chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was very sore
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Headache, Vomiting
Clinical narrative: Suddenly hot, needed to sit down and felt like he was going to faint. Got a headache and threw up. Symptoms lasted about 20 minutes.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Needle issue
Clinical narrative: During time of administation, the needle came off of the syringe barrel and less than half of the vaccine was administered. Vaccine was repeated with same lot/exp an inch below first site of injection.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Blood glucose increased, Cardiac disorder, Cardiac operation, Differential white blood cell count
Clinical narrative: I fell to the ground and could no longer move. This happened to me while I was in a country, an expatriate looking for a living for me, my children, and my wife. There was no one at home except me and my friend. He came and made me stand up and helped me clean myself. I slept at home. The next day, my friends came and booked a plane for me, where my cousin traveled with me. I stayed at home for at least five days or a week. I don't remember exactly. After that, I was transferred to Hospital for treatment. I was transferred to Specialist Hospital, where I was found to have a weak heart muscle and high blood sugar. The doctor decided to perform open heart surgery for me.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Full blood count, International normalised ratio, Liver function test, Mobility decreased
Clinical narrative: I fell to the ground and could no longer move. This happened to me while I was in a country, an expatriate looking for a living for me, my children, and my wife. There was no one at home except me and my friend. He came and made me stand up and helped me clean myself. I slept at home. The next day, my friends came and booked a plane for me, where my cousin traveled with me. I stayed at home for at least five days or a week. I don't remember exactly. After that, I was transferred to Hospital for treatment. I was transferred to Specialist Hospital, where I was found to have a weak heart muscle and high blood sugar. The doctor decided to perform open heart surgery for me.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time, Renal function test
Clinical narrative: I fell to the ground and could no longer move. This happened to me while I was in a country, an expatriate looking for a living for me, my children, and my wife. There was no one at home except me and my friend. He came and made me stand up and helped me clean myself. I slept at home. The next day, my friends came and booked a plane for me, where my cousin traveled with me. I stayed at home for at least five days or a week. I don't remember exactly. After that, I was transferred to Hospital for treatment. I was transferred to Specialist Hospital, where I was found to have a weak heart muscle and high blood sugar. The doctor decided to perform open heart surgery for me.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Patient came and said that her shoulders and arm starting really hurting couple of days after the flu vaccine.  The pain got worst and she had a hard time moving her shoulders and pain is still there (11/08/24).  The pain has been the same and very little improvement has been seen but does seem to be less pain since the few days after the vaccine. Patient was advised to try and use heating pads and tylenol to help with the pain and speed up the healing process. Patient does not want to see the doctor at this time and wants to wait to see if it gets better because she does not want to pay a deductible or copay.  She will wait to see if her arm will get better and follow up is needed but she wanted to just let her know because she thinks the tech gave her and her husband the vaccine a little bit too high in the arm.
Age: 59.0
Sex: M
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Nausea, Pain
Clinical narrative: Patient reports injection site reaction (3 separate areas roughly 2-3 inches in diameter on arm near injection site were red, tender, itchy. started 24 hours after injection, and now subsiding) and immune response (achy, fever 101, nausea. started 24 hours after injection and resolved within 48 hours.) Patient took tylenol on 11/7-11/8 for aches/fever.
