31Dec2023, outcome "recovering", described as "GI upset"; COUGH (non-serious) with onset 31Dec2023, outcome "recovering", described as "dry cough"; HEADACHE (non-serious) with onset 31Dec2023, outcome "recovering", described as "moderate sx Headache"; NAUSEA (non-serious) with onset 31Dec2023, outcome "recovering"; DYSPHONIA (non-serious) with onset 31Dec2023, outcome "recovering", described as "raspy throat"; POOR QUALITY SLEEP (non-serious) with onset 31Dec2023, outcome "recovering", described as "sleeping unwell"; NASAL CONGESTION (non-serious) with onset 31Dec2023, outcome "recovering", described as "stuffy nose"; PAIN (non-serious) with onset 31Dec2023, outcome "recovering", described as "whole body soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, nasal congestion, dysphonia, pain, nausea, poor quality sleep, cough, abdominal discomfort. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003728 same patient/vaccine, different events;
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test type post vaccination=Nasal Swab/ covid test result=Positive; covid test type post vaccination=Nasal Swab/ covid test result=Positive; This is a spontaneous report received from a Nurse.  A 29-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HF9275) at the age of 29 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 4, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 3, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2023, outcome "recovering" and all described as "covid test type post vaccination=Nasal Swab/ covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202400003628 same patient/vaccine, different events;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 28-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown.), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown.), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, (Booster) Single, Manufacturer Unknown.), for COVID-19 Immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment of Paxlovid from 24Dec2023 to 29Dec2023 for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Elevated BP" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient had no known allergy. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2023, stop date: 20Dec2023. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, vaccine lot number=026L204), administration date: 31Dec2020, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, vaccine lot number=013L20A), administration date: 07Jan2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine lot number=ff8841), administration date: 02Nov2021, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 21Dec223 to 26Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Rebound covid after recovery; Rebound covid after recovery; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Rebound covid after recovery". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 17Dec2023 to 22Dec2023 for treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain
Clinical narrative: Patient complained of sharp pains a day after shot which went away after 2 days. Afterwards, there was overall joint pains which still persist as of reporting
Age: 0.33
Sex: M
Vaccine: RSV
Symptoms: Urticaria, Vomiting
Clinical narrative: Within a hour of the injection patient began vomiting and developed hives. O2 Sats on room air was 94%. Patient was admitted to the hospital for observation.
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Diluent was not mixed into the Pfizer COVID-19 vaccine, 6 months - 4 years,  prior to drawing up 3 ml and administering to the patient.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient's son called the pharmacy on 1/4/2024 stating that his mother was in the hospital. As per the patient's son, the last time she received a COVID vaccination she became unresponsive 2 days later and was admitted into the hospital. The son states the patient suffers from dementia and when her questionarre was completed as pharmacy, she answered NO to all inquiring questions, not disclosing her previous reaction that occurred at another pharmacy. Son states he found her unresponsive in her home on 1/4/2024 and she was admitted into the hospital.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hypersomnia, Injection site pain
Clinical narrative: Started with pain at the injection site and 11 hours later I had chills & fever, felt terrible and was very tired. Slept all day and that night and woke up feeling okay.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started with pain at the injection site and 11 hours later I had chills & fever, felt terrible and was very tired. Slept all day and that night and woke up feeling okay.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Hypersensitivity, Injection site pain, Pruritus, Rash
Clinical narrative: pain at site of injection 1 hour later,  itching on neck that same evening becoming worse the next day.  I thought it was dry skin so I put Cerave Healing ointment on it. By   Thursday a rash had appeared and the itching was worse so I put a Hydrocortisone cream 1% on it.  The itching stopped.  I asked a pharmacist about the rash and she said it was an allergic reaction. She said I could take Benadryl but I felt it was not needed.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Severe profuse vomiting during the middle of the night the night she got the vaccination.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Mobility decreased, Myalgia, Neck pain, Product administered at inappropriate site
