chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Neoplasm malignant, Thrombosis
Clinical narrative: Two cancers, a stroke, blood clots
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: resident passed away
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms documented. Patient received 3rd dose MMR on 7/30/2025. Previous doses were given 9/27/22, 4/9/2025. A follow call was made by an RN, and patient reported to be well. Parent denied any symptoms.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient unintentionally received 2 doses of Menveo in the right deltoid at the same time. Doses were of different lot numbers. One dose's lot number was AMVB056A, the other lot number is unknown. The pre-mixed single dose of Menveo was unintentionally used to reconstitute the powder of another Menveo lot. Patient has no adverse reactions.
Age: 34.0
Sex: F
Vaccine: PNC21
Symptoms: Myalgia
Clinical narrative: Patient describes painless and event free vaccination for rabies in early May with a 2 vaccine series. Patient describes ongoing arthralgia 1 week following vaccination, exacerbated by strenuous physical exercise. Patient was not experiencing the left deltoid pain until 1 week following vaccination, to be clear. The pain was brought on initially when driving, exacerbated while rowing a raft. She was encouraged to follow up with a physical therapist and primary care, as I believe the cause is most likely not associated with vaccination, though could have been exacerbated by introduction of IM injection. Patient is very clear that vaccination itself was painless, uneventful, and without symptoms for days following.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Aphasia, Brain fog, Cognitive disorder, Computerised tomogram ear
Clinical narrative: After taking the vaccine, I noticed changes going on in my body.  I felt like my body was vibration internally. Another time I ended up in the hospital with bad chest palpitations.  A month or so after the vaccine, I started to notice a hissing or buzzing sound in my ears, that wasn?t bothersome at first.  Fast forward to 2024, I started having hearing loss and extreme hissing or buzzing sound in my ears that has gotten progressively worst.  It has affected my cognitive function, memory or brain fog.  I am having trouble remembering words, names or even spelling some of them.  I lived a relative healthy life before I took this Johnson and Johnson vaccine.   The most I complained out up until then was some back pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Memory impairment, Palpitations, Sensory disturbance, Tinnitus
Clinical narrative: After taking the vaccine, I noticed changes going on in my body.  I felt like my body was vibration internally. Another time I ended up in the hospital with bad chest palpitations.  A month or so after the vaccine, I started to notice a hissing or buzzing sound in my ears, that wasn?t bothersome at first.  Fast forward to 2024, I started having hearing loss and extreme hissing or buzzing sound in my ears that has gotten progressively worst.  It has affected my cognitive function, memory or brain fog.  I am having trouble remembering words, names or even spelling some of them.  I lived a relative healthy life before I took this Johnson and Johnson vaccine.   The most I complained out up until then was some back pain.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received vaccine on 8/1/25 and again on 8/7/25 - no side effects reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dry eye, Dyspnoea, Erythema, Eye irritation
Clinical narrative: I went back to work and my arm was swelling up and it turned red and i got really weak. The lady i was taking care of at the time thought i had COVID so she sent me home. And i went to the hospital and they gave me a shot for the swelling of my arm and they took pictures. And i have been messed up ever since with sinus infections, eyes burning, dry eyes, and headaches, I'm also always out of breath.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Peripheral swelling, Sinusitis
Clinical narrative: I went back to work and my arm was swelling up and it turned red and i got really weak. The lady i was taking care of at the time thought i had COVID so she sent me home. And i went to the hospital and they gave me a shot for the swelling of my arm and they took pictures. And i have been messed up ever since with sinus infections, eyes burning, dry eyes, and headaches, I'm also always out of breath.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Product preparation issue
Clinical narrative: Patient was given all 3 doses in the Pfizer Covid yellow cap vial for 6month to 4 year olds without the dilution added to the vial.
Age: 67.0
Sex: M
Vaccine: COVID19, MMR
Symptoms: Anxiety, Condition aggravated, Dizziness, Dyspnoea, Hypertension
Clinical narrative: The day after receiving both the COVID-19 ( Moderna ) and the MMR II vaccines patient started feeling very anxious, nausea, dizziness and shortness of breath. Patient called his primary care doctor but because it was Saturday he was directed to the Emergency Room.  They did a full workup, EKG and blood work.  His blood pressure was high.  He was told by the doctor it wasn't necessary for him to receive the MMR II since he got this as an child.
