chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles). 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: 12-DEC-2024 This case was reported by a patient via interactive digital media. The patient reported that screw GlaxoSmithKline vaccine and further said that he/she never had shingles. The patient's physician told him/her into getting the vax (vaccine) and guess what, yes patient got shingles. It was painful. So, they could take it and. 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 regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Insomnia, Malaise, Myalgia
Clinical narrative: muscle pain; pulse rate was up/Heartbeats increased; cannot sleep; feel like shit; Feeling sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE and INFLUENZA VACCINE.   In NOV-2024, the patient received the 1st dose of Shingrix (injection, left arm). In NOV-2024, an unknown time after receiving Shingrix, the patient experienced heart rate increased (Verbatim: pulse rate was up/Heartbeats increased), sleeplessness (Verbatim: cannot sleep), feeling abnormal (Verbatim: feel like shit) and feeling unwell (Verbatim: Feeling sick). On an unknown date, the patient experienced muscle pain (Verbatim: muscle pain). In NOV-2024, the outcome of the feeling unwell was resolved (duration 7 days). The outcome of the muscle pain, heart rate increased and sleeplessness were not resolved and the outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the muscle pain, heart rate increased, sleeplessness, feeling abnormal and feeling unwell to be related to Shingrix.     It was unknown if the company considered the muscle pain, heart rate increased, sleeplessness, feeling abnormal and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-NOV-2024 The reporter reported that patient received Shingrix vaccine first dose in Nov 2024 but did not recall the date with lot and expiration date was unknown.  The patient was vaccinated at a local pharmacy and was administered the vaccine in the left arm. The patient cannot sleep, heart beating so fast, pulse rate up and it all started after the Shingrix shot. The patient had reported muscle pain and feel like shit, because feeling sick for seven days. The patient received the Flu and Covid vaccine two weeks before receiving the Shingles vaccine but did not provide any information of the manufacturing company for the COVID or Flu vaccine.  No additional information was reported. Not all information was provided.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Labelled drug-drug interaction issue
Clinical narrative: He started taking prednisone a couple of days after getting the Boostrix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of labeled drug-drug interaction medication error in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number X357E, expiry date 22-SEP-2026) for prophylaxis.   Co-suspect products included prednisone acetate (Prednisone) for product used for unknown indication.   On 26-JUL-2024, the patient received Boostrix. On 02-AUG-2024, the patient started Prednisone. On 26-JUL-2024, an unknown time after receiving Boostrix, the patient experienced labeled drug-drug interaction medication error (Verbatim: He started taking prednisone a couple of days after getting the Boostrix vaccine). The action taken with Prednisone was unknown. The outcome of the labeled drug-drug interaction medication error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-NOV-2024 The reporter called to report the following that he/she had a question about the boostrix vaccine.  The reporter had a patient that he/she thought he was taking Prednisone.  He started taking Prednisone a couple of days after getting the Boostrix vaccine and he/she knew it reduced the effectiveness of it and caused his wife was currently pregnant and was about to have a child, and they were wondering when he would need to get vaccinated, which led to labeled drug-drug interaction medication error. In August 2nd patient picked up prednisone 30 mg for 1 month. The patient got prednisone a week after being vaccinated with Boostrix. Pharmacist suspected an efficacy reduction to this. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: Pain; not well; had arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of unwell in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unwell (Verbatim: not well), pain in arm (Verbatim: had arm pain) and pain (Verbatim: Pain). The outcome of the unwell and pain in arm were resolved (duration 1 week) and the outcome of the pain was unknown.   It was unknown if the reporter considered the unwell, pain in arm and pain to be related to Arexvy.     It was unknown if the company considered the unwell, pain in arm and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-DEC-2024 The case was self reported by patient. The patient received Arexvy vaccine last year, she did not know the manufacturer. She stated that she had arm pain and was unwell for a week.