chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: RSV
Symptoms: Feeling abnormal, Malaise, Paranasal sinus hypersecretion, Patient isolation, Productive cough
Clinical narrative: Resident recieved vaccine 12/5/24. Came sick and tested positive for RSV on 12/27/24 Resident was on the mend feeling better, came off of isolation. Resident had sudden decline, sudden death. Was unable to got her to ER to be evaluated by ER before she declined. I was leaving the dining room from passing lunch meds I was passing by residents room when I heard resident yell help. Went into residents room resident had c/o SOB. Resident did not have O2 on. I reapplied O2. Resident also said that she had to go to thebathroom. CNA was walking by the room. I yelled out for CNA to take resident to the bathroom. I parked med cart in med room grabbed plus ox and glucometer. Another CNA grabbed v/s cart. Resident kept saying I don't feel good. I can't breath. BS was not low. SPO2 was not low. Resident was slurring her words. I did stroke assessment, it was WNL. I called supervisor RN and stated what was going on and that I was going to send to ER. CNAs and other nurse put resident on gurney as I printed off paperwork. I took resident down to ER. Resident passed in the elevator as we exited into ER. TOD was 1257. Notified Dr @ 1310. @1315 pronounced. @ 1415 Funeral home picked up. Resident coughing productively thick brown sputum. lung sounds rhonchi. o2 sat 85% room air. I have placed on o2@2lpm.nc. Chest x-ray results pending. Dr notified of resident condition and of chest x-ray results. new orders for levaquin 500 mg one daily x 5 days and decadron 8 mg IM daily x 1 dose. Family notified. Resident continues to have cough/congestion/sinus drainage. Lung sounds diminished. she is coughing productively yellow sputum. T 97.9 P 103 R 28 b/p 121/70 o2 sat 92% room air. I spoke with RN. new order received for chest x-ray today. Family notified. Resident coughing productively light yellow sputum, lung sounds diminished bases and rhonchi upper airway. T 97.9 P 96 R 32 b/p 103/59 o2 96% I have administered prn cough syrup and tylenol. results pcr fo follow. allergies: promethazine. Dr. notified new orders received for cefdinir 300 mg one bid x 5 days, decadron 8 mg IM x 1 injection, mupirocin ointment to bilateral nares bid x 5 days. Family notified.
Age: 93.0
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus test positive, Respiratory tract congestion, Rhonchi, Sputum discoloured, Sudden death
Clinical narrative: Resident recieved vaccine 12/5/24. Came sick and tested positive for RSV on 12/27/24 Resident was on the mend feeling better, came off of isolation. Resident had sudden decline, sudden death. Was unable to got her to ER to be evaluated by ER before she declined. I was leaving the dining room from passing lunch meds I was passing by residents room when I heard resident yell help. Went into residents room resident had c/o SOB. Resident did not have O2 on. I reapplied O2. Resident also said that she had to go to thebathroom. CNA was walking by the room. I yelled out for CNA to take resident to the bathroom. I parked med cart in med room grabbed plus ox and glucometer. Another CNA grabbed v/s cart. Resident kept saying I don't feel good. I can't breath. BS was not low. SPO2 was not low. Resident was slurring her words. I did stroke assessment, it was WNL. I called supervisor RN and stated what was going on and that I was going to send to ER. CNAs and other nurse put resident on gurney as I printed off paperwork. I took resident down to ER. Resident passed in the elevator as we exited into ER. TOD was 1257. Notified Dr @ 1310. @1315 pronounced. @ 1415 Funeral home picked up. Resident coughing productively thick brown sputum. lung sounds rhonchi. o2 sat 85% room air. I have placed on o2@2lpm.nc. Chest x-ray results pending. Dr notified of resident condition and of chest x-ray results. new orders for levaquin 500 mg one daily x 5 days and decadron 8 mg IM daily x 1 dose. Family notified. Resident continues to have cough/congestion/sinus drainage. Lung sounds diminished. she is coughing productively yellow sputum. T 97.9 P 103 R 28 b/p 121/70 o2 sat 92% room air. I spoke with RN. new order received for chest x-ray today. Family notified. Resident coughing productively light yellow sputum, lung sounds diminished bases and rhonchi upper airway. T 97.9 P 96 R 32 b/p 103/59 o2 96% I have administered prn cough syrup and tylenol. results pcr fo follow. allergies: promethazine. Dr. notified new orders received for cefdinir 300 mg one bid x 5 days, decadron 8 mg IM x 1 injection, mupirocin ointment to bilateral nares bid x 5 days. Family notified.
