chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pruritus
Clinical narrative: Patient came in for her 2nd shingles shot. Patient was given the vaccine in the left deltoid via im injection at 11:27 am. Patient said that the needle didnt hurt but the serum caused immediate pain/ burning/ slight itching. Patient had no hives no anaphylaxis no syncope no dizziness. Patient was offered apap but said she wasn't allowed to take apap. She was given a single capsule of benadryl 25 mg out of ekit for itching and swelling. She did not use an ice pack/ did not want ice pack. Patient after 10 mins of waiting said she felt much better. Patient was called to make sure the site was still improved from the initial shot. Patient's md will be contacted monday. Vaers report was not initially done due to the website being down (will be done once website back up). Event Details
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Severe chills/shakes 3/17/23 11pm throughout night.  High fever 102.5+ 3/17/23 night.  3/18/23 all day fatigue, aches/pains similar to flu.  Chills stopped after 11am 3/18/23/. Low grade fever 99.2 to 99.9 on 3/19/23.  Injection site red and swollen with redness diameter of 3.25" across left deltoid.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Severe chills/shakes 3/17/23 11pm throughout night.  High fever 102.5+ 3/17/23 night.  3/18/23 all day fatigue, aches/pains similar to flu.  Chills stopped after 11am 3/18/23/. Low grade fever 99.2 to 99.9 on 3/19/23.  Injection site red and swollen with redness diameter of 3.25" across left deltoid.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Periarthritis
Clinical narrative: PATIENT STATES SHE GOT A FROZEN SHOULDER AND AN ALLERGIC REACTION.  THIS REACTION PUT HER IN THE HOSPITAL.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocarditis, Post viral fatigue syndrome
Clinical narrative: Myocarditis Myalgic encephalomyelitis
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Pruritus, Rash
Clinical narrative: Severe headache 3/15/23-3/18/23 Broke out in rash on face, neck, back, stomach, arms on 3/18/23?12 days after her vaccine. Continued to get worse morning of 3/19/23. Some itching.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Impaired driving ability
Clinical narrative: Dizzyness, light-headed, difficulty walking,  Legs feel "asleep" and getting a little worse weekly.  Can't / won't drive - unsafe as feeling in legs is slightly numb.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes simplex test negative, Pain, Rash
Clinical narrative: 1/14/2023, morning around 7AM: Woke up with headaches; weakness; swelling at lower left of back of my head; rash and blisters developed over the following two days; painful upon touching, blisters reached my neck. On 1/16 I called Doctors office, describing symptoms, and provided picture of the blisters on my head. Received medication against Shingles:  Valtrex 1 gm three times a day for 7 days, starting on 1/16. Symptoms started to fade by 1/19, rashes started to disappear, however, it took another two weeks until the blisters vanished.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Tenderness, Varicella virus test positive
Clinical narrative: 1/14/2023, morning around 7AM: Woke up with headaches; weakness; swelling at lower left of back of my head; rash and blisters developed over the following two days; painful upon touching, blisters reached my neck. On 1/16 I called Doctors office, describing symptoms, and provided picture of the blisters on my head. Received medication against Shingles:  Valtrex 1 gm three times a day for 7 days, starting on 1/16. Symptoms started to fade by 1/19, rashes started to disappear, however, it took another two weeks until the blisters vanished.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Immediate soreness, swelling and pain at the sight of the injection that lasted for over a week. Discoloration that is round at the sight of the injection . The same sized that developed right after the injection of the 1st dose of Shingles and has not gone away.
