chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: immunization not given in deltoid, too low. rash around injection site.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster reactivation, Inappropriate schedule of product administration
Clinical narrative: Dose 1: March 2020/Dose 2: June 2020; It was after dose 2 - 6 weeks to the day again. another case of shingles; This is a spontaneous report and received from Other HCPs.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Jun2020 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIVALO taken for blood cholesterol increased. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Mar2020, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "Herpes zoster reactivation". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Jun2020, outcome "unknown", described as "Dose 1: March 2020/Dose 2: June 2020"; HERPES ZOSTER REACTIVATION (non-serious) with onset 2020, outcome "unknown", described as "It was after dose 2 - 6 weeks to the day again. another case of shingles".  Additional information: The patient called her MD and opted not to take anti-viral as she was afraid it would interfere with effectiveness of the vaccine. Afer dose 1, the patient did not correlate the shingles to the vaccine; it was after dose 2 - 6 weeks to the day again another case of shingles. Never had an issue with a vaccine before.  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-202500074522 same patient, different dose and event;
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient described it as hives all over the body that was extremely itchy and debilitating.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient describes constant dull pain in left arm affecting activities of daily living that has not gotten better or subsided since getting vaccine on 5/12/25, Other Vaccines:  VaccineTypeBrand: Boostrix; Manufacturer: glaxosmithkline; LotNumber: EB499; Route: Intramuscular; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: limited range of motion of the injected arm-Medium, Additional Details: Patient states that the issue with range of motion is slowly improving but hasn't fully recovered. Patient will mention to PCP if no improvement
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Flushing, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt had fainted, was pale and was sweating. 911 was called and the emt took pt out to the ambulance to examin her. I spoke with her father ( who brought her for the vaccine) 5/24/25 and he stated pt was doing well and did not go to hospital
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt had fainted, was pale and was sweating. 911 was called and the emt took pt out to the ambulance to examin her. I spoke with her father ( who brought her for the vaccine) 5/24/25 and he stated pt was doing well and did not go to hospital
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Diarrhea-Mild, Systemic: Headache-Mild, Systemic: Vomiting-Mild, Additional Details: per urgent care visit states virus infection
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Viral infection, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Diarrhea-Mild, Systemic: Headache-Mild, Systemic: Vomiting-Mild, Additional Details: per urgent care visit states virus infection
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Lethargy, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Unable to Sleep-Medium
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Unable to Sleep-Medium
Age: 49.0
Sex: M
Vaccine: PNC21
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever of 100.5 F, headache, extreme soreness at injection site and from shoulder to elbow and significant fatigue.  Symptoms lasted for approximately 72 hours.
Age: 11.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: No adverse event, Product preparation error
Clinical narrative: RN mixed 0.75cc sterile water with Meningococcal Conjugate.  I talked to manufacturer 05/28/2025 and they stated that shot would need to be given again asap.  I contacted the father today and explained what happened.  Father stated son was doing well today. Patient will receive another dose on June 4th, 2025.
Age: 11.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: No adverse event, Product preparation issue
Clinical narrative: RN mixed 0.75cc sterile water with Meningococcal Conjugate.  I talked to manufacturer 05/28/2025 and they stated that shot would need to be given again asap.  I contacted the father today and explained what happened.  Father stated son was doing well today. Patient will receive another dose on June 4th, 2025.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin lesion
Clinical narrative: 2 days after injection had 3 blisterlike lesion on her right thumb.  no injury or other reason for blisters.   no symptoms otherwise - just the blisters.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Kinrix at 4 months of age.  This is not the correct vaccine to have been given.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccination given was expired. Date of administration: 05/28/2025, Date of expiration: 05/23/2025.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Anxiety, Blood test normal, Dyspnoea, Fatigue, Lethargy
Clinical narrative: I was visiting for my annual. Everything was great and i was in good health. The Nurse asked me if I would like the shingles vaccination.  I said sure. Later that day i started feeling a  tired  and lethargic. I tried to play golf the next morning and I was unable to finish the round from pure exhaustion. I then started having bad anxiety attacks and sleep deprivation.  I started waking up in the night and with the feeling that i coudn't breathe and the feeling of panic. The panic attacks started out for just a few hrs but then would happen again and again at longer intervals. I ended up in the ER with an attack that lasted over 10 hrs. It was so bad i wanted to kill myself.  Worst experience ever. The panic attacks started getting lesser and shorter. I still felt unrest and like there was a battery plugged into my brain making it hard to relax or sleep.   At around the 30 -40 day mark the symptoms finally went away.  I finally feel like myself again but i am constantly in feer that i will feel that way again.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Panic attack, Sleep deficit, Suicidal ideation
