chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported.; Inbound call from HCP reporting GARDASIL 9 that was out of range, unmonitored for an unknown amount of time at unknown temperatures. Lot number was provided, expiration date was unknown. Administered 2/6/2025. Consent to contact is yes. No adverse si; This spontaneous report was received from Other health professional and refers to a 24-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On 06-Feb-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, frequency, route of administration, vaccination site, and vaccination scheme were not provided; lot # 1965046,  which has been verified as a valid number, and expiration date reported and validated as 22-Jan-2026) as a prophylaxis. The vaccine was out of range, unmonitored for an unknown amount of time at unknown temperatures (improper storage of product in use). However, no adverse side effects were reported.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This spontaneous report was received from a physician and refers to a female patient of 21-years old by reporting time. The patient's medical history, concurrent conditions were not reported. The pt vaccination history included unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 07-JUL-2014, 26-JUL-2007, 23-NOV-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified immunoglobulin antihepatitis b (HEPATITIS B VACCINE) (reported as Hep B, adolescent or pediatric) (on 30-MAY-2003, 30-JUN-2003 and 05-MAR-2004) (captured in case 2262117); unspecified immunoglobulin antihepatitis a (HEPATITIS A VACCINE) (reported as Hep A, ped/adol, 2 dose) (on 02-MAY-2006 and 29-JUN-2005), unspecified hib vaccine (reported as HIB) (on 30-AUG-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 07-JUL-2014); unspecified polio vaccine (reported as IPV) (on 26-JUL-2007, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003); unspecified varicella zoster vaccine (reported as varicella) (on 26-JUL-2007 and 11-JUN-2004); unspecified measles vaccine, mumps vaccine, rubella vaccine (MMR) (on 26-JUL-2007 and 11-JUN-2004): unspecified pneumococcal vaccine (reported as pneumococcal conjugate PCV 7) (on 29-JUN-2005, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003), unspecified influenza vaccine (reported as Influenza, seasonal, injectable, presentative free) (on 22-OCT-2013), unspecified tuberculin PPD (reported as TST-PPD intradermal) (on 11-JUN-2013) and quadrivalent human papillomavirus (GARDASIL) (on 18-AUG-2015 On 18-AUG-2015, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) intramuscular injection (valid lot number K010215, expiration date: 05-MAY-2017 obtained per internal validation) (1 (units not provided) for prophylaxis.  On an unknown date, the patient experienced anaphylaxis. The patient also was vaccinated with unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 02-MAR-2020), unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 02-MAR-2020). On 26-MAR-2021, the pt was vaccinated with the first dose of human papillomavirus, recombinant (GARDASIL 9) (captured in case 2221838) and with pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE) (reported as Tdap). At the reporting time, the outcome of Anaphylaxis was not provided.   The causal relationship between the event of anaphylaxis and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was not reported.    Upon internal review, the event of anaphylaxis was determined to be medically significant.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 6 cm circular area of redness and itching at vaccine site commencing 4 days after vaccine administration and persisting until date of report.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Costochondritis, Inflammation
Clinical narrative: Adverse Events and Symptoms: After receiving the COVID-19 vaccine, I began experiencing significant inflammation and muscle pain throughout my body. These symptoms persisted and worsened over time.  On March 13, I was admitted to the hospital due to severe chest pain. After ruling out heart attack it is believed to be costochondritis. Since that time, I have continued to suffer from persistent inflammation and swelling in various areas of my body. These symptoms have affected my daily life and overall well-being.  Medical Interventions:  Hospital admission on March 13 for chest pain.  Ongoing medical consultations and treatments and monitoring  Current Condition: As of now, I am still experiencing ongoing swelling and persistent symptoms related to costochondritis. These symptoms have not fully resolved, and I continue to seek medical care.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Adverse Events and Symptoms: After receiving the COVID-19 vaccine, I began experiencing significant inflammation and muscle pain throughout my body. These symptoms persisted and worsened over time.  On March 13, I was admitted to the hospital due to severe chest pain. After ruling out heart attack it is believed to be costochondritis. Since that time, I have continued to suffer from persistent inflammation and swelling in various areas of my body. These symptoms have affected my daily life and overall well-being.  Medical Interventions:  Hospital admission on March 13 for chest pain.  Ongoing medical consultations and treatments and monitoring  Current Condition: As of now, I am still experiencing ongoing swelling and persistent symptoms related to costochondritis. These symptoms have not fully resolved, and I continue to seek medical care.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Brain fog, Chills, Dyspnoea, Heart rate increased, Pruritus
Clinical narrative: Rash, itching, fast heart rate, shortness of breath, chills, brain fog, used epi pen and took Benadryl, symptoms starting to go away
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash, itching, fast heart rate, shortness of breath, chills, brain fog, used epi pen and took Benadryl, symptoms starting to go away
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Malaise, Nodule