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia
Clinical narrative: PATIENT LOST ALL HER HAIR AND EYEBROWS
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardiac flutter, Death, Laboratory test normal
Clinical narrative: Two weeks after the 1st dose of the Pfizer vax, heart started to flutter. Went to Urgent Care, then to the ER. They diagnosis him with Bundle Branch Blockage. Then came back to home location where he started to see (Cardiologist). Ran a bunch of tests, which turned out to be all clear. They couldn't find anything, that was making his heart flutter. (no clots, no artery blockage, etc.) Dr. put him on Cartia XT ER 120mg and saw him every 2 to 3 months. Heart still was fluttering after taken the medicine prescribed.  On February 24, 2023, went out mtn. bike riding and his heart just stopped. Paramedics were able to get his heart going again, then they transported him to the hospital, where he then past away 2 days later, 02/26/2023.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was stored in the refridgerator instead of the freezer  from receipt 2/27/23
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received PCV13 on March 7, 2023.  The patient came in for catch Rotavirus on March 17, 2023.  The individual screening the record noticed the patient only had 1 dose of PCV13, and needed 2nd dose for 4 month old vaccines.  The individual, however, did not review the dates at which the vaccine 1st dose was administered.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy breast abnormal, Breast cancer, Breast conserving surgery, Invasive ductal breast carcinoma, Mammogram abnormal
Clinical narrative: Diagnosed with Invasive Ductal Breast Cancer of left breast in April 2022. It was determined that the size of the cancerous tumor indicated it had been growing for 10 months to 1 year which puts the time the cancer began right after I received the 2 Covid vaccines.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Radiotherapy, Ultrasound breast
Clinical narrative: Diagnosed with Invasive Ductal Breast Cancer of left breast in April 2022. It was determined that the size of the cancerous tumor indicated it had been growing for 10 months to 1 year which puts the time the cancer began right after I received the 2 Covid vaccines.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Shortness of breath, chest pan, stomach pains/nausea started around 1 pm with a fever of 103.. around 5 pm, only nausea and fever of 101 remained. Overnight, nausea was the main symptom and it caused my daughter to throw up around 3 am. Around 5 pm, she feels much better but still has some queasiness.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Shortness of breath, chest pan, stomach pains/nausea started around 1 pm with a fever of 103.. around 5 pm, only nausea and fever of 101 remained. Overnight, nausea was the main symptom and it caused my daughter to throw up around 3 am. Around 5 pm, she feels much better but still has some queasiness.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood test, Bronchitis, Pain, Pruritus
Clinical narrative: Hives, large, painful, itchy, temperature within hives, recurring breakouts, all over body except, hands feet, face 4 1/2 months, complete with severe asthma, then bronchitis, all together suffered 7 months, 5 Drs, 2 Hospitals
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives, large, painful, itchy, temperature within hives, recurring breakouts, all over body except, hands feet, face 4 1/2 months, complete with severe asthma, then bronchitis, all together suffered 7 months, 5 Drs, 2 Hospitals
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Chest X-ray abnormal, Death, Endotracheal intubation
Clinical narrative: 7/7/22 pt had a positive COVID test from local Primary Care; monitored and treated outpatient by PCP; 08/28 - 08/31/2022 pt admitted to alternate Medical Center for SIRS pneumonia, post sequela of COVID and hyponatremia; dc'd to home with ABX and steroids; on 9/1/22 pt brought to local Medical Center for syncope by EMS; CXR showed multifocal pneumonia; ABX; O2 supplementation; O2 needs increased requiring intubation; AKI worsened; family decided to have pt extubated and pursue comfort care; pt passed away in the hospital
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hyponatraemia, Pneumonia, SARS-CoV-2 test positive, Syncope, Systemic inflammatory response syndrome
Clinical narrative: 7/7/22 pt had a positive COVID test from local Primary Care; monitored and treated outpatient by PCP; 08/28 - 08/31/2022 pt admitted to alternate Medical Center for SIRS pneumonia, post sequela of COVID and hyponatremia; dc'd to home with ABX and steroids; on 9/1/22 pt brought to local Medical Center for syncope by EMS; CXR showed multifocal pneumonia; ABX; O2 supplementation; O2 needs increased requiring intubation; AKI worsened; family decided to have pt extubated and pursue comfort care; pt passed away in the hospital
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: felt ill after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose: 1st, Date: 28Jan2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 030L20A), administration date: 28Jan2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 2nd, Date: 25Feb2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 010A21A), administration date: 25Feb2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 3rd , Date/Time: 04Nov2021 Moderna, Anatomical site of injection: Arm , Route of Administration: Intramuscular, Batch/Lot number: 033F21A), administration date: 04Nov2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt ill after each vaccine".
