chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Frank Hematuria-bloody urine; This is a spontaneous report received from a Pharmacist.  A 56-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATURIA (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "Frank Hematuria-bloody urine".  Additional information: It was reported that the patient received the first dose approximate on May2021 and within three days developed Frank Hematuria which lasted 3-4 days but thought it was a mild reaction and it went away  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Muscular weakness, Paraesthesia
Clinical narrative: Patient was very weak in the arm after vaccine.  She states she had to use her other hand for everything  for 2 days.  She reported tingling in the fingertips as well.  Pt went to hospital on 9/1/24 through 9/2/24.
Age: 65.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Emotional distress, Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: received shot on 8/26/2024 and then noticed bumps on the base of my spine, red and in alot of pain and then saturday noticed the same on the belly and on the belly there were and still are red spots and very painful, then went to the doctors office , i believe  september the 4th and then i was diagnosed with shingles.  np then prescribed valacyclovir and i asked many questions and she answered all of them in a professional and courteous manner and it was very painful physically and emotionally.
Age: 65.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Rash macular
Clinical narrative: received shot on 8/26/2024 and then noticed bumps on the base of my spine, red and in alot of pain and then saturday noticed the same on the belly and on the belly there were and still are red spots and very painful, then went to the doctors office , i believe  september the 4th and then i was diagnosed with shingles.  np then prescribed valacyclovir and i asked many questions and she answered all of them in a professional and courteous manner and it was very painful physically and emotionally.
Age: 65.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Herpes zoster, Illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: received shot on 8/26/2024 and then noticed bumps on the base of my spine, red and in alot of pain and then saturday noticed the same on the belly and on the belly there were and still are red spots and very painful, then went to the doctors office , i believe  september the 4th and then i was diagnosed with shingles.  np then prescribed valacyclovir and i asked many questions and she answered all of them in a professional and courteous manner and it was very painful physically and emotionally.
Age: 65.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: Swelling
Clinical narrative: received shot on 8/26/2024 and then noticed bumps on the base of my spine, red and in alot of pain and then saturday noticed the same on the belly and on the belly there were and still are red spots and very painful, then went to the doctors office , i believe  september the 4th and then i was diagnosed with shingles.  np then prescribed valacyclovir and i asked many questions and she answered all of them in a professional and courteous manner and it was very painful physically and emotionally.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: A week later she got it.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: A week later she got it.). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-SEP-2024 The case was received from the patient via interactive digital media. The reporter reported that a friend took the patient (her mother) for the shingles shot.  A week later the patient got it.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pyrexia
Clinical narrative: vaccinated yesterday at CVS pharmacy and today she tested positive for covid; Tested positive for covid-19; Loss of smell; no taste; runny nose; fever; This spontaneous case, initially received on 27-Aug-2024, was reported by a non-health professional and concerns an adult female patient.  No relevant medical history and concomitant medications were reported.  Administration of company suspect drug(s): On 26-Aug-2024, the patient received Influenza virus vaccine for Indication not reported., Dose regimen: Not reported, Route of administration: Not reported, Site of administration: Right arm, Lot number: No batch number available.  Non-company suspect drugs: On 26-Aug-2024, the patient received COVID-19 vaccine (COVID-19 vaccine) Route of administration: Not reported, Site of administration: left arm, Lot number: No batch number available.   Adverse reactions/events and outcomes: On 26-Aug-2024, the patient experienced vaccinated yesterday at pharmacy and today she tested positive for covid (Medically Significant, outcome: Not Reported).  On 26-Aug-2024, the patient experienced Tested positive for covid-19 (outcome: Not Reported), and had the following symptoms loss of smell, no taste, runny nose and fever.   