chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: a severe case of pneumonia; a severe case of pneumonia; This is a spontaneous report received from an Other HCP from a sales representative.  A 67-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Feb2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant) all with onset Feb2025, outcome "unknown" and all described as "a severe case of pneumonia". The patient was hospitalized for pneumonia, drug ineffective (start date: Feb2025).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (pneumonia) with the suspect product PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; it didn't work, it didn't protect at all; got Covid; it didn't work, it didn't protect at all; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization, reaction(s): "it didn't work, it didn't protect at all"; Bnt162b2 (dose 2), for COVID-19 immunization, reaction(s): "it didn't work, it didn't protect at all"; Bnt162b2 (dose 3, formulation NOS), for COVID-19 immunization, reaction(s): "it didn't work, it didn't protect at all". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 6 months after the suspect product(s) administration, outcome "unknown" and all described as "got Covid; it didn't work, it didn't protect at all". Clinical course: The reporter was calling for husband and yesterday (unspecified) he got Covid and the doctor prescribed the medication. The patient took the four times vaccines, in six months and he still got it. The reporter informed that they didn't get sick very often. The reporter informed that every time they took all the vaccine, seemed it didn't work, it didn't protect them at all. The last ones they did last Nov (unspecified). The reporter stated "You can tell your company our concerns."
Vaccine: COVID19
Symptoms: Blood test, Ocular myasthenia
Clinical narrative: right eye closed shut / Ocular Myasthenia Gravis; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 18Dec2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On 22Dec2024, patient's right eye closed shut and a blood test showed that patient had developed Ocular Myasthenia Gravis. Outcome of the event was unknown.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID". During an inbound call for financial assistance, a 75-year-old retired caller mentioned they had just been diagnosed with COVID-19. When asked about adding an email address to their account, the caller explained they did not have an email and struggled with accessing messages. After listening to the consents, the caller apologized, stating they had just come from the doctor's office. The caller inquired whether one could recover from COVID-19 without medication and expressed hope that prayer might help. They also voiced frustration that despite choosing Pfizer inoculations, they still contracted the virus. Toward the end of the call, the caller complimented the representative for speaking clearly, which was appreciated by someone with "old ears." . The patient indicated that they were referring to Pfizer inoculations. The patient did not clarify what the inoculations were for only that they still got COVID after getting them.
Sex: M
Vaccine: HPV9
Symptoms: Anogenital dysplasia, Colonoscopy abnormal
Clinical narrative: Consumer was diagnosed in February with "anal Intraepithelial neoplasia (ain iii)" after having colonoscopy in November 2024. Consumer said he has had vaccines from Merck before, but did not remember which types or when.; This spontaneous report has been received from a consumer and refers to himself, a 68-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with an unspecified vaccine (indication, expiration date, lot #, strength, dose number, route and anatomical site of administration were not reported). The patient did not remember which types of vaccines received or when.  On an unknown date on February 2025, the patient experienced anal Intraepithelial neoplasia (ain iii) after having colonoscopy in November 2024. At the reporting time, the outcome of the event was unknown.   The causal relationship between the event and an unspecified vaccine was not provided.   Upon internal review, the event of anal Intraepithelial neoplasia was determined to be medically significant.   Follow up information has been received on 19-MAR-2025 from a registered nurse (RN) from the physician's office. The RN shared the only information concerning vaccines was  Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) listed in patient chart (date of administration, dose, route, lot# and expiration date were not provided) for prophylaxis. I was the patient's primary physician who ordered the vaccination. This office has no information concerning it completion. Also, the patient was not taken any company oncology medications. Additional information is not expected.  The causality assessment between the event and  Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) was not reported.  This was a previous Invalid report due to lack of therapy identification, however, upon follow up it was confirmed that the patient received Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9).