Clinical narrative: The second made me so sick; Chills; Fever; Arm was red; big knot on arm; hot; sore almost to my neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had them starting in his/ her twenties and had them multiple times). Previously administered products included shingles vaccine (1st dose on unknown date).   In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, less than a week after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The second made me so sick), chills (Verbatim: Chills), fever (Verbatim: Fever), erythema of extremities (Verbatim: Arm was red), local swelling (Verbatim: big knot on arm), feeling hot (Verbatim: hot) and pain (Verbatim: sore almost to my neck). The outcome of the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain were not reported.   It was unknown if the reporter considered the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2025 This case was reported by a patient via interactive digital media.  Patient had them starting in his/her twenties and had them multiple times. Sometimes not so bad. Other times a nightmare. Patient just took second shot last week. Patient stated that first one was fine. The second made patient so sick, chills , fever, arm was red with big knot, hot and sore almost to neck. Patient thanked goodness that he/she was done.
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: The second made me so sick; Chills; Fever; Arm was red; big knot on arm; hot; sore almost to my neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had them starting in his/ her twenties and had them multiple times). Previously administered products included shingles vaccine (1st dose on unknown date).   In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, less than a week after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The second made me so sick), chills (Verbatim: Chills), fever (Verbatim: Fever), erythema of extremities (Verbatim: Arm was red), local swelling (Verbatim: big knot on arm), feeling hot (Verbatim: hot) and pain (Verbatim: sore almost to my neck). The outcome of the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain were not reported.   It was unknown if the reporter considered the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness, chills, fever, erythema of extremities, local swelling, feeling hot and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2025 This case was reported by a patient via interactive digital media.  Patient had them starting in his/her twenties and had them multiple times. Sometimes not so bad. Other times a nightmare. Patient just took second shot last week. Patient stated that first one was fine. The second made patient so sick, chills , fever, arm was red with big knot, hot and sore almost to neck. Patient thanked goodness that he/she was done.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; got shingles 3 times; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 3 times). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shot and got shingles 3 times and he/she mentioned that the vaccine did not work for him/her. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for herself. The reporter stated that patient could get the shots and still had gotten a bad case of shingles.  She was in so much pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: a little rash on the neck and upper back; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a adult female 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 rash (Verbatim: a little rash on the neck and upper back). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date : 20-MAR-2025 Medical doctor called to informed that patient got the first dose of Shingrix in a pharmacy (unknown date and location) and after the administration developed a little rash on the neck and upper back.  Reporter questioned that could the patient received the 2nd dose still.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of skin at the injection site.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pallor, Visual impairment, Vomiting
Clinical narrative: pt receieved HPV , went to waiting room, about 5 minutes after, got pale, felt like she was going to be sick, vomited and reports vision going black. Got into exam room, given ice pack to neck and juice and sat for  5-10 mins and felt fine
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on chest- patient returned to clinic 20 minutes after vaccine admininstration      in three agrea two on chest and one on face temperature checked pt reported no itching checked temperature elevated fever last reading 100.2  Follow up phone call with parents 3-25-25 in the am state that he is doing well had tylenol over night and has improved  and hives are gone
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Diarrhoea, Erythema, Headache, Hyperhidrosis
Clinical narrative: large localized reaction a few hours after vaccine administered, nausea, sweats, chills, body aches, headache, diarrhea for 4 days, her left upper arm is erythematous, swollen and itchy. Prescription for oral prednisone given for 5 days
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Nausea, Pain, Peripheral swelling, Pruritus
Clinical narrative: large localized reaction a few hours after vaccine administered, nausea, sweats, chills, body aches, headache, diarrhea for 4 days, her left upper arm is erythematous, swollen and itchy. Prescription for oral prednisone given for 5 days
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Injection site reaction, Injection site warmth, Malaise
Clinical narrative: Site reaction with redness and heat spreading down arm toward elbow from injection site covering most of outer upper arm. Patient complains of pain, chills, malaise, fever and states that it began a couple of days after the vaccine was administered. There is a language barrier and all information was obtained via a smartphone translation app.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pyrexia
Clinical narrative: Site reaction with redness and heat spreading down arm toward elbow from injection site covering most of outer upper arm. Patient complains of pain, chills, malaise, fever and states that it began a couple of days after the vaccine was administered. There is a language barrier and all information was obtained via a smartphone translation app.