As of 27-Aug-2024, patient was vaccinated yesterday at pharmacy and today she tested positive for covid. According to patient, she received covid vaccine on her left arm and flu vaccine on her right arm. Patient did not know what flu vaccine she took. Patient reported symptoms of: loss of smell, no taste, runny nose, fever.  Influenza virus vaccine action taken: Not Applicable  Reporter's assessment: The reporter assessed the event Tested positive for covid-19 non-serious but did not provide a causality assessment. The reporter did not provid seriousness and a causality assessment for event vaccinated yesterday at pharmacy and today she tested positive for covid.; Reporter's Comments: Causality: Not related for event drug ineffective, as event reported in view of co-suspect COVID-19 vaccine administerd. Not related for COVID-19. The recent global COVID-19 pandemic with high prevalence of respiratory transmission within the community provides a more plausible alternative explanation.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rhinorrhoea
Clinical narrative: vaccinated yesterday at CVS pharmacy and today she tested positive for covid; Tested positive for covid-19; Loss of smell; no taste; runny nose; fever; This spontaneous case, initially received on 27-Aug-2024, was reported by a non-health professional and concerns an adult female patient.  No relevant medical history and concomitant medications were reported.  Administration of company suspect drug(s): On 26-Aug-2024, the patient received Influenza virus vaccine for Indication not reported., Dose regimen: Not reported, Route of administration: Not reported, Site of administration: Right arm, Lot number: No batch number available.  Non-company suspect drugs: On 26-Aug-2024, the patient received COVID-19 vaccine (COVID-19 vaccine) Route of administration: Not reported, Site of administration: left arm, Lot number: No batch number available.   Adverse reactions/events and outcomes: On 26-Aug-2024, the patient experienced vaccinated yesterday at pharmacy and today she tested positive for covid (Medically Significant, outcome: Not Reported).  On 26-Aug-2024, the patient experienced Tested positive for covid-19 (outcome: Not Reported), and had the following symptoms loss of smell, no taste, runny nose and fever.   As of 27-Aug-2024, patient was vaccinated yesterday at pharmacy and today she tested positive for covid. According to patient, she received covid vaccine on her left arm and flu vaccine on her right arm. Patient did not know what flu vaccine she took. Patient reported symptoms of: loss of smell, no taste, runny nose, fever.  Influenza virus vaccine action taken: Not Applicable  Reporter's assessment: The reporter assessed the event Tested positive for covid-19 non-serious but did not provide a causality assessment. The reporter did not provid seriousness and a causality assessment for event vaccinated yesterday at pharmacy and today she tested positive for covid.; Reporter's Comments: Causality: Not related for event drug ineffective, as event reported in view of co-suspect COVID-19 vaccine administerd. Not related for COVID-19. The recent global COVID-19 pandemic with high prevalence of respiratory transmission within the community provides a more plausible alternative explanation.
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Physician ordered Kinrix vaccine for 3 month old patient.  There were no known adverse outcomes or symptoms.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Kinrix vaccine instead of Tdap and Polio vaccine.  No adverse reactions to vaccine. Consulted with provider on site, Dr.  No treatments recommended or needed. Informed parent that patient received wrong vaccine.  Contacted Immunization Branch representative who advised that no additional vaccines need to be administered to meet State Law and provided parent of patient with electronic report stating this information.  Patient discharged from clinic approximately 45 minutes after receiving vaccine.
Age: 1.17
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient given MMRV and Varicella
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Migraine, Vomiting
Clinical narrative: Severe migraine, unable to keep food or medicine down. Began at 11pm previous night and is continuing without improvement as of writing at 8:21am.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 2 doses of moderna in error, was supposed to get 1 dose moderna and 1 dose flu. Spoke with caregiver and patient has no adverse event or complications. This is an administration error.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin reaction, Tenderness
Clinical narrative: Upper arm got bright red, large area swollen painful, warm to the touch, and very itchy. It's day 6 and it's an area about 3.5" wide by 6" long today. It's gotten lighter in color, but is still painful and itchy and red as well as swollen looking.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth
Clinical narrative: PT MOTHER CALLED WITH QUESTIONS REGARDING VACCINES THAT WERE GIVEN AND POSSIBLE  REACTION. MOTHER STATES IT IS HIS LEFT UPPER LEG. MMRV AND HEPA WAS GIVEN IN THE  LEFT LEG. SHE SAYS SHE NOTICED A KNOT AND SOME REDNESS AT SITE. MOTHER STATES  REDNESS WENT FROM SIZE OF A PENNY TO THE SIZE OF DOLLAR OVER THE PAST COUPLE  DAYS AND WARM. NO OTHER SYMPTOMS NOTED. MOTHER HAS GIVEN IBUPROFEN,TYENOL, AND  TRIED TO PUT ICE PACK BUT UNSUCCESSFUL IN HAVING CHILD LEAVE IT. NO REACTION  FROM PREVIOUS VACCINES. ADVISED THAT SOME REDNESS IS NORMAL, BUT WOULD RECOMMEND  SHE HAVE HIM SEEN BY PCP OR WALK IN CLINIC.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Pt received both Meningococcal both in left arm and HPV in right arm. Mom stated pt passes out every shot. Had cold compress ready. Before even applying alcohol swab pt had already passed out. Still able to hear and aware of what was going on. With parents' permission still administered two shots in eft arm while mom held her. Pt came to went to administer one shot in right arm pt passed out again. Laid her down applied cold compress. Pt was coherent and talking pt stated she felt nauseous continued to lay down 7 mins. Pt sat up for 2 mins then passed out again. Laid back reapplied cold compress 5mins. Was given ice pack pt then got up and walked out on her own.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: got second flu shot for second when wasnt due
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: Within 24hrs of receiving MMR, Varicella and Hep A vaccines, she developed tactile fever, fussiness and runny nose. 11 days later, she developed a measles-like rash that is spreading from head to toe. Pt has tactile fever and runny nose again with the rash
Age: 15.0
Sex: M
Vaccine: HEP, HPV9, IPV, TD, VARCEL
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: Varicella vaccine administered, 9/9/2024, Imm Trac stating vaccine is invalid.  Previous dose #1 administered 8/13/2024.  Patient monitored for 15 mins, no signs or symptoms of adverse reaction during this time.  Called patients mother at 11:30 am, no complaints, signs or symptoms of reaction.  Informed mother, dose stating invalid, scheduled for child to return on Oct 14 to repeat dose.  informed mother if patient experiences SOB, hoarseness, wheezing, allergic reaction, rapid heart rate, syncope, dizziness, unconsciousness, to visit the nearest ER.   Contacted mother 9/10/24, at 8:50 am, patient is well no symptoms and attending school.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: Chest pain started about an hour after the vaccine.    It was worse the first two days.  Now it comes and goes with increase in activity of movement.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: This patient was given a 2nd Arexvy vaccination inadvertently.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Vision blurred
Clinical narrative: pt experienced weakness and blurred vision about 2 minutes after vaccination
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Pharmacist administered a second injection of Spikevax 12 + (COVID 2024-25) 0.5 ML.   Pharmacist has been giving patients both the COVID and FLU vaccination in the same sitting.  He followed my Spikevax injection with a second one intended for my wife who was present waiting for her vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: Injection site pain started on the day of administration (8/30), then the following day (8/31) an erythematous rash developed on the right upper arm measuring ~1X2.5-3cm with the proximal edge about 1cm distal from the the injection site, which was still painful; temperature on 9/1 was 99.8° F. On 9/1 the erythematous rash spread distally, measuring ~2.5X5cm. On 9/2 the rash was significantly improved, and on 9/3 it resolved.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received a third dose of HEPA at the time of visit. Pt did not have an adverse reaction to the vaccine.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Device malfunction, Underdose
Clinical narrative: Patient was injected at first and given approximately half the dose at which time the plunger would not continue to push, pulled back the needle to verify that I was not in patient bone, still would not work, even after taking the needle out of her arm, for some reason the liquid would not push through the needle.   I had to reinject patient with a new needle and she got the full dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Condition aggravated, Urticaria, Urticaria pressure
Clinical narrative: Beginning one day post vaccination and really 2nd day post vaccination, mu urticaria went out of control with hives and some angioedema.  I have been stable on Xolair for about 6 years with nary a hive. It was definitely the vaccine that triggered this. No other new exposures or illness at that time.  Treatment required  steroids, increased H2 blockers and antihistamines and Xolair dosing escalation.  It has still not  fully resolved.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: patient experiencing fever and nausea
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Wrong immunization given to the patient. No reaction as of 1 1/2 hours later.
