chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only received the liquid component and not the full reconstituted dose; only received the liquid component and not the full reconstituted dose;  This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis.   On 18-JUN-2025, the patient received Shingrix. On 18-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only received the liquid component and not the full reconstituted dose) and inappropriate dose of vaccine administered (Verbatim: only received the liquid component and not the full reconstituted dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 23-JUN-2025 Reporter stated that they had a patient who only received the liquid component and not the full reconstituted dose. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administration instead of Boostrix; Infanrix out of the recommended age administration/Infanrix administration instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old female patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 23-JUN-2025, the patient received Infanrix. On an unknown date, the patient did not receive Boostrix. On 23-JUN-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix administration instead of Boostrix) and adult use of a child product (Verbatim: Infanrix out of the recommended age administration/Infanrix administration instead of Boostrix). The outcome of the wrong vaccine administered and adult use of a child product were not applicable.   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: 23-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter. The Health Care Provider wanted to know how to proceed after a 15 year old patient received Infanrix instead of Boostrix as a second dose in the immunization schedule which led to wrong vaccine administered and adult use of a child product.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number b32ng, expiry date 13-JUN-2025) for prophylaxis.   On 20-JUN-2025, the patient received Boostrix. On 20-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of expired dose). The outcome of the expired vaccine used was not applicable.   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: 24-JUN-2025 The Licensed Practitioner Nurse reported that on 20 June 2025 was given Boostrix that expired on 13 June 2025 which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: administration of an adult dose on a eighteen year old patient; administration of an adult dose on a eighteen year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 18-year-old female patient who received HAV (Havrix adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   On 20-JUN-2025, the patient received Havrix adult. On 20-JUN-2025, an unknown time after receiving Havrix adult, the patient experienced adult use of a child product (Verbatim: administration of an adult dose on a eighteen year old patient) and overdose (Verbatim: administration of an adult dose on a eighteen year old patient). The outcome of the adult use of a child product and overdose were not applicable.   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: 24-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter Registered Nurse called asking for safety advise on the administration of an adult dose on a eighteen year old patient which led to adult use of a child product and overdose.   No further information was obtained in this call.
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Shingrix administered in the buttocks; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a 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 vaccine administered at inappropriate site (Verbatim: Shingrix administered in the buttocks). The outcome of the vaccine administered at inappropriate site was not applicable.   Additional Information: GSK Receipt Date: 24-JUN-2025 As per Web form received on June 24th 2025, the pharmacist reported that they had a patient who had receive theirs in the buttocks at the physician's office which led to vaccine administered at inappropriate site.   The pharmacist enquired was it ok or preferred to administer the Shingrix vaccine in the buttocks.  The pharmacist mentioned that they were told deltoid is preferred since this is where it was studied in clinical trials.
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: greater than 6 months since the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose more than 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: greater than 6 months since the first dose). The outcome of the incomplete course of vaccination was not applicable.   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: 23-JUN-2025 The reporter asked what the guidance on the dosing interval was between the second and third doses if there was an interruption between the first and second doses. It had been greater than 6 months since the first dose was administered. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix vaccine which led to incomplete course of vaccination. No further details were available.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025; 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number AZ4TN, expiry date 25-JAN-2027) for prophylaxis.   On 25-JUN-2025, the patient received Engerix B pediatric. On 25-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025) and underdose (Verbatim: 20 year old patient received a pediatric dose of Engerix-B on June 25th 2025). The outcome of the adult use of a child product and underdose were not applicable.   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: 25-JUN-2025 The nurse practitioner reported that a 20-year-old patient received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Crying, Underdose
Clinical narrative: got a partial dose of Kinrix because the child started crying; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 25-JUN-2025, the patient received Kinrix. On 25-JUN-2025, an unknown time after receiving Kinrix, the patient experienced accidental underdose (Verbatim: got a partial dose of Kinrix because the child started crying ). The outcome of the accidental underdose was not applicable.   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: 26-JUN-2025 The licensed practical nurse wanted to know how to proceed after a child got a partial dose of Kinrix because the child started crying and the mom let go of his leg, which led to accidental underdose The Vaccine Administration Facility was the same as Primary Reporter.
