chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Additional Details: patuent felt severy sick on tuesday mornig that she had to be transported to the hospital by ambulance ,CT was done on kidney and bladder to rule out any problems as patient has kidney issues
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pyrexia, Urogram
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Additional Details: patuent felt severy sick on tuesday mornig that she had to be transported to the hospital by ambulance ,CT was done on kidney and bladder to rule out any problems as patient has kidney issues
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Additional Details: Patient was unsure if it was a general rash or an occurence of shingles after being given the 2nd dose. Location: left arm. Advised patient to consult with MD to determine.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Incorrect route of product administration, Injection site pain, Joint range of motion decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Pt reports severe shoulder joint pain and reduced range of motion. Still being treated and undergoing testing by medical team. Video review shows immunizer was standing without crouching and given IM instead of SC as indicated
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Nervous system disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cellulitis-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Other Vaccines:  VaccineTypeBrand: priorix; Manufacturer: glaxosmithkline; LotNumber: 4n222; Route: sq; BodySite: left arm; Dose: 1; VaxDate: 03/15/2025
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Sensory disturbance
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Systemic: Weird nerve sensation that was felt from shoulder down to elbow-Medium
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Systemic: Patient has Pneumonia-Severe, Additional Details: Patient has Pneumonia
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: Patient received three vaccines in an arm and reported that it swelled and became painful. She expressed the pain started in arm and radiated to other side of her body.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: Patient received three vaccines in an arm and reported that it swelled and became painful. She expressed the pain started in arm and radiated to other side of her body.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Patient stated that her collar bone was swollen after she received a second dose of shingrix. She went to the doctor and her doctor gave her ibuprofen and prednisone.  The day that she came in for me to look at the collar bone it was not swollen but she is still experiencing some pain on her left collar bone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Patient stated that her collar bone was swollen after she received a second dose of shingrix. She went to the doctor and her doctor gave her ibuprofen and prednisone.  The day that she came in for me to look at the collar bone it was not swollen but she is still experiencing some pain on her left collar bone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal tenderness, Decreased appetite, Injection site erythema, Injection site mass
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient got the usual vaccine side effects the next day such as sore/tender arm, fever (for 2-3 days), chills, muscle ache, swollen & red at injection site. Patient also experienced lost of appetite, swollen/distended belly and tenderness to side of abdomen. She was nauseous but didn't develop rashes/hives and could still move her arm. She went to see her primary care doctor and they advised her not to take the second vaccination. After 2 weeks, there is still a small lump at injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient got the usual vaccine side effects the next day such as sore/tender arm, fever (for 2-3 days), chills, muscle ache, swollen & red at injection site. Patient also experienced lost of appetite, swollen/distended belly and tenderness to side of abdomen. She was nauseous but didn't develop rashes/hives and could still move her arm. She went to see her primary care doctor and they advised her not to take the second vaccination. After 2 weeks, there is still a small lump at injection site.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Fever-Medium, Other Vaccines:  VaccineTypeBrand: capvaxive; Manufacturer: merck sharp &dohme; LotNumber: y019158; Route: intramuscular; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild, Systemic: 99 low grade fever-Mild
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Joint injury
Clinical narrative: Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: Glaxosmithkline; LotNumber: 7349L; Route: IM; BodySite: Left Deltoid; Dose: 1; VaxDate: 04/13/2025
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Chest pain, Dysphagia, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Other Vaccines:  VaccineTypeBrand: abrysvo; Manufacturer: ; LotNumber: lh4s08; Route: injection; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Other Vaccines:  VaccineTypeBrand: abrysvo; Manufacturer: ; LotNumber: lh4s08; Route: injection; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Influenza like illness, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flu-like symptoms-Medium, Additional Details: Per patient, she received all 3 shots on one day, Flu+RSV+Shingles. She had flu-like symptoms for 48 hours., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GlaxoSmithKline (GSK); LotNumber: 47P9H; Route: IM; BodySite: Left Arm; Dose: 2 of 2; VaxDate: 12/17/2023, VaccineTypeBrand: Flu vaccine; Manufacturer: Unknown; LotNumber: Unknown; Route: IM; BodySite: Unknown; Dose: 1; VaxDate: 12/17/2023
