chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Monocyte count increased, Monocyte percentage, Muscular weakness, Nitrite urine absent, Nucleated red cells
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Platelet count normal, Protein total normal, Protein urine absent, Red blood cell count normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Red blood cell sedimentation rate increased, Red blood cells urine negative, Red cell distribution width normal, Specific gravity urine normal, Urine abnormality
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urine ketone body absent, Urobilinogen urine decreased, White blood cell count normal, White blood cells urine negative, pH urine normal
Clinical narrative: Patient with mom,  seen in the clinic on 3/15/2024 for her wellness check . Patient received both Menquadfi and Bexsero that day.  parent reports that patient began experiencing leg pain and weakness the day after getting these two vaccines. After the third day of her legs hurting, parent took patient to the emergency department to be evaluated on 3/20/2024. Patient was given Ibuprofen 600 mg to take every 6 hours as needed for pain as well as Robaxin 500 mg to take four times daily as needed.  Patient was ruled out of not having a DVT , Gillian Barre syndrome, ligament injury or muscle strain or contusion. Patient came back to the clinic on 4/15/2024 to receive her second dose of Bexero and the immunization was withheld. Dr with our infectious disease department stated that patient should not receive anymore doses of the meningitis vaccines and should be listed as an allergy in her chart as well as reports to Vaers.
Age: 53.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was not an adverse reaction.  Vaccines was given outside the licensed recommendation.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea x 24 hours  day after donation
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test
Clinical narrative: MODERNA #1 1/4/2021 MODERNA #1 1/12/2021 ABOUT ONE MONTH LATER DEVELOPED CHEST PAIN, NECK PAIN, PALPITATIONS WAS SEEN AT MULTIPLE EMERGENCY ROOMS AND CLINICS.  FINAL DIAGNOSIS WAS MRNA VACCINE PERICARDITIS.  TREATED WITH COLCHICINE AND PROTOCOL
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Palpitations, Pericarditis
Clinical narrative: MODERNA #1 1/4/2021 MODERNA #1 1/12/2021 ABOUT ONE MONTH LATER DEVELOPED CHEST PAIN, NECK PAIN, PALPITATIONS WAS SEEN AT MULTIPLE EMERGENCY ROOMS AND CLINICS.  FINAL DIAGNOSIS WAS MRNA VACCINE PERICARDITIS.  TREATED WITH COLCHICINE AND PROTOCOL
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after expiration of 3/31/2024
Age: 80.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac failure congestive, Hypoaesthesia, Immediate post-injection reaction, Laboratory test normal, Malaise
Clinical narrative: immediately having  numbness  to his right arm and hand less than 50% of using his hand and didn't feel very well . Went to  the Dr. was diagnosed with  CHF .  In Nov.  after 2 weeks of getting vaccine and started treatment  with lasix  still seeing Cardilogy for CHF. He hasn't seen anyone for his arm but has an appointment with PCP at the end of the month and going to ask about the arm at that time .
Age: 80.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Mobility decreased
Clinical narrative: immediately having  numbness  to his right arm and hand less than 50% of using his hand and didn't feel very well . Went to  the Dr. was diagnosed with  CHF .  In Nov.  after 2 weeks of getting vaccine and started treatment  with lasix  still seeing Cardilogy for CHF. He hasn't seen anyone for his arm but has an appointment with PCP at the end of the month and going to ask about the arm at that time .
