chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC20
Symptoms: Wheezing
Clinical narrative: anaphylaxis - Hives (diffuse to head, trunk, extremities), pruritis, wheezing, angioedema, more persistent cough w/in 30 minutes after vaccine administration. Returned to pediatricians and recieved zyrtec 10 ml and Epi-pen JR.  Refered to Emergency Department for further evaluation x 4 hours. discharged home with improved symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Varicella post vaccine
Clinical narrative: Patient reported red, itchy spots on bilateral lower legs approx 2 days after receiving the varicella vaccine.  Patient presented to her PCP, who identified the reaction as varicella.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: pt was given 3 vaccines by the MA, pt had syncopal episode immediately after. Pt was laid down. When RN entered the room the patient was awake, pale, diaphoretic. Pulse 89, o2 sat 99%, blood pressure 117/62. pt sat up. Drank juice, chatted. Offered snacks, pt declined. allowed to sit until she felt ready to go home. Parent of patient and patient expressed gratitude for care given.
Age: 60.0
Sex: F
Vaccine: HEP, RSV
Symptoms: Heart rate irregular, Injection site nodule, Injection site warmth, Migraine
Clinical narrative: Migraine headache started same day, later that evening.   A hot knot developed in the left arm near RSV injection site.  Patient also reported erratic heartbeat for part of 5.16.24, the day after injection.  The heartbeat issue seems to have resolved.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: She got her vaccine, nothing happened for the first 3 hours, and then all of a sudden her arm between the shoulder and elbow got really red and started to swell up.  It is the size of a small tomatoe and it's been that way since last night.  She had a fever of 100 last night.  She also had some nausea with the pain and anytime she tried to move her arm she had real sharp pain in the arm and so she quit moving the arm.  She did not take anything for her arm  pain as she has numerous stomach problems.  She tried to get a hold of her doctor but not able to get a hole of anyone.  She is going to call the pharmacy to let them know about this.  It's been very itchy today, not as red as it was.  She is not able to move her arm and if she does she makes her scream.  It is in a 90 degree angle and it's right above her elbow and if she tries to move it is extremely painful.   She is a very small person, weighs less than 100#, and may be too strong for her as she is allergic to a lot of preservatives and dyes.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: She got her vaccine, nothing happened for the first 3 hours, and then all of a sudden her arm between the shoulder and elbow got really red and started to swell up.  It is the size of a small tomatoe and it's been that way since last night.  She had a fever of 100 last night.  She also had some nausea with the pain and anytime she tried to move her arm she had real sharp pain in the arm and so she quit moving the arm.  She did not take anything for her arm  pain as she has numerous stomach problems.  She tried to get a hold of her doctor but not able to get a hole of anyone.  She is going to call the pharmacy to let them know about this.  It's been very itchy today, not as red as it was.  She is not able to move her arm and if she does she makes her scream.  It is in a 90 degree angle and it's right above her elbow and if she tries to move it is extremely painful.   She is a very small person, weighs less than 100#, and may be too strong for her as she is allergic to a lot of preservatives and dyes.
Age: 14.0
Sex: M
Vaccine: HEPAB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did no have any physical symptoms, but he is below the recommended age for vaccine administration. He is 14 years old and the required age for administration is at least 18 years old
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient received a tdap (boostrix) vaccination in error, when patient should have received dtap (infanrix).
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TD, VARCEL
Symptoms: Syncope
Clinical narrative: Patient had a syncopal event after receiving the HPV vaccine, Patient monitored closely, vital signs taken took water and crackers which were tolerated, orthostatic vital done, examed by NP and was cleared to go home
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Developmental delay, Developmental regression, Speech disorder developmental
Clinical narrative: Child started exhibiting behaviors of developmental delay as well as autism spectrum disorder after receiving his 12 month MMR vaccine. At his 12 month well visit we discussed with the doctor that he was doing very well and saying "momma and dadda." However by his 18 month appointment I reported to the pediatrician that he had regressed and was no longer saying "momma and dadda" and had developed many other concerning behaviors including: speech regression, speech delay, does not notice others feelings, lining up toys and getting upset if the order is changed, plays with toys the same way every time, focuses on parts of objects such as the wheels, gets upset by minor changes, must follow routines, has obsessive interests and delayed cognitive/learning skills.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client given live varicella vaccine less than 4 weeks after receiving  live MMR vaccine. No treatment was required. Client educated regarding the need to repeat dose in 28 days and made future appointment.