Age: 67.0
Sex: M
Vaccine: COVID19, MMR
Symptoms: Nausea
Clinical narrative: The day after receiving both the COVID-19 ( Moderna ) and the MMR II vaccines patient started feeling very anxious, nausea, dizziness and shortness of breath. Patient called his primary care doctor but because it was Saturday he was directed to the Emergency Room.  They did a full workup, EKG and blood work.  His blood pressure was high.  He was told by the doctor it wasn't necessary for him to receive the MMR II since he got this as an child.
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: SARS-CoV-2 infection post vaccine; This serious initial Spontaneous (Literature) safety report was received by Novavax on 04-Aug-2025 from a Consumer or other non-health professional.  An individual of an unspecified age (65 year or older) and unspecified gender was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report), on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date after vaccination, the patient experienced "SARS-CoV-2 infection post vaccine" (Breakthrough COVID-19) (Serious: Caused/Prolonged Hospitalization).  At the time of reporting, the event outcome of Breakthrough COVID-19 was Unknown.; Sender's Comments: This individual of an unspecified age (65 year or older) and unspecified gender experienced Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Breakthrough COVID-19 was reported as 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autonomic nervous system imbalance, Brain fog, Exercise tolerance decreased, Fatigue
Clinical narrative: Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypotension, Impaired work ability, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Orthostatic intolerance, Postural orthostatic tachycardia syndrome, Pyrexia, Wheelchair user
Clinical narrative: Fever, joint pain, fatigue, nausea, brain fog after injection, continued dysautnomia including POTS, hypotension, hot flashes, and orthostatic intolerance, joint pain, muscle weakness, brain fog, unrelenting fatigue, exercise intolerance resulting in significant disability including need for wheelchair and loss of ability to work or perform ADLS without assistance
Age: 79.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Rph administered a dose of Boostrix while patient had it recently (09/07/2024). There was no justification for a dose so close to prior (i.e. cut/injury, Newborn baby etc) checked with patient.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Alcohol intolerance, Allergy test negative, Anaphylaxis treatment, Dyspnoea, Erythema
Clinical narrative: The vaccine was given at Super Store in (withheld).  The groceries I purchased, I thought had been poisoned as I was extremely sick for a week.  My fav Xmas gift from my husband each year is perfume.  That Xmas, I reacted to by becoming bright red and had a hard time breathing.  From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot.  I had to stop drinking wine or beer.  I have been to the ER twice for the worse cases of hives because of air borne flowering bushes.  Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Lip swelling, Malaise, Perfume sensitivity, Swelling face
Clinical narrative: The vaccine was given at Super Store in (withheld).  The groceries I purchased, I thought had been poisoned as I was extremely sick for a week.  My fav Xmas gift from my husband each year is perfume.  That Xmas, I reacted to by becoming bright red and had a hard time breathing.  From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot.  I had to stop drinking wine or beer.  I have been to the ER twice for the worse cases of hives because of air borne flowering bushes.  Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The vaccine was given at Super Store in (withheld).  The groceries I purchased, I thought had been poisoned as I was extremely sick for a week.  My fav Xmas gift from my husband each year is perfume.  That Xmas, I reacted to by becoming bright red and had a hard time breathing.  From that day on ward, I was totally allergic to anything with scent [laundry soap, shampoo, conditioner, dish soap, perfume, flowers with scent] as well, hard drinks caused my face to become red and hot.  I had to stop drinking wine or beer.  I have been to the ER twice for the worse cases of hives because of air borne flowering bushes.  Hives on my scalp and all over my body, with swollen lips and face that eppy shots were needed.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy in all four extremities. More stronger on left side/arm as left arm was where injections where given. I received initial shot and two boosters. All Moderna. Second booster is what gave me reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: skin lesions in face and back; This serious case was reported by a pharmacist via sales rep and described the occurrence of skin lesion in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included recurrent urinary tract infection.   On 26-MAY-2025, the patient received the 1st dose of Shingrix. On 30-JUN-2025, 35 days after receiving Shingrix, the patient experienced skin lesion (Verbatim: skin lesions in face and back) (serious criteria other: Other medically imp. condition). The outcome of the skin lesion was not resolved.   The reporter considered the skin lesion to be related to Shingrix.     The company considered the skin lesion to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 05-AUG-2025 Patient reported skin lesions in face and back was reported as worsened. Patient with skin lesions (similar to shingles lesion) need to consult specialist dermatologist. The patient was taking antibiotics for Recurrent urinary tract infections.; Sender's Comments: A case of  Skin lesion, 35 days after receiving Shingrix, in a  66-year-old male patient.  Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Antibody test negative, Autoimmune disorder, Rheumatoid arthritis, Systemic lupus erythematosus, Varicella virus test negative
