chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Contrast echocardiogram, Diplopia, Echocardiogram
Clinical narrative: Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Eye movement disorder, Lacrimation increased, Magnetic resonance imaging, Scan with contrast
Clinical narrative: Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Apraxia, Computerised tomogram, Contrast echocardiogram, Diplopia, Electrocardiogram
Clinical narrative: Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid function disorder, IIIrd nerve paralysis, Impaired driving ability, Laboratory test, Lacrimation increased
Clinical narrative: Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Vision blurred
Clinical narrative: Patient came in 10/27/2023 in the morning to report the side effects. She said she went to the hospital down the street on Saturday 10/21/23 and got admitted and didn't leave until yesterday 10/26/23. According to patient after many tests they came in conclusion that she had 3rd cranial nerve palsy due to the covid vaccine she got 10/20/23. Patient showed her left eye lid was not able to open at all. She used her fingers to lift her eyelid she said she can see a blurry vision of two people in front of her.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Injection site urticaria
Clinical narrative: Hives at injection site
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: This incident happened today sometime after 4pm. Patients mother is MD I work with and I noticed them in the waiting room. Nurse clinic has been very busy with patients flow for past few weeks with COVID RSV AND FLU vaccines. We are administering vaccines most of the day in NC. ( back story I worked COVID clinic and I have administered to children before so this didnt feel like something I shouln't be doing) I drew up COVID vaccine for patient, sibling, and father when seeing all of them on schedule. I was in auto pilot from the busy afternoon. I called back all 3 together. Patient was crying and screaming because he did not want to get vaccine. Normally when this is the case  vaccine is administered as quickly as possible to avoid patient to get sticked with needle twice, waste a dose, or even get your self injured from patient kicking or stick self with needle. Once Dr and another nurse helped stabilize arm from squirming  for injection I administered.  Once given to all 3 patient sibling and father they left. Once I started to document I realized I made a huge mistake. COVID vaccine administered  should have never been given to patient.  I immeadiatley called patients mother DO to inform her of the mistake that was made myself because I believed she should hear it from me and as soon as possible so she can look for any adverse reaction to wrong vaccine administered. As soon as I was off the phone with Dr I immeadiatley reached out to CS via message. After I didnt get a response within a minute or two I walked myself to admin to report my mistake to MOA. I explained to MOA everything that happened and she let me know next steps to take with report. I am truly very very sorry. I was working fast, its been a long week we are all so short staffed and I honestly was trying to make the visit as convienent as possible for Dr. whom I really enjoy working with. But today I learned convienence is not always safe for my patients.  I take full accountibility  for what happened today.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: I administered the Pfizer 3-4 (Covid) 23-24 Toddler dose without diluting the vaccine first on Sunday 10/22/23 around 10:30am to a 4 year old.  I contacted the patient's father later that afternoon around 4:30pm when I realized what happened.  The father stated that the patient did not have any adverse reactions.  I explained that I would follow up with the manufacturer and primary doctor on Monday morning when they opened and to monitor the child for any signs of reactions.  I spoke with a Pfizer rep on Monday, 10/23/23 and was told that if the child had no local or systemic reactions that they should still receive their final 3rd dose 8 weeks later but if they had any reactions to discuss with their primary doctor and make a decision if to give the final dose.  I spoke with the doctor's office and they said to have the patient follow the directions from Pfizer.  I then called the patient's father and explained what Pfizer and the doctor's office stated.  He said the child was fine and still not showing any signs of adverse reactions.
