chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per patient portal message received from mother of patient: "Patient is having a lot of redness and swelling at his vaccine location on his right thigh. He seems fine otherwise but the redness is continuing to increase in size and now the center looks bruised and purple. The thigh is hard and hot. We spoke with the team in the immunization clinic as soon as we noticed the redness (about 24 hours after the vaccine) and they suggested hot compresses and Benadryl. I wanted to make sure you were looped in and wondered if you had any other advice as it doesn?t seem to be improving. The picture attached is from the first day of redness. The redness is larger than patient?s hand now and purple in the center." Reporter was the nurse to speak with Mother of patient.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Blood smear test normal, Blood test normal, Echocardiogram normal, Lymphadenopathy, Lymphoedema
Clinical narrative: 5-6 day post vaccine, I had swelling of lymph nodes under arm pit.  Beginning in fall of 2021, intermittent Lymphedema in right lower extremity.  Lymphedema became persistent in June 2024. Ruled out DVT, Baker's Cyst, Venous insufficiency, infectious disease (filariasis).  I have had no trauma, cancer, or surgery on the limb and do not fit the profile (not overweight, obese or have T2D) for primary or secondary lymphedema.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound scan normal
Clinical narrative: 5-6 day post vaccine, I had swelling of lymph nodes under arm pit.  Beginning in fall of 2021, intermittent Lymphedema in right lower extremity.  Lymphedema became persistent in June 2024. Ruled out DVT, Baker's Cyst, Venous insufficiency, infectious disease (filariasis).  I have had no trauma, cancer, or surgery on the limb and do not fit the profile (not overweight, obese or have T2D) for primary or secondary lymphedema.
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Acne, Arthralgia, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Hard swollen from shoulder down to elbow. red area approximately 4 inches. Hot to touch, red spot in middle, achy shoulder, itchiness, fine pimples in red area.
Age: 72.0
Sex: F
Vaccine: PNC21
Symptoms: Skin warm
Clinical narrative: Hard swollen from shoulder down to elbow. red area approximately 4 inches. Hot to touch, red spot in middle, achy shoulder, itchiness, fine pimples in red area.
Age: 65.0
Sex: M
Vaccine: PNC21
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: rash width of arm and 2 inches long swollen bright red spots size of pinhead on neck, chest and leg. Low grade fever 99.4, itchiness
Age: 45.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia, Pain
Clinical narrative: Patient presented to clinic for vaccinations, receiving Prevnar20 in right deltoid and Tdap in left deltoid on Friday afternoon (5/2). Patient complained of some pain during the injection process of the Prevnar 20 vaccine to her right deltoid. The vaccine was given in full, and she said it felt like a muscle spasm in her arm. Patient left message for clinic later that evening that arm had radiating pain from shoulders to fingertips. Clinic called patient back Monday morning upon seeing message where patient states pain increased around 7:30 pm the evening of 5/2, to the point where she was not able to lift her arm above her head. She stated there was no redness or swelling at the injection site.  All of her pain resided in her muscle/joint area. She did not seek further medical attention over the weekend. The provider was notified and called the patient advising that patient needs to come in for an exam if she continues to have issues with range of motion of arm. Patient states no improvement in pain and was scheduled to see provider in clinic on 5/7.  Patient encouraged to continue taking ibuprofen as needed, ice, and to seek treatment at the ER if her pain worsened. At visit, patient was prescribed prednisone in the morning for 5 days and to follow up in clinic if still no improvement will plan for EMG. A follow-up message was sent to patient on her improvement however patient stated that symptoms have improved minimally, with pain still in shoulder, triceps and radiating down the arm. Provider has planned to schedule and EMG.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Staff administered the wrong vaccine (0.25mL dose for ages 6 months to 11 years), no signs or symptoms were present. Patient left facility.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received third HPV Vaccine in error. Notified guardian of this mistake. No adverse side effects from 3 versus 2 doses.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had covid vaccine on 6/9/2025 then developed a fever 102.4 on 6/10/2025 no other symptoms
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope.  Patient lost consciousness for about 15 to 20 seconds.  Ice pack on back of neck then patient was feeling fine afterward.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Injection site erythema, Injection site swelling, Insomnia, Myalgia
