chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: PNC13
Symptoms: Dyspnoea, Heart rate decreased
Clinical narrative: shortness of breath; low heart rate; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 02842711 (Merck).  An infant patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jul2020 as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immunocompromised with immunodeficiency" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE 1, SINGLE), administration date: 2019, for Immunization; Prevnar 13 (DOSE 2, SINGLE), administration date: Jan2020, for Immunization. The following information was reported: HEART RATE DECREASED (life-threatening, medically significant) with onset 2020, outcome "unknown", described as "low heart rate"; DYSPNOEA (life-threatening, medically significant) with onset 2020, outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: Heart rate: (2020) low. Clinical course: HCP called and stated a patient had received PREVNAR 20 shortness of breath, low heart rate, and the "almost called code blue" and had it in 2020, and the patient was a child and still growing, now looking to see if they could receive pneumovax23. Had 1 dose in 2019, and then 2 doses in Jan2020 and Jul2020. Patient had PREVNAR 20 at a different clinic. Patient received those doses at 1 year old or less. Patient was immunocompromised with immunodeficiency and asthma. Reporter was asking what ingredients are in PNEUMOVAX23.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: As there is limited and conflicting information in the case provided, the causal association between the events dyspnoea, and heart rate decreased; and the suspect drug PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine: VARZOS
Symptoms: Dermatomyositis, Immediate post-injection reaction
Clinical narrative: dermatomyositis; This serious case was reported by a consumer via interactive digital media and described the occurrence of dermatomyositis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced dermatomyositis (Verbatim: dermatomyositis) (serious criteria GSK medically significant). The outcome of the dermatomyositis was not reported.   It was unknown if the reporter considered the dermatomyositis to be related to Shingles vaccine.     The company considered the dermatomyositis to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUL-2025 This case was reported by a patient via interactive digital media. The patient had a shingles shot and got dermatomyositis an autoimmune disease shortly after it's like lupus.; Sender's Comments: A case of Dermatomyositis, immediately after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute hepatic failure, Cardiac arrest, Death, Nausea
Clinical narrative: Date of Death: 6/29/25 Causality: unlikely related to ambrisentan and tadalafil. Per chart review, pt went to ED via ambulance for consistent abdominal pain, nausea, and vomiting for the past 2 weeks after receiving COVID vaccine. Later found to have acute liver failure with unclear etiology. Pt became unresponsive during pending potential transfer to tertiary care facility. Pt had cardiac arrest despite aggressive interventions and passed away.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Date of Death: 6/29/25 Causality: unlikely related to ambrisentan and tadalafil. Per chart review, pt went to ED via ambulance for consistent abdominal pain, nausea, and vomiting for the past 2 weeks after receiving COVID vaccine. Later found to have acute liver failure with unclear etiology. Pt became unresponsive during pending potential transfer to tertiary care facility. Pt had cardiac arrest despite aggressive interventions and passed away.