Clinical narrative: Received shot in the very upper arm on Jan. 4.  Everything went surprising well since I spend two days in bed after COVID vax.  By Jan 8, I was feeling an unexpected neck pain.   On the 9th it was getting suspicious and found that the pain went from the injection site under the top of the shoulder to the neck.  It seemed to be spreading.  On the 10th, it had progressed to the point where I could see that the next day I would be unable to rise from the mattress, so I called the nurse line.  The doctor advised ER.  I was skeptical, thinking I needed a specialist.  That said, the ER doc was very good.   He confirmed the situation and left trapezius pain.  He gave me a four day course of steroids, a neck brace and said to take Tylenol.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: X-ray limb abnormal
Clinical narrative: Received shot in the very upper arm on Jan. 4.  Everything went surprising well since I spend two days in bed after COVID vax.  By Jan 8, I was feeling an unexpected neck pain.   On the 9th it was getting suspicious and found that the pain went from the injection site under the top of the shoulder to the neck.  It seemed to be spreading.  On the 10th, it had progressed to the point where I could see that the next day I would be unable to rise from the mattress, so I called the nurse line.  The doctor advised ER.  I was skeptical, thinking I needed a specialist.  That said, the ER doc was very good.   He confirmed the situation and left trapezius pain.  He gave me a four day course of steroids, a neck brace and said to take Tylenol.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Dizziness, chills, nausea
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient reports itching at joints then development of a rash on arms, chest, and stomach.  Occurred 2-3 days after injection and lasted about 3 weeks.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Deafness unilateral, Ear infection, Sudden hearing loss
Clinical narrative: Within a few minutes of the shot in my right arm, I suddenly lost the hearing in my right ear.
Age: 84.0
Sex: M
Vaccine: HEPAB
Symptoms: Carotid angioplasty, Carotid artery occlusion, Nausea, Pain, Pyrexia
Clinical narrative: 1/5/24 nausea, feverish, aches and pains.   the following tuesday was hospitalized for blocked carotid artry. not able to clear with angioplasty. is now taking medications to clear. will be following up with cardiologist.  refused second dose
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: 2 days after receiving the vaccine, developed pain and aches in left arm where injected. pain in the elbow varies mild to strong. muscle aches just above and below elbow varies from mild to strong.  ache in area where vaccine injected, not every day but several days a week.  able to move arm and fingers normally, but pain always with certain movements especially when holding elbow bent at 90 degrees
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient presented on 1/11/24 stating that her arm was still warm, red, swollen and was painful to the touch.  She stated symptoms began the day after vaccination and lasted for a few days before resolving.  She then stated that the soreness and redness returned to the vaccination site after a couple days with no presentation.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site pain
Clinical narrative: Patient presented on 1/11/24 stating that her arm was still warm, red, swollen and was painful to the touch.  She stated symptoms began the day after vaccination and lasted for a few days before resolving.  She then stated that the soreness and redness returned to the vaccination site after a couple days with no presentation.
Age: 79.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Full blood count normal, Injection site pain, Metabolic function test
Clinical narrative: Initial injection of RSV in right arm was more painful than the COVID vaccination at the same time in the left arm.  Mild pain in both arms for 2-3 days after injections.  Severe deep pain and tenderness in right arm at injection site beginning 10 days after the injection. Over next 3 days the pain and tenderness increased and spread to over the shoulder and into the scapular area.  There was no limitation of movement of the shoulder. Pain persisted despite taking her usual arthritis medications - Celebrex and Tramadol with tylenol.  Jan 4- Evaluated at Hospital ER. Blood tests including CBC, C-reacive protein, Creatine Kinase, comprehensive metabolic panel, ESR - all normal. No fever or skin abnormalities. No itching or redness. No systemic symptoms of GI, pulmonary, cardiac abnormalities. Ultrasound of right upper extremity no evidence of thrombosis. No additional findings.  No evidence of absess , mass or muscle abnormalities.   Began on Medrol dose pack 4 mg pills methylPrednisolone beginning with 6 pills (24 mg) and reducing by one pill each day.  Pain lessened after the first day but increased again on following days. Unable to sleep because of pain in the arm.  On Jan 8 went to Dr,  rheumatologist, who prescribed higher dose of steriod.  (40 mg PREDNISONE x 3 days then taper by 1 tablet each day). This higher dose of steroid resulted in gradual reduction in the pain over 2-3 days.  Currently still on tapering doses of prednisone with greatly reduced pain.  Not taking celebrex while on steroids. Tramadol with tylenol now gives pain relief.  Pain reduced but continues to date (18 days after initial injection).