Age: 59.0
Sex: M
Vaccine: FLU3, PNC21
Symptoms: Pyrexia
Clinical narrative: Patient reports injection site reaction (3 separate areas roughly 2-3 inches in diameter on arm near injection site were red, tender, itchy. started 24 hours after injection, and now subsiding) and immune response (achy, fever 101, nausea. started 24 hours after injection and resolved within 48 hours.) Patient took tylenol on 11/7-11/8 for aches/fever.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient came and said that his shoulder and arm starting really hurting couple of days after the flu vaccine.  The pain got worst and he had a hard time moving his shoulder and pain is still there (11/08/24).  The pain has been the same and very little improvement has been seen but does seem to be less pain since the few days after the vaccine. Patient was advised to try and use heating pads and tylenol to help with the pain and speed up the healing process. Patient does not want to see the doctor at this time and wants to wait to see if it gets better because he does not want to pay a deductible or copay.  He will wait to see if his arm will get better and follow up is needed but he wanted to just let us know because he thinks the tech gave him and his wife the vaccine a little bit too high in the arm.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: The day after vaccination, patient experienced fatigue and joint pain (in wrists, fingers, ankles and knees) that has not diminished. Patient has not yet seen a doctor. Patient is considering a zoom visit with her PCP.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Blood pressure immeasurable, Body temperature increased, Electrocardiogram, Heart rate increased
Clinical narrative: On 11/9/2024, patient arrived and requested walk-in vaccination with seasonal flu and COVID-19 vaccines. Patient is a 30 year old female who reported a medical history of anxiety. Patient takes After filling out appropriate paperwork, pharmacy technician and pharmacist processed and prepared the two vaccines. The pharmacist administered both FLUBLOK TRIVALENT (Sanofi) 2024-2025 formula and COMIRNATY COVID-19 (Pfizer; NDC 00069-2432-10) 2024-2025 formula in the patient's right deltoid.   Approximately 5 minutes later, patient reported to the pharmacist and other patients present that she was "not feeling well", and was observed to be diaphoretic, had elevated body temperature, elevated heart rate, and said that she felt nauseous. When asked, she reported that she did not have trouble breathing. Furthermore, the patient reported a "tingling" feeling in her hands.   The pharmacist directed the pharmacy technician to call 911 and then he gathered materials to perform necessary first aid. Fingertip pulse oximeter showed HR (approximately) 99 BPM and spO2 >98% . The pharmacist attempted to take patient's blood pressure, but the automated BP monitor could not obtain a reading, and the patient reported that readings have been difficult to get in the past because she "has deep veins".   Fire Department and EMS arrived approximately 10 minutes after the start of symptoms. Fire department performed vitals and found blood glucose 99 mg/dL and temperature WNL. Fire workers were unable to determine blood pressure with manual sphygmomanometer.   EMS began to question and assess the patient. EMS also performed EKG and observed pulse, which was still similarly elevated. The EKG reading was unavailable to this writer. EMS personnel described that the patient was having syncope, likely due to receipt of the vaccine. Patient reported that she has "had this happen before" after "giving blood". EMS remained with the patient, who reported that she was beginning to feel better. She reported feeling better and both she and EMS left the pharmacy approximately 30 minutes after the onset of symptoms. No further information was available at the time of this writing other than what is contained in this report.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hyperhidrosis, Malaise, Nausea, Paraesthesia, Syncope
Clinical narrative: On 11/9/2024, patient arrived and requested walk-in vaccination with seasonal flu and COVID-19 vaccines. Patient is a 30 year old female who reported a medical history of anxiety. Patient takes After filling out appropriate paperwork, pharmacy technician and pharmacist processed and prepared the two vaccines. The pharmacist administered both FLUBLOK TRIVALENT (Sanofi) 2024-2025 formula and COMIRNATY COVID-19 (Pfizer; NDC 00069-2432-10) 2024-2025 formula in the patient's right deltoid.   Approximately 5 minutes later, patient reported to the pharmacist and other patients present that she was "not feeling well", and was observed to be diaphoretic, had elevated body temperature, elevated heart rate, and said that she felt nauseous. When asked, she reported that she did not have trouble breathing. Furthermore, the patient reported a "tingling" feeling in her hands.   The pharmacist directed the pharmacy technician to call 911 and then he gathered materials to perform necessary first aid. Fingertip pulse oximeter showed HR (approximately) 99 BPM and spO2 >98% . The pharmacist attempted to take patient's blood pressure, but the automated BP monitor could not obtain a reading, and the patient reported that readings have been difficult to get in the past because she "has deep veins".   Fire Department and EMS arrived approximately 10 minutes after the start of symptoms. Fire department performed vitals and found blood glucose 99 mg/dL and temperature WNL. Fire workers were unable to determine blood pressure with manual sphygmomanometer.   EMS began to question and assess the patient. EMS also performed EKG and observed pulse, which was still similarly elevated. The EKG reading was unavailable to this writer. EMS personnel described that the patient was having syncope, likely due to receipt of the vaccine. Patient reported that she has "had this happen before" after "giving blood". EMS remained with the patient, who reported that she was beginning to feel better. She reported feeling better and both she and EMS left the pharmacy approximately 30 minutes after the onset of symptoms. No further information was available at the time of this writing other than what is contained in this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Condition aggravated, Pain, Pyrexia
Clinical narrative: Within 8 to 10 hours of receiving a vaccine I got a fever and chills and achiness all over my body.  The adverse reaction that I want to report is that it made my asthma flare up. This started on the day after receiving a vaccine and has continued now to the third day. I had to start taking my Albuterol asthma medication.
