chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Intra-abdominal fluid collection, Lymphocyte count decreased, Lymphopenia, Mucocutaneous disorder, Multisystem inflammatory syndrome in children
Clinical narrative: Patient developed symptoms of MISC on 7/22/24; fevers began on 7/22/24 with a Tmax of 38.3 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, headache, abdominal pain, vomiting, diarrhea, hand/foot swelling, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, decreased lymphocytes. ECHO showed only left ventricular hyperdynamic systolic function. Chest x-ray was normal. Abdominal US showed common bile duct dilatation and simple free fluid in the lower abdomen. Patient was admitted to the hospital on 7/25/24 and treated with IVIG and infliximab x 2; he was discharged on 7/30/24. He did not require admission to the ICU.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, SARS-CoV-2 antibody test positive, Ultrasound abdomen abnormal
Clinical narrative: Patient developed symptoms of MISC on 7/22/24; fevers began on 7/22/24 with a Tmax of 38.3 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, headache, abdominal pain, vomiting, diarrhea, hand/foot swelling, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, decreased lymphocytes. ECHO showed only left ventricular hyperdynamic systolic function. Chest x-ray was normal. Abdominal US showed common bile duct dilatation and simple free fluid in the lower abdomen. Patient was admitted to the hospital on 7/25/24 and treated with IVIG and infliximab x 2; he was discharged on 7/30/24. He did not require admission to the ICU.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient developed symptoms of MISC on 7/22/24; fevers began on 7/22/24 with a Tmax of 38.3 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, headache, abdominal pain, vomiting, diarrhea, hand/foot swelling, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, decreased lymphocytes. ECHO showed only left ventricular hyperdynamic systolic function. Chest x-ray was normal. Abdominal US showed common bile duct dilatation and simple free fluid in the lower abdomen. Patient was admitted to the hospital on 7/25/24 and treated with IVIG and infliximab x 2; he was discharged on 7/30/24. He did not require admission to the ICU.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drooling, Electroencephalogram, Facial paralysis, Injection site discolouration, Injection site erythema
Clinical narrative: 24 hours after the shot was given, the site had a reddish brown halo, approximately 2 inches in a circular pattern around the site that was painful and hot to the feel. This remained on the site and documented through pictures at various days for 13 plus days. Additionally, an email with attached photo was sent to physician on June 6, 2024 at 3:13 PM. The doctor emailed back and assured me saying this is common and to give patient Benedryl if it became itchy and use a compress. None was given, since only painful and a compress was used.                                                                                                              (MAIN ADVERSE EVENT) In addition on June 9, at 3:00 PM, I woke patient up from his nap and half of his face (anatomical left side of his face) was covered in drool and drooping his face. Upon discovery we rushed him to hospital and then took him to another hospital where he was admitted and given an MRI which read normal.  We met with a neurology doctor and are in the process of testing via EEG. He recovered normal face expression gradually over 72 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site warmth, Magnetic resonance imaging normal
Clinical narrative: 24 hours after the shot was given, the site had a reddish brown halo, approximately 2 inches in a circular pattern around the site that was painful and hot to the feel. This remained on the site and documented through pictures at various days for 13 plus days. Additionally, an email with attached photo was sent to physician on June 6, 2024 at 3:13 PM. The doctor emailed back and assured me saying this is common and to give patient Benedryl if it became itchy and use a compress. None was given, since only painful and a compress was used.                                                                                                              (MAIN ADVERSE EVENT) In addition on June 9, at 3:00 PM, I woke patient up from his nap and half of his face (anatomical left side of his face) was covered in drool and drooping his face. Upon discovery we rushed him to hospital and then took him to another hospital where he was admitted and given an MRI which read normal.  We met with a neurology doctor and are in the process of testing via EEG. He recovered normal face expression gradually over 72 hours.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Flank pain, Gait disturbance, Liver disorder, Mobility decreased, Swelling
Clinical narrative: Patient received her Arexvy immunization on Wednesday 7-24-24. Patient reported that the Arexvy attacked her liver. She reported that the either the evening or next morning she had right side pain from front to back and swelling. She said she had problems walking and needed to use a cane, and today 7-31-24 was the first day she could walk without her cane.  She also had problems getting out of bed and chairs. She said she used aspercream, aspirin and ibuprofen for her pain. She reported being 100% better today, Wednesday 7-31-24.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Walking aid user
Clinical narrative: Patient received her Arexvy immunization on Wednesday 7-24-24. Patient reported that the Arexvy attacked her liver. She reported that the either the evening or next morning she had right side pain from front to back and swelling. She said she had problems walking and needed to use a cane, and today 7-31-24 was the first day she could walk without her cane.  She also had problems getting out of bed and chairs. She said she used aspercream, aspirin and ibuprofen for her pain. She reported being 100% better today, Wednesday 7-31-24.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dental operation, Infection, Pain in jaw, Tooth extraction, Tooth infection
Clinical narrative: Started with the most intense pain to my jawbone that felt like I was struck by lightening. Then endless, acute dental infections which let to consistent antibiotics. The end results has been constant dental visits for dental surgery of tooth extractions!