Clinical narrative: Red, raised area at injection site, arm pain extending to whole body pain, paresthesia and myalgias in neck, shoulder, deltoid, and left arm;  Tachypnea, tachycardia, and anxiety,  insomnia.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Tachycardia, Tachypnoea
Clinical narrative: Red, raised area at injection site, arm pain extending to whole body pain, paresthesia and myalgias in neck, shoulder, deltoid, and left arm;  Tachypnea, tachycardia, and anxiety,  insomnia.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Tdap given too early
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Headache, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: redness in right arm, spreading up to right axillary area with pain. mild focal itching, arm pain with fever of 100, headache, malaise and sore throat.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Pyrexia
Clinical narrative: redness in right arm, spreading up to right axillary area with pain. mild focal itching, arm pain with fever of 100, headache, malaise and sore throat.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: There were no adverse reactions to the vaccine it's an error giving the pregnant woman the Dtap instead of the Tdap and the provider was informed after it was given.  Pt. is 29 weeks and 6 days estimated delivery date is 08/23/2025
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient received Prevnar vaccine on 06/05/2025 on her left arm.  Patient presented to pharmacy on 6/10/2025 stating her arm is still sore, swollen, red, itchy, and warm to the touch.  Patient does not have fever.  I asked patient what has she taken and she said nothing yet.  Patient said she also did not massage her arm or apply ice as rph directed her to.  Rph advised her to take massage her arm, apply ice, and take ibuprofen to help with swelling and anti-histamine to help with itching. Rph also advised patient to see doctor if symptoms does not improve.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: patient said left arm hurts when he raises it
Age: 1.42
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose given too early
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Hypertension
Clinical narrative: Chronic fatigue, blood pressure scare and stomach issues but no one can find a cause.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given too early
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given 12 month vaccines instead of 15 month vaccines. Mother of patient was called and informed by Provider that patient received duplicate vaccines. Mother of patient notes that he is doing well. No high temp, highest was 99.8F. Reports he is acting like himself. Eating well, drinking well, voiding and stooling well. Denies rash or sleeping concerns. Mother of patient was very understanding.
Age: 30.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Dysgeusia, Throat clearing
Clinical narrative: On 6/6/2025 c/o metallic taste back of tognue after all vaccinations were adminstrated.  Was clearing her throat, stated like when having reflux. No other symptoms, no other findings. No distress noted. No SOB, no stridor, no wheezing, throat and tongue appear normal, no rash, no itching. Observed one hour. Pt said the metallic taste was decreasing. Vital signs remained normal thru out. Left health unit in no distress.  Advised to seek immediate medical attention if worsen.  Advised to consult with PCP.    Follow up: she said the symptom resolved later that afternoon.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I BY MISTAKE GAVE PT MMR2 WHEN PROQUAD WAS OREDERED
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Muscle pain has been so bad I can't lift my arm days later. Tomorrow it will have been a week and I still can't fully lift the arm the vaccine was given in. I am taking Aleve and using heating pad and ice. Today I can move it a little mor but it is still painful to get dressed.
Age: 55.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Bone pain, Deafness unilateral, Erythema, Influenza like illness, Pain in extremity
Clinical narrative: For the first 6 days, patient experienced what she describes as severe bone pain, especially from the waist down, so bad that she had to lay down. Patient says she still has bone pain as of day 8, but not as bad.  Flu-like symptoms are ongoing as of day 8 and have been since she received the vaccines. Also after receiving the vaccines, she has experienced loss of hearing in her right ear. Her left arm became red and hot to the touch on day 8. Arm has been swollen and sore since day one.
Age: 55.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Skin warm
Clinical narrative: For the first 6 days, patient experienced what she describes as severe bone pain, especially from the waist down, so bad that she had to lay down. Patient says she still has bone pain as of day 8, but not as bad.  Flu-like symptoms are ongoing as of day 8 and have been since she received the vaccines. Also after receiving the vaccines, she has experienced loss of hearing in her right ear. Her left arm became red and hot to the touch on day 8. Arm has been swollen and sore since day one.
