chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient describes a tingling sensation that starts at the injection site and goes down the arm towards the elbow. This started the day after the vaccine and occurs every day. Patient also states that the tingling increases when they sleep on their back at night all the way down to the wrist.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Patient received TDAP on 06/09/2025 due to right hand abrasion. She then started experiencing symptoms the following day 06/10/2025. Symptoms included right arm ( at injection site) redness, swelling, and pain. Had associated fever, chills, sweating,  body aches, headaches, and fatigue. Was diagnosed with cellulitis and treated with  oral Keflex.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient received TDAP on 06/09/2025 due to right hand abrasion. She then started experiencing symptoms the following day 06/10/2025. Symptoms included right arm ( at injection site) redness, swelling, and pain. Had associated fever, chills, sweating,  body aches, headaches, and fatigue. Was diagnosed with cellulitis and treated with  oral Keflex.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient received TDAP on 06/09/2025 due to right hand abrasion. She then started experiencing symptoms the following day 06/10/2025. Symptoms included right arm ( at injection site) redness, swelling, and pain. Had associated fever, chills, sweating,  body aches, headaches, and fatigue. Was diagnosed with cellulitis and treated with  oral Keflex.
Age: 58.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: rash on arm on the side of the shingles vaccine , also a slight fever
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is currently 11 years old and patient was administered by another Medical Assistant a COVID19 Pfizer Vaccine of 12 year +
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: On 06/10/2025 developed a red rash and welts, slightly raised, itchy. no oral/ facial swelling/ cough/ wheeze/ gi upset. Came to clinic, was prescribed medrol pak and started on oral zyrtec once a day. Returned to clinic 06/12/2025 because symptoms worsening and severe, over whole body. Red blanchable rash on trunk, arms, legs, hands, and feet.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On 06/10/2025 developed a red rash and welts, slightly raised, itchy. no oral/ facial swelling/ cough/ wheeze/ gi upset. Came to clinic, was prescribed medrol pak and started on oral zyrtec once a day. Returned to clinic 06/12/2025 because symptoms worsening and severe, over whole body. Red blanchable rash on trunk, arms, legs, hands, and feet.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient cam into clinic and requested Pneumonia vaccine. PPSV23 given to patient. PCV 20 should have been offered instead.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Shivering and feeling tired.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Confusional state, Dizziness, Dysarthria
Clinical narrative: A light headache will start to occur letting me know it's about to happen, followed by excessive blinking whenever I focus on performing any act (driving, typing, texting, writing, etc.). Once It sets in after a day or two of this, I experience the following symptoms for weeks at a time: Headache, nausea, dizziness, excessive blinking, confusion, memory loss, slurred speech, unable to speak, loss of motor function. At it's worst Its felt as though lightning struck across my brain and I hunched over, nearly falling to the ground unable to speak. The only occasional relief I can get is applying pressure to the nape of my neck, which doesn't work for too long. There has been no treatments found to alleviate this, as most medical professionals that I've seen don't seem to take it seriously or tell me it's a migraine.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Excessive eye blinking, Headache, Migraine, Motor dysfunction
Clinical narrative: A light headache will start to occur letting me know it's about to happen, followed by excessive blinking whenever I focus on performing any act (driving, typing, texting, writing, etc.). Once It sets in after a day or two of this, I experience the following symptoms for weeks at a time: Headache, nausea, dizziness, excessive blinking, confusion, memory loss, slurred speech, unable to speak, loss of motor function. At it's worst Its felt as though lightning struck across my brain and I hunched over, nearly falling to the ground unable to speak. The only occasional relief I can get is applying pressure to the nape of my neck, which doesn't work for too long. There has been no treatments found to alleviate this, as most medical professionals that I've seen don't seem to take it seriously or tell me it's a migraine.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Posture abnormal
Clinical narrative: A light headache will start to occur letting me know it's about to happen, followed by excessive blinking whenever I focus on performing any act (driving, typing, texting, writing, etc.). Once It sets in after a day or two of this, I experience the following symptoms for weeks at a time: Headache, nausea, dizziness, excessive blinking, confusion, memory loss, slurred speech, unable to speak, loss of motor function. At it's worst Its felt as though lightning struck across my brain and I hunched over, nearly falling to the ground unable to speak. The only occasional relief I can get is applying pressure to the nape of my neck, which doesn't work for too long. There has been no treatments found to alleviate this, as most medical professionals that I've seen don't seem to take it seriously or tell me it's a migraine.