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Patient received her second dose of Twinrix Vaccine on 7-24-24 (Wednesday) and patient called the pharmacy and reported she developed a rash on 7-27-24 (Saturday). I recommended she use hydrocortisone cream and benadryl. She reported back on Tuesday 7-30-24 that the Benadryl helped and her rash was gone. She reported she did not change anything (soap/lotion/laundry) that would have caused a rash.  She did not report any reactions to her first dose.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Myalgia, Swelling
Clinical narrative: Selling, fatigue, muscle aches for 5 days
Sex: F
Vaccine: RSV
Symptoms: Dysarthria, Swelling
Clinical narrative: neck swelling, slurred speech, better with time over a couple days, no treatment
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Gait disturbance, Hypoaesthesia, Immunisation reaction
Clinical narrative: I received the second dose of my COVID-19 Pfizer vaccination on November 28, 2021. I awoke on the morning of November 29, 2021 and experienced excessive fatigue, difficulting ambulating, feelings of heaviness and numbness in my bilateral lower extremities, brain fog, and severe neurological pain throughout my upper and lower extremities. These symptoms have lasted since November 29, 2021 to present day.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nervous system disorder, Neuralgia, Neuropathy peripheral, Post-acute COVID-19 syndrome
Clinical narrative: I received the second dose of my COVID-19 Pfizer vaccination on November 28, 2021. I awoke on the morning of November 29, 2021 and experienced excessive fatigue, difficulting ambulating, feelings of heaviness and numbness in my bilateral lower extremities, brain fog, and severe neurological pain throughout my upper and lower extremities. These symptoms have lasted since November 29, 2021 to present day.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Myalgia, Pain in extremity
Clinical narrative: Patient states that 3-4 hours after the vaccine was given he developed achy muscles and chills.  He states this progressed to a swollen and very sore warm area on the left arm that was about a 4 inch diameter by 7/28/24-7/29/24.  He said his thigh muscles were extremely sore, his appetite is gone, and BP was in the 160/100 range.   He went to his primary care doctor, who prescribed Cephalexin 500mg  four times a day for five days.  Dr advised him to contact the pharmacy regarding the reaction.  He came by on 7/30/24 and advised of his reaction to one of our technicians.  I was not there that day.  When I came to work on 7/31/24 at 4pm, I was given the message to call him to discuss the reaction.  He came in to see me on 7/31/24 in the evening.  He showed me his arm and the unopened prescription bag for cephalexin that he had not started taking yet.   His arm was very mildly reddened and slightly warm to the touch at that time.  He states that other than that and mild soreness and reduced appetite he felt much improved by today (7/31/24).  I advised him to go ahead and start taking the antibiotic that Dr had prescribed as she directed.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient states that 3-4 hours after the vaccine was given he developed achy muscles and chills.  He states this progressed to a swollen and very sore warm area on the left arm that was about a 4 inch diameter by 7/28/24-7/29/24.  He said his thigh muscles were extremely sore, his appetite is gone, and BP was in the 160/100 range.   He went to his primary care doctor, who prescribed Cephalexin 500mg  four times a day for five days.  Dr advised him to contact the pharmacy regarding the reaction.  He came by on 7/30/24 and advised of his reaction to one of our technicians.  I was not there that day.  When I came to work on 7/31/24 at 4pm, I was given the message to call him to discuss the reaction.  He came in to see me on 7/31/24 in the evening.  He showed me his arm and the unopened prescription bag for cephalexin that he had not started taking yet.   His arm was very mildly reddened and slightly warm to the touch at that time.  He states that other than that and mild soreness and reduced appetite he felt much improved by today (7/31/24).  I advised him to go ahead and start taking the antibiotic that Dr had prescribed as she directed.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Migraine, Photophobia
Clinical narrative: unusually severe migraines that lasted three days...pain was in the left side of my head, included light sensitivity and could not be alleviated with excedrine migraine, hydration, or sleep, which usually clear my migraines up.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Muscle rigidity, Nausea, Posture abnormal, Tinnitus