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: couple of patients receiving expired vaccines and they were approximately 1 month expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   In JAN-2025, the patient received Havrix. In JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: couple of patients receiving expired vaccines and they were approximately 1 month expired). The outcome of the expired vaccine used was not applicable.   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: 03-APR-2025 The reporter had a couple of patients who received an expired Havrix vaccines, and they were approximately 1 month expired. The reporter was calling to verify if GlaxoSmithKline have any data on effectiveness of their vaccines after the expiration, to see if they need to revaccinate these patients or if what was given was considered effective by some of GSKs post data.  The vaccines were administered January 16th till January 30th, 2025.  The vaccine administration facility was the same as primary reporter. No other information was provided.
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix out of the recommended age multiple administrations; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix out of the recommended age multiple administrations). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 27-JUN-2025 The health care provider wanted to confirm that GlaxoSmithKline did not have a vaccine recommended for children from 7 to 10 for Diphtheria and Tetanus Toxoids and Acellular Pertussis immunization and mentioned that because of that, she was giving Boostrix to the patients in that range of age, which led to an inappropriate age at vaccine administration. The agent read the information found on the prescribing information of Boostrix, including the part of dosage and administration where mentioned cases where it could be given out the recommended age and offered to put on hold while searching further information (and if not, contacting second line) but the health care provider declined and mentioned that she was following the centers for disease control's recommendation, to which the agent reply that still would be needing to gather the data of the patients in between those ages that received the vaccine, but the health care provider commented that she would be needing to go back in the past and search all of the patients that she gave the vaccine to, because she received a lot from different countries and moved onto trying to collect the agent's contact details, so there was not the cooperation needed to collect the adverse event data. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: he ran into a fellow physician that had the vaccine and he lost his hearing in his ear; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS (he ran into a fellow physician that had the vaccine and he lost his hearing in his ear) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (he ran into a fellow physician that had the vaccine and he lost his hearing in his ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (he ran into a fellow physician that had the vaccine and he lost his hearing in his ear) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-270609 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-270609:Master case (Same reporter, different patient)
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Fatigue, Gait inability, Heart rate
Clinical narrative: emotional trauma/distress; She cannot even walk around the house or perform simple household tasks without distress.; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (emotional trauma/distress), GAIT INABILITY (She cannot even walk around the house or perform simple household tasks without distress.) and FATIGUE (extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EMOTIONAL DISTRESS (emotional trauma/distress), GAIT INABILITY (She cannot even walk around the house or perform simple household tasks without distress.) and FATIGUE (extreme fatigue). At the time of the report, EMOTIONAL DISTRESS (emotional trauma/distress), GAIT INABILITY (She cannot even walk around the house or perform simple household tasks without distress.) and FATIGUE (extreme fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: Elevated dangerously.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient was a physician and, as a frontline healthcare provider during the pandemic, she selflessly cared for COVID-19 patients and took the vaccine in good faith, trusting it was safe and effective. She suffered severe long-term health consequences following her Moderna COVID-19 vaccination nearly four years ago. Since then, she faced unrelenting health problems including a dangerously elevated heart rate with even minimal exertion, extreme fatigue, and an inability to function normally in her daily life. She could not even walk around the house or perform simple household tasks without distress. Over the four years that followed, she endured not only profound physical challenges but also emotional trauma, financial strain from ongoing medical care, and countless hours spent searching for answers. Despite consultations with specialists and trying numerous treatments, she continued to suffer with no clear resolution in sight. The reporter wanted to advocate for recognition, support, and action for individuals like her whose lives had been drastically altered. They hoped Moderna would show compassion and responsibility by helping those rare but real cases who trusted in science and stepped forward to protect the greater community only to be left behind when things went wrong.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Wrong technique in product usage process