Age: 60.0
Sex: M
Vaccine: PNC20
Symptoms: Influenza like illness, Tendon rupture
Clinical narrative: I believe I have a partial or full rupture of my proximal long head of right biceps tendon as well as pain at injection site and flu-like symptoms that began the day following vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: The technician that administered the vaccine, injected the vaccine below the deltoid and I believe that means it was erroneously injected subcutaneously and not intramuscularly.  Also, it felt like the and I believe injection was not going in at a 90 degree angle.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: The technician that administered the vaccine, injected the vaccine below the deltoid and I believe that means it was erroneously injected subcutaneously and not intramuscularly.  Also, it felt like the and I believe injection was not going in at a 90 degree angle.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Patient called in 6/12 stating that she developed a local reaction on 6/11 and it has gotten worse today (red, warm, swollen). Nurse came to home and advised pt to take Benadryl and steroids
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Bloody discharge, Contusion, Erysipelas, Erythema, Swelling
Clinical narrative: Erysipelas, red, swollen, bruised, serosanguinous drainage
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: no adverse reaction just partial dosing
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: proquad administered instead of varicella. Patient received additional dose of mmr and Proquad is not indicated at this age. Error noted immediately after administration.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth, Paraesthesia
Clinical narrative: The patient experienced tingling in right arm with no redness or numbness at 0828. At 0835 the tingling improved, and the patient left in stable condition. At 0845, the patient returned to the ambulatory care unit with complaints of itching, redness, and warm to touch in right deltoid.  At 0849 the rapid response team was called.  The rapid response team gave the patient Benadryl in the left deltoid. At 0912, the patient complained of itching in the left deltoid and was sent to the emergency room. The patient was accessed at 0923 and reassessed at 1024 and the condition had improved. The diagnosis was an acute allergic reaction, and the patient was discharged with Pepcid 20 mg oral tablet and hydrOXYzine pamoate 25mg oral capsule.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Back pain, Central nervous system lesion, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: numbness of right leg. started in toes, progressed upwards, stopped at his knee, resolved 18 hrs later.  right leg muscle weakness, limited ROM of feet toes. increased deep tendon reflexes. hyper reflexia, positive babinski in Left side. Back pain several days later.  worsening persistent fatigue
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Condition aggravated, Extensor plantar response, Fatigue, Hyperreflexia, Hypoaesthesia
Clinical narrative: numbness of right leg. started in toes, progressed upwards, stopped at his knee, resolved 18 hrs later.  right leg muscle weakness, limited ROM of feet toes. increased deep tendon reflexes. hyper reflexia, positive babinski in Left side. Back pain several days later.  worsening persistent fatigue
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Joint range of motion decreased, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging whole body
Clinical narrative: numbness of right leg. started in toes, progressed upwards, stopped at his knee, resolved 18 hrs later.  right leg muscle weakness, limited ROM of feet toes. increased deep tendon reflexes. hyper reflexia, positive babinski in Left side. Back pain several days later.  worsening persistent fatigue
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Muscular weakness
Clinical narrative: numbness of right leg. started in toes, progressed upwards, stopped at his knee, resolved 18 hrs later.  right leg muscle weakness, limited ROM of feet toes. increased deep tendon reflexes. hyper reflexia, positive babinski in Left side. Back pain several days later.  worsening persistent fatigue
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an extra dosage of IPV by the IPOL injection.  Patient did not have any adverse reaction, just had a double dosage of IPV on 05/13/25.  Patient also received an extra dosage of Hepatitis B with the Pediarix vaccine.  Again patient did not have any adverse reaction, just received an extra dosage of Hepatitis B on 05/13/25.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: The patient received the first dose for Hepatitis A, Menquadfi, and HPV on 6/9/2025. The patient woke up the next morning and saw that hives appeared on both arms. The patient denies taking any medications when he saw the hives. The patient's father reports that this is the first time his son has had a reaction after receiving vaccines.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Anaphylactic reaction, Cough, Urticaria, Wheezing
Clinical narrative: Patient received ProQuad dose, about 5-10minutes after administration started to develop hives to face and abdomen, also developed cough and wheezing.  Epinephrine, Benadryl and albuterol administered for anaphylactic reaction. Patient then transferred to emergency room for further evaluation.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Patient received first dose of the Hepatitis A vaccine on 6/9/2025. The patient's father stated that the patient had hives appear on both upper extremities. He stated the hives appeared when he woke up the next morning after receiving the vaccines. The patient's father denies that patient had a reaction in the past to vaccines.