Clinical narrative: Patient was fine for about 30 seconds. She stated that she was feeling light headed and nauseous. She slumped back into the chair and was rigid with her neck and upper body. I supported her head and kept her legs in place to keep her from sliding down off the bench onto the floor. Shortly after she regained consciousness and asked if she could lay down on the floor. With the help of her mother we supported her head, used her sweater as a make-shift pillow and laid her down. After 20 minutes or so she stated that the mild tinnitus had gone away, she no longer felt nauseous and wished to sit upright. With her mothers assistance we sat her up and monitored for another 5-10 minutes. Patient then stated she was ok to walk to her moms car and go home. I advised her mom to check on El every 15 to 20 minutes for the next several hours to make sure she was stable and ok and to contact EMS if needed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Muscular weakness, Paraesthesia
Clinical narrative: Patient is complaining of onset of decreased strength in bilateral lower extremities - onset 2 days after injection. Also, today c/o paresthesia sensation in both hands and feet. This is accompanied by lightheadedness.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: She reports during administration one of the breaks caused her to cut her right index finger; She reports during administration one of the breaks caused her to cut her right index finger; two GARDASIL 9 finger flanges broke during administration to patients/2.~Both products she reports the finger flange broke while she was administering the GARDASIL 9 to a patient; This spontaneous report has been received from a female registered nurse of unknown age, who was the patient. Her pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.  On 18-JUL-2024, two HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection finger flanges broke during administration as prophylaxis (lot number X026668 has been verified to be valid, expiration date 10-APR-2026; doses, routes of administration and anatomical locations were not provided) (syringe issue). Both vaccines were from the same box; there was no damage to the box, shipping container or tray; no damage was observed to the syringes while they were in the tray. Additionally, it was reported that one of the breaks caused her to cut her right index finger (skin laceration and injury associated with device). It was reported that product was available for return.  The outcome and causality assessment were not provided.   This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2407USA011902:
Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: No additional AE; two GARDASIL 9 finger flanges broke during administration to patients/2.~Both products she reports the finger flange broke while she was administering the GARDASIL 9 to a patient; two GARDASIL 9 finger flanges broke during administration to patients/2.~Both products she reports the finger flange broke while she was administering the GARDASIL 9 to a patient; This spontaneous report has been received from a registered nurse and refers to an unidentified patient of unknown age and gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 18-JUL-2024, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (lot number X026668 has been verified to be valid, expiration date 10-APR-2026; dose, route of administration and anatomical location were not provided), however, the finger flange broke during administration (syringe issue and poor quality device used). The patient was able to receive the complete dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and there were no injuries to the patient. No additional adverse events were reported. It was reported that product was available for return.  This is a non-valid case due to the lack of patient's identifiers.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2407USA011900:MSD US-009507513-2407USA011902:MSD
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had eruptions that don't break out; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "eruptions" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had eruptions that don't break out".  Additional information: Caller stated that she (reporter) used to often get cold sore breakouts and since she received the vaccine and additional boosters since Dec 2020 that she noticed a reduction or elimination in sore breakouts. Caller stated that one friend, in her case, had eruptions that don't break out or crust. This was her friend the one on social media that she does not know. Reporter stated she was part of a social media group in the beginning of covid, which was like in the beginning of 2020/2021.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400218794 Different patient, same drug/event.;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: keep getting covid; keep getting covid; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: four times. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "keep getting covid". The patient reported via the Patient Support Program stating that she/he had taken all the Pfizer COVID-19 vaccine booster shots and still keep getting COVID-19. The patient said that she/he has had COVID-19 four times and after all the shots and boosters she/he keep getting COVID-19 and got the Pfizer COVID-19 shot. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: FLU4