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19, COVID19
Symptoms: Illness
Clinical narrative: felt ill after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose: 1st, Date: 28Jan2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 030L20A), administration date: 28Jan2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 2nd, Date: 25Feb2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 010A21A), administration date: 25Feb2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 3rd , Date/Time: 04Nov2021 Moderna, Anatomical site of injection: Arm , Route of Administration: Intramuscular, Batch/Lot number: 033F21A), administration date: 04Nov2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt ill after each vaccine".
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, SARS-CoV-2 test
Clinical narrative: felt ill after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 67 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose: 1st, Date: 28Jan2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 030L20A), administration date: 28Jan2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 2nd, Date: 25Feb2021 Moderna, Anatomical Site of Location: Arm, Route of Administration: Intramuscular, Batch/Lot number: 010A21A), administration date: 25Feb2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine"; moderna (Dose: 3rd , Date/Time: 04Nov2021 Moderna, Anatomical site of injection: Arm , Route of Administration: Intramuscular, Batch/Lot number: 033F21A), administration date: 04Nov2021, when the patient was 66-year-old, for Covid-19 Immunization, reaction(s): "felt ill after each vaccine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt ill after each vaccine".
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Drug ineffective, Interchange of vaccine products, Myalgia, Pain in extremity
Clinical narrative: got a bad reaction from Moderna; got COVID a couple of days after he received the vaccine; joint pain on his left leg; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (got a bad reaction from Moderna), COVID-19 (got COVID a couple of days after he received the vaccine) and ARTHRALGIA (joint pain on his left leg) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Type 1 diabetes mellitus (Class 1 diabetic).   On 15-Sep-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ARTHRALGIA (joint pain on his left leg). On an unknown date, the patient experienced IMMUNISATION REACTION (got a bad reaction from Moderna) and COVID-19 (got COVID a couple of days after he received the vaccine). At the time of the report, IMMUNISATION REACTION (got a bad reaction from Moderna) and COVID-19 (got COVID a couple of days after he received the vaccine) outcome was unknown and ARTHRALGIA (joint pain on his left leg) was resolving.            No concomitant medication was reported.  Patient had to take pain medications every day. He was supposed to get a surgery but had to be delayed. The surgery was steroid injections to zap pain out of left hip. In that same week, the pain went away and was because of the Pfizer vaccine. One side effect of vaccine, which happened a couple weeks ago, pain went away and decided not to have the operation.  Patient had pain started in his knee and that was during like the middle of year 2022 and then he was doing exercises for knee and leg and pain went up on left calf. Left leg was really thin because he was not using his leg. When he used his leg, he had tremendous pain in knee and calf. Then pain went on hip and he was not able to walk but would have to in little steps and kept exercising the leg. Once the effect of the Pfizer medication got to be around 5 months or so, the pain lessened so much and decided not to have the steroid injections in leg. He could walk a mile.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Follow-up received include updated reporter details, medical history, suspect and co-suspect product coding. Report type updated to spontaneous from Invalid. Event (Vaccination adverse reaction) added and I-narrative updated.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Therapeutic response unexpected
Clinical narrative: got a bad reaction from Moderna; got COVID a couple of days after he received the vaccine; joint pain on his left leg; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (got a bad reaction from Moderna), COVID-19 (got COVID a couple of days after he received the vaccine) and ARTHRALGIA (joint pain on his left leg) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Type 1 diabetes mellitus (Class 1 diabetic).   On 15-Sep-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ARTHRALGIA (joint pain on his left leg). On an unknown date, the patient experienced IMMUNISATION REACTION (got a bad reaction from Moderna) and COVID-19 (got COVID a couple of days after he received the vaccine). At the time of the report, IMMUNISATION REACTION (got a bad reaction from Moderna) and COVID-19 (got COVID a couple of days after he received the vaccine) outcome was unknown and ARTHRALGIA (joint pain on his left leg) was resolving.            No concomitant medication was reported.  Patient had to take pain medications every day. He was supposed to get a surgery but had to be delayed. The surgery was steroid injections to zap pain out of left hip. In that same week, the pain went away and was because of the Pfizer vaccine. One side effect of vaccine, which happened a couple weeks ago, pain went away and decided not to have the operation.  