Age: 11.0
Sex: M
Vaccine: UNK, UNK, FLUX, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of oroduct in use; This spontaneous report was received from a consumer referring to a 12-year-old male patient.   Information regarding the patient's pertinent medical history, drug allergies, reactions, or concomitant medications was not provided. Concurrent conditions included autism (Autism spectrum disorder) and attention deficit and hyperactivity disorder.  On 23-OCT-2024, the patient was vaccinated with an improperly stored dose of  human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL9), administered intramuscularly for prophylaxis (dose, vaccination scheme frequency, anatomical location were not reported, lot number X025115 with an expiration date not provided but upon internal validations established as 19-MAY-2026) and with a dose of quadrivalent influenza vaccine (INFLUENZA VACCINE INACT SPLIT 4V) administered intramuscularly for an unknown indication dose, vaccination scheme frequency, anatomical location were not reported, lot number V18415MA, expiration date not provided). The administered dose of the vaccine experienced a temperature excursion 6 degrees Fahrenheit up to 14 degrees Fahrenheit for 30 minutes, as recorded by a data logger. There was no adverse effect reported.; Sender's Comments: Priority: 4 , Is case serious: No , Index user:  Index date: 2025-03-13 , MNSC number: , CLIC number: , ESTAR number: , IRMS number:  Central date: 2025-03-13 , Classification: DMC, Attachment description: Post Marketing Basic , Safety case number:
Age: 60.0
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I got shingles anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles anyway). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient said he/she dreaded them, so when patient turned 60 got the two step Shingles shot and four months later, the patient got shingles anyway.  The patient said believe them when they said it hurted This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles which affected her eyes; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: still got shingles which affected her eyes) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and still got shingles which affected her eyes. 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 for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got both and my shingles reactivated; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both and my shingles reactivated). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got both (shingles vaccine) and shingles reactivated. 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 for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose)and Shingles vaccine (2nd dose) .
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; still got shingles /extremely painful; 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: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles /extremely painful). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 The patient reported he/she got the vaccines and still got shingles an extremely painful condition that nobody wanted. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a tdap vaccine on 01/25/2025 and received a second dose on 03/20/2025. I called the patient today and she said she is feeling fine. No side effects to report at the moment.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Cranial nerve paralysis, Vision blurred
Clinical narrative: PT PRESENTED WITH BLURRED VISION TO ER AND WAS DIAGNOSED WITH 6 CRANIAL NERVE PALSY
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: itching and rash on arm
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pruritus, Injection site swelling, Nodule, Ultrasound scan abnormal
Clinical narrative: Bump at location of injection site still present and itchy 8 months later . Still trying to find diagnosis
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Injection site pain, Tinnitus
Clinical narrative: Pain at site, fatigue, ringing in both ears
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Severe shoulder pain, get worse when I use the shoulder, hard to get dressed or reach for items in the cabinet. Pain also showed up in the thumb joint and into the palm area. Pain is intermittent and is round 5 when sitting. When I use the shoulder pain can go to 8 or 9 and can cause me to drop things I am carrying.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Blood gases abnormal, Dyspnoea, Feeding disorder, Fibrin D dimer increased
Clinical narrative: Two days after receiving the vaccine, I woke up gasping and short of breath. I have been short of breath ever since. Unable to sleep or eat most days because lying in certain positions makes it impossible to breathe. My oxygen has dropped as low as 75% and I have been to the ER 3 times since November. I have seen a cardiologist, a neurologist, a rheumatologist, and a pulmonologist - none of them can pinpoint what is wrong. When I am sick, the shortness of breathe worsens dramatically.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Two days after receiving the vaccine, I woke up gasping and short of breath. I have been short of breath ever since. Unable to sleep or eat most days because lying in certain positions makes it impossible to breathe. My oxygen has dropped as low as 75% and I have been to the ER 3 times since November. I have seen a cardiologist, a neurologist, a rheumatologist, and a pulmonologist - none of them can pinpoint what is wrong. When I am sick, the shortness of breathe worsens dramatically.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt age 4m17d and was give vaccine recommended for age 4-6 yrs.