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: allergic reaction to your vaccines; Initial information received on 25-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is related to case- 2024SA220941  This case involves an unknown age and unknown gender patient who had allergic reaction to influenza quadrival A-B HIGH dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2013, the patient received Influenza Quadrival A-B High Dose HV Vaccine of lot U4756BA via unknown route in unknown administration site for immunization (strength, formulation, dose, expiry date unknown).  On 19-NOV-2013 the patient had allergic reaction to your vaccine (allergy to vaccine) (unknown latency).  Action taken not applicable.  Reportedly, we wish to assess if the excipients are still the same today, in 2024, as they were in 2013. We wish to know what excipients present and/or what excipients have changed.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  US-SA-2024SA220941:TDAP
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Disturbance in attention, Headache, Hypertension, Immune system disorder
Clinical narrative: TERRIBLE HEADACHES, IMMUNE SYSTEM DOWN, HIGH BLOOD PRESSURE,  MID EAR INFECTIONS, LONG LASTING COLD AND FLU SYMPTOMS, CONSENTRATION, EXTENDED DEPRESSIVE EPISODES
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis, Otitis media
Clinical narrative: TERRIBLE HEADACHES, IMMUNE SYSTEM DOWN, HIGH BLOOD PRESSURE,  MID EAR INFECTIONS, LONG LASTING COLD AND FLU SYMPTOMS, CONSENTRATION, EXTENDED DEPRESSIVE EPISODES
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Headache; Stomachache; Fatigue; Pain at injection site.; Vertigo; Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUL-2024, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. In JUL-2024, 4 days after receiving Shingrix, the patient experienced vertigo (Verbatim: Vertigo) and dizziness (Verbatim: Dizziness). On 19-JUL-2024, the patient experienced injection site pain (Verbatim: Pain at injection site.). On 20-JUL-2024, the patient experienced headache (Verbatim: Headache), stomach pain (Verbatim: Stomachache) and fatigue (Verbatim: Fatigue). On 20-JUL-2024, the outcome of the injection site pain was resolved (duration 24 hrs).  On 21-JUL-2024, the outcome of the headache, stomach pain and fatigue were resolved (duration 1 day). The outcome of the vertigo and dizziness were not resolved.   It was unknown if the reporter considered the injection site pain, headache, stomach pain, fatigue, vertigo and dizziness to be related to Shingrix.     It was unknown if the company considered the injection site pain, headache, stomach pain, fatigue, vertigo and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The patient self-reported this case. The patient received 2nd dose of Shingrix and reported pain immediately at the injection site that resolved in 24 hours.   Also, reported headache, stomachache and fatigue 1 day after vaccine that resolved 1 day after the symptoms began.   The patient had vertigo or dizziness currently and stated that the dizziness began 4 days after the vaccine and was not resolved.   The reporter did not had the lot number and expiration date of suspect product. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vertigo
Clinical narrative: Headache; Stomachache; Fatigue; Pain at injection site.; Vertigo; Dizziness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUL-2024, the patient received the 2nd dose of Shingrix (left deltoid) .5 ml. In JUL-2024, 4 days after receiving Shingrix, the patient experienced vertigo (Verbatim: Vertigo) and dizziness (Verbatim: Dizziness). On 19-JUL-2024, the patient experienced injection site pain (Verbatim: Pain at injection site.). On 20-JUL-2024, the patient experienced headache (Verbatim: Headache), stomach pain (Verbatim: Stomachache) and fatigue (Verbatim: Fatigue). On 20-JUL-2024, the outcome of the injection site pain was resolved (duration 24 hrs).  On 21-JUL-2024, the outcome of the headache, stomach pain and fatigue were resolved (duration 1 day). The outcome of the vertigo and dizziness were not resolved.   It was unknown if the reporter considered the injection site pain, headache, stomach pain, fatigue, vertigo and dizziness to be related to Shingrix.     It was unknown if the company considered the injection site pain, headache, stomach pain, fatigue, vertigo and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The patient self-reported this case. The patient received 2nd dose of Shingrix and reported pain immediately at the injection site that resolved in 24 hours.   Also, reported headache, stomachache and fatigue 1 day after vaccine that resolved 1 day after the symptoms began.   The patient had vertigo or dizziness currently and stated that the dizziness began 4 days after the vaccine and was not resolved.   The reporter did not had the lot number and expiration date of suspect product. The reporter did not consent to follow-up.