Clinical narrative: IM injection with subcutaneous needle with subq technique. After visit it was discovered that the Men B vaccine was given with at subcutaneous needle so would not have gotten into the muscle bed.  Parent contacted and informed of the error and that it will not be effective and will need to get the vaccine again.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Full blood count normal, Irritability
Clinical narrative: extreme irritability,  started shortly after administration and continued for 4 days
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Product preparation error
Clinical narrative: Patient received ACTHIB but it was not mixed with the diluent that came in the box.  Instead it was mixed with diluent used to mix MMR, Varicella and Proquad.  Sterile diluent used was from MERCK manufacturing company.  Lot # 2053179 exp. 5/2/2027.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Fall, Head injury, Headache, Limb injury
Clinical narrative: Administered first dose of HPV vaccine to patient after confirming no prior hx of syncope with blood draws or vaccines. Approximately 1-2 minutes post-vaccination I observed the patient just before she hit the floor, landing on her left shoulder and then hitting head - fall partially witnessed. Emergency cord pulled. Patient appeared unresponsive for approximately 30-45 seconds. Responded to verbal stimuli gradually. Two nurses and the provider arrived immediately to assist. Vitals assessed - BP 120/68, HR 66, RR unlabored, airway patent. She reported left shoulder pain and HA upon gaining full consciousness. Ice pack applied to left shoulder; water provided. Patient was slowly assisted into a sitting position on the floor, and then safely transferred to wheelchair. Provider spoke with mom about needing further evaluation in UC for xray. Patient was A/O, and stable at the time of transfer and was escorted to UC via wheelchair by self for further assessment.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine error, given at the wrong age
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Chills, Diarrhoea, Dyspnoea, Electrocardiogram normal
Clinical narrative: Patient developed chills, nausea, fever, diarrhea, shortness of breath the day after the vaccination. Now a week later seeing me she feels better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient developed chills, nausea, fever, diarrhea, shortness of breath the day after the vaccination. Now a week later seeing me she feels better.
Age: 2.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: My 2 year old daughter was supposed to receive a HEP A vaccination. The doctor's office contacted us after leaving to let us know that they had given her an HPV vaccination in error.
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: FEVER, LARGE BRUISE AT INJECTION SITE 5 INCHES IN SIZE.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: After receiving the vaccine pt became lightheaded and fainted. she was lain down on exam table and her feet were elevated. was assessed by provider. water and snack were provided. she was monitored for 20 minutes and was back at her baseline and was feeling fine when she left the office
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction reported by patient noted to be redness, hardened lump area, swelling, tender to touch, warm to touch.  patient did send photos via mychart
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance; This is a spontaneous report received from an Other HCP from product quality group.  No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: LN4930, Expiration Date: 31Jul2026) for immunisation. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance". Additional information: the reporter stated that they have Prevnar 20, a couple boxes of it. Confirmed that the product was not administered to patient. Noticed that there was a growth of some sort in the vial in the prefilled syringe. It was like a tan color substance.   Causality for "there was a growth of some sort in the vial, in the prefilled syringe; a tan color substance" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 60.0
Sex: M
Vaccine: COVID19, HEP, HEPA, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra dose of Comirnaty. Doses 20 days apart. No treatment. Patient states he is doing just fine. No problems.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC20, RV5
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pentacel was administered instead of giving ActHIB by itself. Consequently patient ended up receiving pediarix and pentacel the same day.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Pneumonia
Clinical narrative: Within one week, I had pneumonia
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Erythema, Swelling
Clinical narrative: Redness and Swelling
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of 11 year old vaccines (Tdap, Meningococcal, HPV). Previously received these vaccines in February 2025.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Blood test normal, Computerised tomogram head normal, Electroencephalogram abnormal, Febrile convulsion, Intensive care
Clinical narrative: fever and then complex febrile seizure resulting in 911 call and to ER and then admission to pediatric ICU
