chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose of havrix administered to an adult patient; Pediatric dose of havrix administered to an adult patient; Pediatric dose of havrix administered to an adult patient and it was also expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 42-year-old female patient who received HAV (Havrix) (batch number 2X2EJ, expiry date 14-OCT-2024) for prophylaxis.   On 21-OCT-2024, the patient received the 1st dose of Havrix. On 21-OCT-2024, an unknown time after receiving Havrix, the patient experienced adult use of a child product (Verbatim: Pediatric dose of havrix administered to an adult patient), underdose (Verbatim: Pediatric dose of havrix administered to an adult patient) and expired vaccine used (Verbatim: Pediatric dose of havrix administered to an adult patient and it was also expired). The outcome of the adult use of a child product, underdose and expired vaccine used were 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: 21-OCT-2024 The reporter on vaccine (Havrix), a pediatric vaccine, that was given to an adult and it was also expired which led to underdose, adult use of a child product and expired vaccine used.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received FLUZONE T after the excursion; they were in and out of the refrigerator and left the door open for too long.Max /low temperature reached: 1.7CDuration: 170 minutes with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to other case US-SA-2024SA327135 (cluster case)  This case involves a 1-year-old female patient and reporter stated that they were in and out of the refrigerator and left the door open for too long max /low temperature reached: 1.7cduration: 170 minutes with no reported adverse event and 7 patients received influenza USP trival A-B subvirion vaccine [fluzone] after the excursion.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.  On 09-OCT-2024 the 0.5 ml of standard dose of suspect influenza USP trival A-B subvirion vaccine Suspension for injection lot UA435AA via intramuscular route in right thigh for immunization was in and out of the refrigerator and left the door open for too long max /low temperature reached: 1.7cduration: 170 minutes with no reported adverse event (product storage error).   On 22-Oct-2024, patient received fluzone T after the excursion (poor quality product administered) (Latency same day)  Reportedly, Human error was involved. Product was used.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA327135:02295266
Age: 73.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received a booster dose of menquadfi 16 days after the previous dose with no reported adverse event; Initial information received on 05-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 73 years old female patient who received a booster dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 16 days after the previous dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Apr-2024, the patient received a 0.5 ml (once) booster dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (strength:  not reported) 16 days after the previous dose with no reported adverse event (inappropriate schedule of product administration) (latency: same day) (lot: U7827AB, expiry date: 30-Sep-2025) via Intramuscular route in left deltoid for immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 9-year-old male patient was given 3 mL of IPOL instead of the standard 0.5 mL with no reported adverse event; Initial information received on 05-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 years old male patient who was given 3 ml of Ipv (Vero) [Ipol] instead of the standard 0.5 ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis b vaccine rHBsAg (yeast) (Engerix b) and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for immunizaton.  On 04-Nov-2024, the patient received 3 ml once dose of suspect Ipv (Vero), Suspension for injection (strength: not reported) instead of the standard 0.5 ml with no reported adverse event (extra dose administered) (latency: same day) (lot: W1383M, expiry date: not reported) via unknown route in unknown administration site for immunization.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: MEN, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to 1 yr old patient was supposed to receive MMR vaccine but was given MENQUADFI with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 12 months old male patient who was supposed to receive Mmr (Measles Vaccine, Mumps Vaccine, Rubella Vaccine) but was given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Nov-2024, the patient was supposed to receive Mmr (Measles Vaccine, Mumps Vaccine, Rubella Vaccine) but was given a dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (strength: not reported) (once) with no reported adverse event (wrong product administered) (latency: same day) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization. Information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-month-old female patient was given fluzone tiv that are for 6 months and older with no adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] that are for 6 months and older with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (PEDIARIX); hepatitis B vaccine (HEP B VAX); pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20); and rotavirus vaccine live reassort oral 5V (Rotateq) all for Immunisation.  