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient developed cellulitis appearing reaction to injection site of CAPVAXIVE. Extensive erythema, subjective fevers, warm to touch.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction, Patient was to be given MMRV vs Menvo.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia
Clinical narrative: when pt arrived for her 4th dose of rabies vaccine, 06/12/2025, Pt states she noticed persistent numbness in fingertips of right arm within a few days after receiving her 3rd rabies vaccine.dose. pt states she has history of fingertip numbness previously but it has not resolved in this case. pt states she was evaluated by her dr and that "the dr said she will be fine and to ask for the next dose be given in left arm." No other symptoms were reported and pt denies any pain at the time 3rd dose was given. counseled pt on risks again and for her to follow up with her dr again if no improvement. 4th dose was given in left arm per the request of pt per dr.
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient developed cellulitis type reaction 1 day after administration of vaccine. Subjective fevers, increasing erythema and swelling  to injection site.
Age: 13.0
Sex: F
Vaccine: HIBV
Symptoms: Breast cyst, Cyst removal, Impaired healing, Keloid scar
Clinical narrative: When she was vaccinated she had to have 3 series, she started growing cyst in her breast and they were the size of a golf ball and they had to be removed. Once she was cut she grew keloids and it affected her body from healing and she kept growing cyst that had to be removed and creating more keloids that scared her.  She was seen by plastic surgery but they could not remove any more because they would come back worse and now we are going to see another doctor to see if there is any other treatment.
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Pruritus, Urticaria
Clinical narrative: 7 month old with itchy hives all over the body post vaccination within less than 2 hours. Patient was referred to ER for further evaluation.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Patient vomited after vaccines
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 7 years old and was given quadracel which is indicated for ages 4-6 years old
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Skin warm
Clinical narrative: Experienced nausea, stomach cramps, warmness, and diarrhea  about 12 hours after receiving shot (06/06/2025 at 4pm), which went away on 06/08/2025 at 10pm. She states that she did not receive treatment but waited it out.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine on 6/12/25 that was expired. Vaccine lot number was 8080799 and expiration was 6/7/25. No signs/symptoms. Pt waited around 30 min after vaccination and was fine.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure, treated at local ED, simple (<15mins), back to baseline prior to discharge
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event- patient above eligible age to receive this vaccination
Age: 17.0
Sex: F
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse Event- patient above eligible age to receive MMRV
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: Swelling and redness at injection site, small bumps on back and 1 small bump on forearm.
Age: 18.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Incorrect dose administered
Clinical narrative: Administrator accidentally gave an adult dose of Hepatitis A vaccine to an 18 year old instead of a pediatric dose. Parent was called and notified.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The mother stated the child woke up the following morning with reddness & swelling & itchiness at injection site. Mom spoke to on call doctor that night & was told to draw a circle around it. Mom stated it was a little larger this morning. Told to give Ipuprophen, Benedryl & warm compresses
Age: 0.67
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red bump on the right thigh
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Pregnancy test negative, Product administered to patient of inappropriate age
Clinical narrative: Staff member administered vaccine above to patient. vaccine was not ordered. vaccine was ordered by provider as meningococcal, but MMRV was given.  notified patient's mother of vaccine that was given incorrectly. mother was given VIS and possible side effects to be aware of, patient and mother verbalized understanding.  patient and mother agreed to come into clinic today 6/12/25 for pregnancy test and to give correct vaccine as instructed by Dr. patient came in with grandmother at 3:00PM. pregnant test was given, Dr. confirmed test was negative. patient was given correct vaccine and VIS information sheet was given as well to patient and grandmother. patient advised to wait in lobby for at least 15 minutes and report any adverse effects or reactions. patient waited and tolerated vaccine without any adverse effects or reactions.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: Within 5 minutes of receiving her HPV vaccine while seated, patient expressed that she felt lightheaded.  RN advised her to put her head between her knees but before she could comply she had a syncopal event with tonic-clonic movements lasting about 45 seconds. She resumed consciousness and reported feeling very tired. She was moved by her father into a lying position on the exam table. Vital signs were taken noting a decrease in her blood pressure, patient reported feeling nauseated and continuing to feel lightheaded. Cool cloths were placed on her forehead and the back of her neck and an emesis bag was provided.   At 15 minutes vital signs were rechecked and had returned to baseline, patient remained nauseated, tired, weak, and lightheaded. A juice box and a handful of crackers were placed at bedside, patient declined to eat/drink due to nausea.   RN continued to monitor patient in 10-minute intervals with no change in symptoms, gave a dose of Zofran at 45 minutes per verbal order from Dr.   Patient vomited at 60 minutes and immediately reported feeling better, nausea and lightheadedness resolved, patient ate some crackers and drank some water, tolerated both. Patient reported complete resolution of symptoms at 75 minutes. Discharged home with all symptoms resolved.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Tonic clonic movements