Age: 84.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of vaccine. 1 dose- 8/12/22, 2nd dose-9/9/22,  3rd dose- 5/17/24
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Gait disturbance, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Received 4 year vaccines (MMR/Varicella subcutaneous to left thigh and DTaP/IPV IM to right thigh) two days ago, 5/15/24. Within 30 hours from vaccination, patient complained of pain and started limping. At this time she also developed large red, raised spots at both vaccine sites; photos uploaded to chart. Her DTaP/IPV vaccination site to right thigh has tripled in size from when mom first noticed it, about 16 hours ago. She did not develop fever.    Mother noted some coughing last night, but coughing is "pretty typical" for her; not out of her norm. Denies shortness of breath, wheezing, difficulty swallowing, chest tightness, nausea, vomiting, diarrhea, dizziness or fainting.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bradycardia, Bronchitis, Cough, Dyspnoea, Hypoxia
Clinical narrative: Hospitalized 1/5/23-1/9/23 cough, vomiting, congestion, bradycardia, SOB, hypoxia, bronchitis, elevated troponin,
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, Troponin increased, Vomiting
Clinical narrative: Hospitalized 1/5/23-1/9/23 cough, vomiting, congestion, bradycardia, SOB, hypoxia, bronchitis, elevated troponin,
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammation, Myalgia
Clinical narrative: pt has generalized myalgia and arthralgia after vaccination and systematic inflammation
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: Patient given 3 doses. 1st dose- 7/1/22, 2nd dose- 8/24/22, 3rd dose 5/17/24
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness postural
Clinical narrative: Patient got vaccinated and once she stand up felt dizzy, she immediately was seated at post vaccination waiting area and monitored. Patient wanted to wait for symptom to resolve and did not want emergency service to be called. After 15 minutes she stated symptoms improved and she was ready to go home so she left with her son
Age: 45.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: Patient given 3 doses. 1st dose- 8/16/22, 2nd dose- 9/14/22, 3rd dose 5/17/24
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient developed redness and swelling/lump and injection site. Painful to the touch.
Age: 40.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses. 1st dose- 8/12/22, 2nd dose- 9/16/22, 3rd dose- 5/17/24
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client was given expired vaccine. Expiration date was 2/15/2024. No adverse event happened. Hepatitis B Dose was repeated on 4/25/2024
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Faeces discoloured, Fatigue, Melaena
Clinical narrative: Hospitalized 1/7/23-1/9/23 tired, dark stools, weakness, anemia, melena,
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: patient complained of severe pain at time of injection. pain increased over several days, persisted for approximately for 3 months, gradually reduced over next 6 months, then dissipated gradulally. currently patient is pain free
Age: 24.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Arthralgia, Hypersensitivity, Mobility decreased, Neck pain, Weight bearing difficulty
Clinical narrative: After getting my HPV vaccine on the 5/1/2024, I had extreme pain in my shoulder and neck. I was unable to turn my head in most directions and could not put any weight on my left arm. Both vaccines I got on the 1st were administered in the same arm. On 5/11/2024 the pain was still persisting so I went to urgent care where I was told this is likely an allergic reaction. In November of 2020 I received my second dose of HPV vaccine and had the same reaction and had to go to the emergency room.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Blood test, Cerebrovascular accident, Computerised tomogram abnormal, Death
Clinical narrative: As per daughter in law - As soon as he returned home, he began vomiting. He lost his appetite and no energy. He lost 15 lbs. He experienced chronic fatigue. Multiple blood tests - inflammatory markers. CT scan revealed minor stroke. GI studies shows nothing except erosion, was put on Prilosec. Neurology could not explain any of the symptoms. CArdiolofy was good. March 7 Major stroke March 21 died.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Decreased appetite, Fatigue, Gastrointestinal erosion, Inflammatory marker test, Vomiting