On 04-Nov-2024, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection with standard strength (lot UT8423LA and expiry date- 30-Jun-2025) once via intramuscular route in the left thigh as Immunization that are for 6 months and older with no adverse event (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: patients received FLUZONE T after the excursion with no reported adverse event; the refrigerator and left the door open for too long.Max/low temperature reached: 1.7CDuration: 170 minutes, with no reported adverse event; Initial information received on 06-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Punctured influenza USP TRIVAL A-B subvirion vaccine [Fluzone] exposed to temperature excursion due to the refrigerator and left the door open for too long. max/low temperature reached: 1.7c duration: 170 minutes, and a 17 years old female patient received after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for; and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) both for Immunisation.  On 22-Oct-2024, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE lot UA435AA via intramuscular route in the right deltoid.  On 09-Oct-2024 Punctured influenza USP TRIVAL A-B subvirion vaccine [Fluzone] exposed to temperature excursion due to the refrigerator and left the door open for too long. max/low temperature reached: 1.7c duration: 170 minutes with no reported adverse event (product storage error).  On 22-Oct-2024, the patient received 0.5 ml of Punctured influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (strength- standard, lot UA435AA and expiry date- 30-Jun-2025) once via intramuscular route in the right deltoid for Influenza after the excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received daptacel today but the vaccine already expired with no reported adverse event; Initial information received on 06-NOV-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] today but the vaccine already expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant :  ''no other vaccines''.  On 06-NOV-2024, the patient received 0.5ml (Standard) (once) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE  suspension for injection (lot 2CA28C1, expiry: 04-NOV-2024) via intramuscular route in right thigh for prophylactic vaccination today but the vaccine already expired with no reported adverse event (expired product administered).  Reportedly, as reported it was an inappropriate use due to administering an expired vaccine to a patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Athus reaction at site or similar. Large tender bump at site for 5+ days. Bruising on day 6-7, along with very slight itching on former reaction site.
Age: 33.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Athus reaction at site or similar. Large tender bump at site for 5+ days. Bruising on day 6-7, along with very slight itching on former reaction site.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Gastrointestinal disorder
Clinical narrative: I can no longer eat eggs at all. I have been eating eggs all my life, but gastric can no longer handle them anymore.
Age: 0.17
Sex: M
Vaccine: PNC13, RV1
Symptoms: Constipation, Irritability, Vomiting
Clinical narrative: Had rotavirus vaccine. Prior to vaccine had minimal spitting up, pooping 1-4 times per day (breastfed baby). Post vaccine, was extremely fussy, didn?t poop for 3 days, had to give suppository. Now almost 3 weeks post vaccine, vomiting finally subsided, but now has only pooped on his own without medication or prune juice one day. Had to give suppositories every other day but don?t want him to rely on that so switched to prune juice. Had to bring him back to the doctor the next week after vaccination (where they recommended suppository and did agree it was caused by the vaccine)
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dyskinesia, Feeling abnormal, Hemiparesis
Clinical narrative: Person who administered the shot went way too high on my shoulder causing my entire body to jump having hit a nerve in my shoulder, my shoulder was instantly in pain and burning, my eyes instantly started tearing up , I was immediately feeling strange and not like my usual self,  the whole left side of my body extremely weak , woke up the next day to multiple occular manifestations , blood clots in my cornea and retina , perfect blood circle around my iris at one point, started getting fuzzy vision which I am still experiencing to this day in my left eye, I fear the person who immunized me may have caused life long damage to myself and my vision .
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Iris haemorrhage, Lacrimation increased, Ophthalmic vascular thrombosis, Peripheral nerve injury
Clinical narrative: Person who administered the shot went way too high on my shoulder causing my entire body to jump having hit a nerve in my shoulder, my shoulder was instantly in pain and burning, my eyes instantly started tearing up , I was immediately feeling strange and not like my usual self,  the whole left side of my body extremely weak , woke up the next day to multiple occular manifestations , blood clots in my cornea and retina , perfect blood circle around my iris at one point, started getting fuzzy vision which I am still experiencing to this day in my left eye, I fear the person who immunized me may have caused life long damage to myself and my vision .