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus
Clinical narrative: Pt came into pharmacy on friday 3/21/25 after getting shot on 3/18 (tuesday) saying her arm was red and itchy the day after. Arm was still red in bicep area but patient stated itchy feeling went away
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Erythema; Peripheral swelling; Information has been received from Food and Drug Administration (FDA) (VAERS ID: 2802669)  This spontaneous report has been received from the regulatory authority, concerning to a 66-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2024, the patient was vaccinated with the first dose of pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, administered intramuscularly for prophylaxis at the pharmacy (strength was not provided; lot #Y011819 was verified to be valid for this vaccine, expiration date not reported but confirmed as 01-OCT-2025).  On 25-OCT-2024, the patient experienced erythema and peripheral swelling; the arm was very red and swollen, the redness got bigger across the entire arm. At the time of reporting, the patient had not recovered from the events.   The causal relationships between the events and the suspect therapy were not reported.  This is one of several reports received from the same reporter.  Investigation Summary for pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE), Batch/Lot#: Y011819  Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of Capvaxive Batch number 0001774623 material number 2017970 at MSD which could have impacted on product quality.  No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch.  Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product.  There have been no additional requests for information or additional testing relating to this Adverse Event.
Vaccine: RVX
Symptoms: Dehydration, Rotavirus infection
Clinical narrative: patient developed rotavirus, became dehydrated and required hospitalization.; This spontaneous report was received from a Physician via company representative and refers to a child patient of unknown gender and age.    The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent, (lot # and expiration date were not reported), for prophylaxis.   On an unknown date, the patient developed rotavirus, became dehydrated and required hospitalization.  At the reporting time, the outcome of the event was unknown.    The causal relationship between the event and Rotavirus Vaccine, Live, Oral, Pentavalent was not provided.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported; Customer called to report that 2 years ago a female patient in her 20s received her 2nd and 3rd dose of GARDASIL 9 within 10 weeks of each other.  No symptoms reported.  See related request case 02772685.   Patient's first dose received on 20DEC2022; Information has been received from Business Partner/CRO on 18-Mar-2025.  This spontaneous report was received from a/an Pharmacist and refers to a(n) Adult female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 30-Jun-2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W026150, expiration date: 20-Oct-2024), dose number 3, 0.5 mL.  On 20-Dec-2022, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W011264, expiration date: 05-Sep-2024), dose number 1, 0.5 mL.  On 13-Apr-2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (lot #W011264, expiration date: 05-Sep-2024), dose number 2, 0.5 mL. On an unknown date, the patient started therapy with  unknown dosage.  On an unknown date, the patient started therapy with  unknown dosage.  On an unknown date, the patient started therapy with  unknown dosage. The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis.  The patient started therapy with  for the treatment of prophylaxis.  The patient started therapy with  for the treatment of prophylaxis.  The patient started therapy with  for the treatment of prophylaxis.  The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis.  The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant for the treatment of prophylaxis.  On 30-Jun-2023, the patient experienced Customer called to report that 2 years ago a female patient in her 20s received her 2nd and 3rd dose of GARDASIL 9 within 10 weeks of each other.  No symptoms reported.  See related request case 02772685.   Patient's first dose received on 20DEC2022. On an unknown date, the patient experienced No symptoms reported.   At the reporting time, the outcome of Customer called to report that 2 years ago a female patient in her 20s received her 2nd and 3rd dose of GARDASIL 9 within 10 weeks of each other.  No symptoms reported.  See related request case 02772685.   Patient's first dose received on 20DEC2022 and No symptoms reported was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant. nHuman Papillomavirus 9-valent Vaccine, Recombinant and Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations.
Age: 25.0
Sex: F
Vaccine: COVID19, FLU3, HEP, HEPA, IPV, VARCEL
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: The patient presented to our vaccine clinic on 1/27/2025 for immigration vaccines. On the health questionnaire, she did not indicate that she was pregnant. Our staff does not recall the pt being "visibly pregnant". A live virus vaccine, varicella was administered. On March 20th, Dr. contacted our clinic asking why the pt was given a live virus vaccine while pregnant. Per Dr., the pt was 32 weeks pregnant at the time of vaccination on 1/27/2025. I informed Dr. that the pt did not indicate she was pregnant on her health questionnaire and that I would report the incident to VAERS.