Age: 6.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Gianotti-Crosti syndrome, Rash, Rash papular, Rash pruritic
Clinical narrative: Gianotti-Crosti syndrome. raised red itchy bumps  on the skin of the legs, buttocks, flank and arms
Sex: M
Vaccine: FLUX
Symptoms: Hypotension, Urticaria
Clinical narrative: Reported Symptoms:  10021097:HYPOTENSION; 10046735:URTICARIA;  Narrative: historical patient has egg allergy, not sure when reaction happened but according to notes it is just noted that the patient refused vaccine due to adverse reaction in past Other Relevant HX: Other: URTICARIA; HYPOTENSION
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: As parent, we were told by the office about the mistake and they said they were sorry. However, never were we informed how did it happen and why did it happen, what kind of measures they were to take in order to prevent similar mistakes. The kid keeps shaking his head for a long time after that until recently, which we weren't sure whether it should be connected to the wrong vaccine he wasn't supposed to have. The psychological impact is huge on us because we are always afraid it will happen again. This fear has stopped us from taking my son to the pediatrics to receive all other vaccines he is supposed to have. Pediatric office has since stopped sending us reminders of all my son's visits, which I don't know how to read neither.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot red patch 2-3" below injection site, ca. 3" wide and 2" long discovered by patient less than 24 hours after injection.  Patient noticed the patch was expanding 2 days after injection and sought medical advice 8 a.m. the following morning.  Physician's Assistant diagnosed bacterial infection and prescribed  Cephalexin 500 mg 4X daily for 7 days.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Arthralgia, Erythema, Furuncle, Headache
Clinical narrative: First Shot massive redness and swelling. Body Aches. Sinus congestion. Headache. Rash. Memory Loss. Second shot on 8/21/2021 shingles appeared all over. Massive swelling and boiled on skin. Rash all over. Fever. Bodyaches. Joint pain. Still aches years later
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pain, Pyrexia, Rash, Sinus congestion
Clinical narrative: First Shot massive redness and swelling. Body Aches. Sinus congestion. Headache. Rash. Memory Loss. Second shot on 8/21/2021 shingles appeared all over. Massive swelling and boiled on skin. Rash all over. Fever. Bodyaches. Joint pain. Still aches years later
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: First Shot massive redness and swelling. Body Aches. Sinus congestion. Headache. Rash. Memory Loss. Second shot on 8/21/2021 shingles appeared all over. Massive swelling and boiled on skin. Rash all over. Fever. Bodyaches. Joint pain. Still aches years later
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Lung neoplasm malignant
Clinical narrative: Lung Cancer
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC20, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Nurse at clinic inadvertently administered Pediarix combo vaccine instead of DTaP. This made the additional Hepatitis B and IPV doses invalid in system. Informed parent of patient of this and per parent- patient did not experience any adverse reactions after the vaccinations.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Localised oedema, Pain
Clinical narrative: PATIENT RECIEVED TDAP AND MENQUADFI. PATIENT DEVELOPED LOCALIZED ERYTHEMA AND EDEMA FORM LEFT SHOULDER TO LEFT ELBOW. HE HAD PAIN WHEN LIFTING LEFT ARM UP OVER HEAD. PATIENT TREATED WITH KEFLEX DUE TO CELLULITIS DIAGNOSIS.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Havrix Pediatric formula given (720 EL.U) instead of adult formulation. Vaccine dispensed from another nurse and this RN did not see the box it came out of. This RN did not notice the dose or the color band on the PFS that delineated pediatric formula. This RN assumed that the vaccine would state Pediatric or Adult formula on the PFS like the Hep B Recombivax.  After mistake realized as documenting, called the patient to come back and get a second dose of the pediatric formula to complete the dose. Patient received X2 pediatric doses (720 + 720 = 1440 ELU) adult dose.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: In error a Meningococcal B vaccine was administered instead of a meningococcal ACWY ( MCV4).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Articular calcification, Inflammation, Mobility decreased, Myalgia
Clinical narrative: muscle sore within 2 days.  Chronic soreness like a bruise or feeling you get from overly  working out that arm.  Pain moved to shoulder then  loss of mobility.  Thermal Imaging in 2022 showed inflammation.  X ray in 2024 shows calcification
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Scan abnormal, X-ray abnormal
Clinical narrative: muscle sore within 2 days.  Chronic soreness like a bruise or feeling you get from overly  working out that arm.  Pain moved to shoulder then  loss of mobility.  Thermal Imaging in 2022 showed inflammation.  X ray in 2024 shows calcification
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Arthralgia, Ecchymosis, Lethargy, Nausea, Pyrexia
Clinical narrative: Left shoulder swollen, ecchymotic and painful. Nausea with dry heaves. Headache, lethargy and low grade fever
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Retching, Swelling
Clinical narrative: Left shoulder swollen, ecchymotic and painful. Nausea with dry heaves. Headache, lethargy and low grade fever
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was inadvertently given an pediatric dose instead of the required adult dose.  Patient was attempted to be contacted, message left.  Patient was contacted and unable to come back for the proper dosing.  Informed that dose would not count and that he would need to receive the proper adult dose to be covered.