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Facial paralysis
Clinical narrative: experienced a facial palsy; This serious case was reported by a consumer via call center representative and described the occurrence of facial palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis and Influenza vaccine for prophylaxis.   On 17-JUL-2025, the patient received Shingrix, COVID-19 vaccine and Influenza vaccine. On 17-JUL-2025, less than a day after receiving Shingrix, COVID-19 vaccine and Influenza vaccine, the patient experienced facial palsy (Verbatim: experienced a facial palsy) (serious criteria hospitalization and GSK medically significant). The outcome of the facial palsy was unknown.   It was unknown if the reporter considered the facial palsy to be related to Shingrix, COVID-19 vaccine and Influenza vaccine.     The company considered the facial palsy to be unrelated to Shingrix. It was unknown if the company considered the facial palsy to be related to COVID-19 vaccine and Influenza vaccine.   Additional Information: GSK Receipt Date: 31-JUL-2025 This case was reported by the wife of the patient. The reporter reported that her husband (patient) experienced a facial palsy after receiving Shingrix. The patient also received the Covid and Influenza vaccine the same day. Patient had to go the ER (emergency room) on 17th July 2025.; Sender's Comments: A case of Facial paralysis, less than a day after receiving Shingrix, in a male patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted covid 19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted covid 19 infection) in a 62-year-old male 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. In July 2022, the patient experienced COVID-19 (Contracted covid 19 infection) (seriousness criterion death). The patient died on 29-Jul-2022. The reported cause of death was contracted covid 19 infection. It is unknown if an autopsy was performed.            Concomitant medication was not reported.  It was reported that he contracted COVID-19 infection about one week before he died on 29-Jul-2022. It was unknown if the patient experienced any additional symptoms/events.   Treatment medication was not reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: contracted covid 19 infection
Vaccine: COVID19
Symptoms: Autoimmune disorder, Tinnitus
Clinical narrative: autoimmune disease; developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), 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 nos (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Tinnitus"; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "autoimmune disease", "It's worsened after 2nd and 3rd shots", "Tinnitus". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; TINNITUS (non-serious), outcome "unknown", described as "developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots".  Clinical course: Patient developed tinnitus 2 weeks after 1st covid shot. It was worsened after 2nd and 3rd shots. Patient developed autoimmune disease after 3 covid vaccines. Patient developed autoantibodies but had no diagnosis after 3 covid shots.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500158063 same patient/reporter, different vaccine dose/AE;
Vaccine: COVID19
Symptoms: Autoimmune disorder, Tinnitus
Clinical narrative: autoimmune disease; tinnitus/worsened after 2nd shot; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2, 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, SINGLE), for COVID-19 immunization, reaction(s): "Tinnitus". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/worsened after 2nd shot".  Additional information: The patient developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots. It was also reported that after the 2nd and 3rd vaccine, the patient developed an autoimmune disease. The patient asked if it is safe to get more and asked how to monitor heath after developing autoantibodies  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500158037 same patient/reporter, different vaccine dose/AE;US-PFIZER INC-202500157611 same patient/reporter, different vaccine dose/AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP.  A 91-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single 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) all with onset 31Jul2025, outcome "unknown" and all described as "COVID After Pfizer Shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2025) Positive.  Clinical course: During an inbound call for Financial Assistance a Pfizer Representative, stated Patient's husband was calling on behalf of his wife. He did mention that patient was a 91-year-old, and she was given a prescription for Paxlovid. She became sick on Thursday. She had a high fever last night. He gave her a COVID test this morning, and it tested positive. They have had all of the Pfizer shots except this very latest one and they thought they were good. But she tested positive this morning. She called the Doctor, the Doctor called in this prescription, and the pharmacy did not have it in stock. They have ordered it, they were going to have it tomorrow. They don't know what is going to happen because she cannot afford this. He don't know whether he will have to take her to the hospital or what. When asked to speak with the patient, She was asleep in another room and she can not get up to get on the landline.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Computerised tomogram normal, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: On May 22, 2024 I experienced an episode of syncope with no prodrome and no apparent cause. I was seated at my desk typing (after eating lunch and drinking fluids), and then I was on the floor with coworkers calling my name to revive me from passing out. They let me know that I was out for ~30-60 seconds. This has never happened to me before. I was taken to the ER to rule out heart- and brain-related causes.  No cause was found. One year and two months later, on July 19, 2025, I was sitting at a table eating lunch with friends. I was in the middle of telling a story, and I suddenly passed out with no forewarning or physical signs (e.g., lightheadness, sweating). I was out for ~30 seconds. I regained consciousness in response to my husband calling my name and shaking me. The episode was followed with a persistent headache for about a week. The EKG and brain CT scan with contrast showed no irregularities. I am in the process of being evaluated a cardiologist and neurologist.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Magnetic resonance imaging head normal, Scan with contrast normal, Syncope