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Magnetic resonance imaging head normal, Postictal state, Pyrexia, Urine analysis normal
Clinical narrative: fever and then complex febrile seizure resulting in 911 call and to ER and then admission to pediatric ICU
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity
Clinical narrative: RN administered vaccine to patient. Patient reported feeling fine and appeared well. Moments after leaving the room patient fainted and fell from exam table, injuring her head. RN quickly returned to room to find patient was unconscious on the floor. Patient then became rigid, had muscle contractions, and urinary incontinence during the event. Vital signs were obtained, and patient was assessed by nursing and providers. Ice applied to head injury.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Urinary incontinence
Clinical narrative: RN administered vaccine to patient. Patient reported feeling fine and appeared well. Moments after leaving the room patient fainted and fell from exam table, injuring her head. RN quickly returned to room to find patient was unconscious on the floor. Patient then became rigid, had muscle contractions, and urinary incontinence during the event. Vital signs were obtained, and patient was assessed by nursing and providers. Ice applied to head injury.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Computerised tomogram normal, Condition aggravated, Electrocardiogram normal
Clinical narrative: Fever 100, extreme body aches for 24 hrs, 1 week later vertigo, followed in less than a week with raise in BP, (which had been very stable for two years) and headache. BP med changed. A week later BP still unstable. Now  June 30-appt made with primary for July 1. Daughter driving, vertigo worse. Had to stop on way- vomiting. Primary rerouted us to ER
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, Vertigo, Vomiting
Clinical narrative: Fever 100, extreme body aches for 24 hrs, 1 week later vertigo, followed in less than a week with raise in BP, (which had been very stable for two years) and headache. BP med changed. A week later BP still unstable. Now  June 30-appt made with primary for July 1. Daughter driving, vertigo worse. Had to stop on way- vomiting. Primary rerouted us to ER
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Fatigue
Clinical narrative: Patient got Prevnar 20 on April 02, 2025. Then she was calling us and want pneumonia shot. We   were so busy to check on database ...we gave her Prevnar again on June 29, 25.  I called her on Monday and Tuesday June 30 and July 1. I talked to her about this . She said she ok ..on Monday she was so tired but Tuesday she is back to normal.
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HPV vaccine was administered to a one year old patient.  No adverse reactions to report.  Only vaccine error.  Parents were notified by physician.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Was notified by my corporate pharmacy that the patient has received this vaccine twice in error. On 07/01/2005 and 02/16/2024. Patient has been notified.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling, Swelling face
Clinical narrative: patient was weak and had difficulty breathing for a few days. then immunization site was red, swollen and very itchy. patient took Tylenol for a few days, is still using ice and hydrocortisone 5 days later.  patient today had swelling on face near jawline, patient saw PCP today and was informed to take benadryl and ice. if swelling on face does not go down to followup with doctor in one week
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Body temperature increased, Heart rate increased
Clinical narrative: Owlet pulse oximeter alerted parents of critical high heart rate. Patient was observed to have 15-20 minutes of elevated heart rate 220-240BPM while at rest/asleep. Minimal temperature of 100.5 at the time. HR remained at about 165-170 for an additional 30 minutes before returning to her baseline of 130's. No symptoms of tachycardia since incident occured.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Rash papular
Clinical narrative: Patient had a red rash at injection site that was raised. Stated that it was a burning pain sensation. Told patient to keep an eye on the reaction if it gets bigger are swells to go to the doctor. In the meantime she can take ibuprofen or Tylenol to help with pain
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient experienced pain in left arm beginning after the shot. The pain has not gone away since time of injection.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pallor, Tinnitus, Vision blurred, Vomiting
Clinical narrative: Patient reported her ears were ringing, her vision was blurry, she was nauseous and vomited a small amount, she became pale in the face this happened about 2 minutes after the vaccine was given. A coke was provided, she declined peanut butter crackers. A fan was placed on patient, cold cloth on her neck and head. BP was taken twice, patient reported about 10 minutes after the vaccine she felt better.  4:15 blood pressure was 93/61 heart rate was 62, 4:19 blood pressure 96/73 heart rate 58. Patients color returned to her face and she was able to ambulate out of clinic with mom on her own.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Skin warm
Clinical narrative: PATIENT SAID HER ARM IS RED AND WARM TO THE TOUCH
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Erythema, Influenza virus test negative, Peripheral swelling, Respiratory syncytial virus test negative