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: administer an Respiratory syncytial virus vaccine to a pregnant patient; administer an Respiratory syncytial virus vaccine to a pregnant patient; instead of Abrysvo they administered Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of drug use in unapproved population in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On 09-DEC-2024, the patient received Arexvy. On an unknown date, the patient received Abrysvo. On 09-DEC-2024, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: administer an Respiratory syncytial virus vaccine to a pregnant patient) and wrong vaccine administered (Verbatim: instead of Abrysvo they administered Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administer an Respiratory syncytial virus vaccine to a pregnant patient). The outcome of the drug use in unapproved population, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-DEC-2024 Healthcare Professional reported on 9th December 2024 that they needed to administer an Respiratory syncytial virus vaccine to a pregnant patient but instead of Abrysvo they administered Arexvy.  The patient who was pregnant received Arexvy instead of Abrysvo, which led to vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid symptoms) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In November 2024, the patient experienced COVID-19 (covid symptoms). At the time of the report, COVID-19 (covid symptoms) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient received the booster two weeks ago and now have covid symptoms.   No treatment medications were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Adult T-cell lymphoma/leukaemia
Clinical narrative: triggered my T cell leukemia; This spontaneous case was reported by a patient and describes the occurrence of ADULT T-CELL LYMPHOMA/LEUKAEMIA (triggered my T cell leukemia) in a 26-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ADULT T-CELL LYMPHOMA/LEUKAEMIA (triggered my T cell leukemia) (seriousness criterion medically significant). At the time of the report, ADULT T-CELL LYMPHOMA/LEUKAEMIA (triggered my T cell leukemia) outcome was unknown.            No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel very well for about 10 days after receiving the vaccine; This is a spontaneous report received from a Consumer or other non HCP from License Party.  A 75-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: MALAISE (non-serious), outcome "recovered", described as "did not feel very well for about 10 days after receiving the vaccine".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 15.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Loss of consciousness; Syncope; Fall; This spontaneous case initially received on 17-Dec-2024, was reported by a non-health professional and concerns an adolescent male patient. No medical history was reported Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 16-Nov-2024, the patient received Afluria (TIV) for Influenza immunization, dose regimen: not reported, Route of administration: anatomical location: not reported, Lot number: AW1696A. Lot number matched with CSL Sequirus master batch list.  Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: Covid-19 immunization, dose regimen: not reported, Route of administration: intramuscular, Lot number: 6024MF016.  Adverse reactions/events and outcomes: On 16-Nov-2024, the patient experienced Loss of consciousness (Medically Significant, outcome: Recovered / Resolved), Syncope (Medically Significant, outcome: Recovered / Resolved), Fall (outcome: Recovered / Resolved). Patient fainted approximately 2-3 minutes after receiving these 2 vaccines. They were administered by a certified pharmacy technician. While waiting for his family to finish with their vaccinations, patient fainted. He fell against the administering technician and was lowered the floor by his mother. When the reporter arrived patient was regaining consciousness. Patient was allowed time to sit and regain composure. He did not have any injuries from his fall. He was given water. It was offered to call emergency for patient to be evaluated further, but offer was declined. After about 15 minutes patient was doing well. Both of the parents were comfortable with the patient being released. The reporter followed up with a phone call a few hours later and patient is doing well. A discrepancy was identified in the source document.   Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the events(Loss of consciousness, Syncope) as serious due to medically significant and the causality as assessed as related (possible). The event fall was assessed as non serious.; Reporter's Comments: Causality: Related, due to plausible temporal relationship(on day 1 of vaccination) .of note,Novavax COVID-19 Vaccine received on same day can be considered as confounder.