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Retinal vascular thrombosis, Vision blurred
Clinical narrative: Person who administered the shot went way too high on my shoulder causing my entire body to jump having hit a nerve in my shoulder, my shoulder was instantly in pain and burning, my eyes instantly started tearing up , I was immediately feeling strange and not like my usual self,  the whole left side of my body extremely weak , woke up the next day to multiple occular manifestations , blood clots in my cornea and retina , perfect blood circle around my iris at one point, started getting fuzzy vision which I am still experiencing to this day in my left eye, I fear the person who immunized me may have caused life long damage to myself and my vision .
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness from shoulder to thumb; Tingling from shoulder to thumb; This non-serious case was reported by a consumer and described the occurrence of numbness in a 40-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 5ZG92, expiry date 08-JUN-2025) for prophylaxis.   Concurrent medical conditions included premenstrual dysphoric disorder. Concomitant products included fluoxetine.   On 19-OCT-2024, the patient received FluLaval 2024-2025 season (intramuscular) .5 ml. On 19-OCT-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced numbness (Verbatim: Numbness from shoulder to thumb) and tingling (Verbatim: Tingling from shoulder to thumb). The outcome of the numbness and tingling were resolving.   It was unknown if the reporter considered the numbness and tingling to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the numbness and tingling to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   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: 19-OCT-2024 The patient self-reported this case for herself. The patient received Flulaval 2024-2025. The patient had numbness and tingling from shoulder to thumb next morning after vaccination.  The patient was running when symptoms started, stopped after running.  The patient's symptoms were not treated.
Age: 71.0
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Injection site discolouration, Pain in extremity
Clinical narrative: skin discoloration surrounding the injection site; sore upper arm; tired; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site discoloration in a 71-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 36 hrs after receiving Arexvy, the patient experienced injection site discoloration (Verbatim: skin discoloration surrounding the injection site), pain in arm (Verbatim: sore upper arm), tiredness (Verbatim: tired) and headache (Verbatim: headache). The outcome of the injection site discoloration, pain in arm, tiredness and headache were not reported.   It was unknown if the reporter considered the injection site discoloration, pain in arm, tiredness and headache to be related to Arexvy.     It was unknown if the company considered the injection site discoloration, pain in arm, tiredness and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2024 The case was received from the patient via interactive digital media. The patient was reporter. The patient just had RSV shot. The patient did not run a fever but have been very tired, headache and have a very sore upper arm with an about 3 inch semi round skin discoloration surrounding the injection site. This is approximately 36 hours from when patient got the injection.
Sex: M
Vaccine: RVX
Symptoms: Cough, Feeling abnormal, Nasal congestion
Clinical narrative: Most miserable 3 weeks of cough; Most miserable 3 weeks of snot we have ever day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: Most miserable 3 weeks of cough) and nasal congestion (Verbatim: Most miserable 3 weeks of snot we have ever day). The outcome of the cough and nasal congestion were resolved (duration 3 weeks).   It was unknown if the reporter considered the cough and nasal congestion to be related to RSV vaccine.     It was unknown if the company considered the cough and nasal congestion to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 18-OCT-2024 This case was reported by a consumer via interactive digital media. The patient received RSV vaccine. Most miserable 3 weeks of cough and snot they had ever day. This case has been linked to the case US2024AMR131518 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR131518:same reporter, Male patient
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy additional dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HM955, expiry date 28-FEB-2025) for prophylaxis.   Previously administered products included Arexvy (received first dose of Arexvy vaccine on 19th October 2023 with batch number HF015 and expiration date 28th February 2025).   On 29-OCT-2024, the patient received the 2nd dose of Arexvy. On 29-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Arexvy additional dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2024 The pharmacist reported that the patient received the Arexvy vaccine additionally, which led to extra dose administered. The patient was fine. The vaccine administration facility was the same as primary reporter.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain
Clinical narrative: Very sore and aching (Pain score 8 on 1-10 range) I normally can stand pain. It lasted for 1.5 days. Much better after 1.5 days. I never had the severe on other COVID-19 shots. Only sore arm before. Tylenol 1000 mg twice daily.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Rash
Clinical narrative: Had rash to neck,chest,face for a few days after vaccines.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Muscle spasms, Pain, Sleep disorder
Clinical narrative: Have been in terrible pain for about a month. Gone first to massage therapy and they thought broken rib; went to urgent care for xray--no broken ribs. Then went to Hospital, to emergency room and then by ambulance. Have gone to family dr, heart dr., spine dr and all they can say is muscle spasms on left side under shoulder blade area. taking muscle relaxer at night to be able to sleep; cannot sleep on either side. Using rubs and 8 hr pain medicine, heat on the area. (My wife took the flu shot at same time and she has been in pain to this day on the right side under the shoulder blade area. It was definitely the flu shots we took. She will be filling out this form also and reporting.) I am in physical therapy; still in pain. Mfg: Sequirus, Inc; Lot#388488, qty:0.5, color milky white flu shot given at pharmacy
Sex: U
Vaccine: HPV9
Symptoms: Device connection issue
Clinical narrative: The syringe for Gardasil (NDC 0006-4121-01), Lot x020726, did not contain the leur locking mechanism to attach a needle to the syringe
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability
Clinical narrative: Patient could not stand or walk for 4 days following the vaccine; reported by patient did not consent to follow up AE all available information is provided in this report no further clarification is available.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Atrioventricular block, Blood test, Cardiac monitoring, Cardiac pacemaker insertion
Clinical narrative: In the early afternoon of December 31, 2022, I was doing my annual cleaning of our outdoor barbecue grill.About an hour into the work, I started to get out of breath and lightheaded. I sat down, drank some water, and I felt I just needed a break.About 20 minutes later, I started back to work then got extremely breathless and dizzy so I stopped. I couldn't go back to work, could not bend down to pick up the tools and could not catch my breath.I got up to the couch in the family room and fell asleep for about 2 hours. When I woke up I saw my wife and felt like I was going to black out. She immediately took me to the Emergency Room of Hospital around 5:30 pm. I was checked into the hospital, given a continuous series of tests and blood tests. I was held overnight. I was seen by the Hospital Cardiologist and finally by Electrophysiologist. Later that afternoon the Electrophysiologist told me he had seen some fluctuations in my heart rhythm and was putting me on a heart monitoring device for 30 days. I went home and continued to limit my activities to minor tasks. I was concerned about the VAX being a major cause of the Sudden Death Syndrome incurred by amateur and professional athletes especially when doing strenuous on field activities and then collapsing. On Friday March 24, 2023 late afternoon, I bent down to put my dog's collar on to give him a walk. I passed out bending down and again my wife drove me to the Emergency Room at Hospital They immediately started giving me 24-hour continuous care and with a crash cart put next to my emergency room bed. They immediately took me to the Cardiac Care Floor where they tied me down in bed with leg compression bandages and began 24 hour medical and monitoring protocols. My condition worsened to where my heart beat rate declined to mid 20 beats per minute. The nursing staff told they were concerned about me pulling through. I saw Dr. who was going to do Stent Surgery, but Dr. and his surgeon Dr. immediately told me I needed emergency pacemaker surgery and that would be done on Monday, March 27. The Stent Surgery will be delayed. I still get intermittently dizzy and loose my breath and have to lay down. I sometimes have almost fallen when I walk.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram heart abnormal, Computerised tomogram thorax, Coronary artery stenosis, Coronary ostial stenosis, Dizziness