Clinical narrative: Within 5 minutes of receiving her HPV vaccine while seated, patient expressed that she felt lightheaded.  RN advised her to put her head between her knees but before she could comply she had a syncopal event with tonic-clonic movements lasting about 45 seconds. She resumed consciousness and reported feeling very tired. She was moved by her father into a lying position on the exam table. Vital signs were taken noting a decrease in her blood pressure, patient reported feeling nauseated and continuing to feel lightheaded. Cool cloths were placed on her forehead and the back of her neck and an emesis bag was provided.   At 15 minutes vital signs were rechecked and had returned to baseline, patient remained nauseated, tired, weak, and lightheaded. A juice box and a handful of crackers were placed at bedside, patient declined to eat/drink due to nausea.   RN continued to monitor patient in 10-minute intervals with no change in symptoms, gave a dose of Zofran at 45 minutes per verbal order from Dr.   Patient vomited at 60 minutes and immediately reported feeling better, nausea and lightheadedness resolved, patient ate some crackers and drank some water, tolerated both. Patient reported complete resolution of symptoms at 75 minutes. Discharged home with all symptoms resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Neurological symptom, Palpitations, Rash
Clinical narrative: Lightheadedness and vertigo. Tinnitus, skin rashes and other neurological symptoms. Palpitations and anxiety.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Lightheadedness and vertigo. Tinnitus, skin rashes and other neurological symptoms. Palpitations and anxiety.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient displayed redness of left deltoid and warm to touch.
Age: 55.0
Sex: M
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Heart rate abnormal, Injection site pain, Pyrexia
Clinical narrative: Patient was given 3 vaccines on 6/11/25.  Patient mentioned he experienced pain at the injection site and fever.  Patient also mentioned that he has an abnormal heart beat now after getting the vaccines administered.
Age: 59.0
Sex: M
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Discomfort, Eye swelling, Lacrimation increased, Ocular hyperaemia, Uveitis
Clinical narrative: Severe uveitis of the right (swelling/redness/watery eyes with discomfort on cheek and nose.
Age: 1.08
Sex: M
Vaccine: UNK
Symptoms: Febrile convulsion
Clinical narrative: My baby had a seizure a febrile seizure which are listed rare side effects of this vaccine. Went to hospital by ambulance today.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC15
Symptoms: No adverse event, Wrong patient
Clinical narrative: when the vaccines were drawn up and the vaccine stickers were placed on the forms, the patient name and DOB were switched and the vaccines were switched and administered to the wrong patient. no adverse signs or symptoms occured.
Age: 0.75
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: No adverse event, Wrong patient
Clinical narrative: When the vaccines were drawn up and the vaccine stickers were pulled on the links forms, the patients name and DOB were switched and the vaccines were switched and administered to the wrong patient. No adverse signs or symptoms occured
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Inappropriate schedule of product administration, Malaise, Muscular weakness
Clinical narrative: severe fatigue; leg weakness; post exertion malaise; brain fog; Dose 1 on 24Mar2021 and Dose 2 on 02Apr2021; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 at 16:00 as dose 2, single (Lot number: ER8733) at the age of 51 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, Single; Lot: EW0175; Anatomical location: Upper arm: Administration time: 11:00 AM), administration date: 24Mar2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 at 16:00, outcome "unknown", described as "Dose 1 on 24Mar2021 and Dose 2 on 02Apr2021"; BRAIN FOG (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered"; MUSCULAR WEAKNESS (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered", described as "leg weakness"; MALAISE (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered", described as "post exertion malaise"; FATIGUE (non-serious) with onset 25Apr2021 at 06:00, outcome "not recovered", described as "severe fatigue". Therapeutic measures were not taken as a result of fatigue, muscular weakness, malaise, brain fog.  Additional information: No known allergies. Patient did not received any other vaccines on the same date as the vaccine. Patient did not received any other vaccines within 4 weeks Prior to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. Reported as severe fatigue, leg weakness, post exertion malaise, brain fog. Patient need to know if there is a treatment for this poison you have produced. This has destroyed the quality of his life for over 4 years. Patient was asking whether can the effects of the spike protein be reversed.