Clinical narrative: Consumer calling reports VARIVAX AE. Consumer reports she recently had blood work done and it showed no immunity to chicken pox. Consumer reports she received the VARIVAX vaccine as a child (unknown age of administration) and now at 21 years old she; lupus; autoimmune disorder; have rheumatoid arthritis; Information has been received from Business Partner/CRO on 08-Aug-2025.  This spontaneous report was received from an Consumer or other non health professional and refers to a 21-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot # and expiration date were not reported). On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prevention.  On an unknown date, the patient experienced autoimmune disorder, lupus syndrome, rheumatoid arthritis and varicella virus test negative. The patient recently had blood work done and it showed no immunity to chicken pox. She is not sure if her current prescription could be causing the lack of immunity. She currently seeing a rheumatologist and taking a prescription Hydroxychloroquine to mitigate symptoms of a possible autoimmune disorder. The patient has symptoms of an autoimmune disorder and she may have rheumatoid arthritis or lupus but has not had an official diagnosis.  At the reporting time, the patient had not recovered from the events   The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.   The causal relationship between the events and sterile diluent was not provided. The causal relationship between the events and Varicella Virus Vaccine Live (Oka-Merck) was not provided.    Upon internal review, the events of lupus autoimmune disorder and have rheumatoid arthritis were determined to be medically significant.
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Paraplegia
Clinical narrative: believed it was called GBS; paralyzed from the waist down; 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, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: believed it was called GBS) (serious criteria GSK medically significant) and acute paraplegia (Verbatim: paralyzed from the waist down) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and acute paraplegia were not reported.   It was unknown if the reporter considered the guillain barre syndrome and acute paraplegia to be related to Shingles vaccine.     The company considered the guillain barre syndrome and acute paraplegia to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-AUG-2025 This case was reported by the friend of the patient via interactive digital media. The reporters buddy (patient) received the vaccine for this and was almost instantly paralyzed from the waist down. The reporter believed that it was called Guillain-Barre Syndrome (GBS), it was rare, but it happened.; Sender's Comments: A case of Guillain-Barre syndrome and Paraplegia,  immediately 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.
Sex: F
Vaccine: RVX
Symptoms: Death
Clinical narrative: passed way yesterday do to the  vaccine;  This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On 06-AUG-2025, an unknown time after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: passed way yesterday do to the  vaccine) (serious criteria death and GSK medically significant). The patient died on 06-AUG-2025. The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to RSV vaccine.     The company considered the unknown cause of death to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 07-AUG-2025 This case was reported by a patient's sibling via interactive digital media. The patient passed away yesterday due to the RSV vaccine .; Sender's Comments: The company considers that there was no reasonable possibility that the event death may have been caused by RSV vaccine. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.; Reported Cause(s) of Death: Unknown cause of death
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Asthma, Pneumonia, Respiratory syncytial virus infection
Clinical narrative: It triggered my asthma; pneumonia and put me into the hospital; caught RSV a year and a half ago; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (It triggered my asthma), PNEUMONIA (pneumonia and put me into the hospital) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect products included non-company products Pneumococcal vaccine for an unknown indication and Influenza vaccine for an unknown indication.    The patient's past medical history included Respiratory syncytial virus infection. Concurrent medical conditions included Asthma (acute asthma) and Immune system disorder (compromised immune system).   On 03-Apr-2025, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 03-Aug-2025, received dose of Influenza vaccine (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine (unknown route) 1 dosage form. In February 2024, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) (seriousness criterion hospitalization). On an unknown date, the patient experienced ASTHMA (It triggered my asthma) (seriousness criterion hospitalization) and PNEUMONIA (pneumonia and put me into the hospital) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHMA (It triggered my asthma) and PNEUMONIA (pneumonia and put me into the hospital) outcome was unknown and RESPIRATORY SYNCYTIAL VIRUS INFECTION (caught RSV a year and a half ago) was resolving.            No concomitant medication was reported.  