Age: 84.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Wrong product administered
Clinical narrative: Patient received two flu shots (09/09/24 different facility and  09/10/24 this pharmacy at 650pm). Received by mistake as patient wanted COVID vaccine. On phone call this AM, patient stated slight headache. Notified doctor's office and they will follow-up with patient.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Device connection issue, Exposure via skin contact, Syringe issue
Clinical narrative: The needle came off in patient's leg while administering vaccine and most of the vaccine leaked out of the syringe requiring patient to need a second dose. The hub on the prefilled diluent syringe is 2 pieces so when you tighten the needle, it can loosen the hub, which is what happened.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, FLU4, UNK
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Headache,  chills  muscle pains, pain at injection site
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Cold sweat, Feeling cold, Headache
Clinical narrative: Patient reports that that in the evening September 6 after his shingles vaccination he began having fevers, chills.  Temperature was 104.  Patient reports headache and feeling cool and clammy.  Patient reports mild fevers on the evening of September 7.  He did have a headache last night.  He currently now feels a little cool and clammy
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports that that in the evening September 6 after his shingles vaccination he began having fevers, chills.  Temperature was 104.  Patient reports headache and feeling cool and clammy.  Patient reports mild fevers on the evening of September 7.  He did have a headache last night.  He currently now feels a little cool and clammy
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Patient developed fevers, body aches, chills and minimal cough. No shortness of breath or chest pain.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC20, TDAP, VARZOS
Symptoms: Mouth haemorrhage
Clinical narrative: Pt has had bleeding/blood in the mouth since the following morning after vaccination.  Blood was initially dark colored as stated by patient and then continued to lighten up to bright red blood throughout the day and the following day as well, until reported to pharmacy.  Patient notified doctor as well.   Patient was advised to go to urgent care.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix was given instead of Dtap. Health Department called and no adverse reactions.  Parent of patient has been notified.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site pain
Clinical narrative: right deltoid tenderness, no erythema, swelling, fluctuance. Bandaid at vaccine site still present - removed and no underlying erythema, swelling, fluctuance.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: On 09/10/24 at approximately 10 am Influenza Fluzone vaccine LOT number Ut8144ka EXP  06/30/2024 was administered via IM to Left Arm to patient as indicated above, vaccine administered was noted after vaccination to be expired. There was no noted side effects to patient noted during or after administration. Within one hour of administration it was noted by MA that expired influenza vaccine had been administered to patient.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Blood lactic acid increased, Computerised tomogram head normal, Confusional state, Drug screen negative, Fall
Clinical narrative: flu vaccine given at well visit. then went to a boxing practice. afterwards he was playing a video game at home. He fell and was unresponsive. He was foaming at the mouth. No observed seizure activity.   CTH was normal in the ED. He was confused afterwards. He was discharged after 2 hours in the ED.   Likely first seizure
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Foaming at mouth, Seizure, Unresponsive to stimuli
Clinical narrative: flu vaccine given at well visit. then went to a boxing practice. afterwards he was playing a video game at home. He fell and was unresponsive. He was foaming at the mouth. No observed seizure activity.   CTH was normal in the ED. He was confused afterwards. He was discharged after 2 hours in the ED.   Likely first seizure
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction, Patient was given an extra dose of IPV. Per recommended date is 08/23/2027.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Breast feeding, Dizziness, Malaise, Menstruation irregular
Clinical narrative: She got the vaccine, she was light headed 4 hours later, she was nauseous as well.  She started her period 6 hours later which was 10 days early.  She has a 17 months old and breast fed him at 8:00 PM and at midnight he started throwing up and he has never thrown up before at night.  He continued to throw up throughout the night until he had nothing else to throw up.  Mom gave a bite of a  banana at 6:00 AM and he threw up the banana immediately.  He has eaten banana's before which is his favorite and has never thrown up like this before.  He only threw up once before several months ago while being in a boat.  The baby is presently with his grandmother and she says that he is sick.  She feels very sick and feels uneasy about the recommendations of these vaccines and this should be exempted for mother's who are breast feeding for babies to be throwing up is not right.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: She got the vaccine, she was light headed 4 hours later, she was nauseous as well.  She started her period 6 hours later which was 10 days early.  She has a 17 months old and breast fed him at 8:00 PM and at midnight he started throwing up and he has never thrown up before at night.  He continued to throw up throughout the night until he had nothing else to throw up.  Mom gave a bite of a  banana at 6:00 AM and he threw up the banana immediately.  He has eaten banana's before which is his favorite and has never thrown up like this before.  He only threw up once before several months ago while being in a boat.  The baby is presently with his grandmother and she says that he is sick.  She feels very sick and feels uneasy about the recommendations of these vaccines and this should be exempted for mother's who are breast feeding for babies to be throwing up is not right.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Injury associated with device, Product administration error
Clinical narrative: Administration error. Attempted to stick patient and she pulled away before the needle was fully inserted and no vaccine was delivered. I changed the needle and adminstered the full vaccine to patient.  (administration error-pt was double stuck but only got vaccine on second stick) Vaccine was Fluzone HD TIV PFS.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Deep vein thrombosis, Gait disturbance, Laboratory test abnormal, Limb discomfort, Medical procedure