Clinical narrative: As per daughter in law - As soon as he returned home, he began vomiting. He lost his appetite and no energy. He lost 15 lbs. He experienced chronic fatigue. Multiple blood tests - inflammatory markers. CT scan revealed minor stroke. GI studies shows nothing except erosion, was put on Prilosec. Neurology could not explain any of the symptoms. CArdiolofy was good. March 7 Major stroke March 21 died.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Weight decreased
Clinical narrative: As per daughter in law - As soon as he returned home, he began vomiting. He lost his appetite and no energy. He lost 15 lbs. He experienced chronic fatigue. Multiple blood tests - inflammatory markers. CT scan revealed minor stroke. GI studies shows nothing except erosion, was put on Prilosec. Neurology could not explain any of the symptoms. CArdiolofy was good. March 7 Major stroke March 21 died.
Age: 54.0
Sex: M
Vaccine: COVID19, FLU4, HEP, HEPA, PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client received expired dose of Hepatitis B vaccine, no adverse event occurred. Hepatitis B vaccine repeated on 4/25/2024.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Disorientation, Fall, Urinary incontinence
Clinical narrative: COMPLETE LOSS OF ENERGY BEGINNING HOURS AFTER THE SHOT.  SHE TOOK A NAP AND WOKE UP COMPLETELY DISORIENTED,  HAD NO IDEA WHERE SHE WAS.  SHE COULD NOT FIND THE LIGHTS AND FELL.  SHE CRAWLED TO THE BATHROOM WHERE SHE LOST CONTROL OF BODILY FUNCTIONS AND URINATED ON HERSELF.  4 WEEKS LATER SHE STILL HAS  VERY LITTLE ENERGY.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Incomplete course of vaccination, Pain
Clinical narrative: I developed shingles approximately 24 hours or less within the time of receiving the vaccination. In the next couple of days, the affected area spread and became more painful. I scheduled an appointment with a dermatologist who prescribed an oral medication. The condition lessened with the passage of time, but persisted for approximately 2-4 weeks before subsiding completely. I did not go back for the second dose of the COVID Moderna series. I am a healthy, active individual. I do not smoke, drink alcohol, or take drugs. There are no suspected causal factors other than the vaccine for this adverse reaction.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Back pain, Cardiac failure congestive, Condition aggravated, Dyspnoea
Clinical narrative: Hospitalized 1/23/23-1/26/23 back pain, SOB, tachycardia, a-fib with RVR, CHF, BLE edema, fluid overload,
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypervolaemia, Oedema peripheral, Tachycardia
Clinical narrative: Hospitalized 1/23/23-1/26/23 back pain, SOB, tachycardia, a-fib with RVR, CHF, BLE edema, fluid overload,
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Abdominal distension, Constipation, Crying, Diarrhoea
Clinical narrative: Here with mom for constipation, gas build up, crying in pain, diarrhea twice yesterday (no BM today) and spitting up a little more than usual. She read about Rotateq and is afraid he has intussusception. Mom is concerned this is a side affect of the Rotavirus vaccination. Mom states he had the vaccine yesterday and last evening had 2 watery stools, no blood or jelly like stools. No BM today. She says he has a BM every day since birth. He has bouts of drawing up his legs and crying in pain. Tummy feels bloated. He is nursing and is consolable at this time. Having good wet diapers.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Flatulence, Infantile spitting up, Pain, Stool analysis normal, Ultrasound abdomen normal
Clinical narrative: Here with mom for constipation, gas build up, crying in pain, diarrhea twice yesterday (no BM today) and spitting up a little more than usual. She read about Rotateq and is afraid he has intussusception. Mom is concerned this is a side affect of the Rotavirus vaccination. Mom states he had the vaccine yesterday and last evening had 2 watery stools, no blood or jelly like stools. No BM today. She says he has a BM every day since birth. He has bouts of drawing up his legs and crying in pain. Tummy feels bloated. He is nursing and is consolable at this time. Having good wet diapers.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: X-ray normal