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: This incident happened today sometime after 4pm. Patients mother is MD I work with and I noticed them in the waiting room. Nurse clinic has been very busy with patients flow for past few weeks with COVID RSV AND FLU vaccines. We are administering vaccines most of the day in clinic. ( back story I worked COVID clinic and I have administered to children before so this didnt feel like something I shouln't be doing) I drew up COVID vaccine for patient, sibling, and father when seeing all of them on schedule. I was in auto pilot from the busy afternoon. I called back all 3 together. Patient  sibling was crying and screaming because he did not want to get vaccine. Normally when this is the case  vaccine is administered as quickly as possible to avoid patient to get sticked with needle twice, waste a dose, or even get your self injured from patient kicking or stick self with needle.  Once given to all 3 patient sibling and father they left. Once I started to document I realized I made a huge mistake. COVID vaccine administered  should have never been given to patient.  I immediately called patients mother DO to inform her of the mistake that was made myself because I believed she should hear it from me and as soon as possible so she can look for any adverse reaction to wrong vaccine administered. As soon as I was off the phone with Dr I immediately reached out to CS via teams. After I didn't get a response within a minute or two I walked myself to admin to report my mistake to MOA. I explained to MOA everything that happened and she let me know next steps to take with report. I am truly very very sorry. I was working fast, its been a long week we are all so short staffed and I honestly was trying to make the visit as convenient as possible for Dr. whom I really enjoy working with. But today I learned convenience is not always safe for my patients.  I take full accountability  for what happened today.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Dermatographia/hives. Happened two weeks after 2021 Moderna booster as well. Now realize this is what it is. Started 12 days after, itching and raised welts with pressure.
Age: 40.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: PINK, WARM RAISED AREA WITH IRREGULAR BORDER. WARM TO TOUCH. PT DENIES ITCHING OR PAIN.  TX: ICED AND TAKING IBUPROFEN OUTCOME: RECOMMENDED TO GO TO URGENT CARE/ER TO RULE OUT ANAPHYLAXIS
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Feeling abnormal, Pharyngeal swelling
Clinical narrative: Patient stated that she began "feeling funny" about 5 minutes after I administered the Shingrix vaccination.She said she had a similar feeling when in the hospital and having a reaction to a medication. She stated that she felt like it was "hard to swallow." At that point I requested EMS be contacted and the patient agreed. Blood pressure was checked and it was 152/39. Pulse 126. I asked if she felt like her throat might be swelling and she said yes. An epipen was brought to me which I quickly inspected to verify the dose. A single dose of epinephrine 0.3 mg was administered into the right vastus lateralis at 3:40 pm. Blood pressue was checked again a few minutes later. This time the reading was 121/89, pulse 118. Patient said she felt a little better. Patient remained conscious the entire time and could talk to us. No swelling of face observed. No skin reactions observed. EMS arrived and took over. Patient was treated and released this evening from a local hospital.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malignant melanoma, Pruritus, Skin lesion
Clinical narrative: Started having new lesion on back with itching. Started changing in spring '23 dx with melanoma
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Rash 4 -5 days after RSV vaccine. Itchy, red, urticarial-appearing. Improved in past couple of days, not as itchy or red, with cortisone. No face/neck lesions, facial/lip swelling, or respiratory issues.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has localized redness and swelling at site of injection approximately 6x6cm area near deltoid
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Electrocardiogram, Fatigue, Malaise