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure increased, Dizziness, Malaise
Clinical narrative: Patient received the MMR vaccine Friday morning 4/12/24. She called us on Saturday 4/13/24 to inform us that she had a reaction to the MMR vaccine she received the day before. Patient said she felt dizzy about 30 minutes after the vaccine but felt better. She said that evening she didn't feel well, her blood pressure spiked to 160-180/100+. She said she may have passed out but wasn't sure. Her family call 911 and patient was brought to the hospital for treatment.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Muscle spasms, Myalgia
Clinical narrative: Excruciating pain in my muscles especially in my legs. I cramped up at one time. I just cried! This happened within 24 hours and lasted about a week. I had to have someone come help me massage my legs to help the spasms. I still have the spasms. I still have pain in my thighs and hamstrings.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC20, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Called the CDC and was informed that the pt does not need to repeat the DTap vaccination as the 4th Tdap will count and the pt can continue with the regular vaccination schedule moving forward. Talked to parent today and confirmed that pt was not experiencing any noticeable adverse reactions.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram limb, Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal disorder, X-ray limb
Clinical narrative: My partner and I took the shot same day, October 4, 2021 The arm we got the shot in which was my left and his right we both woke up one day and could not move our arms. We both now have limited mobility without suffering. Any injuries in the very arm shot was given.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Pt came back to pharmacy 4/16/24 with prescription for prednisone by NP. Pt reported Spikevax vaccine given 4/1/24 was given too high in shoulder and was causing her pain and movement problems. Per pt, NP told the pt the shoulder problems were caused by incorrect administration of the vaccine on 4/1/24 and may cause permanent damage.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Dose administered to patient on 04/16/2024 expired on 04/06/2024; contacted Sanofi and they follow CDC guidelines for all expired doses administered and all non-live doses can be re-administered ASAP.  Daptacel is not a live dose
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Injection site cellulitis, Loss of personal independence in daily activities, Migraine
Clinical narrative: Migraine headache for four days, not able to eat for nine days, very bad cellulitis in arm (injection area) very weak, unable to function normally. Stomach was not feeling right for about three weeks.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: limited ROM and pain in over a month since vaccine administered.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody increased, Asthenia, Blood test, COVID-19, Chills
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Decreased appetite, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Gait inability, Gastrointestinal disorder, Gastrooesophageal reflux disease
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Intermenstrual bleeding, Laboratory test abnormal, Menstruation irregular, Migraine
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine with aura, Nausea, Neuropathy peripheral, Oesophageal spasm, Post-acute COVID-19 syndrome
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Premenstrual dysphoric disorder, Presyncope, Rash, Skin exfoliation
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Temperature intolerance, Vision blurred, X-ray
Clinical narrative: Flu-like symptoms with extreme fatigue, nausea, extreme GERD, esophageal spasms, weakness, migraine headache, chills, and POTS dizziness, tachycardia and heat intolerance.  Peeling skin rash on both hands, menstrual spotting and then irregular periods and PMDD for 2.5 years and continuing still.  Chronic fatigue and fluctuating symptoms ever since, including low appetite and digestion problems.   Extreme reaction to future Covid infections, including post-viral POTS, inability to walk, severe weakness and fatigue, and Long Covid with POTS (tachycardia, dizziness, presyncope, GI problems), Ora migraines, blurry vision, esophageal spasms and neuropathy, and elevated ANA and other blood markers.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous, Rash macular, Swelling, Urticaria
Clinical narrative: rash, hives all over arm and back, splotchy, red, little swollen, not warm to the touch. no breathing issues
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was seen and received a Tdap vaccine, as this was prompted on the Care Gap on his chart. His vaccine record on Clinic system showed his last Td vaccine was in the years 1997 and 2000, therefore the Care Gap triggered a vaccine recommendation. Patient was agreeable and signed consent for this. However, after patient got home, he reports he checked his Pharmacy Health app and noticed he received the Td vaccine last year. This was likely given a Pharmacy not Clinic because there is no record on Clinic System in immunization tab about his recent Td vaccine in 2023 as he sees on his Pharmacy phone app.  He is concerned that the Clinic chart does not link with the other parts of Pharmacy and that he was given this vaccine so soon since the previous one. Advised pt that this is not unsafe to have received this so soon, as per the CDC "Tdap is preferred for persons who have not previously received Tdap or whose Tdap history is unknown." Patient v/u. But he is still concerned about the lapse in linking medical information from pharmacy to Clinic, such as his vaccines. Patient was adamant that he wanted to speak with a manager. Advised pt that I will send this concern to management. No adverse effects reported by patient.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Insurance issue