Patient was interested in receiving the RSV vaccine as she had RSV a year and a half ago. She was recovering from it. It triggered her asthma, had pneumonia and went to the hospital. Patient was up to date with every single COVID booster that the patient got. Patient was up to date with pneumonia and flu vaccines. Patient got influenza vaccine on 03-Apr-2025 and got another one 03-Aug-2025. Patient got every vaccine she needed to get only with the exception of the two that were shingles and the RSV. No additional details provided.  It is unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.   Reporter did not allow further contact; Reporter's Comments: Co-suspect products Pneumococcal and Influenza vaccine; past medical history of Respiratory syncytial virus infection, asthma and Immune system disorder are contributors for the events. Due to lack of biological plausibility, the causality of the events Pneumonia and  Respiratory syncytial virus infection  was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) in a 94-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Family history included Cancer (The reporter states that cancer runs in her family) since an unknown date. Concurrent medical conditions included Systemic lupus erythematosus (auto immune disorders (lupus)) and Autoimmune disorder (Patient has a bunch of autoimmune diseases and she is a wreck. The reporter confirmed that her autoimmune illnesses were present before receiving the COVID vaccine).   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2025, the patient experienced NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (had 5 Moderna COVID vaccines and was diagnosed with cancer yesterday) outcome was unknown.            No concomitant medication was reported.  The reporter stated that she had 5 Moderna COVID vaccines and was diagnosed with cancer a day before reporting, even though she had known it for 8 months.  The reporter stated that she really needed the COVID vaccine because there were many things wrong with her and she had a house full of people who won't go by the rules.  The reporter stated that she did not believe there to be a connection to the vaccine.  It was unknown if the patient experienced any additional symptoms or events.  No treatment information was provided.; Reporter's Comments: Concurrent medical condition Systemic lupus erythematosus is a contributor for the event. Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) in a 61-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) had resolved with sequelae.            No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events.  The patient did not know the details of medication and reason for taking the medicine. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mass, Neoplasm malignant
Clinical narrative: Enlarged lymph node on left side of the neck. Started 1 year after vaccination. Saw a physician regarding lump 2 years after vaccination. Diagnosed with cancer 4 years after vaccination
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was administered the pediatric dose of Covid Vaccine. There were no adverse reactions. Patient did not have any symptoms related to administered dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Covid vaccine after the past use date.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Nail operation, Nail ridging, Onychoclasis, Onychomadesis
Clinical narrative: About one week after he notices ridges in his nails on the fingers of both hands.  This progressively became worse and his nails are "decaying" and flaking and falling off.  They are splintering and chipping off his fingers.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Onychomycosis
Clinical narrative: About one week after he notices ridges in his nails on the fingers of both hands.  This progressively became worse and his nails are "decaying" and flaking and falling off.  They are splintering and chipping off his fingers.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Patient came to pharmacy today (8/13/25) to discuss vaccinations. While we were talking, she informed me that she experienced severe vertigo for about 4 months that started 10 days after she was vaccinated with the covid vaccine. She also mentioned that she was hospitalized for the vertigo for a period of time (did not get dates for this). She said this reaction never happened with any of the other covid shots she got (all Pfizer)
Age: 64.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, soreness, and heat around the injection site which is currently ongoing at time of reporting. patient states that after the initial pain from the shot, the other symptoms followed a day or two later.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypoacusis, SARS-CoV-2 test
Clinical narrative: Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday and it tested positive; Tested positive; speak louder cause I can't really hear; This is a spontaneous report received from a Consumer or other non HCP.  A 71-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: HYPOACUSIS (non-serious) with onset 2025, outcome "unknown", described as "speak louder cause I can't really hear"; DRUG INEFFECTIVE (medically significant) with onset 05Aug2025, outcome "unknown", described as "Taking the vaccines (Pfizer Covid-19 Vaccine) in the past; Took rapid test, antigen test yesterday and it tested positive"; COVID-19 (medically significant) with onset 05Aug2025, outcome "unknown", described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2025) positive; (05Aug2025) positive.  Clinical course: The patient mentioned taking the vaccines (clarified as Pfizer Covid-19 Vaccine) in the past. Took antigen test yesterday and it tested positive and just was prescribed the medication (Clarified as Paxlovid) today and some cough syrup. Patient have covid and head feels like it's underwater and can't hear really well. Patient have not taken Paxlovid yet and have to go pick it up. Patient was not feeling well.    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19, COVID19