Clinical narrative: Here with mom for constipation, gas build up, crying in pain, diarrhea twice yesterday (no BM today) and spitting up a little more than usual. She read about Rotateq and is afraid he has intussusception. Mom is concerned this is a side affect of the Rotavirus vaccination. Mom states he had the vaccine yesterday and last evening had 2 watery stools, no blood or jelly like stools. No BM today. She says he has a BM every day since birth. He has bouts of drawing up his legs and crying in pain. Tummy feels bloated. He is nursing and is consolable at this time. Having good wet diapers.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Administered the adjuvant suspension component without reconstituting the vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Hypoxia
Clinical narrative: Hospitalized 2/15/23-2/17/23 hypoxia, O2 supplementation,
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After injection, site became red, warm to the touch, swollen. Red area measured 6"w x 7.5" L. Came her to the office and was given diphenhydramine HCl Elixer 12.5 MG/5ML PO BID .
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza A virus test negative, Influenza B virus test negative, Lymph node pain
Clinical narrative: Fever (99.5 F), chills, myalgias, fatigue, tender cervical lymph nodes
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Respiratory syncytial virus test negative, Respiratory viral panel, SARS-CoV-2 test negative, Streptococcus test positive
Clinical narrative: Fever (99.5 F), chills, myalgias, fatigue, tender cervical lymph nodes
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fall, Gait disturbance, Head injury
Clinical narrative: Hospitalized 2/17/23-2/21/23 Frequent falls, hit head, weakness, unsteady gait, cough, rhinorrhea, debility,
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Hospitalized 2/17/23-2/21/23 Frequent falls, hit head, weakness, unsteady gait, cough, rhinorrhea, debility,
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity, Skin warm
Clinical narrative: BURNING AT TIME OF INJECTION, EXTREMELY SORE ARM POST INJECTION. HOT TO THE TOUCH TWO DAYS AFTER, PAIN NEAR STIRE OF INJECTION AND DELTOID AREA. (NO VISIBLE SWELLING OR REDNESS AT INJECITON SITE) PATIENT HAD BEEN SELF MEDICATED WITH HER PRESCRIBED TRAMADOL AND APAP, ADVISED USE OF ICE PACK AND IBUPROFEN IF CLEARED TO TAKE BY HER MD
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Premature delivery
Clinical narrative: Patient received the RSV vaccine on 1/9/2024 at 34 weeks. Her due date was 2/22/2024. Her water broke early and she gave birth. Patient reported no actual adverse reactions to the vaccine however she wanted to report the early delivery. Patient also reported that both, mom and baby, were healthy following the delivery.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Breath sounds abnormal, Cough, Dyspnoea, Erythema, Pruritus
Clinical narrative: within 1 minute of vaccine patient experienced cough, difficulty breathing, and facial redness.   On exam, decreased breath sounds, occasional wheeze, not talking. No visible swelling within mouth. Tachycardic. Felt itchy
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Tachycardia, Wheezing
Clinical narrative: within 1 minute of vaccine patient experienced cough, difficulty breathing, and facial redness.   On exam, decreased breath sounds, occasional wheeze, not talking. No visible swelling within mouth. Tachycardic. Felt itchy
Age: 37.0
Sex: F
Vaccine: HEP, PNC20, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: patient called the next morning reporting that her left arm was swollen from finger tips up to jaw. Declined anaphylaxis. Reported that it hurt to go to sleep on it last night. Benadryl was recommended however patient was a work. She was advised to take a antihistamine and tylenol for the pain. If it didn't stay localized to that area or go worse to go to the ER.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong patient received product