Clinical narrative: Patient was given wrong dose of Covid vaccine and wrong brand related to insurance
Age: 35.0
Sex: F
Vaccine: COVID19, FLUC4, HPV9, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Patient noticed  raised bump on the right arm at the site of the Novavax administration five days after administration. The bump became red and itchy.  Patient reports that arm is now discolored in that spot, but the site is no longer raised, red, or itchy. All symptoms have resolved.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received her 4th dose of Shingrix. A pharmacist co-worker made an error while checking immunization history. The same pharmacist made an error on the 3rd dose of Shingrix given. I asked patient, prior to vaccinating her, if the dose was her first or second. She was unsure of what dose it was for her. I informed her that if this dose was her first, she would need another one in 2 months. She asked me to schedule her for her second dose after she leaves, if need be. After administering her vaccine, I checked system to confirm that it was her first dose. I noticed that she had already received 3 doses prior to her dose today.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a vaccine that had expired 2 days prior to vaccination.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: pt was not witnessed to have any reactions in clinic, went home and parent notified clinic about 2 hours later that pt started to have hives to face, neck and trunk. pt took 12.5mg benadryl PO and hives resolved within 15 minutes.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on her chest for 4 days
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: INTERVAL ERROR FOR HEP A VACCINE ADMINISTERED DOSE 2 ADMINISTERED TOO SOON.  NOTIFIED PATIENT TO RETURN IN 6 MONTHS FROM INVALID DOSE DATE RECEIVED MOTHER VOICED UNDERSTANDING
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose normal, Malaise
Clinical narrative: After tdap patient stated he didn't feel well. Admitted he had not eaten yet. He was offered juice, water, and granola bar and checked on frequently until he felt better and symptoms resolved.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient presented to clinic along with his mother. Assessment screening completed and vaccination administered.  During documentation of the vaccine in chart it was noted that the patient had received the same vaccine from another providers office on 4/12/2024. This information was not presented to the clinic staff. Patient was monitored and no adverse reactions were noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Vaccine Expired.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Adverse reaction, Expired product administered
Clinical narrative: Expired HIB Administer on DOS 04/15/2024, With Symptoms or reactions
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Eructation, Fatigue
Clinical narrative: She got her vaccine, the arm was a little sore if she felt it at first, but did not start getting sore until later when she was moving around.  She went to bed last night and she has a sleep disorder so she is normally up every 2-3 hours at night and cannot get back to sleep sometimes for hours, and last night she slept like a log.  She got up at 8:30 which was unusual for her, and she had a hard time getting out of bed due to severe weakness, body aches, headache, fever, had irritated stomach and nausea and being tired.   She has a bookshelf next to her bed and she uses that to pull herself up but she had to get on her knees and then had to pull herself up.  She has cancer and she was feeling that she may have some new things going on.  She was also feverish, really hot and she got up and stumbled out to the kitchen and was disgusted by the water.  She went back to bed as she was not able to function.  during the night she had some nausea in the middle of the night like queeziness, feeling like she was going to vomit but did not, this was recurrent.  She felt better when she got up again at 11:00 and was able to get out of bed.  She is belching and has not eaten anything.  She is still having the extreme weakness and has improved some.  She did not call her doctor as she looked it up and they are AE associated with shingles and she checked the CDC.gov site and showed where it was common to have it with the 2nd vaccine.  She does not feel like eating at this point.  She is drinking some fluids, some ORT and drank that.  She did have some blueberries.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: She got her vaccine, the arm was a little sore if she felt it at first, but did not start getting sore until later when she was moving around.  She went to bed last night and she has a sleep disorder so she is normally up every 2-3 hours at night and cannot get back to sleep sometimes for hours, and last night she slept like a log.  She got up at 8:30 which was unusual for her, and she had a hard time getting out of bed due to severe weakness, body aches, headache, fever, had irritated stomach and nausea and being tired.   She has a bookshelf next to her bed and she uses that to pull herself up but she had to get on her knees and then had to pull herself up.  She has cancer and she was feeling that she may have some new things going on.  She was also feverish, really hot and she got up and stumbled out to the kitchen and was disgusted by the water.  She went back to bed as she was not able to function.  during the night she had some nausea in the middle of the night like queeziness, feeling like she was going to vomit but did not, this was recurrent.  She felt better when she got up again at 11:00 and was able to get out of bed.  She is belching and has not eaten anything.  She is still having the extreme weakness and has improved some.  