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flu-like symptoms-Medium, Additional Details: Per patient, she received all 3 shots on one day, Flu+RSV+Shingles. She had flu-like symptoms for 48 hours., Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: GlaxoSmithKline (GSK); LotNumber: 47P9H; Route: IM; BodySite: Left Arm; Dose: 2 of 2; VaxDate: 12/17/2023, VaccineTypeBrand: Flu vaccine; Manufacturer: Unknown; LotNumber: Unknown; Route: IM; BodySite: Unknown; Dose: 1; VaxDate: 12/17/2023
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Systemic: Patient says she has peripheral neuropathy-Medium, Additional Details: Patient says she has peripheral neuropathy and does not want to get the COVID vaccine because it triggers her peripheral neuropathy symptoms.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHib portion of Pentacel was reconstituted with normal saline not the Dtap/IPV portion of Pentacel.  No adverse effects reported from pt.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Shortness of breath, redness and swelling to area of injection site; itching
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Limb mass
Clinical narrative: Patient was seen on 4/8/25 for Immigration physical and was given Tdap and Flu (Flu was given in Right Deltoid), labs were drawn and found that patient had no immunity to MMR. Patient returned on 4/15/25 and was given the MMR vaccine subQ in R Arm. Patient returned on 5/12/25 and informed provider that she noticed a bump under her arm and started noticing it 5/10/25 in the morning. Provider determined that it was acute cellulitis and patient was given Cephalexin Capsule 500mg to take every 6 hours for 10 days. Patient was asked to follow up in 2 days if not getting better. Patient has not followed up or contacted us with any other issues.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Magnetic resonance imaging normal, Muscle disorder, Pain, Paraesthesia
Clinical narrative: Right side muscle failure, pain, tingling, double vision
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: CSF test, Differential white blood cell count, Full blood count, Metabolic function test, Seizure
Clinical narrative: family reports seizure activity
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Urine analysis
Clinical narrative: family reports seizure activity
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Red rash developed in a circle below the vaccine site and then areas in the armpit crease on the same arm of vaccine.  Pt also received 2 other vaccines on the same day but on the opposite arm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autonomic nervous system imbalance, Coagulopathy, Decreased appetite, Diarrhoea
Clinical narrative: I received pfizer vaccine two doses following a month from apart. Side adverse begin same day after second dose with photophobia, headache, muscle stiffness in the neck and back area. dysautonomia,  join pain, allergies to medicines in general only able to tolerate herbal medicine. diarrhea, no appetite, hot flashes, noisy intolerance, cold intolerance, tendinopathies, symptoms like fibromyalgia, insomnia,  irritability, coagulations issues, hematomas, wound delay repair.  Everything is almost resolved with herbal medicine, time, and many physicians I have to consult in order to help me resolve this. Currently taking supplements and herbal medicine and symptoms are stable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Fibromyalgia, Haematoma, Headache, Hot flush
Clinical narrative: I received pfizer vaccine two doses following a month from apart. Side adverse begin same day after second dose with photophobia, headache, muscle stiffness in the neck and back area. dysautonomia,  join pain, allergies to medicines in general only able to tolerate herbal medicine. diarrhea, no appetite, hot flashes, noisy intolerance, cold intolerance, tendinopathies, symptoms like fibromyalgia, insomnia,  irritability, coagulations issues, hematomas, wound delay repair.  Everything is almost resolved with herbal medicine, time, and many physicians I have to consult in order to help me resolve this. Currently taking supplements and herbal medicine and symptoms are stable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Impaired healing, Insomnia, Irritability, Musculoskeletal stiffness
Clinical narrative: I received pfizer vaccine two doses following a month from apart. Side adverse begin same day after second dose with photophobia, headache, muscle stiffness in the neck and back area. dysautonomia,  join pain, allergies to medicines in general only able to tolerate herbal medicine. diarrhea, no appetite, hot flashes, noisy intolerance, cold intolerance, tendinopathies, symptoms like fibromyalgia, insomnia,  irritability, coagulations issues, hematomas, wound delay repair.  Everything is almost resolved with herbal medicine, time, and many physicians I have to consult in order to help me resolve this. Currently taking supplements and herbal medicine and symptoms are stable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Temperature intolerance, Tendon disorder