Age: 0.75
Sex: M
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given too early
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Notable swelling, pain and redness on his left shoulder near the area he was given the Menveo vaccine yesterday. He reports he initially felt fine after the vaccine. About an hour after the vaccine, he started to have some muscles soreness. He became more concerned today when he woke up and saw the left shoulder was very visibly more swollen than the right shoulder as well as red and hard to the touch. He has no past history of allergies or vaccine reactions. He denies any breathing issues like wheezing or shortness of breath. The onset was 1 day ago with worsening symptoms since that time. No fever. Symptoms include erythema located on left shoulder to the side of the injection site of the vaccine, pain is moderate.. Denies fever  and chills. There is history of trauma to the area.  Involved area: Location: left shoulder in the deltoid area. There is a 10 cm by 10 cm area of erythema without fluctuance noted. The area is tender, warm and indurated.  There is not presence of axillary lymphadenopathy.  No rash or swelling elsewhere. The mark from where his vaccine was given is just posterior on the deltoid to the area of erythema and swelling Assessment:   1. Vaccine reaction, initial encounter  2. Cellulitis of left upper extremity      Plan: The diagnosis was discussed along with the usual course and treatment. We discussed that the initial swelling could be a localized allergy to the vaccine, so I would like him to see allergy prior to him getting his second Menveo. I offered allergy referral today but mom would like to hold off on this until he is older and closer to needing his second Menveo vaccine. Supportive care of swelling with icing and NSAIDs Will prescribe prednisone for a couple days to help get the swelling down.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Myalgia
Clinical narrative: Notable swelling, pain and redness on his left shoulder near the area he was given the Menveo vaccine yesterday. He reports he initially felt fine after the vaccine. About an hour after the vaccine, he started to have some muscles soreness. He became more concerned today when he woke up and saw the left shoulder was very visibly more swollen than the right shoulder as well as red and hard to the touch. He has no past history of allergies or vaccine reactions. He denies any breathing issues like wheezing or shortness of breath. The onset was 1 day ago with worsening symptoms since that time. No fever. Symptoms include erythema located on left shoulder to the side of the injection site of the vaccine, pain is moderate.. Denies fever  and chills. There is history of trauma to the area.  Involved area: Location: left shoulder in the deltoid area. There is a 10 cm by 10 cm area of erythema without fluctuance noted. The area is tender, warm and indurated.  There is not presence of axillary lymphadenopathy.  No rash or swelling elsewhere. The mark from where his vaccine was given is just posterior on the deltoid to the area of erythema and swelling Assessment:   1. Vaccine reaction, initial encounter  2. Cellulitis of left upper extremity      Plan: The diagnosis was discussed along with the usual course and treatment. We discussed that the initial swelling could be a localized allergy to the vaccine, so I would like him to see allergy prior to him getting his second Menveo. I offered allergy referral today but mom would like to hold off on this until he is older and closer to needing his second Menveo vaccine. Supportive care of swelling with icing and NSAIDs Will prescribe prednisone for a couple days to help get the swelling down.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Rash, Skin swelling
Clinical narrative: Hands are swollen and puffy. Patient has a rash on the arms. Counseled patient to go to urgent care and let their primary care physician know.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site discolouration, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: 3 days post vaccination, patient reported greater than normal swelling/irritation at injection site. Noticed yellow/purple discoloration in a ~3-inch diameter around injection site with pain, redness and swelling also present in same area.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Malaise, Syncope
Clinical narrative: Patient got shots and waited 15 minutes after injections. Nurse checked arm and patient. Patient was told they could leave. Mother and child were standing at the check out window. Patient told his mother that he did not feel well. Mother of child assisted child to the floor. Child had a syncopal episode. Episode was approximately 2 minutes long. He awoke and remained on the floor while his legs were elevated. Heart rate and blood pressure were checked. Patient was given Gatorade to drink, assisted into a wheelchair, and  placed back on the exam table in a supine position. Cold rags were placed on patients forehead and chest. Vital signs were checked again. Patient was given 4 more Gatorades to drink and a protein bar to eat. Patient became stable after 20 minutes in room. Patient left office with mother.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A given too early
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: first day soreness in injection site and warm sensation second day redness , itching and discomfort , pt stated that redness i moving down in the arm, advised pt to take Ibuprofen and Benadryl