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram, Differential white blood cell count, Dissociation, Disturbance in attention, Dizziness
Clinical narrative: Moderate Injection site pain - no treatment, resolved Fatigue - ongoing Headache (day after only) - resolved Lightheadedness with exertion - short distance walking, standing for short periods - presented to neurologist but no treatment offered - has moderated but still encountering periods of lightheadedness Pressure in head that changed locations and intensity - no treatment - resolved Pain in head that changed locations and intensity - no treatment - resolved Disassociation, short term, possibly only one or two periods long enough to notice - no treatment - resolved  Difficultly concentrating - no treatment - possibly ongoing Can't focus (long distance to short or vice versa) - no treatment - resolved Cramping in toes/feet hands/fingers calves- no treatment- frequency is reduced- ongoing, headaches after exertion - neurologist put on medications - frequency is reduced- ongoing , disassociation of feeling of orgasm with ejaculation - have been referred to urologist - ongoing
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Exertional headache, Fatigue, Full blood count, Head discomfort, Headache
Clinical narrative: Moderate Injection site pain - no treatment, resolved Fatigue - ongoing Headache (day after only) - resolved Lightheadedness with exertion - short distance walking, standing for short periods - presented to neurologist but no treatment offered - has moderated but still encountering periods of lightheadedness Pressure in head that changed locations and intensity - no treatment - resolved Pain in head that changed locations and intensity - no treatment - resolved Disassociation, short term, possibly only one or two periods long enough to notice - no treatment - resolved  Difficultly concentrating - no treatment - possibly ongoing Can't focus (long distance to short or vice versa) - no treatment - resolved Cramping in toes/feet hands/fingers calves- no treatment- frequency is reduced- ongoing, headaches after exertion - neurologist put on medications - frequency is reduced- ongoing , disassociation of feeling of orgasm with ejaculation - have been referred to urologist - ongoing
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Magnetic resonance imaging head, Metabolic function test, Muscle spasms, Platelet count
Clinical narrative: Moderate Injection site pain - no treatment, resolved Fatigue - ongoing Headache (day after only) - resolved Lightheadedness with exertion - short distance walking, standing for short periods - presented to neurologist but no treatment offered - has moderated but still encountering periods of lightheadedness Pressure in head that changed locations and intensity - no treatment - resolved Pain in head that changed locations and intensity - no treatment - resolved Disassociation, short term, possibly only one or two periods long enough to notice - no treatment - resolved  Difficultly concentrating - no treatment - possibly ongoing Can't focus (long distance to short or vice versa) - no treatment - resolved Cramping in toes/feet hands/fingers calves- no treatment- frequency is reduced- ongoing, headaches after exertion - neurologist put on medications - frequency is reduced- ongoing , disassociation of feeling of orgasm with ejaculation - have been referred to urologist - ongoing
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Scan with contrast
Clinical narrative: Moderate Injection site pain - no treatment, resolved Fatigue - ongoing Headache (day after only) - resolved Lightheadedness with exertion - short distance walking, standing for short periods - presented to neurologist but no treatment offered - has moderated but still encountering periods of lightheadedness Pressure in head that changed locations and intensity - no treatment - resolved Pain in head that changed locations and intensity - no treatment - resolved Disassociation, short term, possibly only one or two periods long enough to notice - no treatment - resolved  Difficultly concentrating - no treatment - possibly ongoing Can't focus (long distance to short or vice versa) - no treatment - resolved Cramping in toes/feet hands/fingers calves- no treatment- frequency is reduced- ongoing, headaches after exertion - neurologist put on medications - frequency is reduced- ongoing , disassociation of feeling of orgasm with ejaculation - have been referred to urologist - ongoing
Age: 90.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: No adverse reaction reported when speaking to patient
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Back pain, Diarrhoea, Injection site pain, Mobility decreased
Clinical narrative: Day 0 and Day 1 experienced injection site pain. Day 2 -Day 4 experienced extreme back pain and stiffness preventing me from turning my body at all, starting in the upper back and moving towards the lower back. Day 5 the back pain subsided but started to experience extreme hip pain and diarrhea. Day 6-Day 7 started having extreme leg pain where it hurt to stand but really hurt to sit. Radiating sharp pain down both legs; joints and muscles aching. Heating pads help. Today is Day 8 still having leg pain, knee pain, diarrhea, and some upper back pain is returning.