Clinical narrative: Patient's mother reports patient experienced symptoms Nov 17 following spikevax and fluzone quadrivalent co-administration fluzone quadrivalent NDC is 49281-0423-50 UT8144MA lot 6/30/24 exp. symptoms-("leg pain, heavy, swollen, pain, started climbing stairs on all fours") Nov 27th mom took per to ER after extreme swelling. pt transfered to hospital and ran test to reveal bilateral DVT and PE. Since Nov 27th till present she has been hospitalized 6 times. Last procedure was August 19th. Currently on warfarin therapy 8.5mg qday. scheduled for next procedure Feb 2025. parents believe due to co-adminstration of covid vaccine and flu shot, patient  experienced blood clots
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Pain in extremity, Peripheral swelling, Swelling, Thrombosis
Clinical narrative: Patient's mother reports patient experienced symptoms Nov 17 following spikevax and fluzone quadrivalent co-administration fluzone quadrivalent NDC is 49281-0423-50 UT8144MA lot 6/30/24 exp. symptoms-("leg pain, heavy, swollen, pain, started climbing stairs on all fours") Nov 27th mom took per to ER after extreme swelling. pt transfered to hospital and ran test to reveal bilateral DVT and PE. Since Nov 27th till present she has been hospitalized 6 times. Last procedure was August 19th. Currently on warfarin therapy 8.5mg qday. scheduled for next procedure Feb 2025. parents believe due to co-adminstration of covid vaccine and flu shot, patient  experienced blood clots
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Deep vein thrombosis, Dysstasia, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's mother reports patient experienced symptoms Nov 17 following spikevax and fluzone quadrivalent co-administration fluzone quadrivalent NDC is 49281-0423-50 UT8144MA lot 6/30/24 exp. symptoms-("leg pain, heavy, swollen, pain, started climbing stairs on all fours") Nov 27th mom took per to ER after extreme swelling. pt transfered to hospital and ran test to reveal bilateral DVT and PE. Since Nov 27th till present she has been hospitalized 6 times. Last procedure was August 19th. Currently on warfarin therapy 8.5mg qday. scheduled for next procedure Feb 2025. parents believe due to co-adminstration of covid vaccine and flu shot, patient  experienced blood clots
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Prothrombin time, Pulmonary embolism
Clinical narrative: Patient's mother reports patient experienced symptoms Nov 17 following spikevax and fluzone quadrivalent co-administration fluzone quadrivalent NDC is 49281-0423-50 UT8144MA lot 6/30/24 exp. symptoms-("leg pain, heavy, swollen, pain, started climbing stairs on all fours") Nov 27th mom took per to ER after extreme swelling. pt transfered to hospital and ran test to reveal bilateral DVT and PE. Since Nov 27th till present she has been hospitalized 6 times. Last procedure was August 19th. Currently on warfarin therapy 8.5mg qday. scheduled for next procedure Feb 2025. parents believe due to co-adminstration of covid vaccine and flu shot, patient  experienced blood clots
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Pain, Productive cough, Pyrexia
Clinical narrative: headache, fever, body ache, lungs are full of phlegm moving to nose and mouth
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Hand itching 3-4 hours after vaccine, then welps and deep red rash on neck, under breasts, waist and groin.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills
Clinical narrative: Chills from approximately 9:00-noon
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Single component of a two-component product administered
Clinical narrative: Pt was only given half of the vaccine. This vaccine has a liquid and powder that is to be mixed together, pt was only given the liquid. No adverse effects noted at the time, pt called and notified of error. Per CDC recommendations, pt can return in 4 weeks for repeat dose. Pt is scheduled for injection visit for full dose on 10/7/24.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received MMR and Varisella that was not due.  Family notified of error, no adverse reactions reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Pain, Pyrexia
Clinical narrative: Trouble breathing, chest pains, slight fever, body aches. Ended up in ER. Stayed 4 hours and released with lidocaine pain patch for body aches
Age: 67.0
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt reported pain / weakness of left arm roughly 3 weeks after injection.  she reported the injection was given "low" on her arm. She has trouble lifting her arm up to shoulder height but able to move it fine when its above her head. she reports seeing a chiropractor and physical therapist. also had a steroid injection yesterday. she also mentions she already has a history of "neck / back / shoulder issues"
Age: 67.0
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Nerve injury
Clinical narrative: Pt reported pain / weakness of left arm roughly 3 weeks after injection.  she reported the injection was given "low" on her arm. She has trouble lifting her arm up to shoulder height but able to move it fine when its above her head. she reports seeing a chiropractor and physical therapist. also had a steroid injection yesterday. she also mentions she already has a history of "neck / back / shoulder issues"
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Intussusception, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Pt developed intussusception on 9/3/2024, and required surgery at Medical Center.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: She got her vaccine, she got her vaccine on the 7th around 2:30, and had unexpected pain, more extreme than expected. 9/8/24 after 3:00 PM a shooting pain from her left buttock all the way down her left side of her leg and into her heel.  It felt like a nerve pain, very distressing type of pain which she still has.  She is hoping that it will get better.  Seems like it s close to plantar fasciitis.  It runs from her buttock and into the heel of her foot.  This type of nerve pain is very global and takes over and it zaps her energy and her thoughts.  When I looked up the plantar fasciitis it did not mention anything around nerves, but did not mention pain running down the leg, just the heel pain.  She did have similar reaction many years ago, about 25 years and had PT and it improved.   She has not treated it with anything, and has not called her doctor as she was hoping that it gets better.   It does not seem to be better and does not like taking a lot of pills or pain medication or any neurologic thing if it is nerve pain.  She just feels crumy.