Age: 41.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; inadvertently received a dose of PROQUAD on 18DEC2024; This spontaneous report was received from a nurse and refers to a 41-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical vaccines included first doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) in 2018.  On 18-DEC-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional information was known by reporter. No additional adverse event (AE)/product quality complaint (PQC).  Lot # is being requested and will be submitted if received.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Allergy to vaccine, Chills, Dehydration, Diarrhoea, Injection site pruritus
Clinical narrative: dehydrated; diarrhea; fainted; injection site itching; Injection site bumpy; fever; Chills; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included allergy to vaccine (allergic to the adjuvant).   On 26-NOV-2024, the patient received Arexvy (intramuscular) .5 ml. On 27-NOV-2024, 1 days after receiving Arexvy, the patient experienced injection site itching (Verbatim: injection site itching), injection site swelling (Verbatim: Injection site bumpy), fever (Verbatim: fever) and chills (Verbatim: Chills). On 28-NOV-2024, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant), dehydration (Verbatim: dehydrated) and diarrhea (Verbatim: diarrhea). On 27-NOV-2024, the outcome of the fever was resolved.  On 28-NOV-2024, the outcome of the chills was resolved.  On 29-NOV-2024, the outcome of the fainting and diarrhea were resolved. The outcome of the injection site itching and injection site swelling were not resolved and the outcome of the dehydration was resolved.   It was unknown if the reporter considered the fainting, injection site itching, injection site swelling, dehydration, diarrhea, fever and chills to be related to Arexvy.     The company considered the fainting to be unrelated to Arexvy. It was unknown if the company considered the injection site itching, injection site swelling, dehydration, diarrhea, fever and chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-DEC-2024 The reporter reported that she received her Arexvy vaccination on 26th November 2024. The next morning she awoke with fever and chills which lasted all day.  The following day, the chills and fever were gone, but she had diarrhea.  She fainted on that day and 911 was called.  Emergency medical technician assessed the patient and determined that all vital signs were good and stated that she was dehydrated.   She was not transported.  She also stated that the injection site was itching and bumpy.  The injection site reaction still remained, but all other symptoms had disappeared.  When these issues were reported to the pharmacist, the pharmacist stated that she was allergic to the adjuvant.  She did not spoke with her doctor about the reaction.; Sender's Comments: Syncope is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Pyrexia, Syncope
Clinical narrative: dehydrated; diarrhea; fainted; injection site itching; Injection site bumpy; fever; Chills; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included allergy to vaccine (allergic to the adjuvant).   On 26-NOV-2024, the patient received Arexvy (intramuscular) .5 ml. On 27-NOV-2024, 1 days after receiving Arexvy, the patient experienced injection site itching (Verbatim: injection site itching), injection site swelling (Verbatim: Injection site bumpy), fever (Verbatim: fever) and chills (Verbatim: Chills). On 28-NOV-2024, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant), dehydration (Verbatim: dehydrated) and diarrhea (Verbatim: diarrhea). On 27-NOV-2024, the outcome of the fever was resolved.  On 28-NOV-2024, the outcome of the chills was resolved.  On 29-NOV-2024, the outcome of the fainting and diarrhea were resolved. The outcome of the injection site itching and injection site swelling were not resolved and the outcome of the dehydration was resolved.   It was unknown if the reporter considered the fainting, injection site itching, injection site swelling, dehydration, diarrhea, fever and chills to be related to Arexvy.     The company considered the fainting to be unrelated to Arexvy. It was unknown if the company considered the injection site itching, injection site swelling, dehydration, diarrhea, fever and chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-DEC-2024 The reporter reported that she received her Arexvy vaccination on 26th November 2024. The next morning she awoke with fever and chills which lasted all day.  The following day, the chills and fever were gone, but she had diarrhea.  She fainted on that day and 911 was called.  