Patient had pain started in his knee and that was during like the middle of year 2022 and then he was doing exercises for knee and leg and pain went up on left calf. Left leg was really thin because he was not using his leg. When he used his leg, he had tremendous pain in knee and calf. Then pain went on hip and he was not able to walk but would have to in little steps and kept exercising the leg. Once the effect of the Pfizer medication got to be around 5 months or so, the pain lessened so much and decided not to have the steroid injections in leg. He could walk a mile.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Follow-up received include updated reporter details, medical history, suspect and co-suspect product coding. Report type updated to spontaneous from Invalid. Event (Vaccination adverse reaction) added and I-narrative updated.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Immunisation reaction
Clinical narrative: got a bad reaction from Moderna; got COVID a couple of days after he received the vaccine; joint pain on his left leg; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (got a bad reaction from Moderna), COVID-19 (got COVID a couple of days after he received the vaccine) and ARTHRALGIA (joint pain on his left leg) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Type 1 diabetes mellitus (Class 1 diabetic).   On 15-Sep-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ARTHRALGIA (joint pain on his left leg). On an unknown date, the patient experienced IMMUNISATION REACTION (got a bad reaction from Moderna) and COVID-19 (got COVID a couple of days after he received the vaccine). At the time of the report, IMMUNISATION REACTION (got a bad reaction from Moderna) and COVID-19 (got COVID a couple of days after he received the vaccine) outcome was unknown and ARTHRALGIA (joint pain on his left leg) was resolving.            No concomitant medication was reported.  Patient had to take pain medications every day. He was supposed to get a surgery but had to be delayed. The surgery was steroid injections to zap pain out of left hip. In that same week, the pain went away and was because of the Pfizer vaccine. One side effect of vaccine, which happened a couple weeks ago, pain went away and decided not to have the operation.  Patient had pain started in his knee and that was during like the middle of year 2022 and then he was doing exercises for knee and leg and pain went up on left calf. Left leg was really thin because he was not using his leg. When he used his leg, he had tremendous pain in knee and calf. Then pain went on hip and he was not able to walk but would have to in little steps and kept exercising the leg. Once the effect of the Pfizer medication got to be around 5 months or so, the pain lessened so much and decided not to have the steroid injections in leg. He could walk a mile.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Follow-up received include updated reporter details, medical history, suspect and co-suspect product coding. Report type updated to spontaneous from Invalid. Event (Vaccination adverse reaction) added and I-narrative updated.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she could not breathe for 2 weeks; Dose received: 3, Is bivalent: False; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "recovered", described as "she could not breathe for 2 weeks"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Dose received: 3, Is bivalent: False". The event "she could not breathe for 2 weeks" required physician office visit. Therapeutic measures were taken as a result of dyspnea.  Additional information: The event non serious and had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. This is customer who is a Nurse Practitioner at a pediatric office. When discussing COVID-19 vaccine with her she explain her terrible experience with the third dose of Pfizer's COVID-19 vaccine. She said she could not breathe for 2 weeks after her 3rd dose and the adverse event started immediately after being vaccinated. She tried different think and then received a prescription inhaler which also did not help. After the 2 weeks, she just woke up one day and the AE was gone. If COVID prior vaccination was Unknown. It was unknown if COVID tested post vaccination. Known allergies were reported as unknown. Has had 3 Pfizer Bio N Tech COVID-19 vaccines and has had COVID twice.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300114898 same patient, different dose/event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Wrong product administered
Clinical narrative: she could not breathe for 2 weeks; Dose received: 3, Is bivalent: False; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "recovered", described as "she could not breathe for 2 weeks"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Dose received: 3, Is bivalent: False". The event "she could not breathe for 2 weeks" required physician office visit. Therapeutic measures were taken as a result of dyspnea.  Additional information: The event non serious and had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. This is customer who is a Nurse Practitioner at a pediatric office. When discussing COVID-19 vaccine with her she explain her terrible experience with the third dose of Pfizer's COVID-19 vaccine. She said she could not breathe for 2 weeks after her 3rd dose and the adverse event started immediately after being vaccinated. She tried different think and then received a prescription inhaler which also did not help. After the 2 weeks, she just woke up one day and the AE was gone. If COVID prior vaccination was Unknown. It was unknown if COVID tested post vaccination. Known allergies were reported as unknown. Has had 3 Pfizer Bio N Tech COVID-19 vaccines and has had COVID twice.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300114898 same patient, different dose/event.;