Clinical narrative: I was visiting for my annual. Everything was great and i was in good health. The Nurse asked me if I would like the shingles vaccination.  I said sure. Later that day i started feeling a  tired  and lethargic. I tried to play golf the next morning and I was unable to finish the round from pure exhaustion. I then started having bad anxiety attacks and sleep deprivation.  I started waking up in the night and with the feeling that i coudn't breathe and the feeling of panic. The panic attacks started out for just a few hrs but then would happen again and again at longer intervals. I ended up in the ER with an attack that lasted over 10 hrs. It was so bad i wanted to kill myself.  Worst experience ever. The panic attacks started getting lesser and shorter. I still felt unrest and like there was a battery plugged into my brain making it hard to relax or sleep.   At around the 30 -40 day mark the symptoms finally went away.  I finally feel like myself again but i am constantly in feer that i will feel that way again.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Costochondritis, Echocardiogram
Clinical narrative: 2 echo cardiograms, still chest pain. having a 3rd next week
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Redness swelling at injection site started within a few hours of administration.  Sx's worsen with soreness and swollen axillary lymph nodes in same arm.  Pt. reports pain soreness and stiffness in L. arm.  Seen by provider on 5/28/25, Dx'ed with cellulitis with improving sx's.  On 5/28/25, injection site  is red, hot, and swollen. Measures 5 inches across and 2 inches in length.  , RN
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Redness swelling at injection site started within a few hours of administration.  Sx's worsen with soreness and swollen axillary lymph nodes in same arm.  Pt. reports pain soreness and stiffness in L. arm.  Seen by provider on 5/28/25, Dx'ed with cellulitis with improving sx's.  On 5/28/25, injection site  is red, hot, and swollen. Measures 5 inches across and 2 inches in length.  , RN
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Circumstance or information capable of leading to medication error, Scratch, Underdose
Clinical narrative: Patient was in office for a WCC and vaccines. Patient is autistic, Mom felt it would be better if the patient could stand and play on the phone while the vaccines are administered. The mother of the patient stood in front and the provider stood behind the patient. When the medical assistants administered the vaccines the patient dropped to their knees causing the needles to come out of the patients are, scratching the patient and the dose only being partially administered.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Lethargy, Pain in extremity
Clinical narrative: starting late evening on day of vaccination, patient L arm felt sore, experiencing headache, lethargy and possible fever; treated with ES Tylenol, fluids and rest.  same symptoms and treatment continued throughout 5/24 and 5/25.  Upon morning of 5/26, patient felt all symptoms resolved.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given 5/21/21. Expired  5/19/25.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: The donor was administered the CAPVAXIVE immunization by one of Nurse on 05/23/2025 at 11:50am IM in the donors left arm. The donor stayed with the Nurse to be assessed for any adverse post immunization reactions related to the vaccination administered. During and after that indicated 30 minutes time frame the donor did not have an immediate adverse reaction to the CAPVAXIVE immunization and the donor left the center in good condition. The donor stated that she had common adverse reaction symptoms related to the CAPVAXIVE vaccination starting on 05/24/2025 at 10:40am that occurred until 05/27/2025. These symptoms reported included injection site pain, erythema, and swelling, dizziness, fatigue, headache, nausea, chills, irritability, weakness, tachycardia, shortness of breath, and an itchy rash over the whole body. When asked about treatments the donor stated she did not seek medical treatment as she did not know if she was having all of these symptoms from the reaction or if she was having a panic attack. Also, the donor stated that they haven't had a reaction to any vaccination that she is aware of. The donor reported these symptoms to the nurse at the center on 05/28/2025 and stated that today she was feeling much better and that these common adverse reaction symptoms have subsided. The donor was instructed to seek medical treatment if these symptoms persist and or return and was advised to report this adverse reaction to VAERS. The donor left the center on 05/28/2025 in good condition.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: The donor was administered the CAPVAXIVE immunization by one of Nurse on 05/23/2025 at 11:50am IM in the donors left arm. The donor stayed with the Nurse to be assessed for any adverse post immunization reactions related to the vaccination administered. During and after that indicated 30 minutes time frame the donor did not have an immediate adverse reaction to the CAPVAXIVE immunization and the donor left the center in good condition. The donor stated that she had common adverse reaction symptoms related to the CAPVAXIVE vaccination starting on 05/24/2025 at 10:40am that occurred until 05/27/2025. These symptoms reported included injection site pain, erythema, and swelling, dizziness, fatigue, headache, nausea, chills, irritability, weakness, tachycardia, shortness of breath, and an itchy rash over the whole body. When asked about treatments the donor stated she did not seek medical treatment as she did not know if she was having all of these symptoms from the reaction or if she was having a panic attack. Also, the donor stated that they haven't had a reaction to any vaccination that she is aware of. The donor reported these symptoms to the nurse at the center on 05/28/2025 and stated that today she was feeling much better and that these common adverse reaction symptoms have subsided. The donor was instructed to seek medical treatment if these symptoms persist and or return and was advised to report this adverse reaction to VAERS. The donor left the center on 05/28/2025 in good condition.