Age: 79.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Red blood cell sedimentation rate normal, Sleep disorder, Ultrasound Doppler normal
Clinical narrative: Initial injection of RSV in right arm was more painful than the COVID vaccination at the same time in the left arm.  Mild pain in both arms for 2-3 days after injections.  Severe deep pain and tenderness in right arm at injection site beginning 10 days after the injection. Over next 3 days the pain and tenderness increased and spread to over the shoulder and into the scapular area.  There was no limitation of movement of the shoulder. Pain persisted despite taking her usual arthritis medications - Celebrex and Tramadol with tylenol.  Jan 4- Evaluated at Hospital ER. Blood tests including CBC, C-reacive protein, Creatine Kinase, comprehensive metabolic panel, ESR - all normal. No fever or skin abnormalities. No itching or redness. No systemic symptoms of GI, pulmonary, cardiac abnormalities. Ultrasound of right upper extremity no evidence of thrombosis. No additional findings.  No evidence of absess , mass or muscle abnormalities.   Began on Medrol dose pack 4 mg pills methylPrednisolone beginning with 6 pills (24 mg) and reducing by one pill each day.  Pain lessened after the first day but increased again on following days. Unable to sleep because of pain in the arm.  On Jan 8 went to Dr,  rheumatologist, who prescribed higher dose of steriod.  (40 mg PREDNISONE x 3 days then taper by 1 tablet each day). This higher dose of steroid resulted in gradual reduction in the pain over 2-3 days.  Currently still on tapering doses of prednisone with greatly reduced pain.  Not taking celebrex while on steroids. Tramadol with tylenol now gives pain relief.  Pain reduced but continues to date (18 days after initial injection).
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Tinnitus
Clinical narrative: Onset of tinnitus approx  1hr 15 minutes after shot.  Still present over 24 hours later.  I?m a healthy individual who eats a mainly vegetarian diet, exercise regularly and am not overweight.  I rarely get sick.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Extra dose administered
Clinical narrative: pt inadvertently received both pediarix and Hep B at 2 month visit so got 2 doses of infant - Hep B vaccine
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC20, RV1, TD
Symptoms: No adverse event
Clinical narrative: No reaction or adverse event. Pt is doing fine. Mother states pt has no symptoms or signs.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Cardiac death
Clinical narrative: cardiac arrest; Initial information received on 09-Jan-2024 regarding an unsolicited valid Social Media courtesy serious case received from a physician.  This case involves a 1 years old female patient who died due to cardiac arrest after receiving prevnar 13, recombivax HB, influenza quadrival A-B vaccine [fluzone quadrivalent] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jan-2020, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, influenza quadrival A-B vaccine and recombivax HB, prevnar 13 not produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date- unknown). Information on the batch number was requested.  On 16-Jan-2020 the patient had cardiac arrest (latency 2 days). Final diagnosis was (fatal) cardiac arrest.  Action taken: not applicable.  It is unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Fatal for the event cardiac arrest. No autopsy was done. The cause of death was reported as Cardiac arrest.  Seriousness criteria- Death and medically significant for Cardiac arrest; Sender's Comments: Sanofi Company Comment dated 11-Jan-2024: This case involves a 1 years old female patient who died due to cardiac arrest 2 days following vaccination with prevnar 13, recombivax HB, influenza quadrival A-B vaccine [fluzone quadrivalent] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel]. This is poorly documented case, with relevant information missing, such as: concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations and test results excluding alternative etiologies for the reported event, and final diagnosis. It is unknown if an autopsy was done. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cardiac arrest
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Death, Respiratory arrest, Resuscitation
Clinical narrative: cardiac arrest; Initial information received on 09-Jan-2024 regarding an unsolicited valid Social Media courtesy serious case received from a physician.  This case involves a 1 years old female patient who died due to cardiac arrest after receiving prevnar 13, recombivax HB, influenza quadrival A-B vaccine [fluzone quadrivalent] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jan-2020, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, influenza quadrival A-B vaccine and recombivax HB, prevnar 13 not produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date- unknown). Information on the batch number was requested.  On 16-Jan-2020 the patient had cardiac arrest (latency 2 days). Final diagnosis was (fatal) cardiac arrest.  Action taken: not applicable.  It is unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Fatal for the event cardiac arrest. No autopsy was done. The cause of death was reported as Cardiac arrest.  Seriousness criteria- Death and medically significant for Cardiac arrest; Sender's Comments: Sanofi Company Comment dated 11-Jan-2024: This case involves a 1 years old female patient who died due to cardiac arrest 2 days following vaccination with prevnar 13, recombivax HB, influenza quadrival A-B vaccine [fluzone quadrivalent] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel]. This is poorly documented case, with relevant information missing, such as: concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations and test results excluding alternative etiologies for the reported event, and final diagnosis. It is unknown if an autopsy was done. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cardiac arrest