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: Day 0 and Day 1 experienced injection site pain. Day 2 -Day 4 experienced extreme back pain and stiffness preventing me from turning my body at all, starting in the upper back and moving towards the lower back. Day 5 the back pain subsided but started to experience extreme hip pain and diarrhea. Day 6-Day 7 started having extreme leg pain where it hurt to stand but really hurt to sit. Radiating sharp pain down both legs; joints and muscles aching. Heating pads help. Today is Day 8 still having leg pain, knee pain, diarrhea, and some upper back pain is returning.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram thorax, Dyspnoea, Laboratory test
Clinical narrative: Patient reported having chest pains, SOB. Reported to ER and findings concluded a PE, no other reasoning for this to develop.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, HPV9, TDAP, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client was given SPIKEVAX12+, but he was 10 years old at the time of administration. Client did not experience any symptoms or adverse effects after receiving the vaccine.
Age: 0.25
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult hepatitis A dose was administered instead of pediatric hepatitis A.  Parent contacted and informed of adverse event, confirmed with parent that child is okay. Consulted with rendering provider regarding vaccine error.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received RSV vaccine twice. Initial dose 7/24/24
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: As the needle was being withdrawn from the patient's arm, a couple drops of the vaccine spilled down the patient's arm.
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine administered; no adverse reactions noted
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Extra dose administered
Clinical narrative: patient already received Td on 2/22/22
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness/swelling of injection arm, light headedness, fever/chills
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arteriogram carotid, Computerised tomogram head, Metabolic function test, Nerve block, New daily persistent headache
Clinical narrative: New Daily Persistent Headache. Started 10/20/2024 and continues every single day through today. Constant headache, only relieved by laying down.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Scan with contrast, Spinal X-ray
Clinical narrative: New Daily Persistent Headache. Started 10/20/2024 and continues every single day through today. Constant headache, only relieved by laying down.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red slightly swollen at injection site
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Injection site pain
Clinical narrative: Pain in Rt upper arm to elbow unresolved after 2 months. Numbness and weakness.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Partial seizures, Road traffic accident
Clinical narrative: Grand Mal seizure within 24 hours after injection. Reoccurring and ongoing grand Mal and focal seizures since vaccination. I deal with this daily. No family records of seizure on either of my parents side. I have been hospitalized many times. I have suffered a car accident, and paid many, many medical bills including doctor visits, overnight hospitalization, ambulance bills, and medicine to treat my symptoms.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 62 at time of vaccination but given the dose approved for patients who are 65+, patient had no adverse reactions at the time of vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Extra dose administered
Clinical narrative: Pentacel (DTaP-IPV/Hib) administered instead of Kinrix (DTaP-IPV). The patient received 5 doses of Hib after this Pentacel vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient was diagnosed with shingles on 01/29/2025 in the same arm the Gardisil 9 injection was given.  The shingles rash began on 01/26/2025.  It is highly unusual for children to contract Shingles.
Age: 80.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the 2024/2025 formulation of Fluad and Spikevax on 9/25/24 at a visit with his doctor's office and again on 12/2/24 at an immunization clinic put on by Pharmacy. No adverse reactions at the time of vaccination.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Patient received a second M-M-R II vaccines 3 days after previously receiving  another M-M-R II vaccine at another pharmacy.  Patient came in another day with their information from another pharmacy showing they got the M-M-R II already but did not mention at the time of vaccine that they received any vaccines recently.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Gave pediatric dose to adult patient.