Age: 47.0
Sex: F
Vaccine: PNC21
Symptoms: Nausea, Rash, Rash pruritic, Tachycardia
Clinical narrative: The donor was administered the CAPVAXIVE immunization by one of Nurse on 05/23/2025 at 11:50am IM in the donors left arm. The donor stayed with the Nurse to be assessed for any adverse post immunization reactions related to the vaccination administered. During and after that indicated 30 minutes time frame the donor did not have an immediate adverse reaction to the CAPVAXIVE immunization and the donor left the center in good condition. The donor stated that she had common adverse reaction symptoms related to the CAPVAXIVE vaccination starting on 05/24/2025 at 10:40am that occurred until 05/27/2025. These symptoms reported included injection site pain, erythema, and swelling, dizziness, fatigue, headache, nausea, chills, irritability, weakness, tachycardia, shortness of breath, and an itchy rash over the whole body. When asked about treatments the donor stated she did not seek medical treatment as she did not know if she was having all of these symptoms from the reaction or if she was having a panic attack. Also, the donor stated that they haven't had a reaction to any vaccination that she is aware of. The donor reported these symptoms to the nurse at the center on 05/28/2025 and stated that today she was feeling much better and that these common adverse reaction symptoms have subsided. The donor was instructed to seek medical treatment if these symptoms persist and or return and was advised to report this adverse reaction to VAERS. The donor left the center on 05/28/2025 in good condition.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: >12 year COVID vaccine administered. Mother reported that child had fatigue and soreness at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inflammation, Product administered at inappropriate site
Clinical narrative: Patient developed localized inflammatory response. Vaccine was given more posterior on left vastus lateralis.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Myalgia
Clinical narrative: Myalgia. Pt came into our clinic after receiving the vaccine. He received the vaccine and within only a couple days showed symptoms of muscle aches and fatigue for multiple weeks following the vaccine.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea, Paraesthesia
Clinical narrative: Patient developed nausea, headache, and tingling legs over night after receiving the vaccine that day.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse reaction
Age: 1.33
Sex: F
Vaccine: HEPA
Symptoms: Breath sounds abnormal, Dermatitis diaper, Immunisation reaction, Skin swelling
Clinical narrative: Mother reports that at approx. 10 pm she noticed a "rash" in patient's diaper area, that patient was "puffy" all over (child is normally very slim) and mom heard a "weird" sound in her airway, as if she was having trouble breathing therefore she took her to Hospital ER for evaluation.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine's expiration date was 5/23/25, 4 days expired at the time of administration. No symptoms at time of vaccination, no symptoms the following morning.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: >12 year old COVID vaccine given. Mother of child reported child had fatigue and soreness at site after injection
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: patient came in and showed up a big bruise almost looked like a hematoma
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: At 15:06 on 5/27/25, the patient received Moderna covid vaccine in physician office during a routine wellness appointment. At 14:06 pm on 5/27/25, it was discovered that the best use by date of the Moderna covid vaccine administered was 5/25/25.
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Arm red swollen lasting 7 days still red. Both arms and ankles rash appeared. Skin itchy . No sign of infection.