Age: 1.58
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine given. ProQuad administered, MMR was ordered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: pt called on 3/25/2025  7 days later to report. she had a fever of 100 degrees for 3 days. The vaccinated area grew bigger in size, spreading to her elbow. she says it was raised and after 7 days it is beginning to calm down. signs of improvements in the area after 7days. Pt says may not need to be seen by md as it is showing signs of improvement. Pt mentions will wait longer than 2 mos for the 2nd dose.
Age: 1.92
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Blister rupture, Pyrexia, Rash, Rash pruritic
Clinical narrative: 23 month 19 day old female presents with c/o Chickenpox Patient has had 2-3 days of low grade fever and pruritic rash, recently had Varicella vaccine.  Rash started on trunk and spread distally to extremities and head.  The rash started as small red bumps that looked like pimples or insect bites. Then developed into thin-walled blisters filled with fluid. The blister walls broke, leaving open sores, which finally crust over to become dry, brown scabs.  All three stages of the chickenpox rash (red bumps, blisters, and scabs) are on the body at the same time.  Patient is otherwise doing well with good appetite, good UOP, and has been febrile..
Age: 1.92
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Varicella
Clinical narrative: 23 month 19 day old female presents with c/o Chickenpox Patient has had 2-3 days of low grade fever and pruritic rash, recently had Varicella vaccine.  Rash started on trunk and spread distally to extremities and head.  The rash started as small red bumps that looked like pimples or insect bites. Then developed into thin-walled blisters filled with fluid. The blister walls broke, leaving open sores, which finally crust over to become dry, brown scabs.  All three stages of the chickenpox rash (red bumps, blisters, and scabs) are on the body at the same time.  Patient is otherwise doing well with good appetite, good UOP, and has been febrile..
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: 1030: PATIENT WAS ADMINISTERED ANTHRAX VACCINE VIA IM TO THE LEFT DELT. 1130: PATIENT RETURNED TO MEDICAL WITH CONCERNS OF ELEVATED HEART RATE, SHORTNESS OF BREATH. THE IDC HS2 PERFORMED A WORKUP INCLUDING VITALS PHYSICAL EXAM AND BRIEF HISTORY. UPON COMPLETING THE EXAM WITH THE ASSISTANCE OF APA-C, IT WAS DECIDED TO SEND PATIENT TO THE EMERGENCY ROOM FOR CARE AT EMERGENCY ROOM.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Parent (gaurdian) states patient had golf sized swelling on arm a few hours after vaccination that lasted around 48 hours. States patient is also disabled and can not help rubbing injection site after injection. States this might be cause but unsure.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and clammy, sweating, and unsteady. She remained alert and oriented x person, place, time. Once lying down she began to improve slowly, but still did not feel well. BP was 99/62 lying, HR 68, O2 sat 99%. Patient had not eaten prior to vaccination. Patient began complaining of her hands "tingling" and becoming rigid. This subsided minutes later. Another BP taken lying down, 113/72. Sitting up shortly after BP was 86/62. Patient was given gatorade, water and peanut butter crackers AFTER glucose was checked (87). Patient remained in clinic for 15 more minutes, BP before leaving was 106/70, patient stated she felt "about 80%" better.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Nausea, Paraesthesia
Clinical narrative: Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and clammy, sweating, and unsteady. She remained alert and oriented x person, place, time. Once lying down she began to improve slowly, but still did not feel well. BP was 99/62 lying, HR 68, O2 sat 99%. Patient had not eaten prior to vaccination. Patient began complaining of her hands "tingling" and becoming rigid. This subsided minutes later. Another BP taken lying down, 113/72. Sitting up shortly after BP was 86/62. Patient was given gatorade, water and peanut butter crackers AFTER glucose was checked (87). Patient remained in clinic for 15 more minutes, BP before leaving was 106/70, patient stated she felt "about 80%" better.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain
Clinical narrative: Continued soreness in arm at injection site.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Blood glucose normal, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and clammy, sweating, and unsteady. She remained alert and oriented x person, place, time. Once lying down she began to improve slowly, but still did not feel well. BP was 99/62 lying, HR 68, O2 sat 99%. Patient had not eaten prior to vaccination. Patient began complaining of her hands "tingling" and becoming rigid. This subsided minutes later. Another BP taken lying down, 113/72. Sitting up shortly after BP was 86/62. Patient was given gatorade, water and peanut butter crackers AFTER glucose was checked (87). Patient remained in clinic for 15 more minutes, BP before leaving was 106/70, patient stated she felt "about 80%" better.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Paraesthesia