Clinical narrative: Patient developed severe abdominal pain that started 3 days after vaccine that has not improved.  She also had redness and swelling of her arm that resolved after 1 week.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient developed severe abdominal pain that started 3 days after vaccine that has not improved.  She also had redness and swelling of her arm that resolved after 1 week.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Influenza, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: lump on injection site and very itchy; lump on injection site and very itchy; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; flu symptoms; pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 at 11:00 as dose 1, single (Lot number: LK6650) at the age of 60 years, in left arm for immunisation. The patient did not receive any other vaccines on the same date as the vaccine(s) for which the reporter is reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which the reporter is reporting. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SIMVASTATIN. The following information was reported: INFLUENZA (non-serious) with onset 25Jun2025, outcome "recovering", described as "flu symptoms"; VACCINATION SITE PAIN (non-serious) with onset 25Jun2025, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 26Jun2025, outcome "recovering" and all described as "injection site redness and site swelling that spread on the arm including pain"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Jun2025, outcome "recovering" and all described as "lump on injection site and very itchy". Therapeutic measures were not taken as a result of influenza, vaccination site pain, vaccination site erythema, vaccination site swelling, pain in extremity, erythema, peripheral swelling, vaccination site mass, vaccination site pruritus.  Additional information: On 25Jun2025 (day 2), the patient had flu symptoms and pain at the injection site. By 26Jun2025 (day 3), injection site redness and site swelling that spread on the arm including pain. By 27Jun2025 (day 4), all before and lump on injection site and very itchy.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: lump on injection site and very itchy; lump on injection site and very itchy; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; flu symptoms; pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 at 11:00 as dose 1, single (Lot number: LK6650) at the age of 60 years, in left arm for immunisation. The patient did not receive any other vaccines on the same date as the vaccine(s) for which the reporter is reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which the reporter is reporting. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SIMVASTATIN. The following information was reported: INFLUENZA (non-serious) with onset 25Jun2025, outcome "recovering", described as "flu symptoms"; VACCINATION SITE PAIN (non-serious) with onset 25Jun2025, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 26Jun2025, outcome "recovering" and all described as "injection site redness and site swelling that spread on the arm including pain"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Jun2025, outcome "recovering" and all described as "lump on injection site and very itchy". Therapeutic measures were not taken as a result of influenza, vaccination site pain, vaccination site erythema, vaccination site swelling, pain in extremity, erythema, peripheral swelling, vaccination site mass, vaccination site pruritus.  Additional information: On 25Jun2025 (day 2), the patient had flu symptoms and pain at the injection site. By 26Jun2025 (day 3), injection site redness and site swelling that spread on the arm including pain. By 27Jun2025 (day 4), all before and lump on injection site and very itchy.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Red ring around area vaccine was given.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Neuralgia, Periarthritis
Clinical narrative: frozen shoulder/ Lost mobility in his right arm/ could not lift it all the way above his head; it just did not stop hurting/ nerve pain; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), on 27Aug2024 as dose number unknown, single (Lot number: LM2222, Expiration Date: 24Mar2025), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 27Aug2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Immunisation; Covid shots (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PERIARTHRITIS (non-serious) with onset Sep2024, outcome "not recovered", described as "frozen shoulder/ Lost mobility in his right arm/ could not lift it all the way above his head"; NEURALGIA (non-serious) with onset Sep2024, outcome "not recovered", described as "it just did not stop hurting/ nerve pain". The event "it just did not stop hurting/ nerve pain" required physician office visit. Therapeutic measures were taken as a result of periarthritis, neuralgia.  