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: DYSSTASIA; FEELING ABNORMAL; PAIN; Information has been received from a Regulatory Authority (agency # 2833086-1) and refers to a 68-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 20-MAR-2025, the patient was vaccinated with the first dose of  Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), Injection, lot #Y013009, expiration date was not reported but upon internal validation, was established as 17-Nov-2025, administered by Intramuscular in her Right Arm; and with a dose of (Varicella zoster vaccine rgE (CHO)) (SHINGRIX), lot #7ZM55 (expiration date, dose and strength were not reported), administered by Intramuscular route in her right arm; both vaccines were administered for prophylaxis. On 21-MAR-2025, the Patient stated that she felt achy, tired and had difficulty getting up and about like being hatted with a baseball bat. Reaction did not improve, and she saw her physician 2 days following administration.  The physician gave her two "shots", but she was not sure what they were. Patient started feeling two days following being seen by her physician. In March 2025, the patient recovered from the events.  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.  However, it was stated that MD told her "definitely due to (Varicella zoster vaccine rgE (CHO)) vaccine".; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-05-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2833086 , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE PAIN; Information has been received from a Regulatory Authority (agency # 2831941-1) and refers to a 52-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-MAR-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPAXVIVE) Injection, lot #Y013009, expiration date was not reported but upon internal validation was established as 17-NOV-2025 (dose and strength was not reported) administered by Intramuscular route his Right Arm for prophylaxis.  On 09-MAR-2025, the patient experienced Injection site swelling, erythema and pain. At the reporting time, the patient had not recovered from the events.  The causality assessment between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPAXVIVE) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-05-13 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2831941 , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; Nurse called to report TE for VARIVAX and reports the VARIVAX was inadvertently administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) for prophylaxis (lot #Y017063 was verified to be a valid number, expiration date: 11-Oct-2026) (dose, scheme, route of administration, formulation and injection site were not reported) reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose, frequency, route of administration, expiration date and lot # were not reported). The vaccine underwent a temperature excursion of -11.5 Celsius degree for 24 minutes (product storage error). No symptoms were reported (no adverse event).
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received RECOMBIVAX as First Dose, and HEPLISAV-B as Second Dose; Initial report received on 12-May-2025.    A pharmacist reported that a 43-year-old (gender, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) as the second dose for hepatitis B immunization after receiving RECOMBIVAX as the first dose of the series.  No medical history or concomitant medications were reported.    On 04-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [RECOMBIVAX (lot #, expiration date, NDC #, route, and site not available)].   On 14-Feb-2025, 41 days after the receiving RECOMBIVAX, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)].    No additional information was reported.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Had the First Dose of HEPLISAV-B in August 2024 and Have Not Had the Second Dose Yet; Initial report received on 16-May-2025.  A consumer reported that she, a female (age not reported), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in August 2024 but has not received the second dose.  No medical history or concomitant medications were reported.  In Aug-2024, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, and site not reported) intramuscularly.   At the time of report, the patient has not received the second dose of HEPLISAV-B yet.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: Skin hyperpigmentation
Clinical narrative: Hyperpigmentation On The Face; Initial report received on 21-May-2025.    This report was retrieved from a social media post.  A consumer reported that a patient (gender, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the developed hyperpigmentation on their face.   No medical history or concomitant medications were reported.    On an unknown date, the patient received an unspecified dose of hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available).  One day following administration of the vaccine, the patient underwent a laser hair removal procedure. After the procedure, the patient developed hyperpigmentation on their face.  No other information was available.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose 10/24/2024, and Did Not Get Second Dose; Initial report received on 21-May-2025.   A pharmacist reported that a female patient (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet.    No medical history or concomitant medications were reported.    On 24-Oct-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available).  At the time of this report, the patient has not received the second dose yet.  