Age: 67.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Patient received a second M-M-R II vaccines 3 days after previously receiving another M-M-R II vaccine at another pharmacy.  Patient came in another day with their information from another pharmacy showing they got the M-M-R II already but did not mention at the time of vaccine that they received any vaccines recently.  Two patients came in together, report for other patient already submitted.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate RSV vaccine was given to patient. Patient had a dose of the vaccine on 09/15/23 and again on 01/27/25.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-GAD antibody positive, Blood glucose increased, Glycosylated haemoglobin increased, Haemoptysis, Latent autoimmune diabetes in adults
Clinical narrative: Latent Autoimmune Diabetes in Adults (LADA) diagnosed. Initial diabetes diagnosis Blood sugar of 488mg/dl and HbA1c of 8.4 discovered in ER visit for Hemoptysis secondary to a later discovered mycobacterium intracellulare infection in left lobe of lung. This infection occurred likely from a decreased immune system caused by elevated blood glucose. Follow-up with endocrinologist found positive Antibodies to glutamic acid decarboxylase (GAD). Prior to Covid-19 vaccine fasting blood glucose results were below 100mg/dl.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium avium complex infection
Clinical narrative: Latent Autoimmune Diabetes in Adults (LADA) diagnosed. Initial diabetes diagnosis Blood sugar of 488mg/dl and HbA1c of 8.4 discovered in ER visit for Hemoptysis secondary to a later discovered mycobacterium intracellulare infection in left lobe of lung. This infection occurred likely from a decreased immune system caused by elevated blood glucose. Follow-up with endocrinologist found positive Antibodies to glutamic acid decarboxylase (GAD). Prior to Covid-19 vaccine fasting blood glucose results were below 100mg/dl.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Vomiting
Clinical narrative: Upset stomach at 3 pm/vomiting and diarrhea started at 4 pm. until 7 pm/cold chills from 6 pm to 11pm/ sensitive stomach until Jan. 14th.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Deep vein thrombosis, Fibrin D dimer increased, International normalised ratio normal
Clinical narrative: Subclavian DVT in right arm. Observed prominent veins on right shoulder and chest evening January 12th. Some weakness and discoloration in right arm. Saw PCP on January 13th, d-dimer performed in office. Ultrasound performed evening january 13th, DVT diagnosed. Referred to ER. Prescribed Eliquis Starter Pack for DVT/PE, began taking evening January 13th. Currently on Day 17 of treatment, minor improvement in symptoms but veins still prominently visible, weakness and discolouration in right arm persists, and some pain in right shoulder/chest area. No personal history of DVT, no family history of DVT except assosciated with Stage 4 lung cancer (mother, age 77).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Prothrombin time normal, Skin discolouration, Subclavian vein thrombosis, Superficial vein prominence
Clinical narrative: Subclavian DVT in right arm. Observed prominent veins on right shoulder and chest evening January 12th. Some weakness and discoloration in right arm. Saw PCP on January 13th, d-dimer performed in office. Ultrasound performed evening january 13th, DVT diagnosed. Referred to ER. Prescribed Eliquis Starter Pack for DVT/PE, began taking evening January 13th. Currently on Day 17 of treatment, minor improvement in symptoms but veins still prominently visible, weakness and discolouration in right arm persists, and some pain in right shoulder/chest area. No personal history of DVT, no family history of DVT except assosciated with Stage 4 lung cancer (mother, age 77).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Subclavian DVT in right arm. Observed prominent veins on right shoulder and chest evening January 12th. Some weakness and discoloration in right arm. Saw PCP on January 13th, d-dimer performed in office. Ultrasound performed evening january 13th, DVT diagnosed. Referred to ER. Prescribed Eliquis Starter Pack for DVT/PE, began taking evening January 13th. Currently on Day 17 of treatment, minor improvement in symptoms but veins still prominently visible, weakness and discolouration in right arm persists, and some pain in right shoulder/chest area. No personal history of DVT, no family history of DVT except assosciated with Stage 4 lung cancer (mother, age 77).
Age: 94.0
Sex: F
Vaccine: PNC20
Symptoms: Death, Seizure like phenomena
Clinical narrative: Vaccine received on 1/21- had 30 sec seizure like activity that evening. Remained alert and oriented per baseline. Sitting in recliner after evening meal when staff found already deceased. Had extensive health history and comorbidities.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Intracranial aneurysm
Clinical narrative: Began to suffer from aphasia, eventually hospitalized for stroke and then brain aneurysm
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Breast pain
Clinical narrative: patient has been experiencing  pain in arm from shoulder to elbow down around breast, started with vaccine and has continued, she has take tylenol
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness. No treatment
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Syringe issue
Clinical narrative: Unknown dose of MMR administered due to defective sterile diluent prefilled syringe
Age: 1.5
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Idiopathic urticaria, Injection site erythema
Clinical narrative: Idiopathic urticaria that lasted for 2 weeks after administration with erythema that started at the right thigh (site of the HepA vaccine). I am a pediatric allergist and reaction was immunologic related to the innate response to these rather than IgE
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had vaccines on 2/22/22 not sure for one
Age: 1.33
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menveo - 1 vial was ordered by Physician and given by Medical Assistant, but is meant for patients aged 10-55 years, and this patient was 1 when he received the vaccine. Should have received the 2-vial formulation for patients aged 2-10. No harm to the patient as dosing is the same, however, not FDA approved for single vial to be given to patients under 10.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on L upper arm. Rx Keflex
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3, HPV9
Symptoms: Syncope
Clinical narrative: After completing IM Vx administration of Flu, Moderna, and HPV (1) Pt experienced textbook syncopal episode. Pt regained full level of consciousness within seconds. This nurse had Pt in laying position for 5 mins prior to coming to sitting position for additional 10 mins. At that time the Pt was escorted to front desk area to check out. Pt had continued monitoring for another 15 mins. Pt stated they felt safe to leave after checkout was complete. Education was given on S/S to watch for over the next few days.