Age: 16.0
Sex: M
Vaccine: MNP
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: Provider indicated SIRVA.  My son is now several weeks out from injection date and still experiencing severe pain in his shoulder that is negatively impacting his daily living.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: duplicate vaccine within 10 year timeframe
Age: 0.33
Sex: M
Vaccine: FLU3, HEP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever , concerns for aseptic meningitis
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: There was no adverse reaction that occurred.  The wrong vaccine was administered.  The patient was wanting to receive the Covid vaccine and received the Shingrix vaccine in error.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: The patient stated that she had severe soreness and stiffness in her arm a few days after receiving the vaccine that has persisted over the last few months.  The patient perceived that it may have been due to the location the vaccine was given.  She sought medical treatment from her provider due to the persistent soreness and he prescribed the patient medications to help with the pain and stiffness and suggested physical therapy .
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Night of vaccination administration, patient felt pain (worse than normal local pain), next morning patient noticed her arm was swollen and red rash had developed. When patient reported to pharmacy (3/22/25) rash was still slightly visible, appearing further down the arm as vaccine had traveled through muscle.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Musculoskeletal stiffness, Pain in extremity, Tinnitus
Clinical narrative: I have had ringing in my ears ever since a few days after this shot. The location of the shot hurt quite a bit after the shot for a few days, and I was extremely tired. Then the ringing started and it has never quit. I spoke to an ENT about this, but he said there was nothing that could be done. I also experienced stabbing pains in my lower legs for several months, but those have gone away. Now I just have a lot more stiffness than I used to.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Acute myocardial infarction, Coronary arterial stent insertion
Clinical narrative: Experienced a myocardial infarction (NSTEMI) and stent placement in the LAD 2 days after vaccination with PCV20.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Boostrix vaccine previously on 12/2/2024 and again on 3/21/2025.  This is an administration error. Patient had no adverse reaction or side effects.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching 3 inches around injection site
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: swelling and redness at the injection site; redness spread to bicep of arm injected; fatigue, muscle and joint pain; headache
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Myalgia
Clinical narrative: swelling and redness at the injection site; redness spread to bicep of arm injected; fatigue, muscle and joint pain; headache
Age: 63.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: The following day patient presented with left arm tenderness, red and slightly swollen and warm to touch.  Presentation has lasted all week. Also pain in the left hand present. Patient asked for consult today 7 days after vaccination for treatment and will use a cortisone cream and aleve
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Erythema, Fibrin D dimer, Mobility decreased, Pain in extremity
Clinical narrative: 03/21/2025: Swollen face and forehead. Itchy forehead, swollen lip on left side. Pain in hands.  03/22/2025: swollen chin, swollen hands, cannot close hands or move fingers. Red hives on left arm, extra swelling and pain on left hand.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Pruritus, Scan with contrast normal, Swelling face, Ultrasound neck
Clinical narrative: 03/21/2025: Swollen face and forehead. Itchy forehead, swollen lip on left side. Pain in hands.  03/22/2025: swollen chin, swollen hands, cannot close hands or move fingers. Red hives on left arm, extra swelling and pain on left hand.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: 03/21/2025: Swollen face and forehead. Itchy forehead, swollen lip on left side. Pain in hands.  03/22/2025: swollen chin, swollen hands, cannot close hands or move fingers. Red hives on left arm, extra swelling and pain on left hand.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Malaise, Pyrexia
Clinical narrative: My arm is still swollen on the side of the injection. 24 hrs after getting the vaccination I felt very ill with a fever of 101. Most notable,  was my arm swelling and itching with hives around the injection site. I took Benadryl and used an antihistamine ointment. I have never felt this ill from a vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Mobility decreased, Peripheral swelling, Posture abnormal, Pruritus
Clinical narrative: Pt stated she had internal and external itching with whole head being so heavy she couldn't lift it up for 7 days; arm swelled up the size of a baseball and couldn't lift her arm; rash/hives all over her body; fever 101F with which she took Tyl q 4 h for 2 days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Pt stated she had internal and external itching with whole head being so heavy she couldn't lift it up for 7 days; arm swelled up the size of a baseball and couldn't lift her arm; rash/hives all over her body; fever 101F with which she took Tyl q 4 h for 2 days