Clinical narrative: On May 22, 2024 I experienced an episode of syncope with no prodrome and no apparent cause. I was seated at my desk typing (after eating lunch and drinking fluids), and then I was on the floor with coworkers calling my name to revive me from passing out. They let me know that I was out for ~30-60 seconds. This has never happened to me before. I was taken to the ER to rule out heart- and brain-related causes.  No cause was found. One year and two months later, on July 19, 2025, I was sitting at a table eating lunch with friends. I was in the middle of telling a story, and I suddenly passed out with no forewarning or physical signs (e.g., lightheadness, sweating). I was out for ~30 seconds. I regained consciousness in response to my husband calling my name and shaking me. The episode was followed with a persistent headache for about a week. The EKG and brain CT scan with contrast showed no irregularities. I am in the process of being evaluated a cardiologist and neurologist.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: On May 22, 2024 I experienced an episode of syncope with no prodrome and no apparent cause. I was seated at my desk typing (after eating lunch and drinking fluids), and then I was on the floor with coworkers calling my name to revive me from passing out. They let me know that I was out for ~30-60 seconds. This has never happened to me before. I was taken to the ER to rule out heart- and brain-related causes.  No cause was found. One year and two months later, on July 19, 2025, I was sitting at a table eating lunch with friends. I was in the middle of telling a story, and I suddenly passed out with no forewarning or physical signs (e.g., lightheadness, sweating). I was out for ~30 seconds. I regained consciousness in response to my husband calling my name and shaking me. The episode was followed with a persistent headache for about a week. The EKG and brain CT scan with contrast showed no irregularities. I am in the process of being evaluated a cardiologist and neurologist.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Ageusia, Arthralgia
Clinical narrative: Joint pain began after shot 3, worsened and isolated to lower back and knees after shot 4. After shot 4, full sense of taste lost. Neither have been relieved.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Hallucination
Clinical narrative: Severe confusion, hallucinations, not making sense. Resolved in 24 hours.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrospinal fluid leakage, Intracranial pressure increased, Laboratory test, Lipoinjection
Clinical narrative: pt states that a couple of months after 2nd dose of the covid vaccine he woke up and he had a black line in his eye. He looked in the mirror and didn't see anything. He called his insurance and was referred to an ophthalmologist.  He was diagnosed with papilledema and referred to his doctor. He contacted insurance and was sent to a specialist. He lost his vision in his right eye and only has 20% vision in his left eye. Dr. gave him a shot in his lower lumbar to release the pressure. He was then sent to another doctor. He placed a catheter in his groin to go up to his brain to release the pressure. These procedures helped slow the vision loss down to where he still had 20% vision in left eye.  Then a coil was placed to  lower the pressure in and around the brain. These procedures were done in a facility.  Dr. placed a shunt in his brain. He was having fluid coming from his nose. He had to have a procedure done where they took a piece of belly fat and placed inside his nose to be cauterized so it would keep the cerebrospinal fluid  from draining out of his nose. His pressure is normal at this time and has to be checked every 6 months by Dr. and his PCP.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Papilloedema, Reduction of increased intracranial pressure, Ventriculo-peritoneal shunt, Visual impairment
Clinical narrative: pt states that a couple of months after 2nd dose of the covid vaccine he woke up and he had a black line in his eye. He looked in the mirror and didn't see anything. He called his insurance and was referred to an ophthalmologist.  He was diagnosed with papilledema and referred to his doctor. He contacted insurance and was sent to a specialist. He lost his vision in his right eye and only has 20% vision in his left eye. Dr. gave him a shot in his lower lumbar to release the pressure. He was then sent to another doctor. He placed a catheter in his groin to go up to his brain to release the pressure. These procedures helped slow the vision loss down to where he still had 20% vision in left eye.  Then a coil was placed to  lower the pressure in and around the brain. These procedures were done in a facility.  Dr. placed a shunt in his brain. He was having fluid coming from his nose. He had to have a procedure done where they took a piece of belly fat and placed inside his nose to be cauterized so it would keep the cerebrospinal fluid  from draining out of his nose. His pressure is normal at this time and has to be checked every 6 months by Dr. and his PCP.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Alopecia areata, Autoimmune disorder
Clinical narrative: Developed an autoimmune disorder, Alopecia Areata.  Noticed patches of hair falling out of my beard and eyebrows in the months following the injections.