Clinical narrative: The day after the vaccine I developed atrial fibrillation.  Per doctor today, October 27, 2023: The patient has not been feeling well for the past 9 days and has had palpitations, fatigue and more shortness of breath.  Interrogation of his ICD shows that he has been in atrial fibrillation for the past 9 days which likely explains his symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: The day after the vaccine I developed atrial fibrillation.  Per doctor today, October 27, 2023: The patient has not been feeling well for the past 9 days and has had palpitations, fatigue and more shortness of breath.  Interrogation of his ICD shows that he has been in atrial fibrillation for the past 9 days which likely explains his symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: The day after the vaccine I developed atrial fibrillation.  Per doctor today, October 27, 2023: The patient has not been feeling well for the past 9 days and has had palpitations, fatigue and more shortness of breath.  Interrogation of his ICD shows that he has been in atrial fibrillation for the past 9 days which likely explains his symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Heart rate increased
Clinical narrative: The day after the vaccine I developed atrial fibrillation.  Per doctor today, October 27, 2023: The patient has not been feeling well for the past 9 days and has had palpitations, fatigue and more shortness of breath.  Interrogation of his ICD shows that he has been in atrial fibrillation for the past 9 days which likely explains his symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The health care provider mistakenly gave undiluted COVID-19 vaccine to the patient, administering 0.3ml of undiluted solution. The patient had no apparent adverse effect. No redness or swelling occurred at the injection site, nor any systemic side effects.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Injection site bruising, Wrong product administered
Clinical narrative: Patient requested for second dose of Hepatitis-B vaccine but instead she got another dose of RSV vaccine (Arexvy) by mistake. When she complained of bruising in the injection site she found out from the pharmacy that she got RSV vaccine 2 months after getting the first dose of RSV vaccine instead of second dose of Hepatitis-B vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Contusion
Clinical narrative: 10/16/23 patient received covid Moderna brand spikevax vaccine in the left arm and prevnar20 in the right arm. No adverse reaction detected then. About one or two days after the vaccine patient began to notice dark discoloration in his left arm that was spreading. He brought it up to his health care team when he was going under a procedure but they said it was just a bruise. By the time he visited pharmacy again on 10/26/23, it had spread all the way down to his hand, starting to discolor his fingers. Patient reported no pain in arm, no fever, no notable difference in mental state, no increased bruising elsewhere, no shortness of breath, no loss of sensation in arm. The only symptom he reported was the spreading intense discoloration itself. Advised patient to go see a doctor, uncertain if he did so.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: The health care provider mistakenly gave undiluted COVID-19 vaccine to the patient, administering 0.3ml of undiluted solution. The patient had no apparent adverse effect. No redness or swelling occurred at the injection site, nor any systemic side effects.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: The health care provider mistakenly gave undiluted COVID-19 vaccine to the patient, administering 0.3ml of undiluted solution. The patient had no apparent adverse effect. No redness or swelling occurred at the injection site, nor any systemic side effects.
Age: 38.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Anaphylactic reaction, Asthenia, Blood test, Chest X-ray, Dizziness
Clinical narrative: Dizziness, weakness, slurred speech, anaphylaxis
Age: 38.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dysarthria, Electrocardiogram, Urine analysis
Clinical narrative: Dizziness, weakness, slurred speech, anaphylaxis
Age: 19.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: Inadvertently injected flu vaccine when patient already received flu vaccine for this year.
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: The health care provider mistakenly gave undiluted COVID-19 vaccine to the patient, administering 0.3ml of undiluted solution. The patient had no apparent adverse effect. No redness or swelling occurred at the injection site, nor any systemic side effects.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: The health care provider mistakenly gave undiluted COVID-19 vaccine to the patient, administering 0.3ml of undiluted solution. The patient had no apparent adverse effect. No redness or swelling occurred at the injection site, nor any systemic side effects.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Tremor