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Surgery
Clinical narrative: discontinue GARDASIL-9 after receiving one dose in order for him to receive surgery.; This spontaneous report as received from a patient's mother refers to a 22 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (1 dosage form [reported as one dose], 3 dosage schedule, route, strength, batch/lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient had to discontinue hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) after receiving one dose in order for him to receive surgery (Surgery). The reporter inquired if her son would experience any adverse effects, aside from the common side effects, if he started taking hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) again.   Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued. The outcome of surgery was unknown.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and surgery was not reported.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no additional AE's were reported.; a patient was administered VARIVAX intramuscularly instead of subcutaneously.; This spontaneous report was received from a other health professional and referred to a 14-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 27-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 milliliter, lot #W018824, expiration date: 14-JUN-2024, anatomical location and strength were not provided) intramuscularly instead of subcutaneously for prophylaxis (Incorrect route of product administration). No additional adverse events (AEs) were reported (No adverse event).
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired MMR II was administered to a patient.; This spontaneous report as received from a medical assistant refers to a 53 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 27-FEB-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneous Injection (therapy type: recombinant Human albumin (rHA) (0.5 milliliter, lot # U006489, expiration date 26-FEB-2023, route was not reported) for prophylaxis (expired product administered). No additional adverse event (AE) was reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs,; expired lot of PROQUAD was administered on 3/2/2023; This spontaneous report was received from a medical assistant referring to a 5-year-old male infant. The patient's concurrent conditions, medical history, concomitant medications and drug reaction/allergies were not reported.  On 02-MAR-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/once, lot #U022722, expiration date: 16-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse events (AEs) (no AE).
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no additional adverse events; patient was intended to receive MMRII and VARIVAX, but was inadvertently administered PROQUAD and VARIVAX; inadvertently administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse and referred to a 12-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 08-MAR-2023, the patient was intended to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), but was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD), 0.5 milliliter subcutaneous injection, lot #W002784, expiration date: 24-JUL-2023; and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter subcutaneous injection, lot #W012167, expiration date: 12-APR-2024 (both administered for prophylaxis: dose 0.5 milliliter, quantity 1, route of administration was not provided) (wrong product administered, accidental overdose). No additional adverse events reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored; No additional adverse effects; This spontaneous report was received from a consumer and refers to a 2-month-old patient of unknown gender.     On an unknown date, temperature excursion and time frame were unknown. The previous temperature excursion was unknown. On an unknown date, the patient was only vaccinated with the first dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, lot #, expiration date and anatomical location were not provided) orally for prophylaxis (product storage error). No additional adverse effects were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired dose of MMR-II was administered; This spontaneous report was received from a medical assistant, referring to a patient with unknown age and gender. The patient's concomitant therapy, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 13-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) (rHA) (lot number U007685 has been verified to be a valid lot number, expiration date was reported as 09-MAR-2023, dose, route and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) information was reported (no adverse event).