Symptoms: Heat illness, Hypoaesthesia, Paraesthesia
Clinical narrative: due to heat, effects from the heat; numbness; tingling sensation; 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: HEAT ILLNESS (death), outcome "fatal", described as "due to heat, effects from the heat"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation". The patient date of death was unknown. Reported cause of death: "due to heat, effects from the heat". It was not reported if an autopsy was performed. Additional information: reporter stated two "kids" have died and they claimed it was due to heat, effects from the heat. They were in running/in sports. They were having numbness/tingling sensation. The reporter added that this vaccine affects the nerves, heart, and lungs.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500161086 same reporter/products/events, different patient;; Reported Cause(s) of Death: due to heat, effects from the heat
Vaccine: COVID19, COVID19
Symptoms: Heat illness, Hypoaesthesia, Paraesthesia
Clinical narrative: have died and they claimed it was due to heat, effects from the heat.; numbness; tingling sensation; 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: HEAT ILLNESS (death), outcome "fatal", described as "have died and they claimed it was due to heat, effects from the heat."; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation". The patient date of death was unknown. Reported cause of death: "have died and they claimed it was due to heat, effects from the heat.". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500161085 same reporter/events, different patient;; Reported Cause(s) of Death: have died and they claimed it was due to heat, effects from the heat.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Chronic obstructive pulmonary disease, Drug ineffective
Clinical narrative: COVID after Pfizer COVID shots; COVID after Pfizer COVID shots; Asthma; COPD; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID shots"; ASTHMA (non-serious), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD". The events "covid after pfizer covid shots", "asthma" and "copd" required physician office visit. Additional information: patient went to the pharmacy, diagnosed with COVID, for Paxlovid. The doctors prescribed this medication from Urgent Care. Patient had asthma with COPD. All his shots were with Pfizer and added he "got all of them except the last one" and his primary doctor told him to wait a while to get it cause he had done all the rest of them. Patient added "the last one got bout the same thing that the one before that had in it". Primary doctor will let him know when to come get it (COVID shot).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diabetes mellitus, Drug ineffective, Lung neoplasm malignant, Pulmonary sarcoidosis
Clinical narrative: diabetes; lung cancer; sarcoid of the lung; COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "COVID"; LUNG NEOPLASM MALIGNANT (medically significant) with onset 2025, outcome "unknown", described as "lung cancer"; PULMONARY SARCOIDOSIS (medically significant) with onset 2025, outcome "unknown", described as "sarcoid of the lung"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". Clinical course: Patient recently fell Ill to COVID, and was informed he was able to get Paxlovid. Much to his surprise of the cost of this medicine (stated as ridiculous). Patient and his wife did get the Pfizer shot at the start of year (2025). Patient is also dealing with diabetes, sarcoid of the lung (an autoimmune disease) and recently found out to have lung cancer.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did not work; did not work; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not work".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Electrocardiogram abnormal, Electromyogram abnormal, Fatigue
Clinical narrative: PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypertensive crisis, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Lower limb fracture, Mobility decreased, Muscle atrophy, Syncope
Clinical narrative: PAIN SWELLING SWEATING AT THE INJECTION SITE. FAILED EMG PROGRESSIVE WEAKNESS TO WHOLE BODY HYPERTENSIVE CRISIS BP IN 2 WEEK AFTER SHOT AND FOR ABOUT 12 MONTH AFTER BP HAS STABALIZED ALL OVER WEAKNESS SYNSCOPE FROM BP THAT CAUSED BLOOD PRESSURE DROP RESULT BROKEN LEG UNSABLE TO CLIMB STAIRS UNABLE TO SIT UP FOR LONGER THAN 10 MINS UNABLE TO WALK LONG DISTANCE CONSTANT FATIGUE ATROPHY MUSCLE WAISTING
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Pain in the arm was addressed with our pharmacy the next day in February 2025. August 2025 addressed it was numbness in the arm
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in the arm was addressed with our pharmacy the next day in February 2025. August 2025 addressed it was numbness in the arm
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Seizure like phenomena, Syncope
Clinical narrative: Syncopal episode, dizziness, seizure like activity,
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: patient experiencing injection site reaction below the injection area. redness and warmth with some soreness
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain, Chronic kidney disease