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood triglycerides increased, Slit-lamp tests normal, Visual acuity tests abnormal, Visual impairment, Vitreous degeneration
Clinical narrative: Patient presents with flashes, floaters, dark spots in vision.  Last saw Dr. 4/25/25 for similar concerns but was diagnosis with syneresis. States that flashes of light have improved since then but still noticing a handful of floaters.   Received Shingrix vaccine in 4/18/25. When the patient spoke with his PCP, his PCP suggested seeing ophthalmology d/t concern for possible reaction from the vaccine.  Reports mild pain worsened with EOM's.   OS floater in central vision, and flashes superotemporal (12 times per day, fleeting)   Past Ocular History  - Wears glasses, no contacts  - No prior surgery or laser  - No prior trauma  - High myope -7/-6 sphere
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous detachment, Vitreous floaters
Clinical narrative: Patient presents with flashes, floaters, dark spots in vision.  Last saw Dr. 4/25/25 for similar concerns but was diagnosis with syneresis. States that flashes of light have improved since then but still noticing a handful of floaters.   Received Shingrix vaccine in 4/18/25. When the patient spoke with his PCP, his PCP suggested seeing ophthalmology d/t concern for possible reaction from the vaccine.  Reports mild pain worsened with EOM's.   OS floater in central vision, and flashes superotemporal (12 times per day, fleeting)   Past Ocular History  - Wears glasses, no contacts  - No prior surgery or laser  - No prior trauma  - High myope -7/-6 sphere
Age: 1.58
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dtap and polio given to early
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Syncope
Clinical narrative: Patient reported having very low blood pressure the morning after receiving her second dose of Shingrix (Systolic of 90 and 70), and fainting twice. She stated she slept for several hours during the day yesterday and is now feeling back to normal. She reported the reaction today to the pharmacy and to her provider this morning. She is not seeking care currently.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Pruritus, Tenderness
Clinical narrative: Patient received vaccination on Friday 6/10/25 at about 4:30 p.m. Patient states she felt fine the remainder of Friday and all day Saturday. On Sunday she began to notice itching on the right arm. Patient presented to the pharmacy on Tuesday 6/10/25 at 1:15 p.m. with a red circle roughly 4 inches in diameter about an inch and a half below the injection site. There was some bruising and patient reported tenderness in the elbow.
Age: 16.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Provider ordered Proquad (MMRV) for pt. Pt is past manufacture's age range for immunization.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
Age: 26.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient administered Proquad vaccine. Database was not verified before given. called and spoke with vaccine company Merck and was advised per CDC ages 13 & older it is Valid administration as it is no recommended but not harmful to patient and will close the series for the patient and will be consider the booster for the patient.  No side affect or medical concerns at this time reported from patient.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Fatigue, Irritability, Lethargy, Swollen tongue
Clinical narrative: Patient received Pediarix vaccine and immediately at home began to be lethargic, had a swollen tongue, was extremly fussy and fatigue. Patient was seen at an urgent care & given prednisone. MOP stated that this form of medication did not work and it subsided a few days later.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiac monitoring normal, Dizziness, Postural orthostatic tachycardia syndrome, Presyncope, Thyroid function test
Clinical narrative: Complaints of POTS x 6 months after vaccine administration. Last episode was 2 days ago associated with near-syncope, dizziness
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The child covid age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent on 12/18/2024 and 01/10/2025. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
Age: 1.33
Sex: M
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PPSV23 given to 16 month old patient instead of PCV20
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The child covid vaccine, age 6 mon - 11 years comes in a vial of 0.3ml. it is supposed to be diluted with 1.1mL of NS 0.9% to make 3 doses of 0.3mL. The child was given a full vial of 0.3mL Covid without diluent. The mistake was discovered 05 Feb 25. The parents were called and said the child did not have any adverse effects.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Pt. received a Menveo shot instead of PCV20 shot.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a 3rd dose of Rotarix at their 6month Well Child visit in error, not s/sx of adverse reaction noted. Patients physician was notified and patient's mother was notified prior to leaving the visit that day.
Age: 76.0
Sex: M
Vaccine: PNC21, TD
Symptoms: Contusion, Skin warm
Clinical narrative: Right arm large bruised area & warm
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Tremor
Clinical narrative: Tremor of head after immunizations, started within a couple days of immunization and lasted 2-3 weeks. No tremor of extremities. Tremor was nearly constant and infant was always responsive with tremor. Touch did not diminish tremor. Tremor lasted lasted 2-3 weeks and was also noted at daycare. Not facial paralysis or drooping. no weakness noted.