Clinical narrative: Approximately 5 minutes after injection patient complained of dizziness and nausea. She was cold and clammy, sweating, and unsteady. She remained alert and oriented x person, place, time. Once lying down she began to improve slowly, but still did not feel well. BP was 99/62 lying, HR 68, O2 sat 99%. Patient had not eaten prior to vaccination. Patient began complaining of her hands "tingling" and becoming rigid. This subsided minutes later. Another BP taken lying down, 113/72. Sitting up shortly after BP was 86/62. Patient was given gatorade, water and peanut butter crackers AFTER glucose was checked (87). Patient remained in clinic for 15 more minutes, BP before leaving was 106/70, patient stated she felt "about 80%" better.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Pruritus, Rash macular, Skin warm
Clinical narrative: Patient stated the following via phone:   Stated received pneumonia vaccine on 3/20/2025 at this office.  Noted that did well with vaccine but last evening began with redness on LEFT arm at injection site.  This AM, woke up noting "itching, blotching and redness extending down the inner LEFT arm below the elbow.  Shared that arm is warm to touch.  Denies difficulty breathing.  Advised to go to Urgent Care now.  Verbalized understanding of same. On 3/25/2025 during Urgent Care visit, was ordered the following Cleocin,  Prednisone and OTC Benadryl.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: The patient stated that he had no reaction to the 1st vaccine but had blisters on his chest, back, and arms following his 2nd vaccine 6 days later.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Disorientation, Dizziness, Hypotension, Pallor, Presyncope
Clinical narrative: patient became hypotensive, pale, dizzy, disoriented, lightheaded. tachycardia. patient monitored in office x 1.5 hours, sent to e.d.. pt discharged at 1640 from e.d. after vitals stabilized. patient diagnosed with vasovagal reaction after vaccination injections.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tachycardia
Clinical narrative: patient became hypotensive, pale, dizzy, disoriented, lightheaded. tachycardia. patient monitored in office x 1.5 hours, sent to e.d.. pt discharged at 1640 from e.d. after vitals stabilized. patient diagnosed with vasovagal reaction after vaccination injections.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Was given varicella vaccine per schedule that was not frozen, but rather refrigerated. Denies any side effects or adverse reaction.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Erythema of eyelid, Peripheral swelling, Pyrexia, Swelling of eyelid
Clinical narrative: The patient is a 15-month-old male who presents for evaluation of fever and swollen eyelids. He is accompanied by his mother and father who presented today due to facial swelling of his eyes and thigh after a vaccine was given.  Patient has moderate bilateral eye swelling and additional swelling around the injection site.  He had a fever which occurred this morning at 9 AM.  Temperature was 103 this morning and the mom did give Tylenol.  Patient did receive the DTaP, haemophilus influenza B, pneumonia and polio vaccine.  Patient also appears fussy and irritable.  No prior reactions from immunizations in the past   The patient's mother reports that he experienced a significant fever this morning, with temperatures ranging between 103 and 104 degrees Fahrenheit. Upon awakening at 9 AM, he was found to have notably swollen eyelids, which were more erythematous than usual. The mother administered Tylenol in response to the fever. It is noteworthy that the patient received his vaccinations during their last visit yesterday.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Hypoaesthesia, Limb discomfort, Muscular weakness, Paraesthesia, Rash
Clinical narrative: Presented to ED with bilateral lower extremity weakness, and bilateral upper extremity numbness/tingling and heaviness sensation. Admitted to hospital and neurology consulted. Neurology noted  "possible post vaccine transverse myelitis." Patient completed 3-days of IV steroids and minimal to no symptoms at time of discharge. ID was consulted due to rash on his left upper extremity, likely tinea. ID recommended submission to VAERS.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Tinea infection
Clinical narrative: Presented to ED with bilateral lower extremity weakness, and bilateral upper extremity numbness/tingling and heaviness sensation. Admitted to hospital and neurology consulted. Neurology noted  "possible post vaccine transverse myelitis." Patient completed 3-days of IV steroids and minimal to no symptoms at time of discharge. ID was consulted due to rash on his left upper extremity, likely tinea. ID recommended submission to VAERS.