Age: 34.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Bursitis, Magnetic resonance imaging, Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Patient developed SIRVA (likely subacromial bursitis) following the Hep B and HPV9 vaccines. He developed a sore arm the evening after the vaccinations. The soreness progressed and about two weeks later he developed decreased range of motion in the arm.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Malaise, Seizure, Syncope, Tremor
Clinical narrative: Patient was given these three vaccines in his arms at approximately 3:45pm. He also had a finger prick for a blood draw for a lipids test immediately afterwards. After leaving the office, he started to not feel well in the car and had a fainting episode ( with shaking and convulsions) around 4:00pm.  Thankfully he was sitting down and came to soon after. I was able to give him candy and water and let him rest a bit. He has fainted before at the sight of blood, so the fainting may have occurred because of the blood draw, but I still wanted to report it since there is a history of fainting with these vaccines according to the CDC website.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt came into clinic for vaccines. Pt was scheduled as a provider visit but then only wanted vaccines so visit was changed to a nurse visit. The nurse that had roomed the pt. Nurse printed the Immunization record report for pt and asked writer for help getting vaccines ready. Writer reviewed the Immunization record report and it looked accurate with the last listed vaccines having been given on 8/8/24 at Clinic. Provided 4 vaccines indicated on Immunization record report. Writer then went to chart the vaccines and noted there were no care gaps on database, indicating the patient was not due for vaccines. After significant review, writer noted that pt has two Immunization record account. The first one was created for pt with his two last names flip flopped. At his appt with Clinic on 8/12/24, the name was noticed and changed to the correct order. This then generated a new Immunization record account which contained only the vaccines from 8/12/24. When Nurse printed the Immunization record account, it contained all the shots given before 8/12/24 when his last names were in the wrong order. What ultimately occurred is the pt received the exact same vaccines on 8/12/24 as he was given today 9/6/24. Disease Control- Immunization Unit was notified (nurse). Nurse states there is no risk of harm to the patient. However, some of the vaccines given today may be invalidated due to be given too close to other vaccines. The two charts were marked to be merged but that takes up to a week. Nurse would like writer to wait until the merge occurs to determine what vaccines might need to be repeated before contacting the family. Writer will contact the patient once a plan is in place with Disease Control.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Autoimmune disorder, Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test
Clinical narrative: JANSSEN #1 6/20/2021 MODERNA #1 04/13/2022 DEVELOPED COVID VACCINE INDUCED AUTOIMMUNE RHEAUMATOID ARTHRITIS WITH BILATERAL KNEE INVOLVEMENT.  TREATED WITH HCQ, tocilizumab (Actemra), COLCHICINE, AND PROTOCOL BASE SPIKE DETOXIFICATION
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Rheumatoid arthritis
Clinical narrative: JANSSEN #1 6/20/2021 MODERNA #1 04/13/2022 DEVELOPED COVID VACCINE INDUCED AUTOIMMUNE RHEAUMATOID ARTHRITIS WITH BILATERAL KNEE INVOLVEMENT.  TREATED WITH HCQ, tocilizumab (Actemra), COLCHICINE, AND PROTOCOL BASE SPIKE DETOXIFICATION
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to the touch, itching.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was seen for a scheduled appointment with provider. Patient was due for Hepatitis B vaccine. I drew up vaccine and administered it to the patient. I was notified that vaccine was expired when I was recording in patient's chart. I notified my supervisor and completed a report in reporting site. I called, spoke to patient and informed of the expired vaccine that was given, and per CDC guidelines, the vaccine is not harmful, but doesn't count, and that he would be able to get the vaccine in the future.