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Magnetic resonance imaging head abnormal
Clinical narrative: 1/29/21 and 2/26/21 moderna vaccination.      I was first seen on 7/29/21 foer afib in emergency room. I now have chronic constant afib. I have had 2 failed cardioversions. All medications can't keep me out of afib. I now have an abnormal brain mri and will be going in for heart ablasion on March 31st.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Asthenia, Autoimmune thyroiditis, Blood test abnormal, Chronic fatigue syndrome
Clinical narrative: A few weeks after the second dose of the vaccine I began getting very tired and weak.  Over the next few weeks after that I became devoid of all energy and had extreme difficulty waking up in the morning.   This turned into sleeping 16-18 hours a day.  As well as such extreme tiredness I couldn?t fully wake up in order to work my part time job.  The weakness continued until I became basically bed ridden for almost 2 full years.  I had a very noticeable change in memory as well as cognitive ability.  I began experiencing extreme changes in temperature and feeling very weak when I stood.  These symptoms did not change and continue to this day.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Condition aggravated, Fatigue, Feeling of body temperature change, Hypersomnia
Clinical narrative: A few weeks after the second dose of the vaccine I began getting very tired and weak.  Over the next few weeks after that I became devoid of all energy and had extreme difficulty waking up in the morning.   This turned into sleeping 16-18 hours a day.  As well as such extreme tiredness I couldn?t fully wake up in order to work my part time job.  The weakness continued until I became basically bed ridden for almost 2 full years.  I had a very noticeable change in memory as well as cognitive ability.  I began experiencing extreme changes in temperature and feeling very weak when I stood.  These symptoms did not change and continue to this day.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Loss of employment, Memory impairment, Mobility decreased, Post-acute COVID-19 syndrome
Clinical narrative: A few weeks after the second dose of the vaccine I began getting very tired and weak.  Over the next few weeks after that I became devoid of all energy and had extreme difficulty waking up in the morning.   This turned into sleeping 16-18 hours a day.  As well as such extreme tiredness I couldn?t fully wake up in order to work my part time job.  The weakness continued until I became basically bed ridden for almost 2 full years.  I had a very noticeable change in memory as well as cognitive ability.  I began experiencing extreme changes in temperature and feeling very weak when I stood.  These symptoms did not change and continue to this day.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Somnolence
Clinical narrative: A few weeks after the second dose of the vaccine I began getting very tired and weak.  Over the next few weeks after that I became devoid of all energy and had extreme difficulty waking up in the morning.   This turned into sleeping 16-18 hours a day.  As well as such extreme tiredness I couldn?t fully wake up in order to work my part time job.  The weakness continued until I became basically bed ridden for almost 2 full years.  I had a very noticeable change in memory as well as cognitive ability.  I began experiencing extreme changes in temperature and feeling very weak when I stood.  These symptoms did not change and continue to this day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Bell's palsy, Coronary arterial stent insertion, Endotracheal intubation, Hypoxia
Clinical narrative: Bell?s Palsy, High Fever, Oxygen Deprivation, Double Pneumonia, Cardiac Attack, Afib, Intubation, Rehabilitation Therapy, Stent Surgery, Defibrillator Implant
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Implantable defibrillator insertion, Myocardial infarction, Pneumonia, Pyrexia
Clinical narrative: Bell?s Palsy, High Fever, Oxygen Deprivation, Double Pneumonia, Cardiac Attack, Afib, Intubation, Rehabilitation Therapy, Stent Surgery, Defibrillator Implant
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes ophthalmic
Clinical narrative: Herpes eye infection
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Coeliac artery compression syndrome, Condition aggravated, Ehlers-Danlos syndrome, Herpes zoster, Ileus
Clinical narrative: Intestin Obstruction, Intestion Shut down, Mals, EPS, Pots, Gastropresis, Shingles, Knutcracket, MalTherna,
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying, Intestinal obstruction, May-Thurner syndrome, Postural orthostatic tachycardia syndrome, Renal vein compression
Clinical narrative: Intestin Obstruction, Intestion Shut down, Mals, EPS, Pots, Gastropresis, Shingles, Knutcracket, MalTherna,
Age: 48.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Fatigue, Pain in extremity
Clinical narrative: duplicate administration -- pt received dose of vaccine 4/3/2023. Pt informed, not experiencing ADR other than sore arm and fatigue (another vaccine administered simultaneously)
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received a second flu shot this season.