Clinical narrative: SHAKING, AS IF COLD. STARTED ON 10/27/2023. PATIENT WAS ASSESSED FOR CELLULITIS/INFECTION BUT DID NOT PRESENT WITH ANYTHING EXCEPT CHILLS/SHAKING. RECOMMENDED PATIENT BE SEEN BY PRIMARY CARE UNLESS CONDITION WORSENS AT WHICH POINT THE PATIENT SHOULD SEEK MORE URGENT CARE.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Arthralgia, Dizziness, Electrocardiogram normal, Flank pain
Clinical narrative: Immediate nerve and joint pain that has lasted over 9 days, headache, nausea, dizziness, numb tongue on right side, pain on right side of body, misused words when talking, heart palpitations
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia oral, Immediate post-injection reaction, Nausea, Neuralgia
Clinical narrative: Immediate nerve and joint pain that has lasted over 9 days, headache, nausea, dizziness, numb tongue on right side, pain on right side of body, misused words when talking, heart palpitations
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological examination normal, Palpitations
Clinical narrative: Immediate nerve and joint pain that has lasted over 9 days, headache, nausea, dizziness, numb tongue on right side, pain on right side of body, misused words when talking, heart palpitations
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Large family came in for PFizer vaccination, requiring all 3 dosages of the Pfizer.  RN gave 3 year old the 5 year old dose.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site mass, Injection site pain
Clinical narrative: At time of injection I felt severe pain as if something was tearing inside at the injection site.  The site was very painful and turned red, hot, and swollen on the first day.  The redness progressed daily and it felt like I had lumps spreading out that were painful.  This continued and I went to see the doctor after 2 weeks as it was not getting better.  She examined and felt a hematoma.  It was painful and she was worried about streaks and put me on Clindamycin HCL 300 MG capsule by mouth 4 times a day for 10 days.  She drew with a marker around the area that was red, bruised, and swollen and told me to call her right away if it continued to spread beyond the area where she drew. She also told me to put some warm compresses on to help dissolve the hematoma that had formed.  It has only been two days since I saw her and started taking the antibiotics.  The arm is still  painful and the lump is still there.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: At time of injection I felt severe pain as if something was tearing inside at the injection site.  The site was very painful and turned red, hot, and swollen on the first day.  The redness progressed daily and it felt like I had lumps spreading out that were painful.  This continued and I went to see the doctor after 2 weeks as it was not getting better.  She examined and felt a hematoma.  It was painful and she was worried about streaks and put me on Clindamycin HCL 300 MG capsule by mouth 4 times a day for 10 days.  She drew with a marker around the area that was red, bruised, and swollen and told me to call her right away if it continued to spread beyond the area where she drew. She also told me to put some warm compresses on to help dissolve the hematoma that had formed.  It has only been two days since I saw her and started taking the antibiotics.  The arm is still  painful and the lump is still there.
Age: 74.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Amnesia, Chest X-ray normal, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Complete loss of memory for approximately 6 hours.  Performed several tasks during the period according to spouse, but I kept asking the same questions over and over.  Taken to local ER where MRI, CT and x-ray imaging were performed along with blood tests.  I have absolutely no recollection of these events.  Eventually, I recognized that I was in the ER.  Subsequently, I was transported to main hospital where additional examinations were performed.  Ultimately diagnosed with Transient Global Amnesia (TGA).  Initial treatment consisted of Plavix and Lipitor because potential causes could have included stroke or heart-related issues.  Imaging did not find any evidence of either potential cause.  Follow-up with primary care physician resulted in revision of treatment to include only Lipitor because HDL cholesterol level was low (37mg/dL) and LDL cholesterol was 110mg/DL.  Previous levels were 47 and 100 respectively.  Continued follow-up will include routine monitoring of blood lipids.