Age: 1.25
Sex: M
Vaccine: HIBV, SMALL
Symptoms: Autism spectrum disorder, Brain lobectomy, Developmental regression, Ear infection, Electroencephalogram
Clinical narrative: Patient began regressing in cognition.  His speech did not develop and he began having repeated ear infections.  He had his first seizure 4 months later and was diagnosed with epilepsy.  He has had his whole genome sequenced with no findings that would suggest congenital abnormalities.
Age: 1.25
Sex: M
Vaccine: HIBV, SMALL
Symptoms: Epilepsy, Laboratory test, Magnetic resonance imaging, Magnetoencephalography, Scan
Clinical narrative: Patient began regressing in cognition.  His speech did not develop and he began having repeated ear infections.  He had his first seizure 4 months later and was diagnosed with epilepsy.  He has had his whole genome sequenced with no findings that would suggest congenital abnormalities.
Age: 1.25
Sex: M
Vaccine: HIBV, SMALL
Symptoms: Seizure, Speech disorder developmental, Surgery, Whole-genome sequencing
Clinical narrative: Patient began regressing in cognition.  His speech did not develop and he began having repeated ear infections.  He had his first seizure 4 months later and was diagnosed with epilepsy.  He has had his whole genome sequenced with no findings that would suggest congenital abnormalities.
Age: 77.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received the same RSV vaccine on 1/9/2024.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Demyelination, Nerve degeneration, Neuropathy peripheral
Clinical narrative: Late onset of Peripheral neuropathy bilaterally in both feet that was gradual over the next year(2022) to the point currently. I have confirmed demyelination and degeneration of the nerves in my feet bilaterally, requiring me to start gabapentin (which I did not tolerate)
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, Dermatitis atopic, Dermatosis, Hidradenitis, Psoriasis
Clinical narrative: Developed psoriasis, atopic dermatitis, hidradenitis suppurativa, alopecia areata and dermatoses on the chest, trunk, back, arms and inner thighs.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland abnormal, Lymphoedema, Malignant melanoma in situ, Melanocytic naevus, Pathology test
Clinical narrative: Within a few weeks of the COVID shots I had noticed a congenital mole on my left calf starting to change.  This was a mole I was told would never cause me problems and that it was just ugly.  I continued to watch it for a few weeks until I reached out to my doctor in May 2021 and I was diagnosed with melanoma in June.  I had SLNB and then WLE surgery with clear margins.  As a result of the lymph node testing I was left with severe lymphedema in the left leg which is still problematic.  I have since had more melanoma - forehead in-situ and then the original calf melanoma spread as in-transit melanoma to my shin in 2023.  Now stage 3b.  I now have a 4th melanoma on my back that I have WLE for next week.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Skin neoplasm excision
Clinical narrative: Within a few weeks of the COVID shots I had noticed a congenital mole on my left calf starting to change.  This was a mole I was told would never cause me problems and that it was just ugly.  I continued to watch it for a few weeks until I reached out to my doctor in May 2021 and I was diagnosed with melanoma in June.  I had SLNB and then WLE surgery with clear margins.  As a result of the lymph node testing I was left with severe lymphedema in the left leg which is still problematic.  I have since had more melanoma - forehead in-situ and then the original calf melanoma spread as in-transit melanoma to my shin in 2023.  Now stage 3b.  I now have a 4th melanoma on my back that I have WLE for next week.