She did not call her doctor as she looked it up and they are AE associated with shingles and she checked the CDC.gov site and showed where it was common to have it with the 2nd vaccine.  She does not feel like eating at this point.  She is drinking some fluids, some ORT and drank that.  She did have some blueberries.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: She got her vaccine, the arm was a little sore if she felt it at first, but did not start getting sore until later when she was moving around.  She went to bed last night and she has a sleep disorder so she is normally up every 2-3 hours at night and cannot get back to sleep sometimes for hours, and last night she slept like a log.  She got up at 8:30 which was unusual for her, and she had a hard time getting out of bed due to severe weakness, body aches, headache, fever, had irritated stomach and nausea and being tired.   She has a bookshelf next to her bed and she uses that to pull herself up but she had to get on her knees and then had to pull herself up.  She has cancer and she was feeling that she may have some new things going on.  She was also feverish, really hot and she got up and stumbled out to the kitchen and was disgusted by the water.  She went back to bed as she was not able to function.  during the night she had some nausea in the middle of the night like queeziness, feeling like she was going to vomit but did not, this was recurrent.  She felt better when she got up again at 11:00 and was able to get out of bed.  She is belching and has not eaten anything.  She is still having the extreme weakness and has improved some.  She did not call her doctor as she looked it up and they are AE associated with shingles and she checked the CDC.gov site and showed where it was common to have it with the 2nd vaccine.  She does not feel like eating at this point.  She is drinking some fluids, some ORT and drank that.  She did have some blueberries.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Erythema, Interchange of vaccine products, Malaise, Pain in extremity
Clinical narrative: Client was given Trumenba at Clinic on 8/9/23 and Bexsero on 4/1/24. Called clients mom on 4/16/24 at 1:40 PM to inform her that Trumenba and Bexsero are not interchangeable. Instructed to be considered fully vaccinated, client must receive one more Trumenba or one more Bexsero. Client's mom shared; this is probably why client got so sick. Apparently, client experienced a red, swelled, sore arm, and experienced fever, chills, and told his mom he had trouble breathing, like he couldn't get air. She considered taking him to the ED, but it is my understanding she didn't. Mom shard she most likely will not be able to take client into getting another vaccine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Client was given Trumenba at Clinic on 8/9/23 and Bexsero on 4/1/24. Called clients mom on 4/16/24 at 1:40 PM to inform her that Trumenba and Bexsero are not interchangeable. Instructed to be considered fully vaccinated, client must receive one more Trumenba or one more Bexsero. Client's mom shared; this is probably why client got so sick. Apparently, client experienced a red, swelled, sore arm, and experienced fever, chills, and told his mom he had trouble breathing, like he couldn't get air. She considered taking him to the ED, but it is my understanding she didn't. Mom shard she most likely will not be able to take client into getting another vaccine.
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The vaccination had been previously administered in 2023 during a wellness visit. This was not an adverse reaction this was a medication error.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Formication, Paraesthesia
Clinical narrative: PT CAME IN ON 04/11/24 AND COMPLAINED OF CRAWLIES OR TINGELING RADIATING DOWN HER LEFT ARM.  STATED THAT TINGELING HAS BEEN PRESENT SINCE DATE OF INJECTION.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12+ vaccine given to a child who was 11 at the time.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12+ vaccine given to an 11 year old
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria
Clinical narrative: Patient started to experience local hives around injection site about 24 hours after vaccine and lasted 5-6 days; pt did not receive treatment and considered it a mild reaction
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Only one dose of Arexvy is recommended. Upon giving patient Arexvy vaccination on 04/14/2024, we realized patient had already received an Arexvy dose on 11/29/2023. Therefore, patient had mistakenly received 2 doses of Arexvy.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Facial paralysis, Hypoaesthesia oral, Sinus disorder
Clinical narrative: Patient experienced facial droop & numbness in mouth on 4/15.  Sinuses were bothering her.  She had a cold sore a few weeks prior.  Went to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Diffuse rash
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Lymphadenopathy
Clinical narrative: STATED ARM WAS RED AND SWOLLEN, BLISTERS ON ARM AT INJECTION SITE, SWOLLEN LYMPHNODES
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was given Pfizer BioNTech COVID-19, 2023-2024 formulation, 5-11 years, vaccine on 4/11/2024 instead of the 6month-4 year vaccine. The dosage was 0.3mL. This was the third dose in the primary series. Pfizer was contacted regarding this vaccination error upon finding the error. At this time the patient/parent has not reported any side effects.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood glucose increased, Fall, Head injury, Seizure like phenomena, Syncope
Clinical narrative: Syncope and collapse.  Patient hit head on hard surface floor when she fell from exam table minutes after vaccine administration.  Patient had two episodes of seizure-like activity during this event, each lasting less than 2 minutes.  Patient was taken to the Emergency department by ambulance.