Age: 55.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Patient had no physical effects from either vaccine.  However, patient had a Libre 3 sensor on the right arm.  Patient states that after he received the vaccines the sensor had a low reading, and a few minutes later the sensor went dead.  During administration of the vaccines, the sensor did not appear to be stable on patient's arm, as patient continued to press the sensor down to keep it stuck to arm.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Heart rate increased, Herpes zoster, Malaise, Neuralgia, Pain in extremity
Clinical narrative: ved Capvaxive vaccine.  The following day (5/20/25) had fever, an elevated heart rate (increase from 83 to 88 bpm resting heart rate, and approx 24 hours after vaccination HR was as high as 118 while resting) and a very sore arm (pain 6/10).  Patient overall didn't feel well.  About a week after vaccination, developed a shingles rash in several areas, include L side of torso (2 spots, one mid side and one higher up) as well as some spots on the back of each arm just outside of the armpit area.  This patient had chicken pox as a child and has not been vaccinated against shingles.  Had one prior flare up of shingles in 2017 when undergoing a stressful life event.  Nothing since until this episode.  This is all self-report.  Patient did not visit her physician. As of this report, shingles rash is resolving with only mild postherpetic neuralgia
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia
Clinical narrative: ved Capvaxive vaccine.  The following day (5/20/25) had fever, an elevated heart rate (increase from 83 to 88 bpm resting heart rate, and approx 24 hours after vaccination HR was as high as 118 while resting) and a very sore arm (pain 6/10).  Patient overall didn't feel well.  About a week after vaccination, developed a shingles rash in several areas, include L side of torso (2 spots, one mid side and one higher up) as well as some spots on the back of each arm just outside of the armpit area.  This patient had chicken pox as a child and has not been vaccinated against shingles.  Had one prior flare up of shingles in 2017 when undergoing a stressful life event.  Nothing since until this episode.  This is all self-report.  Patient did not visit her physician. As of this report, shingles rash is resolving with only mild postherpetic neuralgia
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient had received a dose of Varicella on 5/6/25 and then went to Urgent care for an appointment and they gave him a Dose of MMR on the that day. The dose of MMR is considered invalid. Patient did not have any side effect or symptoms post vaccination.
Age: 66.0
Sex: M
Vaccine: PNC21
Symptoms: Dizziness, Erythema, Peripheral swelling
Clinical narrative: The patient presented with a red and swollen arm. She stated the she felt dizziness after taking the vaccine but reported to the pharmacy on 06/10/2025
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Chills; Arm soreness; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing); "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: DOXAZOSIN; MELATONIN; METOPROLOL; MIRALAX; SIMVASTATIN; VITAMIN D [VITAMIN D NOS]. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness". Additional information: When the patient received the original two shots, the only reactions were chills and arm soreness.  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-202500117105 same patient and drug, different dose and events;US-PFIZER INC-202500117641 same patient and drug, different dose and events;US-PFIZER INC-202500117116 same patient and drug, different dose and events;US-PFIZER INC-202500117114 same patient and drug, different dose and events;
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: chills; arm soreness; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing), notes: heart arrhythmia; "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "chills", "arm soreness". The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: When the patient received the original two shots, his only reactions were chills and arm soreness.  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-202500117105 same patient, different dose/events;US-PFIZER INC-202500117641 same patient, different dose/events;US-PFIZER INC-202500117114 same patient, different dose/events;US-PFIZER INC-202500117115 same patient, different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing), notes: heart arrhythmia; "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "chills", "arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chills", "arm soreness". The following information was reported: FATIGUE (non-serious) with onset Sep2022, 12 hrs after the suspect product(s) administration, outcome "recovered", described as "tired".  Additional information: When the patient received the original two shots, his only reactions were chills and arm soreness. He is not sure if he had any other reaction besides these and being tired for the first few booster shots. These started about 12 hours after the shot and ended after about 24 hours.  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-202500117105 same patient, different dose/events;US-PFIZER INC-202500117114 same patient, different dose/events;US-PFIZER INC-202500117115 same patient, different dose/events;US-PFIZER INC-202500117116 same patient, different dose/events;