Age: 18.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Dizziness, Fall, Staring, Tremor
Clinical narrative: Pt got up a couple min after vaccination. She went to drop off to get proof printed for school. She had a blank stare then fell, her sister caught her prior to falling but she did hit her head on the side of a pharmacy area. She was out for a couple seconds. Once she came back she slowly sat up. She was given water and popcorn. The ambulance came and took her to the hospital because she was still shaking and dizzy.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Electrocardiogram ambulatory normal, Palpitations, Supraventricular extrasystoles
Clinical narrative: I received the J&J Covid vaccine in May of 2021, and later that summer, I began experiencing heart palpitations for the first time in my life. These sensations were unfamiliar and concerning enough that I discussed them with my physician. I was prescribed a 48-hour Holter monitor test to evaluate my heart rhythm. During that monitoring period, the results showed multiple (fewer than 100) Premature Ventricular Contractions (PVCs) as well as one or possibly more Premature Atrial Contractions (PACs). At the time, I was advised that these irregularities were benign, however my physician followed up with a cardic stress test, which I passed. However, over time, the symptoms have not improved ? they have worsened. I continue to experience these palpitations, and they can be quite distressing. This has had a negative impact on my overall well-being and quality of life.  I am submitting this report now, rather than earlier, because I?ve recently learned how to better advocate for myself in medical and institutional settings. I also believe it's important to document ongoing and unresolved symptoms, even if the initial reaction occurred years ago, to contribute to the broader understanding of potential adverse effects.
Age: 42.0
Sex: F
Vaccine: FLU3, HEP, HPV9, TDAP
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy with a sore arm after receiving immunizations the day before. Site was not red, but patient states that it feels swollen and that her range of motion is limited. Advised her to follow up with us tomorrow is symptoms persist. Patient applied ice to injection site
Age: 33.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient stood up after receiving  flu and tetanus shot and stated he was feeling dizzy and sweaty. I had him sit back down and put a ice pack on the back of his neck and had him lean over. his wife got him a gatorade and he drank it. I ask him and his wife if they wanted me to call 911, they said no. He sat for a few more minutes and he felt and looked much better. I gave his wife her flu shot and he said he felt much better and could leave. I asked him to call if he had any problems and asked his his wife if she would drive them home, she said she would. I counseled them on any signs or symptoms to look for if he were to have any later allergic reaction.
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: Itchy eyes at night; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: EYE PRURITUS (non-serious), outcome "unknown", described as "Itchy eyes at night".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: TINNITUS (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500157611 same patient/reporter, different vaccine dose/AE;US-PFIZER INC-202500158063 same patient/reporter, different vaccine dose/AE;
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine; Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Didn't like the results of Covid vaccine/It didn't deliver on efficacy of COVID vaccine".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE. PATIENT WAS FEELING WELL AFTER VACCINE AND 5 DAYS AFTER EVENT, PATIENT WAS FEELING WELL
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: There was no adverse event. The patient's mother was contacted and stated her daughter is feeling good, and there were no problems after the administration of the vaccine
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Discoloured vomit, Enema administration, Intussusception, Metabolic function test
Clinical narrative: vaccines administered at 10:55am. Father called office around 3:00pm stating infant was vomiting and crying. Child had several episodes of non-bloody emesis that was described as green and parents took him to ED. Ultrasound showed ileocolic intussusception. Pt transferred to hospital overnight and  had air enema which reduced intussusception.  Child monitored >24 hours and intussusception did not recur. Child discharged home on regular diet.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: vaccines administered at 10:55am. Father called office around 3:00pm stating infant was vomiting and crying. Child had several episodes of non-bloody emesis that was described as green and parents took him to ED. Ultrasound showed ileocolic intussusception. Pt transferred to hospital overnight and  had air enema which reduced intussusception.  Child monitored >24 hours and intussusception did not recur. Child discharged home on regular diet.