Emergency medical technician assessed the patient and determined that all vital signs were good and stated that she was dehydrated.   She was not transported.  She also stated that the injection site was itching and bumpy.  The injection site reaction still remained, but all other symptoms had disappeared.  When these issues were reported to the pharmacist, the pharmacist stated that she was allergic to the adjuvant.  She did not spoke with her doctor about the reaction.; Sender's Comments: Syncope is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Medical assistant staff received DR orders to give patient the HIB vaccine.  After the Vaccine was administered it was discovered that medical assistant staff did not reconstitute the vaccine.  Medical assistant staff provided patient shot of diluent, leaving vaccine powder in vaccination fridge.   Parent of the patient has been notified of the error regarding the vaccine administration and was scheduled to come back to the practice with patient to have vaccine administered.  Mother did not return as scheduled with patient.  At this time, practice is actively attempted reach out to mother of the patient to resolve this issue.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient arrived at hospital ED for administration of 2nd dose of rabies vaccine on day 3, patient was ordered and received a second dose of rabies immune globulin.  The patient returned to ED on day 7 12/20 for dose #2 of the vaccine and a catch-up dose of the vaccine on day 10 12/23. Will return for the last dose on day 14.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Rash, Urticaria
Clinical narrative: Hives ? full-body outbreak six hours after  injection; recurrent outbreaks for several weeks afterward.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: I informed Dr immediately after administering vaccine and we had patient stay in clinic for monitoring. No reaction appeared. patient tolerated.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: SECOND HEP A VACCINE WAS ADMINISTERED TOO SOON
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a flu vaccine on 10/8/2024 and then received a second flu vaccine of the same type and lot number on 12/19/24. The patient did not report any adverse effects to receiving the second vaccine.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Member received Hep A vaccine instead of Hep B vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Accidentally gave patient fluarix instead of boostrix.  Patient did not report any symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Musculoskeletal chest pain, Pain in extremity, Painful respiration, Urinary retention
Clinical narrative: 70 yo male with h/o prostate cancer with bony metastases s/p HD flu shot on 12/11/24 c/o R arm soreness night of injection.  Developed into increased pain throughout trunk, particularly R posterior/anterior thorax and ribs.  Some pain with breathing but not short of breath.  Increased urinary retention, although able to partially empty bladder with pressure applied externally to bladder.  Symptoms reported to PCP on 12/20/24.  Some aspects of thoracic pain improving, urinary retention continuing.  Pt advised to go to ER to ensure symptoms not life-threatening and declined.  f/u appt with PCP 12/23/24 discussed pro/con D-dimer to r/o PE, recommended gold standard of CT w/contrast, pt declined.  Also discussed ER for bladder cath, pt declined.  Did check urine for infection, result pending.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: 70 yo male with h/o prostate cancer with bony metastases s/p HD flu shot on 12/11/24 c/o R arm soreness night of injection.  Developed into increased pain throughout trunk, particularly R posterior/anterior thorax and ribs.  Some pain with breathing but not short of breath.  Increased urinary retention, although able to partially empty bladder with pressure applied externally to bladder.  Symptoms reported to PCP on 12/20/24.  Some aspects of thoracic pain improving, urinary retention continuing.  Pt advised to go to ER to ensure symptoms not life-threatening and declined.  f/u appt with PCP 12/23/24 discussed pro/con D-dimer to r/o PE, recommended gold standard of CT w/contrast, pt declined.  Also discussed ER for bladder cath, pt declined.  Did check urine for infection, result pending.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose twice
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood folate normal, Blood homocysteine normal, Blood test normal, Computerised tomogram head normal, Laboratory test normal