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: non zero rheumatoid so I'm flared up all over the place; broke my ankle; broke my heel; a stye in my eye; Stress causes my disease to flare up; keep losing my voice; stuff in my chest; degenerative bone; degenerative disc; not feeling good/I fell ill; fever; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "non zero rheumatoid so I'm flared up all over the place"; ANKLE FRACTURE (medically significant), outcome "unknown", described as "broke my ankle"; FOOT FRACTURE (medically significant), outcome "unknown", described as "broke my heel"; HORDEOLUM (non-serious), outcome "unknown", described as "a stye in my eye"; STRESS (non-serious), outcome "unknown", described as "Stress causes my disease to flare up"; APHONIA (non-serious), outcome "unknown", described as "keep losing my voice"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "stuff in my chest"; DEGENERATIVE BONE DISEASE (non-serious), outcome "unknown", described as "degenerative bone"; INTERVERTEBRAL DISC DEGENERATION (non-serious), outcome "unknown", described as "degenerative disc"; MALAISE (non-serious), outcome "unknown", described as "not feeling good/I fell ill"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of ankle fracture, foot fracture, chest discomfort.  Clinical course: Caller was transferred to the escalations department to speak with a supervisor to provide their feedback regarding the changes to the patient assistance program for the medication Xeljanz. During the call caller stated the following." I'm sick I have crap in my chest I'm on enough antibiotics. I have nothing but good things to say about Pfizer, I got all the Pfizer boosters. Stress causes my disease to flare up. apparently I have a stye in my eye. Tuesday I got a shot in my ankle the foot doctor said yeah you got a stye in your eye. I'm permanently disabled, I'm handicapped. Unfortunately I fell ill I keep losing my voice I'm just not feeling good I'm running a fever I got stuff in my chest. I have rods and screws in my back I need a knee replacement, I broke my heel I was misdiagnosed and as a result I broke my ankle it never healed right that's why I gotta get shots every 4 months. It's all on my right leg. Unfortunately I got sick. I can't sit down and type up a whole paragraph I'm too sore. I have degenerative bone, degenerative disc. and I have non zero rheumatoid so I'm flared up all over the place I'm swollen and sore right now."   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: she is experiencing unusual scents in smell.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 40-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROSMIA (non-serious) with onset 2025, outcome "unknown", described as "she is experiencing unusual scents in smell.".  Additional information: Reporter mentioned when she had Covid 19 vaccine, after four years getting the shot she is experiencing unusual scents in smell. She experienced something that she shouldn't have experienced.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: one patient in the last year who was hospitalized for pneumonia; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2025 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), outcome "recovered", described as "one patient in the last year who was hospitalized for pneumonia". The patient was hospitalized for drug ineffective (start date: 2024).  Additional information: Doctor believed he had one patient in the last year who was hospitalized for pneumonia, cant recall if they were vaccinated or not but if they were it would have been with Prevnar 20 because that was all he prescribed. Also mentioned that "like any vaccine some people have minor injection site reactions or temporary fever".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective with the suspect product PREVNAR 20 cannot be fully excluded.
Vaccine: PNC20
Symptoms: Product storage error
Clinical narrative: administration after the excursion; administration after the excursion; This is a spontaneous report received from an Other HCP.  An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "administration after the excursion".  Additional information: The reporter wanted to get a stability report because of a temperature excursion for the PREVNAR 20 PEDIATRIC. The vaccine was administered to the patient after the excursion.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Pt describes a rash starting the day after administration on Friday 6/6/25 and continued getting progressively worse  through the weekend.  She reported to the pharmacy to pickup a prescription after seeing Dr. regarding the reaction on Tuesday 6/10/25 and the rash was covering most of her right deltoid and was raised and very red.  Dr. prescribed doxycycline to treat her for vasculitis and allergic reaction.  Patient also reported nausea and body aches Friday thru Sunday.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Injected limb mobility decreased, Injection site swelling, Limb discomfort
Clinical narrative: Unusual and prolonged pain at site of infection lasting at least 8 days.  Initial swelling.  Overall fatigue and ongoing limitation of L arm motion due to discomfort persisting at least  8 days
Age: 1.92
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Psychomotor hyperactivity, Pyrexia
Clinical narrative: My daughter started to act very wild and run around non-stop. She was jumping, rolling, and acting out of the ordinary for a normally calm toddler. She would not follow directions and is normally very calm. She started to have a fever. She would not go to bed. She acted out of character and wouldn't calm down for two days, and had a fever for about two days.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Patient received 4 vaccines (MMR, Adacel, Varivax, and Heplisav-B). The patient briefly passed out and then came back to. She was feeling a little dizzy and vomited. The paramedics arrived and checked her vitals and they were all normal. She was feeling better about 30 minutes after the injections.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection Site had red and had a bump.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Infant irritability, Pyrexia