Age: 26.0
Sex: U
Vaccine: COVID19, FLUC4
Symptoms: Underdose
Clinical narrative: Pediatric version of Pfizer vaccine given to adult patient
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: ongoing arm pain x 2 weeks
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pediatric dose given to adult patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pediatric dose of Moderna Covid vaccine administered to an adult
Age: 44.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Cellulitis, Oedema, Pain
Clinical narrative: cellulitis, edema, pain
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal warts
Clinical narrative: Patient now has genital warts on her vulva; This spontaneous report was received from a physician assistant and refers to a 33-years old female patient.  The patient's medical history, concurrent conditions, allergies, and concomitant therapies were not reported.  On an unknown date (when patient was 12-year-old), the patient started vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, for prophylaxis (strength, dose, frequency, lot number, expiration date, anatomical location of application, and route of administration were not provided). Later, on another unspecified date (when patient was 13-year-old), she completed the series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, lot number, expiration date, and route of administration were not provided).  On an unknown date (reported as "now"), the patient had genital warts on her vulva (vulvovaginal warts). At the time of reporting, the outcome of the event vulvovaginal warts was unknown.    The causal relationship between the event vulvovaginal warts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HCP stated that a 22 year old female patient received her first dose of the GARDASIL 9 vaccine on 07/02/2019.  HCP stated that the patient has not received her second dose; no adverse event; This spontaneous report was received from a Pharmacist concerning to an approximately 24-year-old female patient.   The patient's medical history, historical drugs, known allergies and concurrent conditions was not reported.   On 02-JUL-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 02-JUL-2019, the patient when the patient was 22 years old, she was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). Nevertheless, at the moment, she had not received her second dose yet (inappropriate schedule of vaccine administered), and they did not elaborate as to why she had not as they provided limited pertinent information and had no further clarifications. Permission to contact the pharmacist for a follow-up was not provided. No additional adverse events or product quality complaints reported.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE/No PQC.; HCP calling to report a child received GARDASIL 9 inadvertently. The child's parent refused the vaccine and the HCP did not realize it until after administering it. Filing an AE as a precaution. No side effects/symptoms reported. No additional infor; This spontaneous report was received from a medical assistant and referred to a 13-year-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 04-APR-2024, the patient inadvertently received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1957407, expiration date was reported as 31-MAR-20211, upon validation established as 23-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided), however the patient's parent refused the vaccine and the healthcare professional did not realize it until after administering it (accidental exposure to product). No adverse event reported (no adverse event).
Age: 0.58
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product confusion, Wrong product administered
Clinical narrative: No additional AE/PQC.; Caller reported AE on behalf of a 7-month-old patient who received 1 pediatric dose of VAQTA instead of RECOMBIVAXHB due to product confusion on 2/8/2024. Caller reported that it is assumed that a Nurse accidentally grabbed the wrong product. Patient; VAQTA instead of RECOMBIVAXHB due to product confusion; Caller reported AE on behalf of a 7-month-old patient who received 1 pediatric dose of VAQTA instead of RECOMBIVAXHB; This spontaneous report was received from a pharmacist and refers to a 7-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 08-FEB-2024 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # 1971532 and expiration date 13-SEP-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). On 08-FEB-2024, a 7-month-old patient received 1 pediatric dose of VAQTA instead of RECOMBIVAXHB due to product confusion. Caller reported that it was assumed that a Nurse accidentally grabbed the wrong product (wrong product administered, product administered to patient of inappropriate age, product confusion and no adverse event).  On 22-MAR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 milliliter for prophylaxis (dose number, route and site of administration, lot number and expiration date were not provided).