Age: 5.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given IPV Vaccine by Accident and a extra dose of Varicella that were not needed, Parent gave a list of Vaccines that the Patient Needed, Confirmed Twice the list that the mother gave the clinic and she Continuously confirmed that it was correct. Continued to prepare the vaccines to administer,  As Administering IPV Vaccine mothers friend or family spoke in regards of  vaccines that the patient needed and admitted that the patient needed 2 Vaccines as per her they were the following Varicella 2 doses & the Tuberculin test, when the mothers family/friend spoke the IPV Vaccine was already injected to the Patient and a extra dose of Varicella.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: MMRV and Varicella given at same time
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: MOTHER CALLED AT 9:09 AM ON 8//1/2024 AND STATED THAT PATIENT HAD A LARGE RED SWOLLEN AREA ON HER THIGH.  STATED THAT IT STARTED AS A BLISTER.
Age: 4.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC20
Symptoms: Body temperature increased, Gait disturbance, Injection site bruising, Injection site swelling, Vomiting
Clinical narrative: Mother called 08/01/2024 at approximately 1125 to report her son having symptoms of illness post vaccination on 07/30/2024.  Mother reports that child walking slowly as if leg muscles are pained.  Mother reports small area of bruising "right where shots were given' to both right and left thighs and that it "also looks a little puffy".  On the morning of 08/01/24 mother states that child began vomiting and she has noticed low grade temperature.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Facial pain, Herpes zoster, Tenderness
Clinical narrative: Patient has a Stavax shot in 12/05/2014, and a Shingrix 08/22/2018.  Most recently recieved a vaccine 6/26/2024.  On 7/21/2024 patient exhibited first signs of shingles.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Depressed level of consciousness, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient received routine Tdap and Menveo vaccines at 11-year well check without any complication. Patient released after vaccines per protocol. When father, sibling and patient were leaving the check-out desk, patient passed out, fell straight back, striking the back of his head on the floor. Staff immediately responded, patient pale and semi-conscious.  Patient maintained in a safe position/environment until completely lucid, which only took a matter of seconds. Provider immediately notified; vitals obtained by RN; and rapid physical assessment performed by MA. Patient denied any pain in head, neck, spine, hips or the shoulder (had recently had dx with humerus fracture on 7/18/24). Patient moved to exam room, given Goldfish crackers and orange juice. He and dad stated that he had not eaten breakfast prior to well check appointment. Patient will follow up on Monday 08/05/2024 with Dr to rule out concussion. Patient released once stable.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Contusion, Erythema, Induration, Mass, Swelling
Clinical narrative: Swelling, redness, hard lump, bruising started on July 25, 2024 day 2. Tried ice and ibuprofen. Day 9 I still have redness and bruising , hardness, swelling.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Malaise, Mobility decreased
Clinical narrative: I started feeling "off" about 4 hours after the vaccine, feeling malaise. My left shoulder muscle was twitching and didn't stop until this morning. My left upper arm, is incredibly sore. Like, no one can touch it is so painful ( I have little kids) and i could not raise it yesterday (the day I got the shot) and can barely raise it today. I remembered how sore my arm was from the first two times I got Moderna, back in 2021. It is terribly painful and tbh I don't think I will get another Moderna shot due to how painful it is. Also, this morning my whole upper back was stiff, I started have a low grade fever last night and still do today, right around 100.4/100. I just got "wiped out" last night and feel terrible today, a headache and I feel like I am so tired I can barely move. I am relatively fit and don't smoke or drink.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Musculoskeletal stiffness, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: I started feeling "off" about 4 hours after the vaccine, feeling malaise. My left shoulder muscle was twitching and didn't stop until this morning. My left upper arm, is incredibly sore. Like, no one can touch it is so painful ( I have little kids) and i could not raise it yesterday (the day I got the shot) and can barely raise it today. I remembered how sore my arm was from the first two times I got Moderna, back in 2021. It is terribly painful and tbh I don't think I will get another Moderna shot due to how painful it is. Also, this morning my whole upper back was stiff, I started have a low grade fever last night and still do today, right around 100.4/100. I just got "wiped out" last night and feel terrible today, a headache and I feel like I am so tired I can barely move. I am relatively fit and don't smoke or drink.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Product preparation issue