Clinical narrative: In the early afternoon of December 31, 2022, I was doing my annual cleaning of our outdoor barbecue grill.About an hour into the work, I started to get out of breath and lightheaded. I sat down, drank some water, and I felt I just needed a break.About 20 minutes later, I started back to work then got extremely breathless and dizzy so I stopped. I couldn't go back to work, could not bend down to pick up the tools and could not catch my breath.I got up to the couch in the family room and fell asleep for about 2 hours. When I woke up I saw my wife and felt like I was going to black out. She immediately took me to the Emergency Room of Hospital around 5:30 pm. I was checked into the hospital, given a continuous series of tests and blood tests. I was held overnight. I was seen by the Hospital Cardiologist and finally by Electrophysiologist. Later that afternoon the Electrophysiologist told me he had seen some fluctuations in my heart rhythm and was putting me on a heart monitoring device for 30 days. I went home and continued to limit my activities to minor tasks. I was concerned about the VAX being a major cause of the Sudden Death Syndrome incurred by amateur and professional athletes especially when doing strenuous on field activities and then collapsing. On Friday March 24, 2023 late afternoon, I bent down to put my dog's collar on to give him a walk. I passed out bending down and again my wife drove me to the Emergency Room at Hospital They immediately started giving me 24-hour continuous care and with a crash cart put next to my emergency room bed. They immediately took me to the Cardiac Care Floor where they tied me down in bed with leg compression bandages and began 24 hour medical and monitoring protocols. My condition worsened to where my heart beat rate declined to mid 20 beats per minute. The nursing staff told they were concerned about me pulling through. I saw Dr. who was going to do Stent Surgery, but Dr. and his surgeon Dr. immediately told me I needed emergency pacemaker surgery and that would be done on Monday, March 27. The Stent Surgery will be delayed. I still get intermittently dizzy and loose my breath and have to lay down. I sometimes have almost fallen when I walk.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Gait disturbance, Heart rate decreased, Loss of consciousness
Clinical narrative: In the early afternoon of December 31, 2022, I was doing my annual cleaning of our outdoor barbecue grill.About an hour into the work, I started to get out of breath and lightheaded. I sat down, drank some water, and I felt I just needed a break.About 20 minutes later, I started back to work then got extremely breathless and dizzy so I stopped. I couldn't go back to work, could not bend down to pick up the tools and could not catch my breath.I got up to the couch in the family room and fell asleep for about 2 hours. When I woke up I saw my wife and felt like I was going to black out. She immediately took me to the Emergency Room of Hospital around 5:30 pm. I was checked into the hospital, given a continuous series of tests and blood tests. I was held overnight. I was seen by the Hospital Cardiologist and finally by Electrophysiologist. Later that afternoon the Electrophysiologist told me he had seen some fluctuations in my heart rhythm and was putting me on a heart monitoring device for 30 days. I went home and continued to limit my activities to minor tasks. I was concerned about the VAX being a major cause of the Sudden Death Syndrome incurred by amateur and professional athletes especially when doing strenuous on field activities and then collapsing. On Friday March 24, 2023 late afternoon, I bent down to put my dog's collar on to give him a walk. I passed out bending down and again my wife drove me to the Emergency Room at Hospital They immediately started giving me 24-hour continuous care and with a crash cart put next to my emergency room bed. They immediately took me to the Cardiac Care Floor where they tied me down in bed with leg compression bandages and began 24 hour medical and monitoring protocols. My condition worsened to where my heart beat rate declined to mid 20 beats per minute. The nursing staff told they were concerned about me pulling through. I saw Dr. who was going to do Stent Surgery, but Dr. and his surgeon Dr. immediately told me I needed emergency pacemaker surgery and that would be done on Monday, March 27. The Stent Surgery will be delayed. I still get intermittently dizzy and loose my breath and have to lay down. I sometimes have almost fallen when I walk.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Scan with contrast abnormal, Somnolence