Age: 85.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema
Clinical narrative: Pt reported arm redness around whole area of upper arm.  There were no other symptoms reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: about a minute after getting the vaccine her left cheek and jaw starting feeling a little numb and tingly.  By the time the patient got home about 5 minutes later the numbness had worsened.  After about 10 more  minutes, her left arm started feeling numb.  After another 5 minutes the numbness spread to left leg and food.  the symptoms lasted about 30 hours and gradually improved before disappearing.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Feeling abnormal, Headache, Influenza
Clinical narrative: PATIENT REPORTS FEELING VERY "UNDER THE WEATHER" FOR 7 DAYS, AS THEY WERE VACCINATED ON A FRIDAY AND REPORTS NOT LEAVING THEIR HOUSE UNTIL THE FOLLOWING FRIDAY, 2/21/25. PATIENT EXPERIENCED THE FOLLOWING (REPORTED BY PATIENT AS SEVERE) EVENTS: 102 DEGREE FEVER, SEVERE CHILLS, NAUSEA, HEADACHE, FLU SYMPTOMS, AND EYE PAIN. PATIENT REPORTS THEIR EYE TISSUES BEING UNUSUALLY RED (NOT THE ACTUAL EYEBALL, BUT THE TISSUES WITHIN EYE ORBIT) AND WERE LEAKING/RUNNING SO BAD AND WERE SO PAINFUL, PATIENT REPORTS THINKING THEIR EYES WERE BLEEDING. PATIENT DOES NOT RECALL HOW LONG THE EYE PAIN & WATERING LASTED BUT DID CONSULT WITH HER OPTOMETRIST.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lacrimation increased, Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: PATIENT REPORTS FEELING VERY "UNDER THE WEATHER" FOR 7 DAYS, AS THEY WERE VACCINATED ON A FRIDAY AND REPORTS NOT LEAVING THEIR HOUSE UNTIL THE FOLLOWING FRIDAY, 2/21/25. PATIENT EXPERIENCED THE FOLLOWING (REPORTED BY PATIENT AS SEVERE) EVENTS: 102 DEGREE FEVER, SEVERE CHILLS, NAUSEA, HEADACHE, FLU SYMPTOMS, AND EYE PAIN. PATIENT REPORTS THEIR EYE TISSUES BEING UNUSUALLY RED (NOT THE ACTUAL EYEBALL, BUT THE TISSUES WITHIN EYE ORBIT) AND WERE LEAKING/RUNNING SO BAD AND WERE SO PAINFUL, PATIENT REPORTS THINKING THEIR EYES WERE BLEEDING. PATIENT DOES NOT RECALL HOW LONG THE EYE PAIN & WATERING LASTED BUT DID CONSULT WITH HER OPTOMETRIST.
Age: 76.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed large painful rash on arm several inches below injection site (not at injection site).
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Nausea, Tenderness
Clinical narrative: Patient's arm at and around injection site is very, very red and swollen. She states she feels constantly nauseous since receiving the vaccine, and her chest and left trunk area are extremely tender to the touch.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry mouth, Eye swelling, Skin warm, Swelling of eyelid
Clinical narrative: Same day, patient got dry mouth and severe chills. She skin felt hot to the touch and she was in bed almost all day. on 3/6/25, she had a swollen eye/eyelid that lasted 2 days. She took zyrtec and used cold compresses.