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Headache, Injection site rash, Injection site swelling, Rash
Clinical narrative: Arm red swollen lasting 7 days still red. Both arms and ankles rash appeared. Skin itchy . No sign of infection.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a hep B vaccine on 5/22/25 in addition to vaccine administered on 5/11/25 at hospital at birth. This was too soon and was not discovered as hospital created immunization record in the wrong name (incorrect spelling).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Head injury, Syncope
Clinical narrative: Notes: 1245 with syncopal event, post bexsero #2, Mom reported older brother had a similar reaction to bexsero #2. no prior syncopal events, is fasting, hit head on the floor, but no overt headache. neuro exam within normal limits and given water and asked to rest for 15 minutes. wants to be pharmacist, alert oriented x 3. 1305 spoke with MD, blood sugar was checked and neuro exam WNL. feels better (Orange juice also provided)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial septal defect, Atrial septal defect repair, Autologous blood patching, Back pain
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood gases abnormal, Blood test, Cardiac aneurysm, Cerebral atrophy, Cerebral small vessel ischaemic disease
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram head abnormal, Computerised tomogram normal, Computerised tomogram spine abnormal, Contusion
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Demyelination, Diverticulitis, Echocardiogram, Echocardiogram abnormal, Encephalocele
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of employment, Lung assist device therapy, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial injury, Pulmonary function test, Right-to-left cardiac shunt, Scan with contrast abnormal, Spinal myelogram abnormal
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Stress echocardiogram abnormal, Ultrasound head, Venogram, Vertigo, Vomiting
Clinical narrative: Within 24 hours, debilitating headache, back ache, chest pain, vomiting, vertigo, tiny bruises on both arms and across front of chest. Three weeks later symptoms lessened, bruises faded, vertigo and headache remained. Began to see a neurologist, under went multiple MRIs, CAT scans, blood tests and was sent to specialty Clinic in (redacted). Too scared to get second mandatory vaccine and was let go losing my 34 year career. I have lost brain size and I have diverticulitis along my spinal cord. My heart was damaged and I have undergone a procedure to place a device to prevent my O2 rich blood from mixing with my CO2 blood.
Age: 59.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Chills, Erythema, Headache, Hypoaesthesia, Peripheral swelling
Clinical narrative: THE NEXT DAY, PT EXPERIENCED SEVERE HEADACHE, FEVER AND CHILLS.  THEN SHE HAD REDNESS AND SWELLING IN BOTH ARMS.  RIGHT ARM HAD REDNESS AND SWELLING THAT SPREAD DOWN ARM AND PT HAD TO GET RX FOR CEPHALEXIN.  PT ALSO COMPLAINED ABOUT NUMBNESS IN HER ARM AND SHOOTING DOWN INTO HER HAND/FINGERS.  HAS GOTTEN BETTER BUT STILL HAS NUMBNESS IN FINGERS OF LEFT HAND
Age: 59.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Pyrexia
Clinical narrative: THE NEXT DAY, PT EXPERIENCED SEVERE HEADACHE, FEVER AND CHILLS.  THEN SHE HAD REDNESS AND SWELLING IN BOTH ARMS.  RIGHT ARM HAD REDNESS AND SWELLING THAT SPREAD DOWN ARM AND PT HAD TO GET RX FOR CEPHALEXIN.  PT ALSO COMPLAINED ABOUT NUMBNESS IN HER ARM AND SHOOTING DOWN INTO HER HAND/FINGERS.  HAS GOTTEN BETTER BUT STILL HAS NUMBNESS IN FINGERS OF LEFT HAND
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt experienced small red bumps on both elbows after receiving vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Sleep disorder, Tenderness
Clinical narrative: PATIENT RETURNED TO PHARMACY TODAY 5/28 FOR 2ND DOSE OF SHINGRIX WITH HESITATION REGARDING HER FIRST DOSE, ADMINISTERED 2/21/25. SHORTLY AFTER HER SHOT ON HER DRIVE HOME SHE FELT HER ARM WAS MORE SORE THAN NORMAL. IT WAS DIFFICULT TO SLEEP ON THAT NIGHT AND THEN THE FOLLOWING DAY DID BECOME RATHER PAINFUL, SWOLLEN AND DIFFICULT TO RAISE HER ARM. IT IS NOW 3 MONTHS LATER AND STILL DIFFICULT TO RAISE HER ARM AND PAINFUL TO THE TOUCH, CANNOT SLEEP ON HER SIDE. HAS NOT SEEN A MEDICAL PROFESSIONAL REGARDING THIS ISSUE.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: Pain at the injection site, headache, nausea, vomiting, shivering.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of the left upper arm extending down towards elbow with out systemic s/s. Treated with oral doxycylcine BID for 7 days and f/u 5/30/25.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric Hep A vaccine was given to an adult pt. No reaction afterwards.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Mobility decreased, Pain in extremity
Clinical narrative: After i got my arm hurt like hell, and i did my normal things at night and i started to feel a little bit out of breath. So i cut the evening short and went upstairs and i was having issues breathing all night and the next day i could not get my breath.  I could not find enough oxygen to get into my lungs and i kept trying the breathe in and there was nothing to bring in. I kept using my inhaler every hour and it was the only thing that would allow me breathe. I was super weak and it was hard to get out of bed i was wondering what would happen if i fell out of bed. I couldnt do anything i couldnt think and i couldnt go anywhere. I thought about walking down the steps to feed my fish and i was so worried i would fall. And this last all day long and my dog was next to me the whole time.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vocal cord paralysis