Age: 90.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: patient said she is experiencing diarrhea and nausea.
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Dizziness, Drug ineffective, Fatigue
Clinical narrative: fatigue; dizziness; fogginess; covid again the past Jun; covid again the past Jun; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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 included: "covid", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3, BOOSTER), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "covid again the past Jun"; FATIGUE (hospitalization), outcome "unknown"; DIZZINESS (hospitalization), outcome "unknown"; BRAIN FOG (hospitalization), outcome "unknown", described as "fogginess".  Clinical Course: Patient reported taking 4 pfizer vaccines and covid again the past Jun. Currently on leave because of neurological and vestibular symptoms due to covid. Patient was in the hospital diagnosed with fatigue, dizziness and fogginess and is interested in participating in a trial.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Gillian Barre; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Gillian Barre) (serious criteria death and GSK medically significant). The reported cause of death was guillain barre syndrome.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by a consumer via interactive digital media. Reporter did not get the shingles vaccine.  He/she had a friend who got it, and she died from Guillain-Barre syndrome. Look it up.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.; Reported Cause(s) of Death: Guillain-Barre syndrome
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Guillain-Barre syndrome, Mobility decreased
Clinical narrative: I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome; Bedridden; I can't move at all; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: I got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome) (serious criteria GSK medically significant), bedridden (Verbatim: Bedridden) and mobility decreased (Verbatim: I can't move at all). The outcome of the guillain barre syndrome, bedridden and mobility decreased were not resolved.   It was unknown if the reporter considered the guillain barre syndrome, bedridden and mobility decreased to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the bedridden and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the vaccine, and it triggered a chronic case of Gillian Barre Syndrome. He or she also reported that become so weak and can't move at all, and the treatment for Gillian Barre had started to affect my kidneys. He or she was now completely bedridden. The follow-up could not be possible as no contact details were available.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic hives treated biweekly Xolair and daily Xyzal
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Patient received PCV21 vaccine on 05 August 25  and woke up on 06 Aug 25 with sweating, left arm pain, chills, light headedness, loss of control of bladder, fatigue, hip pain, right arm pain and generalized inflammation in the area of vaccination.  Patient was seen in clinic 08 Aug 2025, and treated with the following medications for the next seven days: Zyretc 10mg, Pepcid 20mg, Hydrocortisone cream 1% , Decadron 4mg IM.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site inflammation, Injection site pain, Pain in extremity, Urinary incontinence
Clinical narrative: Patient received PCV21 vaccine on 05 August 25  and woke up on 06 Aug 25 with sweating, left arm pain, chills, light headedness, loss of control of bladder, fatigue, hip pain, right arm pain and generalized inflammation in the area of vaccination.  Patient was seen in clinic 08 Aug 2025, and treated with the following medications for the next seven days: Zyretc 10mg, Pepcid 20mg, Hydrocortisone cream 1% , Decadron 4mg IM.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Inflammation, Urticaria, Vertigo
Clinical narrative: Patient reported getting a whelt, nausea, diarrhea, inflammation and vertigo symptoms during the night after vaccine.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient had itching following administration
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head abnormal, Electroencephalogram abnormal, Epilepsy, Hyperventilation, Magnetic resonance imaging head normal
Clinical narrative: She had TDAP vaccine 8/14/25, then subsequently seen the following day 8/15 in quick care for syncopal episode, then subsequently in the ED that same day for seizures. She was admitted to the hospital and has been managed with neurology for epilepsy since then. Dad is unsure if incident was reported through the vaccine adverse events system at the time of the event, but would like to make sure it is.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Scalp haematoma, Seizure, Syncope, Ultrasound abdomen normal