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FBE called on behalf of HCP to report inadvertent administration of PROQUAD to a 4-month-old patient.; No additional adverse events; This spontaneous report was received from a company representative on behalf of HCP (physician) and refers to a 4-month-old patient (unknown gender). No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On an unknown date, the patient was vaccinate at age of 4 months old with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (product administered to a patient of inappropriate age).   Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still I got the Shingles; 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: Still I got the Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-APR-2024 This case was reported by a patient via interactive digital media. The patient had the shot of Shingles vaccine. The physician said best there was and still patient experienced the Shingles. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the vaccine but still got shingles; I get all my shingles shot it was painful for 2 days; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got the vaccine but still got shingles) and pain (Verbatim: I get all my shingles shot it was painful for 2 days). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was resolved (duration 2 days).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2024 This case was reported the patient via interactive digital media. The patient got all his shingles shot and it was painful for 2 days. The patient got the vaccine but still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation shingles  were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Chest pain, Cough, Pneumonia
Clinical narrative: Pneumonia; Chest pain; Coughing; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant), chest pain (Verbatim: Chest pain) and cough (Verbatim: Coughing). The outcome of the pneumonia, chest pain and cough were not reported.   It was unknown if the reporter considered the pneumonia, chest pain and cough to be related to Arexvy.     It was unknown if the company considered the pneumonia, chest pain and cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-Apr-2024 This case was reported by a patient via interactive digital media. he patient received Arexvy vaccine and experienced pneumonia, chest pains and coughing. The reporter stated that he or she will ask his or her pulmonologist about this vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Autoimmune disorder
Clinical narrative: had the shot but have autoimmune disease; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced autoimmune disorder (Verbatim: had the shot but have autoimmune disease) (serious criteria GSK medically significant). The outcome of the autoimmune disorder was not reported.   It was unknown if the reporter considered the autoimmune disorder to be related to Arexvy.     It was unknown if the company considered the autoimmune disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The reported that the patient had the shot but had autoimmune disease and though it was as effective because the patient take Retuxin.
Sex: U
Vaccine: RSV
Symptoms: Syncope
Clinical narrative: Fainting; This serious case was reported by a consumer via interactive digital media and described the occurrence of fainting in an unspecified number of patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fainting (Verbatim: Fainting ) (serious criteria GSK medically significant). The outcome of the fainting was not reported.   It was unknown if the reporter considered the fainting to be related to Arexvy.     It was unknown if the company considered the fainting to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The reporter plant the suggestion of fainting. That can happen with any vaccine and should not be over emphasize route which make people faint.
Sex: U
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: caught RSV still getting over it never want to be without the vaccine/ suspected vaccination failure; caught RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In MAR-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: caught RSV still getting over it never want to be without the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: caught RSV). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was resolving.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK Receipt date: 09-APR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. Patient got the vaccine about a month ago from reporting day and went on 2 cruises and caught RSV. Patient was still getting over it. Patient said that never wanted to be without the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory details were unknown at a time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Inflammatory marker increased
Clinical narrative: Abdominal swelling; elevated inflammatory markers; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling abdomen in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling abdomen (Verbatim: Abdominal swelling) and inflammatory marker increased (Verbatim: elevated inflammatory markers). The outcome of the swelling abdomen and inflammatory marker increased were not resolved.   The reporter considered the swelling abdomen and inflammatory marker increased to be related to Shingrix.     The company considered the swelling abdomen and inflammatory marker increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-APR-2024 The patient experienced the abdominal swelling and elevated inflammatory markers and it was worsened. The reporter was very vague, semi reluctant to allow contact and was unsure if vaccine related.