Age: 74.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: High density lipoprotein decreased, Low density lipoprotein decreased, Magnetic resonance imaging normal, Transient global amnesia
Clinical narrative: Complete loss of memory for approximately 6 hours.  Performed several tasks during the period according to spouse, but I kept asking the same questions over and over.  Taken to local ER where MRI, CT and x-ray imaging were performed along with blood tests.  I have absolutely no recollection of these events.  Eventually, I recognized that I was in the ER.  Subsequently, I was transported to main hospital where additional examinations were performed.  Ultimately diagnosed with Transient Global Amnesia (TGA).  Initial treatment consisted of Plavix and Lipitor because potential causes could have included stroke or heart-related issues.  Imaging did not find any evidence of either potential cause.  Follow-up with primary care physician resulted in revision of treatment to include only Lipitor because HDL cholesterol level was low (37mg/dL) and LDL cholesterol was 110mg/DL.  Previous levels were 47 and 100 respectively.  Continued follow-up will include routine monitoring of blood lipids.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 10.21.23 Developed red 2 inch x 2 inch raised area where vaccine was given-warm, slightly itchy lasted ~3 days. Wed. 10/23 red small raised areas notice on right thigh and glutes, spread to left thigh and glutes by next morning. Currently spreading up trunk, down bilateral UEs.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Pfizer comirnaty 12yrs and old. Patient is 7yrs old at time of vaccination
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle fatigue, Pain
Clinical narrative: aches, and pains; muscle fatigue; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches, and pains), MUSCLE FATIGUE (muscle fatigue) and FATIGUE (Tiredness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A, 046B21A and 065F22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy, Allergy, Allergy to lanolin, Allergy and Autoimmune thyroid disorder.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches, and pains), MUSCLE FATIGUE (muscle fatigue) and FATIGUE (Tiredness). At the time of the report, PAIN (aches, and pains), MUSCLE FATIGUE (muscle fatigue) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.   This case was linked to MOD-2023-746812 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Renal atrophy, Renal failure, Ultrasound scan
Clinical narrative: COVID-19 testing: detected (standard range: not detected); COVID-19 testing: detected (standard range: not detected); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757) at the age of 35 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "typhoid infection", start date: 2010 (unspecified if ongoing); "Pregnancy", start date: 2011, stop date: 2012; "Pregnancy", start date: 2015, stop date: 2016. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Feb2022, outcome "unknown" and all described as "COVID-19 testing: detected (standard range: not detected)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2022) Detected.; 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 event Vaccination Failure and COVID 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 testing: detected (standard range: not detected); COVID-19 testing: detected (standard range: not detected); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757) at the age of 35 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "typhoid infection", start date: 2010 (unspecified if ongoing); "Pregnancy", start date: 2011, stop date: 2012; "Pregnancy", start date: 2015, stop date: 2016. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Feb2022, outcome "unknown" and all described as "COVID-19 testing: detected (standard range: not detected)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2022) Detected.; 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 event Vaccination Failure and COVID 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Angiocardiogram, Arrhythmia, Cardiac stress test, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Irregular heartbeat
Age: 74.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Heart rate irregular
Clinical narrative: Irregular heartbeat
Age: 26.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo; Inappropriate age at vaccine administration; 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy (left arm). On 18-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and wrong vaccine administered (Verbatim: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 18-Oct-2023 26 year old female who was 36 week pregnant (4th pregnancy) received Arexvy instead of Abrysvo on the day of reporting about 8:30 am.  Patient identified the error when given the VIS form.   Patient was not upset with them and was willing to do whatever was best for her baby. The reporter did not consent to follow-up. A pregnant patient received a dose of Arexvy instead of Abrysvo at an inappropriate age, which led to vaccine exposure during pregnancy,  inappropriate age at vaccine administration and wrong vaccine administered.
Age: 26.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo; Inappropriate age at vaccine administration; 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy (left arm). On 18-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and wrong vaccine administered (Verbatim: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 week pregnant  patient Staff administered Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 18-Oct-2023 26 year old female who was 36 week pregnant (4th pregnancy) received Arexvy instead of Abrysvo on the day of reporting about 8:30 am.  Patient identified the error when given the VIS form.   Patient was not upset with them and was willing to do whatever was best for her baby. The reporter did not consent to follow-up. A pregnant patient received a dose of Arexvy instead of Abrysvo at an inappropriate age, which led to vaccine exposure during pregnancy,  inappropriate age at vaccine administration and wrong vaccine administered.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Arthralgia, Erythema, Injected limb mobility decreased, Injection site pain, Mass