Clinical narrative: She had TDAP vaccine 8/14/25, then subsequently seen the following day 8/15 in quick care for syncopal episode, then subsequently in the ED that same day for seizures. She was admitted to the hospital and has been managed with neurology for epilepsy since then. Dad is unsure if incident was reported through the vaccine adverse events system at the time of the event, but would like to make sure it is.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received an adult dose of Moderna.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, CSF white blood cell count increased, Clostridium difficile infection, Computerised tomogram normal, Confusional state
Clinical narrative: Pt was in the ER on 7/25/25 and was given the rabies vaccine.  The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile.  She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Encephalitis, Feeding disorder, Hypersomnia, Insomnia
Clinical narrative: Pt was in the ER on 7/25/25 and was given the rabies vaccine.  The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile.  She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Magnetic resonance imaging normal, Malaise, Mental status changes, Mobility decreased
Clinical narrative: Pt was in the ER on 7/25/25 and was given the rabies vaccine.  The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile.  She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Anxiety, Aphasia, CSF culture negative, Cerebral infarction, Clostridium test positive
Clinical narrative: Pt was in the ER on 7/25/25 and was given the rabies vaccine.  The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile.  She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
Age: 82.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypophagia, Klebsiella test positive, Magnetic resonance imaging head abnormal, Mental status changes
Clinical narrative: Pt was in the ER on 7/25/25 and was given the rabies vaccine.  The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile.  She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two doses of Prevnar 20. One was given on 02/14/2025 and the other on 08/06/2025. No adverse symptoms were reported by patient.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain, Vaccination site urticaria
Clinical narrative: Body aches and pains; Chest pain within 48 hours. A 5/10 on pain. Tightness; raised warm welt at injection site within 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours) in a 24-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 01-Aug-2025, the patient experienced PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours). At the time of the report, PAIN (Body aches and pains), CHEST PAIN (Chest pain within 48 hours. A 5/10 on pain. Tightness) and VACCINATION SITE URTICARIA (raised warm welt at injection site within 24 hours) had not resolved.      The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   Concomitant medication was not reported.   Patient had body aches and pains, raised warm welt at injection site within 24 hours, chest pain within 48 hours, A 5/10 on pain, and tightness.  It was unknown if she experienced any additional symptoms/events. The patient had no medical history, concomitant disease, or risk factor. There were no lab data/results available.   Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Polymerase chain reaction
Clinical narrative: Got Covid about 9 months after getting Novavax, last August 2024; This non-serious initial spontaneous report was reported by a Physician via contact center (MI No. NOV25-00560) and concerns a 69-year-old Female who experienced "GOT COVID ABOUT 9 MONTHS AFTER GETTING NOVAVAX, LAST AUGUST 2024" on an unspecified date in August 2024 after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on an unknown day.  At the time of the report, the outcome of the Breakthrough COVID-19 was Unknown.; Sender's Comments: This 69-year-old Female experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Breakthrough COVID-19 was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Breakthrough COVID-19 is considered Possible.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Insomnia, Pain
Clinical narrative: Upper Back pain; excruciating pain; unable to sleep consistently through the night; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 at 12:30 as dose 3, single (Lot number: SENG6198) at the age of 57 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Hypersensitivity". The following information was reported: BACK PAIN (non-serious), outcome "recovering", described as "Upper Back pain"; PAIN (non-serious), outcome "recovering", described as "excruciating pain"; INSOMNIA (non-serious), outcome "recovering", described as "unable to sleep consistently through the night".  Additional information: the pain starts on the right side of his ribs.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 65-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. Vaccination history included: Bnt162b2 (Primary Immunization series complete.), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Aug2025, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2025) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.