The patient received the first dose from a different facility than the facility that the reporter was in.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: received a medication error with the YF-VAX was mixed with the incorrect diluent of sterile water, with no reported adverse event; Initial information received on 11-Jun-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 16 years old female patient who received Yellow fever vaccine - [YF-VAX] that was mixed with the incorrect diluent of sterile water, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Jun-2025, the patient received a 0.5ml dose of suspect Yellow fever vaccine - Solution for injection standard strength (lot UK134AA) frequency once (expiry date-unknown) via intramuscular route in the left arm for Immunization and the vaccine was mixed with the incorrect diluent of sterile water, with no reported adverse event (product preparation error) (latency-same day).  Reportedly- 2-consumers received a medication error with the YF-VAX and the consumers are family members.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: RVX
Symptoms: Immune system disorder, Pneumonia
Clinical narrative: severe pneumonia; immune system was damaged; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 1 day after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: severe pneumonia) (serious criteria GSK medically significant) and immune system disorder (Verbatim: immune system was damaged). The outcome of the pneumonia and immune system disorder were not reported.   It was unknown if the reporter considered the pneumonia to be related to RSV vaccine. The reporter considered the immune system disorder to be related to RSV vaccine.     The company considered the pneumonia to be unrelated to RSV vaccine. The company considered the immune system disorder to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 05-JUN-2025 This case was reported by a patient via interactive digital media. Patient had received the shot, and the next day, he/she began a five-month battle with severe pneumonia.  Patient believe it had damaged his/her immune system, never again.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK RSV vaccine.
Age: 56.0
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Off label use
Clinical narrative: pentacel is prescribed with off label diagnosis code stem cells transplant status with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 56-year-old patient of unknown gender who was prescribed the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV (Vero)/Hib (PRP-T) vaccine [Pentacel (Vero)] for an off-label diagnosis of stem cell transplant status, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was prescribed Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (4 times), Suspension for injection (unknown strength and expiry date) lot not provided via intramuscular route in unknown administration site for prophylactic vaccination (immunization) with off label diagnosis code stem cells transplant status with no reported adverse event (off label use).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Action taken was not applicable.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test positive, Antibody test negative, Arthralgia, Blood uric acid normal, Borrelia test negative
Clinical narrative: Joint hyper mobility syndrome and chronic joint pain. Started immediately after the influenza vaccine received on 10/06/2023. She suffered from a major flare up of joint pain. Involved her knees, elbows, shoulders, left wrist and thumb. Pain lasted Oct 2023 - March 2024. Tried 4 sessions of acupuncture, minimal relief. Took Ibuprofen and Tylenol  daily with some relief other symptoms: migraines, fatigue, disturbed sleep, dark thoughts, and sudden mood swings.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein normal, Fatigue, Hepatitis viral test negative, Hypermobility syndrome, Immediate post-injection reaction
Clinical narrative: Joint hyper mobility syndrome and chronic joint pain. Started immediately after the influenza vaccine received on 10/06/2023. She suffered from a major flare up of joint pain. Involved her knees, elbows, shoulders, left wrist and thumb. Pain lasted Oct 2023 - March 2024. Tried 4 sessions of acupuncture, minimal relief. Took Ibuprofen and Tylenol  daily with some relief other symptoms: migraines, fatigue, disturbed sleep, dark thoughts, and sudden mood swings.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Mood swings, Negative thoughts, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Joint hyper mobility syndrome and chronic joint pain. Started immediately after the influenza vaccine received on 10/06/2023. She suffered from a major flare up of joint pain. Involved her knees, elbows, shoulders, left wrist and thumb. Pain lasted Oct 2023 - March 2024. Tried 4 sessions of acupuncture, minimal relief. Took Ibuprofen and Tylenol  daily with some relief other symptoms: migraines, fatigue, disturbed sleep, dark thoughts, and sudden mood swings.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Joint hyper mobility syndrome and chronic joint pain. Started immediately after the influenza vaccine received on 10/06/2023. She suffered from a major flare up of joint pain. Involved her knees, elbows, shoulders, left wrist and thumb. Pain lasted Oct 2023 - March 2024. Tried 4 sessions of acupuncture, minimal relief. Took Ibuprofen and Tylenol  daily with some relief other symptoms: migraines, fatigue, disturbed sleep, dark thoughts, and sudden mood swings.