Clinical narrative: On December 5, I woke up with a shadow on the very right periphery of my left eye. That is the only symptom I had at the time. I visited my optometrist on December 12, and was diagnosed with optic disc edema on my left eye. My left optic nerve was inflamed. I had reduced vision only on the periphery of that left eye. I was referred to University ophthalmology department and was seen on December 13 for an urgent visit. They confirmed optic disc edema and added optic neuropathy. The results of my vision field test were: 99% on my right eye and 86% on my left eye. They sent me to the ER to get an MRI (brain and orbit scans) immediately. They did not feel it prudent to wait. The MRI and orbit scans were completed clear. No signs of trauma, no tumor, no indication of MS, no damage associated with optic neuritis. They admitted me to conduct more testing. Since then, all blood work has come back in normal ranges and all autoimmune disease tests have also come back negative. They wondered whether having the homozygous presence of MTHFR may have been a factor, but my Folate, B12, and homocysteine levels are all where they should be, negating this risk factor. I was released for out patient follow-up. At my next appointment on December 18, I saw Dr., a neuro ophthalmologist at University. At this appointment, my visual field test results were 100% on the right eye and 93% on the left eye, so there had been improvement in 5 days. We opted not to start steroid treatment because it is a mild case, I have 20/20 vision, and no loss of color, and the improvement in 5 days gave us encouragement that I would heal without steroid treatment. They suspect this is a case of a-typical optic neuritis, the kind that does not show on MRIs and can be caused by any number of reasons. My FUP appointment is in January at 6 weeks.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Magnetic resonance imaging head normal, Optic neuritis, Optic neuropathy, Pseudopapilloedema, Visual field defect
Clinical narrative: On December 5, I woke up with a shadow on the very right periphery of my left eye. That is the only symptom I had at the time. I visited my optometrist on December 12, and was diagnosed with optic disc edema on my left eye. My left optic nerve was inflamed. I had reduced vision only on the periphery of that left eye. I was referred to University ophthalmology department and was seen on December 13 for an urgent visit. They confirmed optic disc edema and added optic neuropathy. The results of my vision field test were: 99% on my right eye and 86% on my left eye. They sent me to the ER to get an MRI (brain and orbit scans) immediately. They did not feel it prudent to wait. The MRI and orbit scans were completed clear. No signs of trauma, no tumor, no indication of MS, no damage associated with optic neuritis. They admitted me to conduct more testing. Since then, all blood work has come back in normal ranges and all autoimmune disease tests have also come back negative. They wondered whether having the homozygous presence of MTHFR may have been a factor, but my Folate, B12, and homocysteine levels are all where they should be, negating this risk factor. I was released for out patient follow-up. At my next appointment on December 18, I saw Dr., a neuro ophthalmologist at University. At this appointment, my visual field test results were 100% on the right eye and 93% on the left eye, so there had been improvement in 5 days. We opted not to start steroid treatment because it is a mild case, I have 20/20 vision, and no loss of color, and the improvement in 5 days gave us encouragement that I would heal without steroid treatment. They suspect this is a case of a-typical optic neuritis, the kind that does not show on MRIs and can be caused by any number of reasons. My FUP appointment is in January at 6 weeks.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Visual field tests abnormal, Vitamin B12 normal
Clinical narrative: On December 5, I woke up with a shadow on the very right periphery of my left eye. That is the only symptom I had at the time. I visited my optometrist on December 12, and was diagnosed with optic disc edema on my left eye. My left optic nerve was inflamed. I had reduced vision only on the periphery of that left eye. I was referred to University ophthalmology department and was seen on December 13 for an urgent visit. They confirmed optic disc edema and added optic neuropathy. The results of my vision field test were: 99% on my right eye and 86% on my left eye. They sent me to the ER to get an MRI (brain and orbit scans) immediately. They did not feel it prudent to wait. The MRI and orbit scans were completed clear. No signs of