Clinical narrative: 1 hour after shot, patient grabbed her chest and gasped for a moment. Then at about 30 hours after the vaccine, she started having severe chest pain as if she was having a heart attack.  We went to ER and they found nothing significant.  We went home, she tried to nap but felt the same severe pain so we went to another ER.  She then was in and out of ERs about 10-15 times over the next month, with severe Afib issues, needing to have her heart stopped/restarted to control the Afib.  On Dec 1-10 she was put in Hospitol for 10 days for pneumonia  and to control the Afib.  Had 2 stints put in and by the end of that Hospitol stay, she was labeled as having  congestive heart failure and significant kidney damage (within 4 months she was labeled as having Stage 3 kidney failure).  She repeatedly was in and out of the hospitol until May 25, 2025 when she passed away.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Coronary arterial stent insertion, Death, Electrocardiogram, Pneumonia
Clinical narrative: 1 hour after shot, patient grabbed her chest and gasped for a moment. Then at about 30 hours after the vaccine, she started having severe chest pain as if she was having a heart attack.  We went to ER and they found nothing significant.  We went home, she tried to nap but felt the same severe pain so we went to another ER.  She then was in and out of ERs about 10-15 times over the next month, with severe Afib issues, needing to have her heart stopped/restarted to control the Afib.  On Dec 1-10 she was put in Hospitol for 10 days for pneumonia  and to control the Afib.  Had 2 stints put in and by the end of that Hospitol stay, she was labeled as having  congestive heart failure and significant kidney damage (within 4 months she was labeled as having Stage 3 kidney failure).  She repeatedly was in and out of the hospitol until May 25, 2025 when she passed away.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dyspnoea, Electric shock sensation, Headache, Immediate post-injection reaction
Clinical narrative: Patient experienced shortness of breath, became clammy and had a headache immediately after vaccine. About 5 minutes later, she started to feel better, however, her blood pressure was 207/98. It appeared to be a panic attack. She states that it felt like an electric shock when the vaccine was given. Her son then took her to the ER to be evaluated.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experienced shortness of breath, became clammy and had a headache immediately after vaccine. About 5 minutes later, she started to feel better, however, her blood pressure was 207/98. It appeared to be a panic attack. She states that it felt like an electric shock when the vaccine was given. Her son then took her to the ER to be evaluated.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Eye pruritus, Generalised tonic-clonic seizure, Headache
Clinical narrative: Patient's guardian reported grand mal seizures the morning after vaccination.  Patient was sent EMS to hospital.  Guardian reports no side effects the evening after vaccination. Patient participated in a cross-country team run through a corn field that evening.  A headache was reported to Guardian, who recommended on Tylenol.  Guardian reported early in the morning the patient was acting unusual and patient reported to the guardian that they had taken 5 benadryl for itchy eyes the night before.  The patient had grand mal seizure early that morning, witness by Guardian, who is a school nurse.  EMS responded and patient was sent to Hospital before being transferred to another hospital.  Guardian reports that the hospital MD and PCP agreed that the benadryl was  most likely the cause of the seizures.  Of note, the biological sister reportedly was hospialized for a seizure two weeks prior to this event.  No history of personal or family history  of seizure disorders were known of previously.  Guardian was present for all DTAP and TDAP given in 2018 and no adverse effects were noticed after those vaccinations.  Guardian reports that the patient has recovered back to baseline.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Memory impairment
Clinical narrative: Memory started to go bad.  I had a hard time remember things.  I because fuzzy minded.  My short term memory was affected as I couldn't recall thing as sharply as I used to.
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   The reporter considered the unknown cause of death to be possibly related to Shingles vaccine.     The company considered the unknown cause of death to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter's cousin got the shot, died three days later. It was reported as there seems to be a connection. Keep your shot.; Sender's Comments: A case of Death, 3 days 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. US-GSK-US2025AMR104452:Original Case Number : US2025AMR104452_Same reporter; Reported Cause(s) of Death: Unknown cause of death
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Vaccine overdose; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 062E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 2 milliliter. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criteria disability and medically significant) and OVERDOSE (Vaccine overdose). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) had not resolved and OVERDOSE (Vaccine overdose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had no medical history, concomitant disease, or risk factor.  Vaccine had compromised his immune system and had induced psoriatic arthritis.  It was reported as 95,000.00 a year as an MRI Technologist, 43-year career gone because the vaccine altered his immune system.  It was unknown if the patient experienced any additional symptoms or events.  The patient was taking topical steroids. The patient had dermatology biopsy. There were no additional lab data or results available.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500097878 Same reporter/product/event, different patient;