Age: 3.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menveo for age 10-55 was given to a 3-year old.  There was no adverse reaction and no harm reached the patient.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: On January 16, 2025, donor received first Anti-HBS immunization. Within 15 minutes of the immunization, the donor started to experience itchy and swelling on the left hand. A rash developed on the donor's hand and finger.  Donor was monitored and ice pack placed on hand. Donors breathing and heart rate remained normal and denied any other symptoms. Donor's vital signs remained within normal limits. Donor was monitored for approximately 20 minutes in which the hand color returned to normal. The itching and swelling subsided almost immediately after ice pack was placed.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Raised reddened area warm to touch and 2 small
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported that 1 week after receiving their first dose of Shingrix they developed shingles and required treatment.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Cerebrovascular accident, Injection site erythema, Injection site swelling
Clinical narrative: injection site redness and swelling, stroke 24-48 hours after vaccine, no history of stroke
Age: 73.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Pain
Clinical narrative: Pt received 4 doses of rabies post-exposure treatment, 3 in the R deltoid and the final dose in the L deltoid. Pt reports soreness at the injection site since the vaccines were administered, but last weekend (1/25) began experiencing intense pain with movement and bruising on the right bicep. The bruising is new, but the soreness has been ongoing on his right shoulder since the vaccines were administered.  Hook test performed, negative for tear. Will see sports medicine for medical management/therapy. Ice/heat for relief. Topical lidocaine and diclofenac.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to site where COVID vaccine was previously administered, new order to apply warm compress and administer Tylenol as needed for pain.
Age: 24.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 RSV vaccines 1/8 and 1/22, provider noted no harm to patient was caused. patient did not seek emergency care as none was needed per provider
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Muscle twitching
Clinical narrative: twitching for a day after getting the vaccines
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test normal, Lymph nodes scan abnormal, Lymphadenopathy, Pain in jaw, Swelling face
Clinical narrative: In subsequent evening going into the AM, patient developed submandibular swelling with pain, and no systemic symptoms.  Worsening, and showing obvious swelling to that area of his face, without erythema.
Age: 52.0
Sex: M
Vaccine: PNC21
Symptoms: Dizziness, Head injury, Seizure
Clinical narrative: The patient had a seizure four minutes after received a vaccine.  The seizure lasted around 10 minutes. At first patient felt light headed and was sitting down then stood up right before he slowly went to the floor but head slowly hit the floor. Paramedics were called and patient came out of seizure while they were there present. Patient went with paramedics to run some tests. Patient discussed prior fainting with vaccinations but only happened a few times and has received vaccinations at pharmacy in past. Also discussed epilepsy but controlled on medications
Age: 68.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Hyperhidrosis, Swelling
Clinical narrative: On 01/29/2025 Patient came back to pharmacy complaining about local adverse reaction (redness,soreness, swelling ) from capvaxive vaccine from 01/24/2025. I advised her to take over the counter benadryl  and do ice compression. If it does not get better then it needs to have provider's attention.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Confusional state, Dyskinesia, Musculoskeletal stiffness, Nausea
Clinical narrative: Adolscent female became pale and confused after walking to the waiting area at the completion of vaccinations. Her mother reports She leaned back in her chair and became stiff, then her arms began to jerk for approximately 15 seconds. Nurse had her sit bent over with her head down over her knees, cold compress was applied to her neck and under her chin. She complained of a sharp headache across her forehead at a 10 on a 1-10 scale. Student remained pale and clammy for the next 10-15 minutes. Headache went to a 5 on 1-10 scale after five minutes. Observed a full 30 minutes more. Student began to feel better with some nausea and dull headache. Mother decline a ride to the emergency department. Hard candy was offered. Student left alert, oriented and ambulated out of the lobby with her parent. Follow up to the mother the following day and she reports that the student is doin fine now.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Adolscent female became pale and confused after walking to the waiting area at the completion of vaccinations. Her mother reports She leaned back in her chair and became stiff, then her arms began to jerk for approximately 15 seconds. Nurse had her sit bent over with her head down over her knees, cold compress was applied to her neck and under her chin. She complained of a sharp headache across her forehead at a 10 on a 1-10 scale. Student remained pale and clammy for the next 10-15 minutes. Headache went to a 5 on 1-10 scale after five minutes. Observed a full 30 minutes more. Student began to feel better with some nausea and dull headache. Mother decline a ride to the emergency department. Hard candy was offered. Student left alert, oriented and ambulated out of the lobby with her parent. Follow up to the mother the following day and she reports that the student is doin fine now.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: client received a dtap and a IPV on 10/18/2024  a fourth dose in each series. I misread the record and gave an additional dose of DI today to client that wasn't necessary. dose was not due until 04/18/2025.   Explained the error to patients mother and she verbalized understanding .  Mom stated she will return on 07/29/2025 for appropriate dose.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Fatigue, Inappropriate schedule of product administration, Lethargy