Age: 21.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Cold sweat, Paraesthesia, Syncope
Clinical narrative: I fainted and when I came to people were around me asking me if I was ok. I'm not totally sure how long I was out, but I woke up in a cold sweat with my hands/fingers tingling. The adverse reaction happened around 5 minutes after last injection of the 3, and continued for around 20-25 minutes.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm since time of vaccination, patient had seen doctor and was treated with different pain medications and still not resolved, MD referred to physical therapy for pain. Pain to the point at even when showering, unable to move arm.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Electrocardiogram normal, Fall, Full blood count normal, Mental status changes
Clinical narrative: Friday morning, patient woke up achy/shaking with visible tremors/weakness in the legs/brain fog. Patient tried to walk but because he felt so weak, he fell. Wife called EMS and was taken to ER. The wife said the doctor said EKG, CBC and basic metabolic panel, as well as urinalysis came back normal. After that the wife took the patient home - she said during the 6 hours in ER it appears his mental status return to normal.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test normal, Muscular weakness, Pain, Tremor, Urine analysis normal
Clinical narrative: Friday morning, patient woke up achy/shaking with visible tremors/weakness in the legs/brain fog. Patient tried to walk but because he felt so weak, he fell. Wife called EMS and was taken to ER. The wife said the doctor said EKG, CBC and basic metabolic panel, as well as urinalysis came back normal. After that the wife took the patient home - she said during the 6 hours in ER it appears his mental status return to normal.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye pain, Fatigue, Headache, Myalgia
Clinical narrative: Headache in eyes, fatigue, stomach ache, muscle soarness
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, FLU3, PNC20, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None reported
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: PAIN IN UPPER ARM THAT IS PAINFUL TO THE TOUCH SINCE FRIDAY, PAIN RADIATING INTO SHOULDER AND DOWN ARM.  PATIENT'S HUSBAND STATES SHE HAS TAKEN TYLENOL AND TRIED ICING THE ARM TO ALLEVIATE PAIN. PAIN HAS IMPROVED 'A LITTLE' SINCE FRIDAY.  IF IT IS STILL NOT BETTER BY MONDAY 11/11, PATIENT WILL CALL MD.
Age: 82.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Burning sensation, Mobility decreased, Tremor
Clinical narrative: Pt wife called saying patient can not move their arm, was shaking, and burning up inside but did not have a fever about  4 hours after the vaccination.  Patient wife was instructed to put ice on arm, get some acetaminophen and call doctor concerning reaction. He was instructed to go to ER  if it continues or gets worse.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Computerised tomogram
Clinical narrative: Patient complained of severe shoulder pain. Went to orthopedic doctor after 10 days and was prescribed tramadol and medrol dose pack.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Clumsiness, Dizziness, Headache
Clinical narrative: pt stated that she had a sever headache and was extremely dizzy, wobbly, and bumped into things when she walked. said her bp at one point was 170/50- we advised pt to seek medical attn- pt stated later an=t check up that she wiped face with warm and cold water/washcloth and was filling better. when asked to retake bp, she did not tell me results but  alluded that it was better and she was going to wait and call her dr the next day
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Dizziness around 10am on Satuday 11/092024, 3 days after vaccine on 11/06. Blood pressure was checked and noticed high at around 158/98 and later 169/84, when patient usually is around 130/80 on blood pressure medication.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: patient has reported 3 cases of rash since receiving shot on 11/1, reported to pharmacist on 11/10. Patient reports no changes in soaps, detergents, etc.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient stated that he experienced extreme swelling starting from his forearm to the palm post vaccine. It was painful per patient.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red, swollen, and inflammed arm at the injection site
Age: 70.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient woke up the morning after the injections with pain and stiffness in the upper arm. Since the vaccines, patient's pain in arm and shoulder comes and goes, but she is occasionally limited in mobility. Patient sought care today and received two medications for treatment (Medrol dosepak and gabapentin).