Clinical narrative: I received pfizer vaccine two doses following a month from apart. Side adverse begin same day after second dose with photophobia, headache, muscle stiffness in the neck and back area. dysautonomia,  join pain, allergies to medicines in general only able to tolerate herbal medicine. diarrhea, no appetite, hot flashes, noisy intolerance, cold intolerance, tendinopathies, symptoms like fibromyalgia, insomnia,  irritability, coagulations issues, hematomas, wound delay repair.  Everything is almost resolved with herbal medicine, time, and many physicians I have to consult in order to help me resolve this. Currently taking supplements and herbal medicine and symptoms are stable.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Decreased appetite, Headache, Peripheral swelling, Pruritus, Rash
Clinical narrative: Rush and swollen on the left arm with 2 times one hand size which started 2nd day of the Shot, now in 7 days, rush and swollen area still larger than a palm size; itchy; 2-days fever; 4-days headache; 7-days no appetites
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Disorientation, Injection site pain, Injection site swelling, Oligomenorrhoea
Clinical narrative: 1. start "menstral cycle" x1wk 2. spacial disoriented x 3 days 3. local injection site swelling and painful x 4 days.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acne, Alopecia, Angina pectoris, Anxiety, Arthralgia
Clinical narrative: I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 minutes there, then I felt my teeth were loose and my joints hurt, especially in my spine, I saw blurry, at the time I did not have medical insurance and I endured the symptoms, with the next dose my hair fell out, I lost a tooth and my body began to fill with small pimples like acne and I could not sit for more than 10 minutes, they told me it was sciatic nerve, I saw blurry, I had panic and anxiety attacks, my limbs fell asleep, my heart hurt, I got varicose veins and my liver and intestines started to hurt, I became intolerant to dairy, gluten and many more foods, I began to feel very weak and exhausted nobody believed me, I do not sleep well, for the third dose I began to suspect the vaccine but I had to have it in order to continue with a process and once I had the last dose all the symptoms They got worse, then I tried to explain it to the doctors and I feel judged, misunderstood, and they don't believe me. They tell me it could be fibromyalgia, spondyloarthritis, etc.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Dairy intolerance, Fatigue, Food intolerance, Gastrointestinal pain
Clinical narrative: I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 minutes there, then I felt my teeth were loose and my joints hurt, especially in my spine, I saw blurry, at the time I did not have medical insurance and I endured the symptoms, with the next dose my hair fell out, I lost a tooth and my body began to fill with small pimples like acne and I could not sit for more than 10 minutes, they told me it was sciatic nerve, I saw blurry, I had panic and anxiety attacks, my limbs fell asleep, my heart hurt, I got varicose veins and my liver and intestines started to hurt, I became intolerant to dairy, gluten and many more foods, I began to feel very weak and exhausted nobody believed me, I do not sleep well, for the third dose I began to suspect the vaccine but I had to have it in order to continue with a process and once I had the last dose all the symptoms They got worse, then I tried to explain it to the doctors and I feel judged, misunderstood, and they don't believe me. They tell me it could be fibromyalgia, spondyloarthritis, etc.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gluten sensitivity, Hepatic pain, Hypoaesthesia, Loose tooth, Panic attack
Clinical narrative: I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 minutes there, then I felt my teeth were loose and my joints hurt, especially in my spine, I saw blurry, at the time I did not have medical insurance and I endured the symptoms, with the next dose my hair fell out, I lost a tooth and my body began to fill with small pimples like acne and I could not sit for more than 10 minutes, they told me it was sciatic nerve, I saw blurry, I had panic and anxiety attacks, my limbs fell asleep, my heart hurt, I got varicose veins and my liver and intestines started to hurt, I became intolerant to dairy, gluten and many more foods, I began to feel very weak and exhausted nobody believed me, I do not sleep well, for the third dose I began to suspect the vaccine but I had to have it in order to continue with a process and once I had the last dose all the symptoms They got worse, then I tried to explain it to the doctors and I feel judged, misunderstood, and they don't believe me. They tell me it could be fibromyalgia, spondyloarthritis, etc.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality sleep, Pruritus, Sciatica, Spinal pain, Tooth loss
Clinical narrative: I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 minutes there, then I felt my teeth were loose and my joints hurt, especially in my spine, I saw blurry, at the time I did not have medical insurance and I endured the symptoms, with the next dose my hair fell out, I lost a tooth and my body began to fill with small pimples like acne and I could not sit for more than 10 minutes, they told me it was sciatic nerve, I saw blurry, I had panic and anxiety attacks, my limbs fell asleep, my heart hurt, I got varicose veins and my liver and intestines started to hurt, I became intolerant to dairy, gluten and many more foods, I began to feel very weak and exhausted nobody believed me, I do not sleep well, for the third dose I began to suspect the vaccine but I had to have it in order to continue with a process and once I had the last dose all the symptoms They got worse, then I tried to explain it to the doctors and I feel judged, misunderstood, and they don't believe me. They tell me it could be fibromyalgia, spondyloarthritis, etc.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Varicose vein, Vision blurred