Age: 6.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was in clinic with her older sister (age 8), and both needed tetanus shots. When vaccinating this patient, RN administered the wrong tetanus shot. Patient should have received DTaP, but received Tdap. Patient will need to repeat the dose with DTaP. All other vaccines in this visit were administered correctly.
Age: 8.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient came to clinic with younger sister (age 6) and both needed tetanus vaccines. When vaccinating, RN accidentally administered DTaP to this patient instead of Tdap. All other vaccines in this visit were administered appropriately. Patient's DTaP is considered a valid dose in the series and will not need to be repeated.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Swelling face
Clinical narrative: 2 hours after vaccination, we got a call from the patient who said she was having swelling in the face and touble breathing. I informed the patient to call 911 and go the nearest hospital and to take benadryl if she has it available.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU3, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong age dose/ No know adverse reaction
Age: 22.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Pt received MMRV vaccine and should have received the same vaccines but separately.  MMR and Varicella
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: MMRV erroneously given by nurse to patient when MMR should have been given.  Was also given a varicella vaccine separately this day as well.
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Injection site rash, Pain, Pyrexia
Clinical narrative: High fever of 104 F, Fatigue, severe body aches, rash on the site of injection with perfused redness to the left arm
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus
Clinical narrative: Progressive erythema, itching at site of injection - treated as secondary cellulitis
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Chest discomfort, Dyspnoea, Nasal congestion, Swelling face, Urticaria
Clinical narrative: Mother reports trouble breathing, chest tightness, hives, nasal congestion, face swelling
Age: 33.0
Sex: M
Vaccine: FLU3, HEP, IPV, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient became dizzy and lightheaded after last dose of vaccine given. Patient was moved to bench and cool air and towel placed on neck. Patient was also given a soda to sip. Patient passed out while sitting on bench being assisted by two nurses. Used ammonia swab to wake patient up. Patient was able to talk to nurses then he went out again. Ammonia swab used again. Patient came around and was lowered to the floor and placed on left side. Patient was able to tell us his name and date of birth. Patient was kept in recovery position until he felt better. Patient was then escorted to his car where his wife was. BP checked several times: 9:44am- BP-108/62 P-79; 9:46am BP-78/48 P-559; 9:48am- BP- 97/71 P-68; 9:50am- BP-94/68 P-72. Patient also had a TB skin test placed prior to vaccines being given. After event, patient stated that this happened when he had blood drawn yesterday. Explained to patient that he did not report this when he was asked about previous reactions he said no. Advised patient to report this in the future when receiving vaccines or having blood drawn. Patient voiced understanding.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose given in series instead of peds dose given, by accident.
Age: 52.0
Sex: F
Vaccine: MMR, PNC21, VARZOS
Symptoms: Body temperature increased, Imaging procedure, Incisional drainage, Laboratory test normal, Localised infection
Clinical narrative: Patient received 3 vaccines stated she was hospitalized for infection of left arm, swelling, temperature, and had to have arm lanced 3 days after vaccines. Stated she was in the hospital for 3 days with temperature and pain, stated pain with 12 hours of vaccine. Verbally upset she stated she does not want any of the vaccines again and wanted me to document issue.  Pharmacist told patient of all risk at time of vaccine, increased temperature, swelling of arm, arm hot to the touch, red swollen area, and other flu like symptoms/ body pain, along with any treatment suggestions for side effects.  Patient had arm lanced and drained, given IV antibiotics, and given oral and antibiotics and pain medication.