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: reporting a missed dose of VARIVAX.; No additional AEs; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions were not reported. The patient did not receive varicella virus vaccine live (oka/merck) (VARIVAX) at 12 months of age. On an unknown date (at 4-year-old), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection subcutaneously for prophylaxis.  He had not received a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis as of 14-MAR-2023 (missed dose) (product dose omission issue). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Malaise, Myalgia, Pain
Clinical narrative: very painful; had both shots and a small patch each time / Suspected vaccination failure; It was a small patch each time; side effects like muscle pain; headaches; general feeling of being unwell; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice, once in 2007 and again in 2010. A small patch on my midriff in the same spot). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had the old vaccine on an unknown date between outbreaks; one needle).   In JAN-2023, the patient received the 2nd dose of Shingrix. In OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had both shots and a small patch each time / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: It was a small patch each time), pain (Verbatim: very painful), muscle pain (Verbatim: side effects like muscle pain), headache (Verbatim: headaches) and feeling unwell (Verbatim: general feeling of being unwell).  The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 1 month) and the outcome of the pain was not reported and the outcome of the muscle pain, headache and feeling unwell were recovered/resolved (duration 3 days).   It was unknown if the reporter considered the vaccination failure, shingles, pain, muscle pain, headache and feeling unwell to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain, muscle pain, headache and feeling unwell to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Recently, the patient received the first and second Shingrix shot and stated it was a small patch each time but very painful which lasted each time about a month. The patient reported that he/she was lucky that it was only a small spot each time. The second time gave him/her side effects like muscle pain, headaches and general feeling of being unwell which lasted about 3 days. The patient reported that still he/she would recommend getting the vaccine because some get a more advanced rash than others. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: very painful; had both shots and a small patch each time / Suspected vaccination failure; It was a small patch each time; side effects like muscle pain; headaches; general feeling of being unwell; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice, once in 2007 and again in 2010. A small patch on my midriff in the same spot). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had the old vaccine on an unknown date between outbreaks; one needle).   In JAN-2023, the patient received the 2nd dose of Shingrix. In OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had both shots and a small patch each time / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: It was a small patch each time), pain (Verbatim: very painful), muscle pain (Verbatim: side effects like muscle pain), headache (Verbatim: headaches) and feeling unwell (Verbatim: general feeling of being unwell).  The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 1 month) and the outcome of the pain was not reported and the outcome of the muscle pain, headache and feeling unwell were recovered/resolved (duration 3 days).   It was unknown if the reporter considered the vaccination failure, shingles, pain, muscle pain, headache and feeling unwell to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain, muscle pain, headache and feeling unwell to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Recently, the patient received the first and second Shingrix shot and stated it was a small patch each time but very painful which lasted each time about a month. The patient reported that he/she was lucky that it was only a small spot each time. The second time gave him/her side effects like muscle pain, headaches and general feeling of being unwell which lasted about 3 days. The patient reported that still he/she would recommend getting the vaccine because some get a more advanced rash than others. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Intensive care
Clinical narrative: Got my shot and ended up in ICU (intensive care unit) for a week; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hospitalization (Verbatim: Got my shot and ended up in ICU (intensive care unit) for a week) (serious criteria hospitalization).  The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunosuppression, Neoplasm malignant, Vaccination failure
Clinical narrative: I had vaccine and still got it / Suspected vaccination failure; cancer; immunosuppressed; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had vaccine and still got it / Suspected vaccination failure) (serious criteria GSK medically significant), cancer (Verbatim: cancer) (serious criteria GSK medically significant), immunosuppression (Verbatim: immunosuppressed) (serious criteria GSK medically significant) and shingles (Verbatim: still got it).The outcome of the vaccination failure was unknown and the outcome of the cancer, immunosuppression and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, cancer, immunosuppression and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, cancer, immunosuppression and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had Shingles vaccine and still got shingles but he/she was immunosuppressed and also got cancer when he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: did get shingles after those shots/ Suspected Vaccination Failure; get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did get shingles after those shots/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: get shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that, one can still get shingles with the vaccine, but it is usually a very milder case. The reporter had three friends who did get shingles after those shots. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting This case had been linked with US2023AMR038930, US2023AMR038934 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038930:Same reporter