Clinical narrative: Paralyzed Vocal Cord,  recurrent laryngeal nerve paralysis or vocal fold paralysis
Age: 72.0
Sex: M
Vaccine: CHIK, HEPA, TYP
Symptoms: Feeling abnormal, Headache, Influenza virus test negative, Listless, Malaise
Clinical narrative: Thursday 3/13: He I felt slightly "off" but attributed it to other factors. Friday: He developed a headache and fever, prompting me to cancel an evening engagement.  Saturday: He felt unwell and listless. My temperature rose to around 100?101°F, which is 2?3 degrees higher than his normal 98.1°F. Sunday: He spent most of the day in bed, experiencing intermittent fever cycles. Though he can?t recall all his symptoms, he just felt very unwell. Monday: With a flight scheduled for Wednesday, he thought I might be improving but decided to consult me(Dr. ). To ensure I could make an informed decision about traveling, he opted to get tested for other potential illnesses. I visited a clinic, where he was tested for COVID-19, flu, and RSV?all of which came back negative. Tuesday: The day before his flight, he started feeling better in the afternoon. Wednesday: Although he still had minor lingering symptoms, he flew.  He improved shortly after.
Age: 72.0
Sex: M
Vaccine: CHIK, HEPA, TYP
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Thursday 3/13: He I felt slightly "off" but attributed it to other factors. Friday: He developed a headache and fever, prompting me to cancel an evening engagement.  Saturday: He felt unwell and listless. My temperature rose to around 100?101°F, which is 2?3 degrees higher than his normal 98.1°F. Sunday: He spent most of the day in bed, experiencing intermittent fever cycles. Though he can?t recall all his symptoms, he just felt very unwell. Monday: With a flight scheduled for Wednesday, he thought I might be improving but decided to consult me(Dr. ). To ensure I could make an informed decision about traveling, he opted to get tested for other potential illnesses. I visited a clinic, where he was tested for COVID-19, flu, and RSV?all of which came back negative. Tuesday: The day before his flight, he started feeling better in the afternoon. Wednesday: Although he still had minor lingering symptoms, he flew.  He improved shortly after.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Injection site reaction, Pruritus
Clinical narrative: Initial reaction occurred approximately three days after injection which injection site reaction and itching. 2 months later, patient is still reporting infrequent/occasional crawling up the left arm between elbow and shoulder.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expiration was 5/4/25. Medical assistant gave vaccine 2 days past exp date. No harm or injury to the patient.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed dermatographia within two weeks of second dose.  Have consistently had this since then.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid, Experiencing mild symptoms; This spontaneous case, initially received on 12-May-2025, was reported by a non health professional and concerns an adult female patient.  Historical drug included unspecified product (reaction: allergy).  Administration of company suspect drug: On 03-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Left arm, Lot number: 388527.  Non-company suspect drugs: On 03-Oct-2024, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Deltoid, Lot number: LM2210. On 07-Apr-2025, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for an indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Not Reported, Lot number: LM2210.  Adverse reactions/events and outcomes: On 09-May-2025, the patient experienced Tested positive for Covid, Experiencing mild symptoms (outcome: Recovering / Resolving). Intensity: Mild  Additional information received as event started on 09-May-2025 as well. In other words, patient felt symptoms on 09-May-2025 and took a Covid test that same day, which was how patient became aware she had Covid.  It was reported that this report that Tested positive for Covid. Experiencing mild symptoms, appeared to be related to efficacy of the drug which was not device related. As there was no issue reported with the device (Tozinameran), this would be closed as not device related.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event Tested positive for Covid, Experiencing mild symptoms as non-serious and did not provide causality assessment.  Follow up (19-May-2025) received from consumer: New reporter added (second), New dosing regimen added for co-suspect, event onset date updated to 09-May-2025. Upon internal review, race had been removed from patient tab and updated with other, narrative updated accordingly.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the event covid-19 is considered coincidental with no biological and temporal plausibility (7 months after vaccination) for Flucelvax to cause/contribute. Of note, there could be a lack of effect with non company COVID-19 vaccine (Tozinameran).