Age: 52.0
Sex: F
Vaccine: MMR, PNC21, VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: Patient received 3 vaccines stated she was hospitalized for infection of left arm, swelling, temperature, and had to have arm lanced 3 days after vaccines. Stated she was in the hospital for 3 days with temperature and pain, stated pain with 12 hours of vaccine. Verbally upset she stated she does not want any of the vaccines again and wanted me to document issue.  Pharmacist told patient of all risk at time of vaccine, increased temperature, swelling of arm, arm hot to the touch, red swollen area, and other flu like symptoms/ body pain, along with any treatment suggestions for side effects.  Patient had arm lanced and drained, given IV antibiotics, and given oral and antibiotics and pain medication.
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site rash, Skin exfoliation
Clinical narrative: A patient came to the consultation counter and told the pharmacist that a couple of days after her capvaxive vaccine (03/05/2025) she noticed a rash that was red well below the site of her injection.  It later healed and the top layer of skin peeled off.
Age: 68.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Dysstasia, Feeling abnormal, Pain
Clinical narrative: Patient states that she felt achy, tired and had difficulty getting up and about like being "hit with a baseball bat" . Reaction did not improve and she saw her MD 2 days following administration. MD told her "definitely due to Shingrix vaccine". MD gave her two "shots" , but she is not sure what they were. Patient starting feeling two days following being seen by her MD.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: fever (topped out at 102.2), chills, some aches, fatigue, lack of appetite, sleepiness; began in evening of 3/21 and lasted until 3/24 in late afternoon
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: fever (topped out at 102.2), chills, some aches, fatigue, lack of appetite, sleepiness; began in evening of 3/21 and lasted until 3/24 in late afternoon
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects noted.
Age: 80.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: patient's daughter called stating since she received the shot, that same night patient has been feeling feverish and treating that with Tylenol. Daughter also reported patient's legs don't have any strength and have to help support her to use the restroom.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC reported.; Product origin unknown; HCP stated that a female patient inadverntly received a unknown HPV quadrivalent vaccine when she was 5 years old.; This spontaneous report was received from a registered nurse and refers to a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2013 when she was 5 years old, the patient inadvertently received quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (manufacturer unknown) (reported as an unknown HPV quadrivalent vaccine) (strength, dose, formulation, route of administration, lot # and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age, Product origin unknown). The patient was currently 17 years old. No additional adverse event (AE) reported (No adverse event).
Sex: M
Vaccine: RV5, RV5, UNK, UNK
Symptoms: Infant irritability
Clinical narrative: The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an UNKNOWN ROTAVIRUS on 11/11/2024 and 12/12/2024. The patient received a dose of ROTATEQ on 2/25/2025; The parents brought the patient to a pediatric urgent care because they were being fussy. The patient has since completely recovered from being fussy and has not had any medical concerns since.; The patient received their first dose of ROTATEQ on 10/9/2024, then traveled where they received an UNKNOWN ROTAVIRUS on 11/11/2024 and 12/12/2024. The patient received a dose of ROTATEQ on 2/25/2025; This spontaneous report was received from a medical assistant and refers to a 5-month-old (also reported as 6-month-old, conflicting information) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-Oct-2024, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), 2 mL / three dose series, administered by oral route as rotavirus vaccination (lot # and expiration date were not reported). Then the patient traveled where he (reported as they, conflicting information) received unknown rotavirus vaccine on 11-Nov-2024 (second dose, strength, dose, formulation, indication, expiration date, and lot # were not reported) and 12-Dec-2024, (third dose, strength, dose, formulation, indication, expiration date, and lot # were not reported). On 25-Feb-2025, the patient was vaccinated with the forth dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (lot #Y005880, expiration date: 19-Nov-2025), 2 mL / three dose series, administered by oral route as rotavirus vaccination (Interchange of vaccine products, Extra dose administered). Operator of device was health professional.  On 25-Feb-2025, after the patient received Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), the parents brought the patient to a pediatric urgent care because they were being fussy. The Physician of the urgent care told the parents that the patient was ok and no medical treatments were necessary and to continue to monitor the patient. The patient had since completely recovered from being fussy and has not had any medical concerns since." Medical Assistant confirmed the patient had made a recovery from "being fussy", and was not provided any additional information.  The action taken was not applicable.  The causal relationship between the event of fussy and Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), unknown rotavirus vaccine was not reported.  Lot # is being requested and will be submitted if received.