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, DTAP, FLUX, HEP, PNC13, DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cardiac arrest, Death
Clinical narrative: cardiac arrest; Initial information received on 09-Jan-2024 regarding an unsolicited valid Social Media courtesy serious case received from a physician.  This case involves a 1 years old female patient who died due to cardiac arrest after receiving prevnar 13, recombivax HB, influenza quadrival A-B vaccine [fluzone quadrivalent] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jan-2020, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, influenza quadrival A-B vaccine and recombivax HB, prevnar 13 not produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date- unknown). Information on the batch number was requested.  On 16-Jan-2020 the patient had cardiac arrest (latency 2 days). Final diagnosis was (fatal) cardiac arrest.  Action taken: not applicable.  It is unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Fatal for the event cardiac arrest. No autopsy was done. The cause of death was reported as Cardiac arrest.  Seriousness criteria- Death and medically significant for Cardiac arrest; Sender's Comments: Sanofi Company Comment dated 11-Jan-2024: This case involves a 1 years old female patient who died due to cardiac arrest 2 days following vaccination with prevnar 13, recombivax HB, influenza quadrival A-B vaccine [fluzone quadrivalent] and diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [pentacel]. This is poorly documented case, with relevant information missing, such as: concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations and test results excluding alternative etiologies for the reported event, and final diagnosis. It is unknown if an autopsy was done. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cardiac arrest
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Sudden death
Clinical narrative: Died suddenly; This serious case was reported by a physician via other manufacturer and described the occurrence of sudden death in a 2-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included Elasomeran (Moderna COVID-19 vaccine) for prophylaxis.   On 15-DEC-2022, the patient received FluLaval Quadrivalent 2022-2023 season and Moderna COVID-19 vaccine. On 16-DEC-2022, 1 days after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced sudden death (Verbatim: Died suddenly) (serious criteria death and GSK medically significant). The patient died on 16-DEC-2022. The reported cause of death was sudden death.   It was unknown if the reporter considered the sudden death to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the sudden death to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Jan-2024 The reporter reported that the patient received Moderna COVID-19 mRNA Vaccine and Flulaval Quadrivalent vaccine. On 16th December 2022, 1 day after received both vaccines patient died suddenly. It was unknown if the reporter considered the sudden death to be related to Moderna COVID-19 vaccine. This US2024AMR005310 case has been linked to the case reported by the same reporter. Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Sudden death
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 03:30 as dose 1, single (Lot number: HD9876) at the age of 69 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "Depresssion" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Overactive bladder" (unspecified if ongoing); "Vertigo" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Non-melanoma skin cancer" (unspecified if ongoing); "SBO (small bowel obstruction)" (unspecified if ongoing); "Non ulcer dyspepsia" (unspecified if ongoing); "Acute neck pain" (unspecified if ongoing); "Sulfa, SulfaX drugs," (unspecified if ongoing); "known allergies: Silicon tape products" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrocodone, reaction: "Allergies: Hydrocodone"; Reglan, reaction: "Allergies: Reglan"; Morphine, reaction: "Allergies: Morphine"; Codeine, reaction: "Allergies: Codeine". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, vaccine brand: Pfizer / BioNTech,, vaccine lot number: GH9694, vaccine location: Left arm), administration date: 21Sep2022, when the patient was 68-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, vaccine brand: Pfizer / BioNTech,, vaccine lot number: FK9893, vaccine location: Left arm), administration date: 07Apr2022, when the patient was 67-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, vaccine brand: Pfizer / BioNTech,, Lot: Unknown), administration date: 04Mar2021, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, vaccine brand: Pfizer / BioNTech,, Lot: unknown), administration date: 11Feb2021, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine brand: Pfizer / BioNTech,, Lot: Unknown), administration date: 30Sep2021, when the patient was 67-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Fall, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.; This spontaneous case was reported by a patient and describes the occurrence of FALL (I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 17-Aug-2023. Concurrent medical conditions included Melanoma (Melanoma stable).    On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 30-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FALL (I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.). At the time of the report, FALL (I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms/events.   The patient did not have any additional medical history, concomitant disease or risk factor.   There were no lab data/results available.  Patient had taken iv meds, names not specified.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Fall