Clinical narrative: I started to feel a lot of itching and I scratched my arm, they told me it was normal, I waited 10 minutes there, then I felt my teeth were loose and my joints hurt, especially in my spine, I saw blurry, at the time I did not have medical insurance and I endured the symptoms, with the next dose my hair fell out, I lost a tooth and my body began to fill with small pimples like acne and I could not sit for more than 10 minutes, they told me it was sciatic nerve, I saw blurry, I had panic and anxiety attacks, my limbs fell asleep, my heart hurt, I got varicose veins and my liver and intestines started to hurt, I became intolerant to dairy, gluten and many more foods, I began to feel very weak and exhausted nobody believed me, I do not sleep well, for the third dose I began to suspect the vaccine but I had to have it in order to continue with a process and once I had the last dose all the symptoms They got worse, then I tried to explain it to the doctors and I feel judged, misunderstood, and they don't believe me. They tell me it could be fibromyalgia, spondyloarthritis, etc.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Cardiac disorder, Resuscitation
Clinical narrative: Pt reported cardiac emergency when home later that day.  CPR was performed until EMT arrived.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pt was given a ped. dose of Hep A instead of an adult dose.  Pt recently turned 19 ten days ago.  Pt to be given 2 ped doses today to make dosage correct per recommendation of PEDIATRIC IMMUNIZATION NURSE COORDINATOR  Department for Public Health Division of Epidemiology and Health Planning (DEHP) Immunization Branch
Age: 12.0
Sex: F
Vaccine: PNC21
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given wrong pneumococcal vaccine based on the patient's age.  Not treatment or adverse outcomes
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: mild redness, swelling and warmth at site of injection. vaccine was not given by the reporter, it was documented as IM, but site of reaction appears subcutaneous as it is not over the deltoid
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: shoulder/arm pain after vaccine administration
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: CLIENT REPORTED VIA PHONE 5-14-25, REDNESS AND WARM TO TOUCH AT INJECTION SITE FROM 5-13-25.  CLIENT RETURNED TO CLINIC 5-15-25 AND REDNESS, WARM TO TOUCH , AND HARDNESS NOTED AT CENTER. CLIENT WAS REFERRED TO PCP.  CLIENT PHONED BACK 5-15-25 PM AND STATED SHE WAS TREATED WITH PREDNISONE INJECTION AND ORAL ANTIBIOTIC PER FNP.  STATED SHE HAD NO FOLLOW UP APPOINTMENT AT THIS TIME.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt noted reaction started about an hour after initial injection. Experiencing swelling of injection site, painful, itching, and injection site hot to touch. Sxs started 5/9 and completely resolved on 5/13. Pt used cortizone cream for the itching.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Contusion, Epistaxis, Haemoglobin normal, Immune thrombocytopenia, Petechiae
Clinical narrative: Small red rash over body, scattered pettechiae all over body with many bruises on forehead and lower extremities. ITP diagnosis received on 4/9/25. Spontaneous nosebleed on 4/9/2025. Started on oral prednisone, received in 2 weeks; now off treatment. Platelets on 5/6: 154.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Platelet count decreased, Rash, Rash erythematous, White blood cell count normal
Clinical narrative: Small red rash over body, scattered pettechiae all over body with many bruises on forehead and lower extremities. ITP diagnosis received on 4/9/25. Spontaneous nosebleed on 4/9/2025. Started on oral prednisone, received in 2 weeks; now off treatment. Platelets on 5/6: 154.
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pyrexia, Rash
Clinical narrative: Patient started developing a rash and fever shortly after getting capvaxive vaccine, along with redness at the site of administration and area became warm to the touch. Patient followed up with her provider who diagnosed the reaction as cellulitis and prescribed keflex to the patient.
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Asthenia, Ataxia, Chills, Cough, Diarrhoea
Clinical narrative: Extreme fever, uncontrollable shivering, full body myalgia, weakness, ataxia with actual falls, diarrhea, rough cough, hematuria
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Fall, Haematuria, Myalgia, Pyrexia
Clinical narrative: Extreme fever, uncontrollable shivering, full body myalgia, weakness, ataxia with actual falls, diarrhea, rough cough, hematuria
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Tdap given instead of Dtap. Patient had not reaction or symptoms from vaccine
Age: 10.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: 5/9/25 - HA, tiredness, fever, soreness.  Rash presented on 5/14/25.  Hurt pt to move her neck to look down but that has gotten better throughout the day today.