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: patient received vaccine and a few minutes later passed out (turned pale, sweaty). patient's feet were elevated, water given, ice pack used to cool down. patient was back to normal within a few minutes. we had patient stay for 20 minutes to monitor them. patient stated they felt back to normal and they had a support person with them to drive them home.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Headache
Clinical narrative: Chest & stomach ache, fatigue, headache
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Lymphadenopathy, Oral pain, Rhinalgia
Clinical narrative: swollen gland left side of neck, referred sensitivity/pain to left side palate and left nostril starting a few hrs after the vaccine continuing for at least 2 days.  2 days post vaccine onset of diarrhea in the morning lasting most of the day; it's that evening now, so I don't know if this symptom it has cleared yet.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Peripheral swelling, Temperature intolerance, Tenderness, Urticaria
Clinical narrative: Monday Morning woke up with hives on stomach. Hands were swollen and felt like they were badly burned. Hands were VERY sensitive to touch and temperature. This lasted all day. Sensitivity and hives were much better on Tuesday and nonexistent on Wednesday.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Dizziness, Flatulence, Gastrointestinal pain
Clinical narrative: Following day began having tightness in muscles around throat area, bloating, gas, and nausea.  Felt lightheaded and had severe arm pain.  Had to keep moving my arm or it would almost freeze up and be used to move.   The evening after the day of the shot I began having intestinal pains and diarrhea.  The diarrhea has only gotten worse as time goes on with severe pain and cramps putting me in the bathroom for sometimes an hour.  It's also at times almost like intestinal or bowel dry heaves with nothing left to come out.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle tightness, Nausea, Pain in extremity
Clinical narrative: Following day began having tightness in muscles around throat area, bloating, gas, and nausea.  Felt lightheaded and had severe arm pain.  Had to keep moving my arm or it would almost freeze up and be used to move.   The evening after the day of the shot I began having intestinal pains and diarrhea.  The diarrhea has only gotten worse as time goes on with severe pain and cramps putting me in the bathroom for sometimes an hour.  It's also at times almost like intestinal or bowel dry heaves with nothing left to come out.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Fall, Medical device implantation, Nausea, Pain
Clinical narrative: 630pm in my kitchen I felt a whirling in my head and fell to the floor' on my left arm. I came to in about 60 seconds in severe pain very dizzy and nauseous. My son helped me to a chair, My left arm was already black and blue. I experienced severe hausea for 4 days. On Octohrt 9 I went to the Satellite ER . X-rays revealed a fractured shoulder. I saw the Surgeon on October 14 and had reconstructive shoulder surgery with a pin and plate on October 18.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Shoulder fracture, Shoulder operation, Skin discolouration, X-ray limb abnormal
Clinical narrative: 630pm in my kitchen I felt a whirling in my head and fell to the floor' on my left arm. I came to in about 60 seconds in severe pain very dizzy and nauseous. My son helped me to a chair, My left arm was already black and blue. I experienced severe hausea for 4 days. On Octohrt 9 I went to the Satellite ER . X-rays revealed a fractured shoulder. I saw the Surgeon on October 14 and had reconstructive shoulder surgery with a pin and plate on October 18.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site.