Clinical narrative: I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.; This spontaneous case was reported by a patient and describes the occurrence of FALL (I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 17-Aug-2023. Concurrent medical conditions included Melanoma (Melanoma stable).    On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 30-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FALL (I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.). At the time of the report, FALL (I fell to the floor 12 hours after the vaccine and was unable to get up, was taken to ER by EMTs.) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms/events.   The patient did not have any additional medical history, concomitant disease or risk factor.   There were no lab data/results available.  Patient had taken iv meds, names not specified.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea
Clinical narrative: in about a week from receiving the vaccine, I have been having dyspnea; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: MERCAPTOPURINE; ALLOPURINOL; VITAMIN D [VITAMIN D NOS]; VITAMIN B [VITAMIN B COMPLEX]. Past drug history included: Iodine, reaction(s): "Allergy". 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, manufacturer unknown), for COVID-19 immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 29Dec2023, outcome "not recovered", described as "in about a week from receiving the vaccine, I have been having dyspnea". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: in about a week from receiving the vaccine, I have been having dyspnea; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: MERCAPTOPURINE; ALLOPURINOL; VITAMIN D [VITAMIN D NOS]; VITAMIN B [VITAMIN B COMPLEX]. Past drug history included: Iodine, reaction(s): "Allergy". 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, manufacturer unknown), for COVID-19 immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 29Dec2023, outcome "not recovered", described as "in about a week from receiving the vaccine, I have been having dyspnea". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 2.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a TE with VAQTA and MMR II. Both were administered on 12/7/2023 after being improperly stored; No adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unkown gender. Informaiton regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.  On 07-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 ml, lot #W034593 (rHA) expiration date: 10-MAY-2024 (strength, and route of administration were not provided); and with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml, lot number: 197152 expiration date: 13-SEP-2024, (strength, lot #, and route of administration were not provided) both administered as prophylaxis.   It was reported that the vaccines were administered after being improperly stored (product storage error.)   No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; HCP called to report that the patient received an expired dose of  MMR II. The dose expired on 02/27/2021 and was administered on 03/09/2021.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  09-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (expired product administered), at a dose of 0.5 milliliter (mL) (lot number S006051 has been determined to be valid, expiration date reported and validated as 27-FEB-2021, recombinant human albumin (rHA) therapy type), administered for prophylaxis (strength, vaccination scheme, anatomical site of administration and route of administration were not provided). The product had no previous excursions. No symptomatic events or additional adverse event information were reported.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC.; HCP calling to report PROQUAD was administered after experiencing a temperature excursion. No additional information/clarification provided. No additional AE/no PQC.; This spontaneous report was received from a medical assistant concerning a 1-year-old male patient. The patient's concurrent condition and medical history were not provided.   On an unknown date, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) (lot# X021757, expiry date: 23-FEB-2025) was stored at a temperature of 31 degree Fahrenheit (F) for 24 minutes. There was no previous temperature excursion. On 05-JAN-2024, after temperature excursion, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection 0.5 mL (route of administration, and anatomical location not provided) (product storage error) reconstituted with sterile diluent solution for injection/infusion 0.5 mL (frequency, route of administration, lot#, and expiration date not provided) as prophylaxis. There was no additional information/clarification provided. No additional adverse event (AE) was reported (no adverse event).