Age: 10.0
Sex: F
Vaccine: YF
Symptoms: Rash, White blood cell count decreased
Clinical narrative: 5/9/25 - HA, tiredness, fever, soreness.  Rash presented on 5/14/25.  Hurt pt to move her neck to look down but that has gotten better throughout the day today.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no know adverse reactions however injection was given IM instead of SQ
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site erythema, Rash, Rash pruritic
Clinical narrative: Right after administering the vaccine in the right deltiod , I noticed some bright redness form at the site of the injection. I asked that patient wait around in office for 15mins to make sure no other reactions form. Pt waiting in the room for 20mins and when I went back to examine the arm, the redness had resolved. I discharged the patient at the time.  After returning home,  patient developed a pruritic rash on biceps bilaterally. After benadryl, that rash subsided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient came to the pharmacy on 05/16/25, states they recieved a Shingrix vaccine on 05/13/25. Patient states, the next day they had a burning sensation on their left arm, skin hot to the touch, patient states it is itchy, and site of injection has a rash is increasing. Informed patient to seek medical attention and to inform primary provider.
Age: 57.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dizziness, Hypotension, Pain, Pyrexia
Clinical narrative: 3 days after DTap injection I felt faint as I walk into my work office.  When I got home I measured my blood pressure and it was between SYS: 91-99    DIA: 45-59    BPM: 43-50.  On 5/12 I went back to my doctor to report my low blood pressure issue and he referred me to contact my cardiologist ( appointment on May 20).  On May 14 I had a fever with body ache and again low bp.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Fall, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Vaccine given at 11:35. Pt tolerated well. Moved on to siblings, Pt fell out of chair she was sitting in while giving sibling vaccine. Pt was posturing in a stiff position with head back and bilateral legs and arms stiff. Appeared momentarily unconscious but regained consciousness within seconds. VS: 126/78 HR: 81 RR:38 O2 sats: 99%. Completely oriented within seconds and denied any pain. No further follow up required.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Right arm swelling, welts, and pain - Advised to apply ice for 15 minutes three times a day. Medrol Dose pack and Benadryl OTC as directed or Cetirizine OTC as directed.  At time of visit no welts, mild swelling and redness.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Crying, Diarrhoea, Injection site erythema, Injection site nodule, Insomnia
Clinical narrative: 10 pm patient woke up with inconsolable crying for 3 hours, injection sites noted to be dollar coin size red and large knots underneath the skin. Patient started having diarrhea around 2 am. Around 8 stools a day for 13 days, unsure if related to vaccine (rotavirus vaccine was NOT given). However the inconsolable crying lasted 2 nights, within the 48hrs of administration.  Resolved with time and lack of sleep.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a pregnant woman who is "30 or 31 weeks gestation." She states that the woman was in the office for her second dose of an unspecified hepatitis b vaccine; Nurse practitioner calling to report that a dose of GARDASIL 9 was inadvertently administered to a pregnant woman who is "30 or 31 weeks gestation.; She states that the woman was in the office for her second dose of an unspecified hepatitis b vaccine when the  medication error occurred; She states that the patient has been alerted and has has not experienced any clinical side effects; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age.   The patient's medical history, historical drugs, obstetric history, concurrent conditions, and concomitant therapies were not reported. There were no known allergies.  On an unspecified date (reported as about 30-31 weeks ago), the patient became pregnant. All the information regarding this pregnancy such as last menstrual period date and date of conception were not reported.  On 11-Apr-2025, when she presented to the office for her second dose of an unspecified hepatitis B vaccine, she was inadvertently vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Suspension for injection (lot #Y015179, expiration date: 28-Jan-2027), administered by intramuscular route in a medication error while she was at 30 or 31 weeks of gestation (Maternal exposure during pregnancy) (Product use in unapproved population) (Wrong vaccine administered). She stated that the patient had been alerted and had not experienced any clinical side effects. The patient had been advised to follow up with her OBGYN but the caller was unsure if the patient had called at that point. Nurse practitioner stated that the patient did sign a form that stated the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was going to be administered even though it was a medication error. She also stated she had alerted compliance and her medical director about the incident as well. At the time of this report, both fetal and pregnancy outcome were unknown.