trauma, no tumor, no indication of MS, no damage associated with optic neuritis. They admitted me to conduct more testing. Since then, all blood work has come back in normal ranges and all autoimmune disease tests have also come back negative. They wondered whether having the homozygous presence of MTHFR may have been a factor, but my Folate, B12, and homocysteine levels are all where they should be, negating this risk factor. I was released for out patient follow-up. At my next appointment on December 18, I saw Dr., a neuro ophthalmologist at University. At this appointment, my visual field test results were 100% on the right eye and 93% on the left eye, so there had been improvement in 5 days. We opted not to start steroid treatment because it is a mild case, I have 20/20 vision, and no loss of color, and the improvement in 5 days gave us encouragement that I would heal without steroid treatment. They suspect this is a case of a-typical optic neuritis, the kind that does not show on MRIs and can be caused by any number of reasons. My FUP appointment is in January at 6 weeks.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Everything's fine till I got diagnosed with Covid-19 on 12-21-24.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Patient experienced mild swelling and redness later on in the day vaccine was received.  Swelling subsided quickly, but redness remained for 2 days following vaccination.  Symptoms resolved on their and patient did not seek or receive professional care for this event.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: received vaccine.  No adverse event at the time.  Became ill on Dec 16 2024
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: BRUISING, REDNESS, SWELLING AND WARMTH IN LEFT ARM WHERE BOTH VACCINES WERE ADMINISTERED. PTS HUSBAND STATES SHE HAD A SLIGHT FEVER THE NIGHT AFTER SHE RECEIVED BOTH VACCINES. PT HAS BEEN TAKING IBUPROFEN, WAS ADVISED TO CONTINUE TAKING FOR A COUPLE MORE DAYS AND TO APPLY COLD CLOTH TO AREA TO HELP WITH SWELLING.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Influenza virus test negative, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, SARS-CoV-2 test negative
Clinical narrative: Came down with  RSV 14 months after the vaccination
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pollakiuria, Pyrexia
Clinical narrative: ABOUT 6 HOURS AFTER VACCINATION, PATIENT FIRST STARTED TO GET A HEADACHE.  THIS SHORTLY PROGRESSED TO A MIGRAINE HEADACHE AND THE PATIENT ALSO DEVELOPED FEVER AND SEVERE CHILLS.  SHE ALSO DEVELOPED A "VIRAL RASH" ON HER TRUNK (CHEST, ABDOMEN, UPPER AND LOWER BACK).  SHE ALSO NOTICED HER URINE OUTPUT TO BE MUCH HIGHER THAN NORMAL DURING THIS TIME.  SHE DID TAKE TYLENOL FOR THE FEVER AND CHILLS, AND LATER SOME DAYQUIL.  NO BENADRYL TAKEN.  THESE SYMPTOMS MOSTLY RESOLVED OR GREATLY IMPROVED WITHIN 24 HOURS.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Viral rash
Clinical narrative: ABOUT 6 HOURS AFTER VACCINATION, PATIENT FIRST STARTED TO GET A HEADACHE.  THIS SHORTLY PROGRESSED TO A MIGRAINE HEADACHE AND THE PATIENT ALSO DEVELOPED FEVER AND SEVERE CHILLS.  SHE ALSO DEVELOPED A "VIRAL RASH" ON HER TRUNK (CHEST, ABDOMEN, UPPER AND LOWER BACK).  SHE ALSO NOTICED HER URINE OUTPUT TO BE MUCH HIGHER THAN NORMAL DURING THIS TIME.  SHE DID TAKE TYLENOL FOR THE FEVER AND CHILLS, AND LATER SOME DAYQUIL.  NO BENADRYL TAKEN.  THESE SYMPTOMS MOSTLY RESOLVED OR GREATLY IMPROVED WITHIN 24 HOURS.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Sore arm / redness /warmth no swelling or knot - still present after 7 days
Age: 1.42
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FluMist rated for children two years and older; given at one year five months old. Patient had no adverse reaction.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Influenza like illness, Malaise, Rectal haemorrhage, Thrombosis
Clinical narrative: both my parents became sick a few weeks after getting the j&j shot. flu like symptoms which lasted a month. My dad found my mother on the bathroom floor bleeding out her rectum. no explanation from dr or hospital for the cause. they said maybe from a medication. really?  My mother had said to me she wished she never got that shot. I have all records from 8/20/2021-until her death.  I need to understand why this happened my dad also died days after my mother and the detective had no explanatiion for his  death  just that he had a medical issue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: The shot was given according to the patient more forward and higher on the shoulder. She stated she was still having significant pain at the injections site.