Clinical narrative: IN TRAVEL CONSULT WITH 6 KIDS RANGING IN AGE FROM 11 TO 2.5 AND PARENT.  CHILDREN RAMBUNCTIOUS. A COUPLE FIGHTING TO GO FIRST OTHERS THROWING FIT BECAUSE DON'T WANT SHOTS. HAD COWORKER HELP GIVE VACCINES. FIVE OF THE KIDS NEEDED MCV4 FOR TRIP. THE CLIENT  (11 KID) DID NOT. HAD ALREADY RECEIVED HIS 7TH GRADE VACCINES. COWORKER GAVE CLIENT MCV4. REALIZED WHAT HAD HAPPENED ABOUT 5 MINUTES LATER WHEN I WAS SHORT ONE MCV4 VACCINE FOR THE LAST CHILD TO RECEIVE VACCINES. EXPLAINED TO MOM WHAT HAD HAPPENED AND WHAT TO EXPECT. MOM STATED UNDERSTANDING.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Differential white blood cell count, Electrocardiogram, Electromyogram normal, Facial paresis, Full blood count
Clinical narrative: I received the RSV vaccine on 12/8. The following morning  i started to experience severe tingling, burning pain, muscle twitching and weakness in my legs, arms, lips and chin area.  These symptoms continued to get worse through the day.  About 1:45pm on 12/9/2023, my husband drove me to the Emergency Room. I was at the ER for approximately 4-4.5 hours. End result there were no conclusive results from the ER visit.   Muscles feel tight, similar to after a hard workout, but no cramping.   Still experiencing intermittent tingling and numbness in legs, arms and lower lip.   Sometimes my calf muscles start twitching.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Metabolic function test, Muscle tightness, Muscle twitching
Clinical narrative: I received the RSV vaccine on 12/8. The following morning  i started to experience severe tingling, burning pain, muscle twitching and weakness in my legs, arms, lips and chin area.  These symptoms continued to get worse through the day.  About 1:45pm on 12/9/2023, my husband drove me to the Emergency Room. I was at the ER for approximately 4-4.5 hours. End result there were no conclusive results from the ER visit.   Muscles feel tight, similar to after a hard workout, but no cramping.   Still experiencing intermittent tingling and numbness in legs, arms and lower lip.   Sometimes my calf muscles start twitching.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Muscular weakness, Nerve conduction studies normal, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: I received the RSV vaccine on 12/8. The following morning  i started to experience severe tingling, burning pain, muscle twitching and weakness in my legs, arms, lips and chin area.  These symptoms continued to get worse through the day.  About 1:45pm on 12/9/2023, my husband drove me to the Emergency Room. I was at the ER for approximately 4-4.5 hours. End result there were no conclusive results from the ER visit.   Muscles feel tight, similar to after a hard workout, but no cramping.   Still experiencing intermittent tingling and numbness in legs, arms and lower lip.   Sometimes my calf muscles start twitching.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Troponin, White blood cell count increased
Clinical narrative: I received the RSV vaccine on 12/8. The following morning  i started to experience severe tingling, burning pain, muscle twitching and weakness in my legs, arms, lips and chin area.  These symptoms continued to get worse through the day.  About 1:45pm on 12/9/2023, my husband drove me to the Emergency Room. I was at the ER for approximately 4-4.5 hours. End result there were no conclusive results from the ER visit.   Muscles feel tight, similar to after a hard workout, but no cramping.   Still experiencing intermittent tingling and numbness in legs, arms and lower lip.   Sometimes my calf muscles start twitching.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Vaccination site reaction
Clinical narrative: the day after vaccination, the patient awoke with reddened indurated local reaction ca 10x6 cm around the injection sites on RIGHT deltoid. No systemic reaction noted, normal behavior and activity, no fever noted. Appears to be delayed local reaction to DTap or less likely to IPV since they were administered in this location.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dry throat, Eye irritation, Oropharyngeal discomfort
Clinical narrative: patient was given both vaccines, then she waited to be monitored after 15 minutes patient complained of abnormal sensation in the throat and it felt dry. She also complained of burning sensation in the left eye. There was no sign of rash and injection site appeared normal. patient was further monitored by pharmacist and she stated that she felt better and was ok to leave .