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller reported AE on behalf of a patient who was administered expired MMR-II on 04/24/2025 w/ no TEs-- SUPPORTED via post-expiry memo. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. Additional AEs Filed (Ca; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Apr-2025, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X011431, expiration date: 19-Apr-2025, 0.5 mL (formulation, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expired vaccine used). No additional adverse event reported (no adverse event).
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HBP reported patient was administered GARDASIL9 during a temperature excursion. Date of administration was 04/22/2025. No additional details reported. No additional AE reported. No PQC reported.   ?    Names of vaccines involved (including lot/exp); This spontaneous report was received from a non health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 22-Apr-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #Y012508, expiration date: 01-Jan-2027), dose number 1, (anatomical location and administration route were not reported) as prophylaxis. It was reported that this first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was administered during a temperature excursion of 0°C, in a time frame of 1 hour 0 minutes; and was confirmed that no previous temperature excursions occurred. No additional details and no additional AEs were reported.
Sex: M
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reports an expired dose of MMR II was inadvertently administered; Information has been received from Business Partner/CRO on 15-May-2025.  This spontaneous report was received from a/an Nurse and refers to a(n) 64-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 13-May-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X013193, expiration date: 08-May-2025). On an unknown date, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), for the treatment of Prophylaxis.  On 13-May-2025, the patient experienced HCP reports an expired dose of MMR II was inadvertently administered. On an unknown date, the patient experienced No additional AE.   At the reporting time, the outcome of HCP reports an expired dose of MMR II was inadvertently administered and No additional AE was unknown.   The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was reported as not applicable.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received ENGERIX-B as second dose; 17 Year Old Patient Received Heplisav-B; Initial report received on 29-Apr-2025.  A physician in the US (PA) reported that a 17-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.  On 21-Mar-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number 945658, expiration date 31-Jan-2027, and NDC number 43528-003-01) intramuscularly in the left deltoid. After the vaccine was administered, the staff discovered the product was not approved in patients of her age.  In Apr-2025, approximately one month after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number, expiration date, route, and site not provided)] that had expired.  On an unknown date, the patient had unspecified bloodwork performed which showed no immunity from her childhood vaccines. The patient's college noted that her childhood vaccine was "given too early."  No adverse effects were reported. No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Headache, Nausea, Product use issue
Clinical narrative: Arexvy received to pregnant 35 years old female; Nausea; Headache; Arexvy received to pregnant 35 years old female; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of nausea in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-MAY-2025, the patient received Arexvy. On 05-MAY-2025, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Arexvy received to pregnant 35 years old female). On 06-MAY-2025, the patient experienced nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy received to pregnant 35 years old female). The outcome of the nausea and headache were resolving and the outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable.   It was unknown if the reporter considered the nausea and headache to be related to Arexvy.     It was unknown if the company considered the nausea and headache to be related to Arexvy.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 07-MAY-2025  The pregnant patient received Arexvy vaccine with primary care provider clinic and reported concerns with having received the wrong vaccine to her prenatal care providers, including himself/herself, which led to vaccine exposure during pregnancy and product use for unapproved population.  Patient was encouraged to report incident. The patient received nausea and headache.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: has had a headache on and off for over 3 days; This non-serious case was reported by a nurse via sales rep and described the occurrence of headache in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: has had a headache on and off for over 3 days). The outcome of the headache was resolving.   The reporter considered the headache to be related to Shingrix.     The company considered the headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2025 The reporter mentioned that patient had a headache on and off for over 3 days since vaccine administration.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: I have the shingles now; I did not know you needed a second vaccination after about 7 years; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I have the shingles now) and incomplete course of vaccination (Verbatim: I did not know you needed a second vaccination after about 7 years). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date :06-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she did not knowyou needed a second vaccination after about 7 years. Consumer reported that  no one told , and he/she had the shingles now. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got the shot and both were sick for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in specified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got the shot and both were sick for 3 days). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAY-2025 This case was reported by a patient via interactive digital media.  Reporter stated that a couple at their church got the shot and both were sick for 3 days.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I develop shingles after I got the vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I develop shingles after I got the vaccination). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 08-MAY-2025 This case was reported by a patient via interactive digital media. The patient developed shingles after he/she got the vaccination for it internally. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure?is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Can shingrix be mixed with a plain diluen; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Can shingrix be mixed with a plain diluen) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 08-MAY-2025 The patient administered Shingrix which was mixed with a plain diluent, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked could Shingrix be mixed with a plain diluent.