Age: 47.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Injection site cellulitis, Skin irritation
Clinical narrative: Patient reported to primary care that they have a skin irritation  on left arm. Patient was diagnosed with cellulitus (suspected from injection site) and was prescriber the Sulfamethoxazole-Trimethaprim DS tablets.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury
Clinical narrative: Patient receive a Covid shot 2024-2025 Patient said he felt okay. He and his mother came out front to pay for prescription. Patient fell to the floor with his mother standing next to him Patient hit his head. Ambulance was called & patient was taken to hospital.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: On 5/13/24, I received COVID-19 in one upper arm and the RSV in the other upper arm.  Starting 5/14/2024, I experienced extreme tiredness, weakness, dizziness nausea, one emesis, feeling unsteady when walking, and an unsteady gate.  I needed to stay mostly in bed.  I had hypotension (99/49).  I held all antihypertensive.  These severe symptoms lasted until 5/20/24.  From then until 5/24/24, I still had fatigue, and weakness but not as severe as from 5/14/20 until 5/20/24.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Hypotension, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: On 5/13/24, I received COVID-19 in one upper arm and the RSV in the other upper arm.  Starting 5/14/2024, I experienced extreme tiredness, weakness, dizziness nausea, one emesis, feeling unsteady when walking, and an unsteady gate.  I needed to stay mostly in bed.  I had hypotension (99/49).  I held all antihypertensive.  These severe symptoms lasted until 5/20/24.  From then until 5/24/24, I still had fatigue, and weakness but not as severe as from 5/14/20 until 5/20/24.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Gait disturbance
Clinical narrative: On 5/13/24, I received COVID-19 in one upper arm and the RSV in the other upper arm.  Starting 5/14/2024, I experienced extreme tiredness, weakness, dizziness nausea, one emesis, feeling unsteady when walking, and an unsteady gate.  I needed to stay mostly in bed.  I had hypotension (99/49).  I held all antihypertensive.  These severe symptoms lasted until 5/20/24.  From then until 5/24/24, I still had fatigue, and weakness but not as severe as from 5/14/20 until 5/20/24.
Age: 70.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Hypotension, Nausea, Vomiting
Clinical narrative: On 5/13/24, I received COVID-19 in one upper arm and the RSV in the other upper arm.  Starting 5/14/2024, I experienced extreme tiredness, weakness, dizziness nausea, one emesis, feeling unsteady when walking, and an unsteady gate.  I needed to stay mostly in bed.  I had hypotension (99/49).  I held all antihypertensive.  These severe symptoms lasted until 5/20/24.  From then until 5/24/24, I still had fatigue, and weakness but not as severe as from 5/14/20 until 5/20/24.
Age: 38.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Lymphadenopathy, Pyrexia, Swelling, Tenderness
Clinical narrative: I received the Tdap on 10/2/2024 and by 10/5/2024 I had a fever over 100 degrees, loss of appetite, body chills/aches, my shoulder had a golf ball size knot on it until 10/12/2024. I went to the doctor on 10/9/2024 to see a different provider and I was advised then that I had a shoulder injury from the Tdap vaccine. Dr. advised me that I probably will not be able to no longer receive that vaccine after my reaction to it. I was advised to use hot/cold packs and take ibuprofen and Tylenol for pain and swelling.
Age: 38.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Decreased appetite, Limb injury, Nodule, Pain
Clinical narrative: I received the Tdap on 10/2/2024 and by 10/5/2024 I had a fever over 100 degrees, loss of appetite, body chills/aches, my shoulder had a golf ball size knot on it until 10/12/2024. I went to the doctor on 10/9/2024 to see a different provider and I was advised then that I had a shoulder injury from the Tdap vaccine. Dr. advised me that I probably will not be able to no longer receive that vaccine after my reaction to it. I was advised to use hot/cold packs and take ibuprofen and Tylenol for pain and swelling.
Age: 38.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: I received the Tdap on 10/2/2024 and by 10/5/2024 I had a fever over 100 degrees, loss of appetite, body chills/aches, my shoulder had a golf ball size knot on it until 10/12/2024. I went to the doctor on 10/9/2024 to see a different provider and I was advised then that I had a shoulder injury from the Tdap vaccine. Dr. advised me that I probably will not be able to no longer receive that vaccine after my reaction to it. I was advised to use hot/cold packs and take ibuprofen and Tylenol for pain and swelling.