Clinical narrative: Vaccine Administration Error- Patient was given Hep A and Varicella before recommended administration dates. Patient reported no abnormal reaction or response. Parents stated he had his "typical reaction" of feeling run down and lethargic.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Eye swelling, Facial pain, Feeling hot
Clinical narrative: Patient developed the following symptoms after the vaccine: dizziness, feeling warmth throughout her body, sensation of left eyeball swelling, nausea, drowsiness, left face pain, head feeling weird, headache, weakness.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Head discomfort, Headache, Nausea, Somnolence
Clinical narrative: Patient developed the following symptoms after the vaccine: dizziness, feeling warmth throughout her body, sensation of left eyeball swelling, nausea, drowsiness, left face pain, head feeling weird, headache, weakness.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Gait disturbance, Gastritis
Clinical narrative: pt says her arm was little sore the day of the vaccine but the next day she was running errands she bacame weak and her walking became slower. Her gait was getting worse. She became thirsty and felt like she was going to pass out. She was at a store and needed to drive home but was worried about getting home. Once she got home she had to climb stairs to get into her room. She wanted to email her son to let him know she was not feeling well but was so weak she could not type. Her entire body was hurting. She passed out and slept for hours but stayed in the bed for 5 days total. She only got out of the bed to urinate. She could hear the phone ringing but couldn't answer it. Her stomach was so inflammed she had to stay laying down. She had headach with the stomach ache. After the 5th day she was able to start functioning more normally. By the 6th day she felt normal. She contacted the pharmacy to let them know.  She saw her PCP on Dec 24th and notated her reactions.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: pt says her arm was little sore the day of the vaccine but the next day she was running errands she bacame weak and her walking became slower. Her gait was getting worse. She became thirsty and felt like she was going to pass out. She was at a store and needed to drive home but was worried about getting home. Once she got home she had to climb stairs to get into her room. She wanted to email her son to let him know she was not feeling well but was so weak she could not type. Her entire body was hurting. She passed out and slept for hours but stayed in the bed for 5 days total. She only got out of the bed to urinate. She could hear the phone ringing but couldn't answer it. Her stomach was so inflammed she had to stay laying down. She had headach with the stomach ache. After the 5th day she was able to start functioning more normally. By the 6th day she felt normal. She contacted the pharmacy to let them know.  She saw her PCP on Dec 24th and notated her reactions.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Thirst
Clinical narrative: pt says her arm was little sore the day of the vaccine but the next day she was running errands she bacame weak and her walking became slower. Her gait was getting worse. She became thirsty and felt like she was going to pass out. She was at a store and needed to drive home but was worried about getting home. Once she got home she had to climb stairs to get into her room. She wanted to email her son to let him know she was not feeling well but was so weak she could not type. Her entire body was hurting. She passed out and slept for hours but stayed in the bed for 5 days total. She only got out of the bed to urinate. She could hear the phone ringing but couldn't answer it. Her stomach was so inflammed she had to stay laying down. She had headach with the stomach ache. After the 5th day she was able to start functioning more normally. By the 6th day she felt normal. She contacted the pharmacy to let them know.  She saw her PCP on Dec 24th and notated her reactions.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called ~4pm in Wednesday 1/29/25 asking about what to do with swelling, redness and heat of upper right arm. Recommended going to Walk-in care, trying cold compress for swelling (about 4 inches in diameter) as well as taking some ibuprofen (not to exceed 32oomg/day). She mentioned a similar reaction when receiving the first Shingrix but not as expansive in area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient had a rash develop the day after vaccines on the right thigh. No leg pain, but parents reported patient had been scratching at leg. Parents gave a singular dose of Benadryl but no apparent improvement. Patient was brought in to the office to be seen by his pediatrician. on 1/29/2025
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood iron decreased, Fluid retention, Protein total decreased, Swelling, Vitamin D decreased
Clinical narrative: COVID19 vaccine and flu vaccine given concurrently. Patient has received these vaccines in the past but not given concurrently. Developed fluid retention/swelling after vaccinations, and was hospitalized in 1/2025 for fluid retention, swelling, low protein, low iron, low vitamin D.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Radiotherapy, Surgery
Clinical narrative: Patient states that she received covid19 vaccine on November 18, 2023 and in December 2023 she was diagnosed with breast cancer. She had surgery in 1/2024 and radiation. She states she is currently fine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: PATIENT CALLED THE PHARMACY WANTING TO TELL THE PHARMACY THAT SHE THINKS THE NOVAVAX VACCINE WAS ADMINISTERED INCORRECTLY. SHE STATES THAT THE VACCINATOR PINCHED HER SKIN WHILE INJECTING, AND THAT SHE DID NOT FEEL THE NEEDLE. SHE ALSO STATES THAT SHE DID NOT HAVE TYPICAL VACCINE SIDE EFFECTS FOR 2 DAYS, INSTEAD OF 1 DAY THAT SHE IS USED TO. PHARMACIST TRIED TO RATIONALIZE WITH PATIENT THAT WE USE THE APPROPRIATE NEEDLES FOR IM INJECTION (1 INCH ) AND THE SIDE EFFECTS DOES NOT SOUND ATYPICAL. THE PATIENT WAS ADAMENT THAT SHE THOUGHT IT WAS ADMINISTERED SUBCUTANEOUSLY AND THAT THIS IS REPORTED TO MAKE SURE EVERYONE IS AWARE.