Clinical narrative: Pt was given diluent only (HIB). Vaccine was not mixed with diluent. Mother was contacted, notified and educated on 8-1-2024. Mother has scheduled to return and have pt receive the vaccine on 8-8--2024.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: noted while doing inventory that only one of the two vials had been given to the child.  Pentacel was not properly prepared upon administration.  no s/s at this time.  Only vial containing lyophilized ActHIB vaccine component NDC 49281-544-58
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient was given an additional flu vaccine (Fluad). She had already received one on 07/20/24 and another one on 07/24/24
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Postmenopausal haemorrhage
Clinical narrative: After receiving the SpikeVax/Moderna I had a very mild menstrual period. The first day my breasts were slightly tender and I had a very light blood flow. On the second day my symptoms were almost non-existent. By the third day and since then, I have had no other issues. I did not mention this to my primary physician since it was a one-and-done event.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received this vaccine on 6-7-2024.  Immunization records were not reviewed prior to administering again on 7-5-2024.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Patient returned to pharmacy complaining of red rash on arm of injection site after being out in sun.  First symptom was mild pain at injection site, but when asked if patient had been out in sun she stated she had been spending a lot of time and had been exposed to sun and heat.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Patient received vaccines and about 15 minutes later, he developed hives. He was given benadryl by the physician.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Wheal developed adjacent to varicella injection site on right lateral thigh. Child remained in clinic x 15min post-IZ and was checked q5min during this time. Wheal became slightly larger, was warm to touch. No hives on rest of the body. No breathing difficulty. No nausea. Child was playful and alert. No systemic symptoms. Was allowed to go home with instructions to take to ER for any vomiting/breathing difficulty or hives spread quickly to rest of the body. Advised that wheal may persist x1-2 days, can apply cool compress. May return for recheck in 24h if symptom is not improving.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 8/1/24 nurse administered a Menveo vaccine to patient without realizing the vaccine had expired the day prior, on 7/31/24. Vaccine was administered in patient's right thigh around 10am IM. Nurse did not check out the vaccine from inventory before administration, and was alerted the vaccine was expired by our inventory system after administration. The patient has not reported any symptoms or signs of adverse effects as of now. Patient was contacted and alerted to the incident and informed re-administration is needed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Bexsero was ordered and the CMA drew up Menveo and gave that instead
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: nausea and vomiting that lead to him going to urgent care per patient reporting on 7/30/24 2 days after vaccine when reaction happened
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event, patient received 2 doses of RSV vaccine
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Hypotonia
Clinical narrative: The patient was first administered the MCV4 and then the Tdap. When asked she said that she felt alright. The patient was sitting upright in a chair. I then proceeded to enter the immunization into the database. After a couple of minutes, out of the corner of my eye, I saw the patient leaning to her left. Before I could reach her, she fell out of the chair. When I first looked at her her eyes were closed. When we called her name, she immediately opened her eyes. We asked her what happened, and she responded that she didn't know. She was placed on the patient table in a supine position and her vital signs were taken. Vital signs were within normal limits. She was given a snack and water (the patient had not eaten anything that day). She was monitored for an additional 30 minutes. She said that she felt better, her vital signs were within normal limits, and she was released in the care of her mother.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: after vaccines pt got nauseous and vomiting x1, pt was placed on exam table vital signs taken. Dr notified  b/p 101/68 p 71 b/p 103/71 p 74 gave water and cold compress, examined by Dr   after 10 mins rest pt said she felt better, rechecked by Dr and was allowed to leave
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever 102F, chills, lasting for 2 days. frequency being once a month to twice a month.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Blister, Intensive care, Pain management, Rash, Rash macular
Clinical narrative: SJS/TEN - rash started within the day of injection, progressed to diffuse maculopapular rash with vesicles and bullae, no signs of sepsis, required ICU admission for pain management and wound treatment