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine - patient received original dose 12/5/23
Age: 89.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: AFTER ADMINISTRATION, IT WAS DISCOVERED THAT THE PATIENT HAD PREVIOUSLY BEEN VACCINATED WITH AREXVY ON 9/18/2023. THE PATIENT DID NOT REPORT ANY REMARKABLE ADVERSE EVENTS ON FOLLOW UP 12/23/2024.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate shot dose - original dose on 01/05/2024
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Brain scan abnormal
Clinical narrative: Developed Belles Palsy on 10/18/2024  - 9 days after vaccine  - Diagnosis confirmed on 10/28/2024 with Dr.   Follow up with Neurologist and Brain Scan was done
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient got 2 covid shots within 12 days of each other
Age: 78.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site was swollen and red
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: dizzines; Initial information received on 11-Dec-2024 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had dizzines after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.  On an unknown in 2023, the patient suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient developed dizzines (dizziness) (unknown latency) following the administration of influenza vaccine.  Reportedly, Reporter stated that my best friend got it last year and experienced dizziness in 15 months. To this day the dizziness side effect have not left her.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Age: 85.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort, Chest pain, Chills, Dry skin, Erythema
Clinical narrative: awoke with a bright red, dry face ""like sandpaper""NULL; chest heavniess; awoke with a bright red, dry face ""like sandpaper""NULL; sharp pain in the left side of her chest that she describes as '"'being stabbed with an ice pick""NULL; felt unwell; chills; Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious courtesy case received from a other health professional.  This case involves a 85 years old female patient who awoke with a bright red, dry face ""like sandpaper""null, chest heavniess, chills, sharp pain in the left side of her chest that she describes as '"'being stabbed with an ice pick""null and felt unwell after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] and COVID-19 vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma, Cardiac disorder and Lung disorder.  Concomitant medications included Apixaban (Eliquis) for unknown indication.  On 22-Oct-2024, the patient received an unknown dose of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date- unknown and lot U8519DA via intramuscular route in the right arm and received an unknown dose of COVID-19 vaccine not produced by Sanofi Pasteur (strength, expiry date- unknown and lot 3043924) via intramuscular route in the left arm as both for prophylactic vaccination (Immunisation).   On 22-Oct-2024 the patient developed chills (latency- same day) following the administration of influenza USP trival A-B high dose subvirion vaccine and COVID-19 vaccine. On 23-Oct-2024 the patient felt unwell (malaise) (latency- 1 day) following the administration of influenza USP trival A-B high dose subvirion vaccine and COVID-19 vaccine. On 24-Oct-2024 the patient awoke with a bright red, dry face " "like sandpaper" "null (dry skin) (erythema), chest heavniess (chest discomfort), sharp pain in the left side of her chest that she describes as '"'being stabbed with an ice pick""null (chest pain) (latency- 2 days) following the administration of influenza USP trival A-B high dose subvirion vaccine and COVID-19 vaccine.  Reportedly, patient used her albuterol inhaler but this did not help.   Action taken was not applicable for both.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for all the events.