Age: 4.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report TE where patient received the product. No Side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC; HCP called to report TE where patient received the product. No Side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-May-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0,5 mL (lot #Y010184 and expiration date reported as 31-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. The reporter called to report a temperature excursion (TE) (-4.8C for 0 hours 39 minutes 0 seconds) where the patient received the product (product storage error). No previous excursions were noted. No side effects or symptoms were reported. No additional information was provided. No Additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
Vaccine: RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; HBP called regarding T/E for ROTATEQ and GARDASIL-9. HBP noted that ROTATEQ was administered to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-Jun-2025, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vials 0,5 mL (lot #Y014324 and expiration date reported as 21-Feb-2026) administered for prophylaxis.  The reporter called regarding a temperature excursion (T/E) for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (low TE; duration of temperature excursion: (35.4F) for 1 hour 0 minutes 0 seconds) and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9). No previous excursions were noted. It was noted that Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was administered to a patient and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) was not administered to any patients (product storage error). No symptomatic events were reported (no adverse event). No additional adverse event (AE) and no product quality complaint (PQC) was noted.  This case was considered to be invalid due to lack of patient's identifiers.
Vaccine: RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; ROTATEQ experienced excursion 5/29/2025 and was administered today 6/5/2025 to one patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-MAY-2025, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# 2088619 underwent temperature excursion (3 hours, 7 minutes and 0 seconds in 11.7 degrees Celsius). There were no previous temperature excursions.  On 05-JUN-2025, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution, administered orally, lot #2088619, expiration date was reported as 30-SEP-2026, however upon internal validation determined as 09-MAR-2026, for prophylaxis (dose was not reported); the administered vaccine underwent temperature excursion mentioned above (Product storage error). No side effects reported.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, Irritability
Clinical narrative: Consumer was informed one week after that it was the wrong dosage.; Consumer stated that child was cranky and it lasted five days; he would be more immune, it is not giving Tylenol he will not overdose; This spontaneous report was received from a consumer referring to a 14-month-old male patient. The patient's pertinent medical history included asthma. There were no drug reactions/allergies or concomitant therapies.   On 23-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the three vaccines were all administered by Intramuscular route (strength, dose, dose number, anatomical site, lot # and expiration date were not reported) for prophylaxis (also reported as 15 months vaccinations). The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) were reconstituted with sterile diluent (MERCK STERILE DILUENT) (Intramuscular route; strength, dose, lot # and expiration date were not reported). The consumer reported that their child healthcare professional office gave the child the 12-month vaccinations when he was 15 months.   On the same day, the patient was cranky (irritability), the event was recovered on 29-May-2025 (conflicting information: also reported as lasted five days). Consumer was also informed one week after that it was the wrong dosage (Incorrect dose administered). The doctor stated that "he would be more immune, it is not giving Tylenol he will not overdose" (ill-defined disorder with onset unknown date in 2025).   At the reporting time, the outcome of ill-defined disorder was unknown.   The action taken with all suspect vaccines was not applicable.   The causal relationship between the events of irritability and ill-defined disorder and the suspect vaccines was not provided.    Lot# is being requested and will be submitted if received.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects were reported; a 19yr old patient was inadvertently administered the adult dose instead of the pediatric dose of RECOMBIVAX HB. Lot; This spontaneous report was received from a nurse and refers to a 19-year-old female patient.   The patient's medical history, concurrent conditions or concomitant therapies were not reported.   On 24-MAY-2025, the patient was accidentally vaccinated with the adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) suspension for injection at a dose of 0.5 mL (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis, instead of the pediatric dose (Accidental overdose). No additional adverse events were reported (No adverse event).  Lot# is being requested and will be submitted if received.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: a patient had received 1 dose of the 4-valent HPV vaccine when she was 14, and wanted further guidance regarding completing the dose; No additional AE; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date in approximately 2014, when the patient was 14-year-old, she was vaccinated with 1st dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient wanted further guidance regarding completing the dose (Inappropriate schedule of product administration). No additional adverse event was reported.  Lot# is being requested and will be submitted if received.