Age: 63.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Rash
Clinical narrative: Patient ID: Patient is a 63 y.o. female who presents to clinic for an acute visit to address a chief complaint of rash. Patient says that she received flu shot from Pharmacy on 9/20/2024. She says that within hours of receiving vaccine, she started to have a rash on her shoulder which then moved to her forearm 5 hours later. On the next today (9/21/24), patient said the rash spread to both upper extremities. By 9/23/2024, rash was on both legs, belly and back.   Patient went to urgent care on 10/1/2024 and was given calamine lotion and triamcinolone cream to help with symptoms. Patient today states that she has had the rash for 39 days and that it is not improved significantly with prescribed an over-the-counter trea
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Injection site erythema, Injection site irritation, Pruritus
Clinical narrative: Itching all over my body. Hives developed on my legs. Contacted my pharmacy on 11/9/24 put on Benadryl 25 mg every 6 hours. Went to ER on 11/10/24 when hives appeared and itching got worse. Given oral cortisone and higher dose of Benadryl, gave me a prescription for cortisone ointment.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching all over my body. Hives developed on my legs. Contacted my pharmacy on 11/9/24 put on Benadryl 25 mg every 6 hours. Went to ER on 11/10/24 when hives appeared and itching got worse. Given oral cortisone and higher dose of Benadryl, gave me a prescription for cortisone ointment.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included risankizumab (Skyrizi) and levothyroxine sodium (Tirosint).   On 21-OCT-2024, the patient received Shingrix. On 21-OCT-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). The outcome of the injection site pain was resolving.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt date: 21-OCT-2024 The patient received Shingrix and experienced injection site pain.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Pregnancy due date: October 2024//pregnant patinet received Arexvy; Pregnancy due date: October 2024/pregnant patinet received Arexvy; This non-serious prospective pregnancy case was reported by a other health professional and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number bl473, expiry date 13-OCT-2026) for prophylaxis.   On 25-OCT-2024, the patient received the 1st dose of Arexvy (intramuscular). On 25-OCT-2024, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Pregnancy due date: October 2024/pregnant patinet received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnancy due date: October 2024//pregnant patinet received Arexvy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 28-OCT-2024 The pregnancy due date was October 2024. The pregnant patient received Arexvy, which led to drug use in unapproved population and vaccine exposure during pregnancy.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Insurance issue
Clinical narrative: States he lost his insurance and they did not go back to get the second dose in the series of suspect vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21-JAN-2023 in left arm, batch number:XG7RF and Expiry date:21-MAY-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: States he lost his insurance and they did not go back to get the second dose in the series of suspect vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2024 The patient was the reporter who was reporting for himself and his wife.  The reporter stated that he lost his insurance and they did not go back to get the second dose in the series of suspect vaccine.  The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2024126186, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024126186:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient and husband received the first dose of suspect vaccine SHINGRIX on 01/21/2023.Husband lost his insurance and they did not go back to get the second dose in the series of suspect vaccine.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21-JAN-2023 in left arm, batch number: XG7RF and expiry date:21-MAY-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient and husband received the first dose of suspect vaccine SHINGRIX on 01/21/2023.Husband lost his insurance and they did not go back to get the second dose in the series of suspect vaccine.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2024 The patient was the reporter who was reporting for himself and his wife. The reporter stated that he lost his insurance and they did not go back to get the second dose in the series of suspect vaccine.  The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2024126205, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024126205:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: gave an expire vaccine, a Shingrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number FH79Y, expiry date 06-OCT-2024) for prophylaxis.   On 14-OCT-2024, the patient received the 1st dose of Shingrix. On 14-OCT-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: gave an expire vaccine, a Shingrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-OCT-2024 The reporter reported the following that they gave an expire vaccine, a Shingrix vaccine and he/she just need to find out what the recommendation was and it was expired like 6 days, which led to expired vaccine used. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not go back for the second dose in the vaccine series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not go back for the second dose in the vaccine series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-OCT-2024 The reporter was the wife of the patient. During call she reported that the patient received the first dose of suspect vaccine approximately 1 year ago in November of 2023.  