Clinical narrative: vaccination was very painful upon administration; cannot lift arm over head without immense pain; lump; red spot; cannot lift arm over head without immense pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: vaccination was very painful upon administration), pain in arm (Verbatim: cannot lift arm over head without immense pain), mass (Verbatim: lump), localized erythema (Verbatim: red spot) and mobility decreased (Verbatim: cannot lift arm over head without immense pain). The outcome of the injection site pain, pain in arm, mass, localized erythema and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   It was unknown if the company considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she had an Arexvy vaccination administered. The reporter stated that she could lift her arm over her head without immense pain.  The reporter stated that within the last few days a red spot with a lump has appeared about 2 inches away from the injection site.  The reporter also reported that the vaccination was very painful upon administration. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: vaccination was very painful upon administration; cannot lift arm over head without immense pain; lump; red spot; cannot lift arm over head without immense pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: vaccination was very painful upon administration), pain in arm (Verbatim: cannot lift arm over head without immense pain), mass (Verbatim: lump), localized erythema (Verbatim: red spot) and mobility decreased (Verbatim: cannot lift arm over head without immense pain). The outcome of the injection site pain, pain in arm, mass, localized erythema and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   It was unknown if the company considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she had an Arexvy vaccination administered. The reporter stated that she could lift her arm over her head without immense pain.  The reporter stated that within the last few days a red spot with a lump has appeared about 2 inches away from the injection site.  The reporter also reported that the vaccination was very painful upon administration. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Erythema, Injection site pain, Mass, Mobility decreased, Pain
Clinical narrative: vaccination was very painful upon administration; cannot lift arm over head without immense pain; lump; red spot; cannot lift arm over head without immense pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: vaccination was very painful upon administration), pain in arm (Verbatim: cannot lift arm over head without immense pain), mass (Verbatim: lump), localized erythema (Verbatim: red spot) and mobility decreased (Verbatim: cannot lift arm over head without immense pain). The outcome of the injection site pain, pain in arm, mass, localized erythema and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   It was unknown if the company considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she had an Arexvy vaccination administered. The reporter stated that she could lift her arm over her head without immense pain.  The reporter stated that within the last few days a red spot with a lump has appeared about 2 inches away from the injection site.  The reporter also reported that the vaccination was very painful upon administration. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Pain in extremity
Clinical narrative: vaccination was very painful upon administration; cannot lift arm over head without immense pain; lump; red spot; cannot lift arm over head without immense pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received the 1st dose of Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: vaccination was very painful upon administration), pain in arm (Verbatim: cannot lift arm over head without immense pain), mass (Verbatim: lump), localized erythema (Verbatim: red spot) and mobility decreased (Verbatim: cannot lift arm over head without immense pain). The outcome of the injection site pain, pain in arm, mass, localized erythema and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   It was unknown if the company considered the injection site pain, pain in arm, mass, localized erythema and mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she had an Arexvy vaccination administered. The reporter stated that she could lift her arm over her head without immense pain.  The reporter stated that within the last few days a red spot with a lump has appeared about 2 inches away from the injection site.  The reporter also reported that the vaccination was very painful upon administration. The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reported 4-month-old twins received first dose of ROTATEQ on 10/05/2023.; This spontaneous report was received from an Other Health Professional and referred to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 05-OCT-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, expiration date: 01-NOV-2024, administered orally for prophylaxis (lot# X001085 was an invalid lot# for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) rotavirus vaccine, live, oral, pentavalent (ROTATEQ), strength was not provided) (Product administered to patient of inappropriate age).  This is one of the 2 reports reported by same reporter (referred to twins).
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; PROQUAD that was stored improperly and experienced a temperature excursion; This spontaneous report has been received from a nurse referring to a 3-year-old patient of unknown gender. The patient's medical history, concurrent condition, and concomitant therapies were not reported.  On 16-OCT-2023, an improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis, (strength, dose, anatomical location, and route of administration were not provided; lot number X018571 was a valid number with an expiration date on 05-JAN-2025) was administered after temperature excursion to a patient (improper storage of product in use).  The excursion occurred with a temperature of 3.9 Degree Celsius (C) for 70 hours and 0 minutes and 0 seconds. There was no previous temperature excursion reported and the event was not called because of the data logger. No additional adverse event provided (No adverse event).