Age: 66.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No symptoms reported.; patient erroneously received a dose of PROQUAD instead of MMRII; This spontaneous report was received from a/an Nurse and refers to a(n) 66-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 21-May-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z003310, expiration date: 21-Jul-2026) 0.5 mL (0.5ML),. On 21-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). The patient started therapy with sterile diluent (MERCK STERILE DILUENT), for the treatment of prophylaxis.  The patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for the treatment of Prophylaxis.  On 21-May-2025, the patient experienced patient erroneously received a dose of PROQUAD instead of MMRII. On an unknown date, the patient experienced No symptoms reported.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; son took the vaccine and still ended up with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: son took the vaccine and still ended up with shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient's parent via interactive digital media. The reporter stated that their son took the vaccine and still ended up with shingles.  Between that and watching how many had covid two or three times after having a covid shot, they are very leary of vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain in extremity, Sleep disorder
Clinical narrative: Pt reported today, 5/28/2025, that her arm started hurting immediately after the vaccination on 1/16/2025.  She says it has progressively been getting worse since then.  She's had to take pain meds (advil) at night to be able to sleep and as of today, she cannot lift her left arm to shoulder level without intense pain.  She is going to see her doctor this week about this pain.  I asked why she is just now reporting it and she said she's had a lot going on health wise that she is just now getting around to it.
Age: 70.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: Patient admitted to hospital for undisclosed reason and this was made aware when nurse called patient to confirm her 3rd final Bexsero appt.  We are unsure as to when her discharge date is. Last vaccine date was 01/22/25.
Age: 48.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: Was inadvertantly administered a pediatric dose
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Feeling abnormal, Head injury, Headache, Loss of consciousness
Clinical narrative: 15-year-old female was given the HPV #1 yesterday.  20 minutes after she left she reported that she was starting to feel "a little funny".  Patient did not say anything.  Patient reports later in the day she was changing positions and going from a sitting to a standing position.  Patient reportedly lost consciousness and fell back to the ground hitting the front of her head.  Patient reports a headache today.  Mother shows a picture of bilateral cheeks with a red raised rash.  Skin intact on the head.  No bruising.  Patient does have a headache
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous
Clinical narrative: 15-year-old female was given the HPV #1 yesterday.  20 minutes after she left she reported that she was starting to feel "a little funny".  Patient did not say anything.  Patient reports later in the day she was changing positions and going from a sitting to a standing position.  Patient reportedly lost consciousness and fell back to the ground hitting the front of her head.  Patient reports a headache today.  Mother shows a picture of bilateral cheeks with a red raised rash.  Skin intact on the head.  No bruising.  Patient does have a headache
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Hyperhidrosis, Hypotonia, Pain, Pallor, Unresponsive to stimuli
Clinical narrative: Patient received both vaccines and continued to site in chair beside mother. Mother stated patient does  really well with shots, but just gets a little nervous about them ahead of time. Patient did state that HPV vaccine hurt more than men B. While paperwork was being printed, patient slumped over onto her mother's shoulder and was non-responsive. Nurses and mother eased patient from chair onto floor. Patient immediately became responsive upon laying flat. Pulse was strong and regular. Patient was pale and slightly diaphoretic. Upon regaining responsiveness, patient stated she was okay. Patient encouraged to lay flay. Cool, damp cloth applied to head. Patient became nauseated and was assisted to sit up and did vomit a small amount of emesis. A small scratch was bleeding noted to patient's upper left forehead at the hairline. Scratch cleaned with wet paper towel and did stop bleeding. Patient assisted up into chair and given water, a sucker and animal crackers. VS were stable and patient was able to ambulate to car with mother without further incident.
Age: 1.25
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse reaction. Vaccine was mixed incorrectly with sterile water instead of the diluent that was provided.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Sudden weakness after covid vaccine. Lower limb weakness, difficulty walking / bathing.