Age: 0.75
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP called to report a dose of PROQUAD was given to a 9-month-old patient.; This spontaneous report was received from a physician and refers to a 9-month-old patient of unknown gender.    The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On 05-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y016872, expiration date: 07-Apr-2026) 0.5 mL, diluted in sterile diluent (MERCK STERILE DILUENT), 0.5 mL (expiration date, and lot # were not reported) for prophylaxis (Inappropriate age at vaccine administration). Healthcare provider (HCP) stated he intended to administer the child the vaccine dose for upcoming international travel as the parents were concerned about MMR outbreaks. No symptoms reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: No other AE/PQC reported.; patient was administered less than a full dose of VARIVAX.; This spontaneous report was received from a Nurse and refers to a(n) 12-month-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Mar-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015558, expiration date: 16-Sep-2026) administered by unknown route as prophylaxis. The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), for the treatment of prophylaxis together with sterile diluent (MERCK STERILE DILUENT) (lot#, expiration date, route of administration were all not provided).  On the same date, the patient experienced administered less than a full dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (vaccine underdose). There were no other adverse events reported (no adverse event). Reporter stated he did not know how much of the dose the patient received.
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: pins and needles sensation in her right palm; tip of her right thumb pain; fatigue; right wrist pain; right scapula pain; Skin was tender at the injection site/pain from her right upper arm; This spontaneous report was received from a/an nurse and refers to a(n) female patient (herself) of unknown age. The patient's medical history included pneumonia. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On 07-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), 0.5 mL, administered by intramuscular route in right upper arm for vaccination (strength, lot # and expiration date were not reported).  It was reported that she received Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) on 07-Mar-2025 in her right upper arm and a "few hours later" she developed fatigue and pain from her right upper arm into the right scapula and from the right wrist to the tip of her right thumb as well as a pins and needles sensation in her right palm. Skin was tender at the injection site but no swelling or redness She stated the pain increased overnight and lasted for about 24 hours. No other information provided. The patient recovered/resolved from all events on 08-Mar-2025.   The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.   Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received both doses of MMR II prior to the recommended age of 4 years old; No additional AE reported; This spontaneous report was received from a Pharmacist and refers to her son, a male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. The pharmacist reported her son received both doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) prior to the recommended age of 4 years old (Product administered to patient of inappropriate age). She reported the doses were administered approximately 3 months apart.  No adverse event reported.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AE; Medical Assistant reports another HCP at their office gave PEDVAXHIB to a patient with STERILE DILUENT however PEDVAXHIB does not require reconstitution. The incident occurred as they; This spontaneous report was received from an Other health professional (medical assistant) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 18-Mar-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Suspension for injection (valid lot #Y005248, expiration date: 17-Sep-2026), 0.5 mL administered once for prophylaxis (dose number, anatomical location, and route of administration were not provided) that was incorrectly reconstituted with sterile diluent (BAXTER STERILE DILUENT, reported as DILUENT MRK) Solution for injection, formulation pre-filled syringe (valid lot #1960083, expiration date: 04-Feb-2026) at clinic.   Medical Assistant reported that another health care professional (HCP) at their office gave Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) to a patient with sterile diluent (BAXTER STERILE DILUENT), however suspect vaccine did not require reconstitution (product preparation error). The incident occurred as they were vaccinating siblings, one sibling needed measles mumps and rubella vaccine (MMRII) and one needed Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), so sterile diluent (BAXTER STERILE DILUENT) was mixed into Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and given to one patient. No side effects or symptoms were reported. The whole vial of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) was given with the sterile diluent (BAXTER STERILE DILUENT) pre-filled syringe mixed in. Only one patient was involved as other sibling received their MMRII properly. No additional adverse event (AE) was reported (no adverse event).
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported; Nurse calling to report a 28 year old patient was inadvertently administered a PROQUAD dose.; This spontaneous report was received from a Nurse and refers to a 28-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 21-FEB-2025, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered as prophylaxis (lot number Y004547 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), expiration date 19-AUG-2025; dose, formulation, vaccination scheme frequency, route of administration and anatomical site of injection were not provided) (Product administered to patient of inappropriate age), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (formulation, dose, indication, expiration date, lot number and route of administration were not reported). No symptoms reported and no additional adverse events of details were provided (No adverse event).