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: LPN gave 12+ formulary, 0.25mL to a 10 year old. No adverse reaction noted at this time.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, SARS-CoV-2 test, Urticaria chronic
Clinical narrative: Angioedema; Chronic Urticaria; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient had no known allergy. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in 2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: ANGIOEDEMA (medically significant) with onset 05May2024, outcome "recovered with sequelae"; URTICARIA CHRONIC (non-serious) with onset 05May2024, outcome "recovered with sequelae", described as "Chronic Urticaria". The events "angioedema" and "chronic urticaria" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of angioedema, urticaria chronic including Antihistamines.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] will be requested and submitted if and when received.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: shipping issue; The child did have a red, swollen, hard lump after vaccines; The healthcare worker is reporting that 10 patients received possibly improperly stored vaccines; This non-valid spontaneous report was received from a healthcare professional and refers to 10 unspecified patients.  The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  The vaccines were supposed to be received by the office on 02-MAR-2024 but they were received on 08-MAR-2024 due to shipping issue (product distribution issue). On unknown dates in 2024, the patients received possibly improperly stored doses (incorrect product storage) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot #X023876, expiration date: 27-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided). No previous temperature excursion was reported.  No additional adverse events were reported, no further information was provided.  This case is non-valid due to lack of patients' identifiers.  Follow-up was received from the Vaccine Provider on 07-MAY-2024: The primary reporter was described as a Healthcare Worker. The patient was updated to a 4-year-old male. The patient's medical history, concurrent conditions were not provided.   On 19-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: subcutaneous injection, lot #X023876, expiration date: 27-MAR-2025, administered subcutaneously in the right thigh (exact dose was not provided); and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (manufacturer: Sanofi), lot # was reported as: U7908AA, administered intramuscularly in the left thigh (formulation, expiration date, exact dose were not provided) for prophylaxis.  The product was ordered on 28-FEB-2024. Product was/should have been delivered on or before 02-MAR-2024. Shipment was delayed during transit for an additional 6 days. Received in clinic on 08-MAR-2024 (product distribution issue). Unable to confirm temperature of vaccine for those additional days. The product was inadvertently put into clinic stock for use and 10 doses were administered. The temperature excursion was discovered during an inventory (product storage error). The patients were notified and scheduled for a repeat dose as per recommendations after contacting the manufacturer.  On 19-MAR-2024, the patient experienced vaccination site lump. Upon notification, this patient's father said that child did have a red, swollen, hard lump after vaccines on this date. He was unsure of the site left or right. It was since completely resolved. The vaccine involved was confirmed to be varicella (oka-merck) virus vaccine live (PROQUAD). Staff was educated on cold chain, storage, and vaccines handling.  The causality assessment was not provided.; Sender's Comments:  US-009507513-2405USA003519:
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Device leakage, No adverse event, Underdose
Clinical narrative: No side effects/No additional AE; as the needle was not twisted enough into the luer lock by the HCP during preparation; Patient did not receive a full dose of the GARDASIL 9; This spontaneous report was received from a medical assistant and referred to a 10-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 23-APR-2024, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #x014788, expiration date: 07-MAR-2025, administered intramuscularly at right deltoid for prophylaxis (strength, anatomical site of administration and route of administration were not provided) at Private Doctor's Office/Hospital. Medical assistant inquired that he was unsure how much a patient received during administration, most of the product looked like it ended up on the exam table. It was confirmed that it's human error/mishandling error, as the needle was not twisted enough into the luer lock on syringe by the health care professional (HCP) during preparation (product preparation error) and confirmed it was not a product issue. Patient did not receive a full dose of the rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (incomplete dose administered) (GARDASIL 9). No side effects, injuries, or symptoms reported (no adverse event).