Age: 85.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Malaise
Clinical narrative: awoke with a bright red, dry face ""like sandpaper""NULL; chest heavniess; awoke with a bright red, dry face ""like sandpaper""NULL; sharp pain in the left side of her chest that she describes as '"'being stabbed with an ice pick""NULL; felt unwell; chills; Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious courtesy case received from a other health professional.  This case involves a 85 years old female patient who awoke with a bright red, dry face ""like sandpaper""null, chest heavniess, chills, sharp pain in the left side of her chest that she describes as '"'being stabbed with an ice pick""null and felt unwell after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] and COVID-19 vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma, Cardiac disorder and Lung disorder.  Concomitant medications included Apixaban (Eliquis) for unknown indication.  On 22-Oct-2024, the patient received an unknown dose of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date- unknown and lot U8519DA via intramuscular route in the right arm and received an unknown dose of COVID-19 vaccine not produced by Sanofi Pasteur (strength, expiry date- unknown and lot 3043924) via intramuscular route in the left arm as both for prophylactic vaccination (Immunisation).   On 22-Oct-2024 the patient developed chills (latency- same day) following the administration of influenza USP trival A-B high dose subvirion vaccine and COVID-19 vaccine. On 23-Oct-2024 the patient felt unwell (malaise) (latency- 1 day) following the administration of influenza USP trival A-B high dose subvirion vaccine and COVID-19 vaccine. On 24-Oct-2024 the patient awoke with a bright red, dry face " "like sandpaper" "null (dry skin) (erythema), chest heavniess (chest discomfort), sharp pain in the left side of her chest that she describes as '"'being stabbed with an ice pick""null (chest pain) (latency- 2 days) following the administration of influenza USP trival A-B high dose subvirion vaccine and COVID-19 vaccine.  Reportedly, patient used her albuterol inhaler but this did not help.   Action taken was not applicable for both.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for all the events.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Got flu shot, totally worthless as i sit here with the flu for a freaking week and not any better; Got flu shot, totally worthless as i sit here with the flu for a freaking week and not any better; Initial information received on 16-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Patient.   This case involves Adult female patient who got INFLUENZA VACCINE shot, totally worthless as i sit here with the flu for a freaking week and not any better.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2024, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, route, lot number and expiry: unknown) in unknown administration site for prophylactic vaccination.  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed a non-serious got flu shot, totally worthless as i sit here with the flu for a freaking week and not any better (influenza and malaise) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Got flu shot, totally worthless as i sit here with the flu for a freaking week and not any better).  At time of reporting, the outcome was Unknown for the events (Got flu shot, totally worthless as i sit here with the flu for a freaking week and not any better).
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discharge, Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluad vaccine and when the nurse took of the needle of her arm a lot of white liquid came off.; The Fluad vaccine was for 65 and older; This spontaneous case, initially received on 30-Oct-2024, was reported by a non health professional and concerns an  adult female patient.  Administration of company suspect drug(s): On 30-Oct-2024, the patient received Fluad (TIV) for prevention of influenza; route of administration - Not reported; Lot number: No batch number available. Lot number not reported; will be requested upon follow-up.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 30-Oct-2024, the patient experienced Patient received Fluad vaccine and when the nurse took of the needle of her arm a lot of white liquid came off. (outcome: Unknown), the Fluad vaccine for 65 and older (outcome: Unknown). The  patient stated she took a flu shot on 30-Oct-2024, the Fluad is for 65 and older, and when the nurse took the needle of my arm, a lot of white liquid came off. She cleaned that and said that I shouldn't worry about it I would be protected because the manufacturer fill the syringes with more than the recommended dose. Patient stated that something didn't felt right, so she contacted to check what to do in that case and it  was true that  the syringes are filled  with more vaccine than the recommended dose.    Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not assessed  seriousness  and causality assessment was not reported.  Case correction (30-Oct-2024): Upon internal review, Patient received Fluad vaccine and when the nurse took of the needle of her arm a lot of white liquid came off recoded to Vaccination site discharge and event the Fluad vaccine was for 65 and older recoded to Drug use in unapproved age group. Indication Off label use in unapproved age group and off label check box were removed. Updated narrative accordingly.; Reporter's Comments: The special situation is considered not related to the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia, Syncope
Clinical narrative: Beginning 12 hours after injection: fever and chills, headache, weakness. Beginning 14 hours after injection: fainting twice, and vomiting 5 times.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Beginning 12 hours after injection: fever and chills, headache, weakness. Beginning 14 hours after injection: fainting twice, and vomiting 5 times.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: 22 days after vaccine rash appeared on right half of back and chest and on left wrist. By the next day rash had spread to legs, face and feet. Injection site had also become red and extremely swollen.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: 28 weeks pregnant. experiencing headaches, muscle aches all over body, nausea, fatigue, flu like symptoms.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: 28 weeks pregnant. experiencing headaches, muscle aches all over body, nausea, fatigue, flu like symptoms.