Clinical narrative: In the early afternoon of December 31, 2022, I was doing my annual cleaning of our outdoor barbecue grill.About an hour into the work, I started to get out of breath and lightheaded. I sat down, drank some water, and I felt I just needed a break.About 20 minutes later, I started back to work then got extremely breathless and dizzy so I stopped. I couldn't go back to work, could not bend down to pick up the tools and could not catch my breath.I got up to the couch in the family room and fell asleep for about 2 hours. When I woke up I saw my wife and felt like I was going to black out. She immediately took me to the Emergency Room of Hospital around 5:30 pm. I was checked into the hospital, given a continuous series of tests and blood tests. I was held overnight. I was seen by the Hospital Cardiologist and finally by Electrophysiologist. Later that afternoon the Electrophysiologist told me he had seen some fluctuations in my heart rhythm and was putting me on a heart monitoring device for 30 days. I went home and continued to limit my activities to minor tasks. I was concerned about the VAX being a major cause of the Sudden Death Syndrome incurred by amateur and professional athletes especially when doing strenuous on field activities and then collapsing. On Friday March 24, 2023 late afternoon, I bent down to put my dog's collar on to give him a walk. I passed out bending down and again my wife drove me to the Emergency Room at Hospital They immediately started giving me 24-hour continuous care and with a crash cart put next to my emergency room bed. They immediately took me to the Cardiac Care Floor where they tied me down in bed with leg compression bandages and began 24 hour medical and monitoring protocols. My condition worsened to where my heart beat rate declined to mid 20 beats per minute. The nursing staff told they were concerned about me pulling through. I saw Dr. who was going to do Stent Surgery, but Dr. and his surgeon Dr. immediately told me I needed emergency pacemaker surgery and that would be done on Monday, March 27. The Stent Surgery will be delayed. I still get intermittently dizzy and loose my breath and have to lay down. I sometimes have almost fallen when I walk.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Muscle spasms, Sleep disorder
Clinical narrative: I took the flu shot Fluad Trival 2024-2024 2024-2025 SYR, NDC# 70461-0024-03 On on Oct. 22, 2024 at pharmacy Pharmacy Mfg: Seqirus, Inc Lot#388488 My Lot#388488 My husband has also filed a complaint with you. He took this flu shot and had huge pain in comparison to my shoulder pain; he had to go to the hospital emergency room twice. I had to go to my doctor and she said it looked like muscle spasms under my right shoulder and referred me to physical therapy. It is a deep pain and will not let you sleep without some medications. When you get up in the morning, it is worse. I talked to a lady friend on the phone today and she said that both her shoulder blade blade areas were in pain for days. I told her to file a complaint also.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe headache from 2nd shingles vaccine given on 11/15/24, headache started approcimately 12 hours later and is intense whole top and back of head is painful.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Brain fog, Dizziness, Headache, Musculoskeletal stiffness
Clinical narrative: 100F fever on day 1 after the vaccination, body weakness, can't sit up for longer than ~5 minutes. Headache and dizziness persist on day 2, 3. Body weakness, stiff neck, brain fog, on day 4, 5
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: 100F fever on day 1 after the vaccination, body weakness, can't sit up for longer than ~5 minutes. Headache and dizziness persist on day 2, 3. Body weakness, stiff neck, brain fog, on day 4, 5
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles 8 days later mild caste on forehead
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia
Clinical narrative: Systemic: Joint Pain-Mild, Additional Details: Called pharmacy and said had some shoulder pain on injection arm 2 weeks after administration.  Recommended calling dr to review origin of pain since has been 2 weeks since administration.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Mobility decreased, Paraesthesia, Walking aid user
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient woke up Friday 10/11 the patient could not move or feel his legs. Patient was previously a very active individual and is just today (10/29) being discharged from rehab with a walker.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: hard time using arm-Severe
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: fluzone high dose; Manufacturer: ; LotNumber: u8527ba; Route: im; BodySite: right deltoid; Dose: ; VaxDate: UNKNOWN
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Injection site reaction, Syncope