Age: 75.0
Sex: F
Vaccine: PNC21, RSV, TDAP
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Patient received three vaccines on 3/17/2025, with Boostrix and Capvaxive on her right arm and Arexvy on her left arm. Patient said her left arm was sore for a few days, but just noticed the rash today on 3/23/2025 and reported to the pharmacy. Rash is warm to touch, but doesn't itch. The rash is about the size of 3 quarter coins. I recommended for her to draw a circle around the rash and monitor if the rash improve or spread outside the circle, and reach out to her primary care provider for follow up. Patient also picked up a tube of hydrocortisone cream over the counter to help with her rash.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Pt potentially received a second dose of Prevnar20. Pt did not recollect ever receiving the vaccine, however may have received 3/6/2024 and on 3/12/2025 according to system. Pt reported no adverse effects other than a "sore arm for a couple of days"
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE REACTION WAS REPORTED, WHILE GOING OVER PATIENT PROFILE FOR VACCINATION PHARMACIST NOTICED THAT PATIENT HAD RECEIVED TWO DOSES, RECOMMENDED DOSE BY MANUFACTURER IS ONE.
Age: 68.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site erythema, Malaise, Skin warm
Clinical narrative: Patient's arm is red around the site of the injection. She stated her arm feels warm to the touch. Patient further explained she felt sick with chills for 3 days and went to urgent care today.  Patient also stated provider was not certain if she had an allergic reaction or adverse event from the vaccine or cellulitis. The provider prescribed Augmentin for cellulitis.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Angiocardiogram, Arthralgia, Atrial fibrillation, Carditis
Clinical narrative: Started as preasure in chest, breathing shallow, as week went on, muscles ache.  Joint ache started and by week end, Friday, shortness of breath, preasure in chest and by Friday decided I needed to go to emergency room.  5 days later, after many tests and no knowledge of the last 5 days, I woke up in hospital.  Was told there was inflamation in my heart and was told all the test I had undergone.  During many heart tests they also detected Afib.  which I had never had before.  I am now on blood thinner and causing me heave bruising .  limited ablility to lift or activity
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Echocardiogram, Electrocardiogram, Hypopnoea
Clinical narrative: Started as preasure in chest, breathing shallow, as week went on, muscles ache.  Joint ache started and by week end, Friday, shortness of breath, preasure in chest and by Friday decided I needed to go to emergency room.  5 days later, after many tests and no knowledge of the last 5 days, I woke up in hospital.  Was told there was inflamation in my heart and was told all the test I had undergone.  During many heart tests they also detected Afib.  which I had never had before.  I am now on blood thinner and causing me heave bruising .  limited ablility to lift or activity
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Started as preasure in chest, breathing shallow, as week went on, muscles ache.  Joint ache started and by week end, Friday, shortness of breath, preasure in chest and by Friday decided I needed to go to emergency room.  5 days later, after many tests and no knowledge of the last 5 days, I woke up in hospital.  Was told there was inflamation in my heart and was told all the test I had undergone.  During many heart tests they also detected Afib.  which I had never had before.  I am now on blood thinner and causing me heave bruising .  limited ablility to lift or activity
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Culture stool, Diarrhoea
Clinical narrative: Began with watery diarrhea that day and has persisted 2 weeks
Sex: F
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Anaphylactoid reaction
Clinical narrative: The patient suffered an injury from receiving the Pfizer COVID-19 Vaccine due to the Polyethylene glycol in the vaccine; Pfizer COVID Vaccine injured/ anaphylactic reactions; suffered Anaphylactoid reaction; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on (20Mar2025), this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]) at single (dose 1, single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "unknown", described as "The patient suffered an injury from receiving the Pfizer COVID-19 Vaccine due to the Polyethylene glycol in the vaccine"; ANAPHYLACTIC REACTION (medically significant), outcome "not recovered", described as "Pfizer COVID Vaccine injured/ anaphylactic reactions"; ANAPHYLACTOID REACTION (medically significant), outcome "unknown", described as "suffered Anaphylactoid reaction". Clinical course: the patient was Pfizer COVID 19 vaccine injured due to the polyethylene glycol. It has caused her anaphylactic reactions. The patient suffered an injury from receiving the Pfizer COVID-19 Vaccine due to the Polyethylene glycol in the vaccine, the associated polysorbate but it was the PEG that is the common culprit. She suffered Anaphylactoid reaction.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.