Age: 0.42
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HCP called regarding GARDASIL 9. Caller stated vaccine had been administered to a 5-month-old. Caller was not able/willing to provide patient demographics. No reports of adverse effects from administration. Permission to contact HCP was given. No add; This spontaneous report was received from a nurse and refers to a 5-month-old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 18-OCT-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). No additional AE/no PQC (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product use issue
Clinical narrative: HBP reported a 2-month-old patient received VARIVAX. No additional AE/no PQC.; HBP reported a 2-month-old patient received VARIVAX. No additional AE/no PQC.; This spontaneous report was received from an office manager concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JUN-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W017551, expiration date: 01-JUN-2024, administered as prophylaxis (Drug use in unapproved age group) (strength, and route of administration were not provided). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired PNEUMOVAX 23 to a patient; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 24-OCT-2023, the patient was administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported), lot# W007035 has been verified to be valid, expiration date reported and established as 20-OCT-2023 (expired product administered). No additional adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Consumer stated she only received one dose because her physician told her she only needed one dose; Consumer stated she already asked her physician, and he did not know and suggested she restart the series if she would like two doses.; No additional AE reported.; This spontaneous report was received from a consumer, referring to herself, an adult female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis. Consumer stated she only received one dose because her physician told her she only needed one dose but she read the varicella virus vaccine live (oka/merck) (VARIVAX) patient information (PI) that stated adults need two doses. Varicella virus vaccine live (oka/merck) (VARIVAX) PI section reviewed with consumer. Consumer referred to reach out to her physician and that her physician could provide further guidance. Consumer stated she already asked her physician, and he did not know and suggested she restarted the series if she would like two doses (product prescribing issue and inappropriate schedule of product administration). No additional AE reported.
Age: 0.5
Sex: M
Vaccine: FLU3, PNC15, RV5, UNK
Symptoms: Infant irritability, Infantile diarrhoea, Pyrexia, Sleep disorder
Clinical narrative: patient had a high fever; Trouble sleeping; patient was fussy; patient had diarrhea; This spontaneous report was received from a nurse and refers to a 6-month-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On 19-SEP-2023 at around 11:30 a.m., the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # X008011, expiration date: 25-SEP-2024; pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot #X019110, expiration date: 30-AUG-2025; diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) lot # U7446AA, expiration date: 25-JUN-2025; and with influenza vaccine (FLUZONE), lot #UT8040LA, expiration date: 30-JUN-2024, (strength, route of administration, anatomical location not provided for any vaccine) all as prophylaxis.    On the same date, the patient experienced high fever, trouble sleeping (poor quality sleep), being fussy (irritability) and had diarrhea. I was reported that within the 6 hours of receiving vaccination, his body temperature was 102.6 Fahrenheit (F). On 20-SEP-2023, Body temperature was 102.9 F, and on 21-SEP-2023, body temperature was 99 F. All these temperatures were taken by the patient's mother. On 22-SEP-2023, he was seen in the office, and he had still fever with a temperature not over 100.4 F. At the reporting time, the outcome of all the events was unknown, but the patient was fine.   Causality assessment between fever, trouble sleeping, fussy, diarrhea and all the suspected vaccines was not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension
Clinical narrative: High Blood Pressure; This serious case was reported by a consumer and described the occurrence of blood pressure high in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number RS3A9, expiry date 08-OCT-2024) for prophylaxis.   On 22-SEP-2023, the patient received Shingrix 50 mg. On 23-SEP-2023, 1 days after receiving Shingrix, the patient experienced blood pressure high (Verbatim: High Blood Pressure) (serious criteria clinically significant/intervention required). The outcome of the blood pressure high was not resolved.   It was unknown if the reporter considered the blood pressure high to be related to Shingrix.     It was unknown if the company considered the blood pressure high to be related to Shingrix.   Additional Information: GSK receipt date: 20-OCT-2023 This report was submitted via the online direct entry reporting system.  The reporter gave permission to contact them..