Age: 77.0
Sex: M
Vaccine: PNC21
Symptoms: Erythema, Skin tightness, Swelling, Tenderness
Clinical narrative: Seen via video visit, area appeared erythematous and pt stated swollen, tight and tender. Pt sent to ER for evaluation.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Choking, Erythema, Infantile spitting up, Rash, Rash erythematous
Clinical narrative: 5 hours post vaccination, patient developed a red facial rash and had an episode of choking and small spit up of formula. She was assessed in office 1 hour after reaction, 6 hours after vaccines, and facial rash had resolved to mild erythema to forehead. She had normal assessment with clear lungs.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: A red rash on back of arm, she said she has been using ice and that it hasn't bothered her.  I suggested that she see her primary care physician to have a look at it and see what the physician thinks of it and if she should get the  second dose when appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a second Covid19 vaccine instead of a second Shingrix vaccine.  Patient was informed and will be contacting pharmacy if there are any adverse reaction.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Swelling and feeling of a lump under the skin at injection site
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Anxiety, Brain fog, Depression, Fatigue
Clinical narrative: At 9:00 pm I started convulsing and sweating then I was flu like for days after, my legs got swollen and I started bloating. The swelling came and went but my liver enzymes and hemoglobin have been elevated ever since. The brain fog has persisted and fatigue has persisted as well. With the diminished physical and mental capacity of become depressed and anxious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin increased, Hepatic enzyme increased, Hyperhidrosis, Influenza, Malaise
Clinical narrative: At 9:00 pm I started convulsing and sweating then I was flu like for days after, my legs got swollen and I started bloating. The swelling came and went but my liver enzymes and hemoglobin have been elevated ever since. The brain fog has persisted and fatigue has persisted as well. With the diminished physical and mental capacity of become depressed and anxious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, Seizure, Swelling
Clinical narrative: At 9:00 pm I started convulsing and sweating then I was flu like for days after, my legs got swollen and I started bloating. The swelling came and went but my liver enzymes and hemoglobin have been elevated ever since. The brain fog has persisted and fatigue has persisted as well. With the diminished physical and mental capacity of become depressed and anxious.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient received the following vaccines on Friday, May 23, 2025: Quadracel (Dtap & IPV), and ProQuad (MMRV). Per mom patient started complaining of itchiness on left thigh where Quadracel vaccine was administered. MOC noticed redness, swelling, and site felt warm to the touch. MOC applied ice. Per mom this helped with the swelling a little bit. MOC took patient to UC on Sunday where patient was diagnosed with a rash, Cellulitis of the left leg. Patient was placed on Clindamycin antibiotic 13.5 ml every 8 hours for 5 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Patient received the following vaccines on Friday, May 23, 2025: Quadracel (Dtap & IPV), and ProQuad (MMRV). Per mom patient started complaining of itchiness on left thigh where Quadracel vaccine was administered. MOC noticed redness, swelling, and site felt warm to the touch. MOC applied ice. Per mom this helped with the swelling a little bit. MOC took patient to UC on Sunday where patient was diagnosed with a rash, Cellulitis of the left leg. Patient was placed on Clindamycin antibiotic 13.5 ml every 8 hours for 5 days.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: Myocarditis
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Myocarditis
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itchiness, heat and tenderness at the injection site
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL, MMR, PNC15, VARCEL
Symptoms: Hypersensitivity, Lethargy, Nasal congestion, Vomiting
Clinical narrative: On May 28th 2025, my infant   was scheduled to receive a vaccines at office. We arrived at 1:50 PM for the appointment. The vaccines were administered at 2:40 PM by clinic staff. At the time of the incident, three vaccines were administered during the  visit. Two of those vaccines  Varicella and Pneumococcal Conjugate been given previously to my baby without any prior reactions.This was the first time the third vaccine MMR had been administered and Shortly after the injection with in minutes, my child began to show signs of a severe allergic reaction.  At 2:47 PM, my baby started vomiting, became lethargic, and developed nasal congestion. I immediately informed the clinic staff of these symptoms. Despite the urgency of the situation and visible distress, no emergency action was taken by the clinic. No epinephrine was administered, and 911 was never called.  As our child s condition worsened, my husband and I made the decision to leave the clinic and transport our baby ourselves to the Emergency Room.  Upon arrival, ER staff immediately administered epinephrine, monitored our child, and stabilized the reaction. It is our firm belief that the delayed response by the clinic endangered our child s life and represents a serious breach of medical responsibility.