The reporter stated that patient did not go back for the second dose in the vaccine series (Inappropriate Dose Schedule). The reporter did not have any further information. The reporter stated that a long time had passed and she did not remember any further details. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix for patients age 7-9 years old. In conversation she stated, We do it all the time (administer to patients of this age range); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix for patients age 7-9 years old. In conversation she stated, We do it all the time (administer to patients of this age range)). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-OCT-2024 The reporter was looking for information on the use of Boostrix for patients age 7-9 years old, which led to inappropriate age at vaccine administration. In conversation she stated that they did it all the time (administer to patients of this age range). The reporter did not consent to follow-up. No further information obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had their first and only dose of Shingrix 3 or 4 years ago in another facility, and did not get their second dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 or 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient had their first and only dose of Shingrix 3 or 4 years ago in another facility, and did not get their second dose yet.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-OCT-2024 Pharmacist explained that a patient had their first and only dose of Shingrix 3 or 4 years ago in another facility and did not get their second dose yet.  The reporter did not have a lot number, expiration date or date of administration. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number MS4G9) and (batch number 3043259) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-OCT-2022).   On 04-OCT-2024, the patient received the 2nd dose of Shingrix. On 04-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-OCT-2024 The reporter reported the following that he/she was calling about Shingrix. He/she had patient, they got the shot about a year ago and she just got her 2nd shot, recently. And he/she knew, earlier he/she saw on the website, not to restart the series, he/she did not know was that recommendation still implied where she should go ahead and got a 3rd shot. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Second dose maladministered to the same patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4S4L2, expiry date 06-MAY-2026) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 05-OCT-2023, batch number:94CC4 and expiry date:25-OCT-2025).   On 08-OCT-2024, the patient received the 2nd dose of Arexvy. On 08-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Second dose maladministered to the same patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 15-OCT-2024 The reporter called and ask about a patient received a second Arexvy vaccine, (first one was given a year ago) , he/she wanted to check on you and know if they were ok, which led to extra dose administered. The vaccine detail, vaccination date and patient demographics asked and retrieved from the pharmacist´s end and registered in the corresponding sections above.  No further information was obtained during this call. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 21-OCT-2024 The patient had not received his second dose of Shingrix yet. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 07-DEC-2023).   On 12-AUG-2024, the patient received the 2nd dose of Shingrix. On 12-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter inquired if the patient needed a 3rd dose or not.  The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old was given KINRIX (inappropriate age); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 21-OCT-2024, the patient received the 1st dose of Kinrix (intramuscular, left thigh). On 21-OCT-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 year old was given KINRIX (inappropriate age)). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2024 The medical assistant was the reporter who stated that a 2 year old was given Kinrix (inappropriate age), which led to inappropriate age at vaccine administration. Child was not symptomatic. No symptoms had been reported.  The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix vaccine was administer to two patients of 2 YO; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 04-SEP-2024, the patient received the 1st dose of Boostrix. On 04-SEP-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix vaccine was administer to two patients of 2 YO). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 25-OCT-2024 The reporter called about that he/she guessed a mistake that was made by a staff member, they had given a Tdap (Boostrix) to two-year-old, they were set of twins, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2024133102, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024133102:Same reporter/Different patient
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) (batch number 2X2EJ, expiry date 14-OCT-2024) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt Date: 28-OCT-2024 Nurse Practitioner reported that Havrix vaccines went out of recommended temperature range repeatedly overnight in one of their pharmacy fridges, between midnight and 6:00 am, over the course of 4 weeks, which led to incorrect storage of vaccine. The maximum temperature was 74 degree F and the cumulative time out of range was 168 hours.  There are 3 fridges that the vaccines get moved around in, so they may not had been out of range for the full time, this would be worst case scenario, since there is no way to know for sure.  The vaccines were administered to patients between 19-Sep-2024 and 07-Oct-2024 before they were pulled off the shelf.  At the time of reporting, the Nurse Practitioner did not know how many patients were given the affected vaccines and she did not have any specific patient details. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.