Additional Information: The pharmacist gave the COVID shot straight in to the right arm of his wife, with him, he took an angle. It was like, he avoided the deltoid muscle. The patient had got frozen shoulder after two weeks, after receiving the shot. He had been to therapy and that was finished and they cannot help him anymore. He was just doing exercises but he had lost mobility in his right arm. After he received the COVID shot, within two week afterwards he started having problems with his right arm and did not know what was affecting and he could not lift it straight up and within 2 weeks time, he could not lift it all the way above his head. He can just lift it up to the side, he cannot lift it away from him, it was limited mobility. When he gave him the shot for the COVID, it was hurting. It was not so bad. He had to go to the hospital but it just did not stop hurting. He eventually had to see his general practitioner and she put him on Gabapentin to offset the nerve pain that the shot had given him and he was still taking it. The patient had shots given for years; flu and the COVID shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot #: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Pain in arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered", described as "Sore Arm/my arm might have been sore for a day or so and then it wasn't".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132661 same patient/suspect/events; different dose;US-PFIZER INC-PV202500077806 same patient/suspect/events; different dose;US-PFIZER INC-202500132660 same patient/suspect/events; different dose;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Lot #: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Pain in arm"; BNT162b2 (Dose 2, single, Lot #: EP6955), administration date: 21Mar2021, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "Pain in arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered", described as "Sore Arm/my arm might have been sore for a day or so and then it wasn't".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132661 same patient/suspect/events; different dose.;US-PFIZER INC-202500132659 same patient/suspect/events; different dose.;US-PFIZER INC-PV202500077806 same patient/suspect/events; different dose.;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm/my arm might have been sore for a day or so and then it wasn't; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered", described as "Sore Arm/my arm might have been sore for a day or so and then it wasn't".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500132661 same patient/suspect/events; different dose;US-PFIZER INC-202500132659 same patient/suspect/events; different dose;US-PFIZER INC-202500132660 same patient/suspect/events; different dose;US-PFIZER INC-202500130444 same patient/drug, different AE/dose;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COMIRNATY (primary immunisation series complete), for COVID-19 immunisation: the patient took the vaccine since it's been available, and every 6 months, and it's always been Pfizer. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "I have COVID". Therapeutic measures were taken as a result of vaccination failure, COVID-19: the patient was prescribed PAXLOVID the morning of this report. The patient specified that she had got symptoms pretty major- not major but quite a few symptoms. The patient took the Pfizer COVID vaccine a month prior to this report, and she had been up to date like every 6 months, and she did not understand why she was so sick.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Knee arthroplasty, Pain, Pyrexia, Vertigo
Clinical narrative: fever; sick; aches, pains; Vertigo She had an 8 hour episode and had to go the ER; knee replacement surgery in Jan; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0151) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing); "Blood pressure high" (ongoing); "Weight loss" (ongoing). Concomitant medication(s) included: ZEPBOUND taken for weight decreased (ongoing); NEVIBOLOL DCI taken for hypertension (ongoing); METHYLPHENIDATE taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: BNT162b2 (Dose 1, lot number: ER2613; in left arm, below shoulder, few inches below elbow), administration date: 17Mar2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "knee replacement surgery in Jan", "fever", "sick", "aches, pains". The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 21Jan2025, outcome "unknown", described as "knee replacement surgery in Jan"; VERTIGO (non-serious) with onset 07Mar2025, outcome "unknown", described as "Vertigo She had an 8 hour episode and had to go the ER"; PYREXIA (non-serious), outcome "recovered", described as "fever"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown", described as "aches, pains". The events "vertigo she had an 8 hour episode and had to go the er" required emergency room visit. The patient underwent the following laboratory tests and procedures: Weight: loss. Therapeutic measures were taken as a result of knee arthroplasty.  Clinical course: A patient on the line reporting on Comirnaty vaccine. She said recently received booster vaccine on 28Jun2025 and every time in the past she has gotten a fever in a few hours, but this time did not. She stated she had in past aches, pain, and fever so was surprised to not experience that this time. She also mentioned she had a knee replacement in Jan. She wondering if her vaccine is effective. She also clarified every time got the vaccine, she also gets the fever and aches within 10 hours or so and it would always last for a day or less, but this time did not. She has received both the Moderna and Pfizer vaccines, and this is the first time this did not happen. While capturing details she clarified at up until Jun2025 out of the 8 covid vaccines received only 2, the first two were manufactured by Pfizer. The rest were Moderna. Then this 9th one she just received was her 9th Covid Vaccine, and 3rd Pfizer vaccine manufactured by Pfizer.