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient says she reacts to needles. Unclear if the vaccine or the needle was to blame for reaction. Patient stated this has happened in the past.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient says she reacts to needles. Unclear if the vaccine or the needle was to blame for reaction. Patient stated this has happened in the past.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient is anxious with vaccines and layed on floor due to feelingn overwhelmed; patient came in with wife and got first vaccine and then after second indicated that he needed to lie down and layed on floor; tech called pharmacist over and both pharmacist went to patient side and spoke eith wife; patint bp taken 106/73 and given bottle of water and rph walked patient and wife to car after patient and wife indicated they were fine
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: pt states injection site began feeling sensitive, burning sensation, became hard and itchy and prompted dr visit and antibiotics. arm site looks red and swollen in a large circle area. reaction began day of 10/22/2024 and is ongoing now for 7 days
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Intermenstrual bleeding, Pain, Polymenorrhoea
Clinical narrative: Systemic: Abdominal Pain-Medium, Additional Details: Patient called pharmacy to report experienced off-cycle menstrual bleeding starting on 10/20/2024 (vaccines received 10/17/2024). Menstrual bleeding began as spotting to full bleed and concluded by 10/27/2024. Patient also reported feeling one-sided lower back pain which is painful to touch including by clothing, pain radiates from lower back to rib, no bruising or rash. Patient reported menstrual cycle began on-schedule 10/07/2024 and concluded 10/11/2024., Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: GSK; LotNumber: 5zg92; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Systemic: Abdominal Pain-Medium, Additional Details: Patient called pharmacy to report experienced off-cycle menstrual bleeding starting on 10/20/2024 (vaccines received 10/17/2024). Menstrual bleeding began as spotting to full bleed and concluded by 10/27/2024. Patient also reported feeling one-sided lower back pain which is painful to touch including by clothing, pain radiates from lower back to rib, no bruising or rash. Patient reported menstrual cycle began on-schedule 10/07/2024 and concluded 10/11/2024., Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: GSK; LotNumber: 5zg92; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: CALLED THE PATIENT ON 10/28/24 SAID HE IS FINE AND EVERYTHING IS OKAY THE SYMPTOM WAS RESOLVED NO MORE PAIN,SWELLING OR REDNESS. NO FOLLOW UP NEEDED
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted, regained consciousness quickly, alert and responsive almost immediately
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Systemic: Chills-Severe, Systemic: Headache-Severe
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: Systemic: pt had history of epstein barr, dr told her she contracted mononucleosis from covid immz-Medium, Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: seqirus; LotNumber: 388522; Route: intramuscular; BodySite: left arm; Dose: 00; VaxDate: 10/05/2024
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Vomiting-Severe, Additional Details: rash was only at injection site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Vomiting-Severe, Additional Details: rash was only at injection site
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal disorder
Clinical narrative: Systemic: "legs quit working"-Severe
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: sequiris; LotNumber: 946584; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Other Vaccines:  VaccineTypeBrand: flucelvax; Manufacturer: sequiris; LotNumber: 946584; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: BD needle malfunction and vaccine leaked from needle. Patient had immediate swelling, redness bleeding and bruising in left arm at injection site. Injection was repeated in right arm due to incomplete administration. Patient was given ice pack for swelling and waited in immunization area for 10 minutes. Swelling improved during this time.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Needle issue
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: BD needle malfunction and vaccine leaked from needle. Patient had immediate swelling, redness bleeding and bruising in left arm at injection site. Injection was repeated in right arm due to incomplete administration. Patient was given ice pack for swelling and waited in immunization area for 10 minutes. Swelling improved during this time.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving Moderna vaccine ( as well as Havrix) was unconscious for a brief moment then regained consciousness. Patient refused medical care including BP reading. He said this has happened previously. Patient agreed to sit outside vaccination room for approximately 15 minutes despite feeling better within 5 minutes. , Other Vaccines:  VaccineTypeBrand: Havrix; Manufacturer: GSK; LotNumber: 4t93r; Route: IM; BodySite: Right deltoid; Dose: ; VaxDate: UNKNOWN