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Rash maculo-papular, SJS-TEN overlap, Wound treatment
Clinical narrative: SJS/TEN - rash started within the day of injection, progressed to diffuse maculopapular rash with vesicles and bullae, no signs of sepsis, required ICU admission for pain management and wound treatment
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Developed severe case of Plaque Psoriasis, Clobetasol Propionate, Tacrolimus, Otezla. Plaque Psoriasis is kept at bay as long as I stay on medication
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: 4 yr old patient inadvertently received a Pentacel instead of a Kinrix. Per CDC and guidance no further action is needed since the DtaP in the Pentacel will count as the fifth dose of DTaP. patient left the clinic ambulatory in stable condition after waiting for the required 15minute observation time. no signs or symptoms of reaction was noted.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel inadvertantly given to child under the age of 4. Contacted our Regional VFC Consultant who sent Indications & Guidance for Use of Quadracel.  It stated: If Quadracel vaccine is inadvertently administered before 4 years of age for an earlier dose of the DTaP and/or IPV series and if minimum interval requirements have been met, the dose may be counted as valid for the DTaP and/or IPV series and does not need to be repeated.May 2, 2017  Family will be notified of mistake and assured that dosage will count as valid.  No furthere action will be taken unless parents report adverse side effects.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Immediate post-injection reaction, Rash, Rash pruritic, Tenderness, Urticaria
Clinical narrative: Patient reports hives/rash following yellow fever vaccine.  Patient sates she had an instant reaction to the vaccine but noticed the rash/hives starting to spread over the past week.  Patient says rash is sensitive and itchy.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea within 1 hour of vaccine
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Within hours of her second RZV vccine patient developed mild urticaria of body & extremities.   She did not have same with #1 per her report.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Pediarix given as 4th DTaP,  4th Polio, and 2nd Hep B. Utilizing Nursing Protocol administered the Pediarix vaccine inadvertently missing the fine print in the notes section of the protocol that states Pediarix is not indicated for use as a booster dose following a 3 dose primary series. No treatment needed for patient following this adverse event.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: We are an outpatient pharmacy located in a hospital.  7/31/24 I called our inpatient pharmacy to see if they had a Menveo vaccine in stock as we did not.  They did and tubed it down to be administered 8/1/24.  Patient came in with his mother (an employee).  During reconstitution I noticed the dilute vial had an expiration of 5/25 and went and gave the vaccine on 8/1/24.  The mother asked for a copy of his up to date vaccine record so she could submit it to the school.  Upon entering the vaccine into our state vaccine registry I noticed the powder vaccine vial expired 7/24.  After calling GSK the manufacturer of Menveo, they stated that they have found:       "Menveo remains within the approved specifications for up to a maximum of 30 days following the expiration date, if stored under appropriate temperature and storage conditions." Therefore the expiration of 7/24 can be determined to be 8/30/24.  It was entered into the state vaccine registry this way and no repeat dose will given.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness on injected arm from shoulder to elbow
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Dehydration, Diarrhoea, Escherichia test, Full blood count, Metabolic function test
Clinical narrative: Patient presented to ER 6 days after administration with loose stools and dehydration.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Rotavirus test positive
Clinical narrative: Patient presented to ER 6 days after administration with loose stools and dehydration.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine injection site red, swollen, and warm to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness of injected arm from shoulder to elbow
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Vaccine was pulled from Private stock by MA and was brought over to RMA to be verified RMA looked at vaccine that was thought to be a Td for a 54 year old pt. Vaccine was given to pt by MA. Later it was discovered that a Dtap was given to pt instead of a Td.  Health Department was contacted and the Dtap is a valid dose for the pt and There should not be adverse reactions, just the typical side effects.  Pt called and notified and was not upset, he stated that after he left the office and thought about it he should have gotten the Tdap because he is a firefighter. I did notify him again that it was a DTaP that was given to him and not a Tdap and he said that it is totally fine with him. I did thank him for being so understanding.