Clinical narrative: "Fever and very fussy that day", lasting one day. Resolved
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death in early 50's male EUA countermeasure recipient. DOSE#1 Date 03/19/21 LOT# 047A21A DOSE#2 Date 04/18/21 LOT# 045B21A. Copy of vax available online. Unable to ascertain any other info on subsequent inoculations, the actual onset of post inoculation adverse events or the manner of death. His obituary implies cancer may have been a factor in his demise. Obituary directed donations to a local cancer charity.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Muscle spasms / chest pain
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Muscle spasms / chest pain
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Eye swelling, Rash
Clinical narrative: Swollen eye, rash on lips and hips
Age: 0.58
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC20, RV1
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient had no adverse reactions, hep A shot was given too early
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received PREVNAR 20 on 3/13/23 and on 6/4/25. Based on ACIP guidelines patient was not indicated for the second dose of PREVANR 20.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: vaccine not documented in database from 2024. Pharmacist reviewed file and patient came in requesting vaccine. Since there was no record in database pharmacist administered. Patient reported no adverse effects
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Blood test, Chills, Craniofacial fracture, Dysstasia
Clinical narrative: Got chill on right side of body around 8:30 pm night of vaccination.  Fell on 3/6/2025 @ 4:30am, could not get up, bleeding in several locations, gash on head, broke bridge of nose.  Laid on floor till 10:30am when friends came and called 911.  Taken to hospital; had internal bleeding and sepsis.  Released from hospital on 3/11.  Paid out-of-pocket for very expensive 24/7 care for 5+ weeks.  Still working to build strength and stamina
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Electrocardiogram, Fall, Haemorrhage, Internal haemorrhage, Magnetic resonance imaging neck
Clinical narrative: Got chill on right side of body around 8:30 pm night of vaccination.  Fell on 3/6/2025 @ 4:30am, could not get up, bleeding in several locations, gash on head, broke bridge of nose.  Laid on floor till 10:30am when friends came and called 911.  Taken to hospital; had internal bleeding and sepsis.  Released from hospital on 3/11.  Paid out-of-pocket for very expensive 24/7 care for 5+ weeks.  Still working to build strength and stamina
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Sepsis, Skin laceration
Clinical narrative: Got chill on right side of body around 8:30 pm night of vaccination.  Fell on 3/6/2025 @ 4:30am, could not get up, bleeding in several locations, gash on head, broke bridge of nose.  Laid on floor till 10:30am when friends came and called 911.  Taken to hospital; had internal bleeding and sepsis.  Released from hospital on 3/11.  Paid out-of-pocket for very expensive 24/7 care for 5+ weeks.  Still working to build strength and stamina
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC15
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: The patient had continuous, inconsolable crying for 3hr after vaccination. It was accompanied by a local reaction consisting of redness & swelling at the injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash pruritic, Varicella
Clinical narrative: doctor told her that she most likely has chicken pox/suspected chickenpox; bumps/spots, she indicated they look like mosquito bites and continued to grow and; This non-serious case was reported by a consumer via call center representative and described the occurrence of chickenpox in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included magnesium hydroxide (Magnesium), colecalciferol (Vitamin D), oenothera biennis, vitamin e nos (Evening Primrose Oil) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin).   On 12-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular use, left deltoid). In MAY-2025, between 1 and 2 months after receiving Shingrix, the patient experienced itchy rash (Verbatim: bumps/spots, she indicated they look like mosquito bites and continued to grow and). On an unknown date, the patient experienced chickenpox (Verbatim: doctor told her that she most likely has chicken pox/suspected chickenpox). The outcome of the chickenpox was not reported, and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the chickenpox and itchy rash to be related to Shingrix.     It was unknown if the company considered the chickenpox and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2025 Patient had some questions about side effects/bumps and asked if she should get the 2nd vaccine. She provided further information, she got Shingrix shot 1 on May 12th.  Around May 20th she developed the bumps/spots, she indicated they look like mosquito bites and continued to grow and itch. They asked the patient/reporter where on her body the bumps are and she said they are everywhere from legs, in butt crack, on back, on breasts, from shins to head. As of Saturday May 31st, they stopped growing but every bump was still itching.  She indicated that her doctor did not know what was causing the bumps and prescribed an unspecified topical steroid cream which did not work.  Her son's doctor told her that she most likely has chicken pox. This case is linked with case US2025068863, reported by the same reporter.; Sender's Comments:  US-GSK-US2025068863:SAME REPORTER