Age: 66.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two High Dose Flu vaccinations (Fluad).  One on 7/29/204 and another one on 9/9/2024.  Patient did not experience any side effects.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Patient developed a local reaction greater than 3 inches in diameter. Red, hot, warm to the touch.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Anxiety, Apathy, Arthralgia, Asthenia
Clinical narrative: Lethargy, flu symptoms, body aches and pains, headache, dizziness, extreme fatigue, swollen lymph nodes, thyroid swelling. Joint pain, swelling of the feet, anxiety, depression, loss of sleep. I have been to three different doctors trying to find the cause of these symptoms. None of the above symptoms were experienced before receiving the Phizer Covid vaccines. I lived a normal productive life enjoying outdoor activities, events with my family, and friends. Now I am just lethargic, sick feeling and no energy, stamina, will to do anything at all
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Depression, Dizziness, Fatigue, Goitre
Clinical narrative: Lethargy, flu symptoms, body aches and pains, headache, dizziness, extreme fatigue, swollen lymph nodes, thyroid swelling. Joint pain, swelling of the feet, anxiety, depression, loss of sleep. I have been to three different doctors trying to find the cause of these symptoms. None of the above symptoms were experienced before receiving the Phizer Covid vaccines. I lived a normal productive life enjoying outdoor activities, events with my family, and friends. Now I am just lethargic, sick feeling and no energy, stamina, will to do anything at all
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypothyroidism, Influenza, Insomnia, Lethargy
Clinical narrative: Lethargy, flu symptoms, body aches and pains, headache, dizziness, extreme fatigue, swollen lymph nodes, thyroid swelling. Joint pain, swelling of the feet, anxiety, depression, loss of sleep. I have been to three different doctors trying to find the cause of these symptoms. None of the above symptoms were experienced before receiving the Phizer Covid vaccines. I lived a normal productive life enjoying outdoor activities, events with my family, and friends. Now I am just lethargic, sick feeling and no energy, stamina, will to do anything at all
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipase normal, Loss of personal independence in daily activities, Lymphadenopathy, Malaise, Pain
Clinical narrative: Lethargy, flu symptoms, body aches and pains, headache, dizziness, extreme fatigue, swollen lymph nodes, thyroid swelling. Joint pain, swelling of the feet, anxiety, depression, loss of sleep. I have been to three different doctors trying to find the cause of these symptoms. None of the above symptoms were experienced before receiving the Phizer Covid vaccines. I lived a normal productive life enjoying outdoor activities, events with my family, and friends. Now I am just lethargic, sick feeling and no energy, stamina, will to do anything at all
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Systemic lupus erythematosus
Clinical narrative: Lethargy, flu symptoms, body aches and pains, headache, dizziness, extreme fatigue, swollen lymph nodes, thyroid swelling. Joint pain, swelling of the feet, anxiety, depression, loss of sleep. I have been to three different doctors trying to find the cause of these symptoms. None of the above symptoms were experienced before receiving the Phizer Covid vaccines. I lived a normal productive life enjoying outdoor activities, events with my family, and friends. Now I am just lethargic, sick feeling and no energy, stamina, will to do anything at all
Age: 0.08
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 09/06 during 1 month well-visit HPV was given by mistake to 1 month old instead of Heb B, spoke with Poison Control-referred to infectious disease, Dr. stated it was not a  live virus and infant should be monitored for the 24 to 48 hours. Called on Monday, September 9th and baby was fine had a great weekend.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Death within 90 days of vaccine receipt
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Refusal of vaccination
Clinical narrative: Vaccine given in error.  Family did not want
Age: 40.0
Sex: F
Vaccine: HPV9, PNC20
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: customer called stating her arm was really sore and that she was having difficulty moving it over her head and almost feels like it is numb
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: RN inadvertently gave MenQuadfi via subcut route instead of IM route.  No adverse events noted as of yet.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Limb mass
Clinical narrative: She got her vaccine, and had a lump where she had the shot.  Eventually the lump went off or disappeared from that place, but then went down towards her wrist she has a lump about the size of what was at the top of her arm.  She has a couple of lumps in the back of her arm and she assumes that it migrated.  She did go to the doctor and had them looked at them, and it puzzles her as to what it was.  This is a new provider.  Her provider said it was from the serum from the vaccine that she took.  This provider told her that she had never heard of this and told her to call us.  She has a couple of lumps in the back of her arm, and the biggest one is just about to her wrist.  She refuses to take anymore vaccines as it left lumps in her arm, and feels that since she has them then she does not need anymore, and if it is not caused by the serum she does not need any more lumps.   She did not get her flu shot, but she got her pneumonia vaccine, which she did not have a reaction to it.   When she was traveling she used to swim in a pool that had broken equipment, and also gets sick from a lot things as her immune system is low due to being exposed to this.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Lacrimation increased, Ocular hyperaemia, Palmar erythema, Paraesthesia oral