Age: 73.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT HAD 2 VACCINES ON 01/15/25, SPIKEVAX AND CAPVAXIVE, SINCE THEN PT HAS REPORTED OF RED AND ICTCHING ON THE INJECTION SITE,  PT CALLED TODAY AND REPORTED OF THE SYMPTOMS THAT STARTED ON 1/15/25 EVENING AND LAST UNTIL NOW.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report a T/E and reports improperly stored PROQUAD was given to 2 patients on 1/17/2025. No symptoms or side effects reported. Related AE case filed in 02738574. No additional AE/no PQC.  ?    Names of vaccines involved (including lot; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On an unknown date, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number wheter Y014306 or Y015990 has been verified to be a valid lot number, with expiration date 18-FEB-2026 and 23-MAR-2026, respectively) administered as prophylaxis (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at -13.4 °C (-14 °C up to 10 °C ) for 4 hours 30 minutes and 0 seconds. There was no previous temperature excursion.  No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2501USA006018:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported. No additional AE; The HCP reports that VARIVAX was inadvertently administered after suffering from a Temperature Excursion.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 17-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter,  lot # Y006522; which has been verified to be valid lot # for varicella virus vaccine live (Oka/Merck), expiration date: 25-MAR-2026, administered as prophylaxis (strength, dose number, route, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error) after a temperature excursion (TE) occurred at a temperature of -11.6 C degrees Celsius during a time frame of 3 hours 5 minutes and 0 seconds. Previous temperature excursions could not be confirmed. No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2501USA008877: US-009507513-2501USA009045: US-009507513-2501USA008880: US-009507513-2501USA008882:02740767 US-009507513-2501USA007446: US-009507513-2501USA008935: US-009507513-2501USA007047: US-009507513-2501USA008861:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; FBE called on behalf of nurse to report an expired dose of GARDASIL 9 was administered to 1 patient. Per FBE, nurse stated dose expired on 1/8/2025 and was administered on 1/22/2025. FBE stated the nurse did not report any patient symptoms or provide; This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 22-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number W029724, expiration date 08-JAN-20225 (dose and route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The HCP stated the patient did no experience any adverse issues or side effects from the administered dose of PROQUAD; A HCP called to inquire about the viability of an expired dose of PROQUAD (X018814 01/07/2025) that was administered to a patient on 01/24/2025.; The HCP was unsure if the PROQUAD had ever undergone a temperature excursion (TE).; This spontaneous report was received from a nurse and refers to a 4-year-old patient of an unknown gender.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 24-JAN-2025, the patient was vaccinated with an expired and potentially improper storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live ([rHA recombinant human albumin]) (PROQUAD) injection, lot #X018814; which has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 07-JAN-2025, administered for prophylaxis (strength, vaccination schedule, exact quantity volume, route and anatomical site of administration were not provided) (Expired product administered; Product storage error). The reporter inquired about the viability of this expired dose. In addition, she stated she was not sure if it had ever undergone a temperature excursion (TE) and could not provide more information related to it.  The patient did not experience any adverse issues or side effects (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Influenza virus test positive
Clinical narrative: tested positive for flu; received their second dose of GARDASIL 9 dose 3 weeks after their first dose, instead of the four weeks minimal interval; This spontaneous report has been received from a nurse practitioner regarding a 23-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On an unspecified date, the patient received their second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, scheme, route of administration, anatomical site, lot number and expiration date not reported) 3 weeks after their first dose, instead of the four weeks minimal interval (Inappropriate schedule of vaccine administered).  On an unknown date (also reported as today), the caller stated that the patient tested positive for flu (Influenza virus test positive). The outcome of the events was unknown.  The causal relationship between the suspect vaccine and the events was unknown.