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AEs; Caller reported 2nd dose of VAQTA administered less than 6 months after first dose; This spontaneous report was received from a nurse and referred to a patient of unknown gender and age. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 27-OCT-2023, the patient was vaccinated with the 1st dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X004814, expiration date: 10-OCT-2024, administered intramuscularly for prophylaxis (strength and anatomical site of administration were not provided). On 22-APR-2024, the patient was vaccinated with the 2nd dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X025482, expiration date: 12-APR-2025, administered intramuscularly for prophylaxis (strength and anatomical site of administration were not provided). The 2nd dose of 1st dose of hepatitis a vaccine, inactivated (VAQTA) administered less than 6 months after first dose (inappropriate schedule of product administration). No additional adverse events reported (no AE).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report expired VARIVAX was administered to 12-month-old infant inadvertently after its labeled expiry date.   HCP stated it was administered on 4/29/2024.  HCP stated VARIVAX expired on 4/06/2024.; This spontaneous report was received from a 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-APR-2024, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, first dose, valid lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No temperature excursion occurred. No additional adverse events were reported.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant in the health department reported they administered GARDASIL 9 to a 7 year old patient of unspecified gender with unknown demographics on unknown date. Confirmed no symptoms or; Confirmed no symptoms or side effects reported; This spontaneous report was received from a medical assistant referring to a 7-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product use issue). No adverse event was reported.     Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Product distribution issue, Product storage error
Clinical narrative: due to late (lost) shipment; No adverse reactions; extra dose adminstered; Improper storage due to late (lost) shipment; This spontaneous report was received from healthcare worker and refers to a 12-month-old male.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included hepatitis a vaccine (+) inactivated (VAQTA) (manufacturer unknown), hepatitis a vaccine (+) inactivated (VAQTA SYRINGE (DEVICE)) (manufacturer unknown) and pneumococcal vaccine conj 20v (crm197) (PREVNAR 20).   On 26-MAR-2024, the patient was vaccinated with first dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, unk, lot #X023876, expiration date: 27-MAR-2025, administered subcutaneously for prophylaxis (strength was not provided) (Product storage error). The vaccine was improper stored due to shippment delay (Product distribution issue). The patient was notified and scheduled and administered with repeat dose (Extra dose administered). No additional adverse event was reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product distribution issue
Clinical narrative: shipment was delayed; no adverse reaction; improperly stored vaccine; repeat dose; This spontaneous report was received from nurse and refers to a 5-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 22-MAR-2024, the patient was vaccinated with possibly improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection (lot #X023876, expiration date: 27-MAR-2025, administered subcutaneously in left thight, exact dose dose was not provided) and dose of diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (lot #U7838AA, administered intramuscularly in right thigh, exact dose and expiration date were not provided) for prophylaxis (Product storage error).  On unknown day in 2024, the patient could be vaccinated with repeat dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Extra dose administered).   The vaccines were received late due to shipping issue (Product distribution issue). The vaccines were supposed to be received by the office 02-MAR-2024, but they were received 08-MAR-2024. No additional adverse events were reported, no further information provided (No adverse event).; Sender's Comments:  US-009507513-2404USA005936:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse calling to report adverse event regarding an expired dose of ROTATEQ that was administered to a patient.; This spontaneous report was received from nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-MAY-2024, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml / three dose series, valid lot #1933919, expiration date: 27-APR-2024 (strength, route of administration, and indication were not provided) (expired product administered). It was confirmed that there have been no reports of the patient experiencing any medical concerns or symptoms after being administered the expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). No additional information was provided. No additional adverse event (AE) was reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Medical Assistant calling to report on 5/13/2024 expired ROTATEQ was administered inadvertently to a patient.; This spontaneous report was received from medical assistant refers to a 7-month-old patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAY-2024, the patient was inadvertently vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, valid lot #1933919, expiration date: 27-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). Medical Assistant confirmed there was no temperature excursion (T/E). Medical assistant did not request any additional information. No side effects were reported. No additional adverse event (AE) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Customer called and reported that VARIVAX was administered following a temperature excursion. AE case 02601863 filed for additional administration. No PQC reported. No additional information provided.           ?    Names of vaccines involved (incl; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-MAY-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W018824, expiration date: 14-JUN-2024, administered for prophylaxis (anatomical location, strength and route of administration were not provided), and it was administered following a temperature excursion: temperature 32F, time frame 18 hours, no previous temperature excursion. No PQC reported. No additional information provided.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; HCP called to report a TE with VARIVAX.  It was administered after being improperly stored. No adverse effects were reported. See TE case 02601898. Consent to contact is yes. No additional AE/No PQC.; This spontaneous report was received from a other health professional refers to a 17-month-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 10-MAY-2024 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # W018837 and expiration date 14-JUN-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). It was administered after being improperly stored. No adverse effects were (product storage error and no adverse event).; Sender's Comments:  US-009507513-2405USA004865:
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported; patient received his second VAQTA dose too early; This spontaneous report was received from a consumer and refers to a 17-year-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-DEC-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, specific dosage, route of administration, anatomical site of application, lot number and expiration date were not provided) and on 15-MAY-2024, received the second dose lot number X025342 with expiration date 12-MAY-2025 (strength, specific dosage, route of administration and anatomical site of application were not provided) (Inappropriate schedule of product administration). No symptoms reported and no additional details provided.
Age: 46.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose Heplisav-B, and Second Dose Twinrix; Initial report received on 09-Apr-2024.  A pharmacist reported that a 46-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received TWINRIX as the second dose for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 14-Aug-2023, the patient received the first dose of a hepatitis B vaccine HEPLISAV-B (lot # 943005, expiration date 30-Sep-2025, and NDC # 43528-002-01; route and site not reported).  On 16-Sep-2023, 34 days after having received HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine TWINRIX (lot # 83SG9, expiration date 03-Jan-2025; NDC #, route, and site not reported).  No adverse events were reported. No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes ophthalmic
Clinical narrative: herpes Ophthalmicus; This serious case was reported by a nurse via sales rep and described the occurrence of herpes ophthalmic in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced herpes ophthalmic (Verbatim: herpes Ophthalmicus) (serious criteria GSK medically significant). The outcome of the herpes ophthalmic was not reported.   It was unknown if the reporter considered the herpes ophthalmic to be related to Shingrix.     It was unknown if the company considered the herpes ophthalmic to be related to Shingrix.   Additional Information: GSK Receipt Date:14-MAY-2024 The nurse reported patient developed herpes ophthalmicus within a short time after receiving first dose of shingrix vaccine. The reporter agrees did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/recently got shingles; recently got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/recently got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: recently got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2024 This case was reported by a patient via interactive digital media. The patient had the vaccine about 3 years ago and recently got shingles. The patient do believed because of the vaccine he/she did not got them very bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Continued pain in left arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased. Concomitant products included ulinastatin (Statin).   On 26-OCT-2023, the patient received the 1st dose of Arexvy (left deltoid). On 26-OCT-2023, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: Continued pain in left arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 15-MAY-2024 The patient received 1st dose and had continued pain in left arm and was reported as worsened.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: discard the prefilled diluent syringe after adding diluent to the vials/use a separate labeled syringe to pull up; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate reconstitution technique in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate reconstitution technique (Verbatim: nurses discard the prefilled diluent syringe after adding diluent to the vials. Then, they use a separate labeled syringe to pull up). The outcome of the inappropriate reconstitution technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 07-MAY-2024 A pharmacist reported that the nurses discard the prefilled diluent syringe after adding diluent to the vials, then, they use a separate labeled syringe to pull up the product which led to inappropriate reconstitution technique.