Clinical narrative: Client returns to clinic after reaching vehicle to leave, post vaccine administration. Client reports hands began to turn red and eyes watering. Clients palms red and eyes appear bloodshot. Reports tongue feeling "funny". Client able to converse and assisted to clinic room. EMS contacted. EMS advising RN not to administer any meds due to clients history of open heart surgery as a child. EMS arriving within minutes of call. EMS starts PIV and administered iv epi followed by iv benadryl. Client awake and conversing throughout. Discharged to care of EMS.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Administration site rash
Clinical narrative: rash in site of vaccine administration after one week of receiving
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Pt was fine , no reactions
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Sensory disturbance
Clinical narrative: No known adverse effect.  Patient says after the shot was given she felt drops on her forehead.... unknown what she was talking about, I am not sure if she meant sweat or thought liquid came from her arm/needle onto her head, she even said look there are drops on the floor and we both looked and nothing.  Reporting since patient was concerned and thinks it was due to shot.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test, Myopericarditis
Clinical narrative: PFIZER #1 3/12/2021 PFIZER #2 4/6/2021 PFIZER #3 12/8/2021 DEVELOPED COVID VACCINE MYOPERICARDITIS WAS HOSPITALIZED AND LATER TREATED AS AN OUTPATIENT WITH COLCHICINE AND PROTOCOL BASE SPIKE DETOXIFICATION
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Patient is 16 years old and was inadvertently administered a dose of MMRV, which is only licensed for ages 12 months through 12 years. Per the CDC the dose was given off label but is still considered valid and provides coverage for varicella and MMR.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Nausea, Ocular hyperaemia
Clinical narrative: Red blurry eyes, white  film on eyes, decreased appetite, dizziness, nausea, and diarrhea
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Vision blurred
Clinical narrative: Red blurry eyes, white  film on eyes, decreased appetite, dizziness, nausea, and diarrhea
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 63.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given 2 doses of Flucelvax Trival. No adverse reactions have been reported by the patient at this time.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blister, Herpes zoster, Rash, Sensitive skin
Clinical narrative: Mild shingles - small rash/blisters on left hip, skin across upper belly sensitive to touch
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Unresponsive to stimuli
Clinical narrative: Patient presented to pharmacy requesting dose 2/2 of Shingrix while collecting other prescriptions. Shingrix vaccine was reconstituted by vaccine administrator according to manufacturer instructions using sterile diluent and dessicated vaccine. Patient completed pre-immunization questionnaire per protocol and endorse no acute health concerns at time of screening. Patient was given opportunity to ask questions and declined questions and educational materials regarding vaccination.  Patient appeared to be at baseline - utilizing mobility aid (electric scooter) and portable oxygenator; patient is known to pharmacy and has respiratory difficulties and coughing at baseline. Patient was escorted to consultation room. In consultation room, patient determined by administrator to be slight of stature and vaccine administered in left deltoid per protocol utilizing 25 gauge x 1 inch needle while patient was seated in mobility aid. Patient voiced no complaints at time of administration and was escorted from consultation room to continue her shopping. [Information that follows reported by other pharmacy employees] Approximately 15-20 minutes after vaccine administration patient presented to courtesy center, activated LifeAlert device and instructed staff to contact emergency services. Patient eventually transitioned to the floor (unknown fall vs lowered) and was described as "blued and unresponsive". Patient did rebound somewhat and was able to engage with emergency services who transported her offsite for evaluation.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Administered vaccine and after, I was made aware that vaccine had expired 8/31/24. Provider stated we will make vaccine valid. Pt's mother was informed.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) GARDASIL 9 2014790   4/22/2026 Temperature: -7C Time frame: 5; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #2014790, expiration date: 22-APR-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in -7 degree Celsius for 51 minutes with no previous temperature excursion (Product storage error). No additional adverse event.