chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Brain fog, Chills, Dizziness, Pyrexia
Clinical narrative: Fever, chills, dizziness, full body weakness, foggy thinking
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: 2 x 3 area of erythema at injection site, mild swelling and tenderness, warm to touch.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, RV5
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Day of vaccine: 2 hard knots under skin on LVL, swollen and red (mother has pics) Day 2:  little bumps to the site (mother has pictures) One week after decreased but now has black spots.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Decreased appetite, Irritability, Malaise, Pyrexia, Rash morbilliform
Clinical narrative: Developed Rubella Rash, Low Grade Fever, Malaise, Decrease Appetite, Fussy.
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Malaise
Clinical narrative: Patient also felt tired and general malaise for approximately 24 hours after the injection.; she had received CAPVAXIVE vaccine and experienced swelling and redness in her arm where the injection occurred. Patient also had some head and warmth in the arm at the injection site.; she had received CAPVAXIVE vaccine and experienced swelling and redness in her arm where the injection occurred. Patient also had some head and warmth in the arm at the injection site.; she had received CAPVAXIVE vaccine and experienced swelling and redness in her arm where the injection occurred. Patient also had some head and warmth in the arm at the injection site.; Patient also felt tired and general malaise for approximately 24 hours after the injection.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age (also reported as older than 50).   The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) injection, administered as prophylaxis, strength reported as: 168 mcg/ ml (Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency). On an unknown date, the patient experienced swelling and redness in her arm where the injection occurred (vaccination site swelling) (vaccination site erythema); had some head and warmth in the arm at the injection site (vaccination site warmth) and felt tired and general malaise for approximately 24 hours after the injection (fatigue) (malaise). On an unknown date, the patient recovered from all the events. The causal relationship between all the events with the suspect vaccine was not provided.
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; NSC Specialist transferred customer who reports a 13-month-old was inadvertently administered MMRII, PROQUAD and VARIVAX at the same time on 28APR2025.  No symptoms reported.  HCP agreed to correspondence. No additional AE/No PQC reported.; This spontaneous report was received from a Nurse and refers to a 13-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On 28-Apr-2025, the patient was inadvertently vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL, administered as prophylaxis (Lot No. Y007623 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 11-Apr-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); also with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA [recombinant Human albumin]) (PROQUAD), 0.5 mL, administered as prophylaxis (Lot No. Y012077 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 05-Jan-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided), and with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), 0.5 mL, administered as prophylaxis (Lot No. Y010045 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 29-May-2026) strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); all doses were reconstituted with sterile diluent (indication, Lot No., expiration date and route were not provided (accidental overdose). No additional adverse event was reported (No adverse event).
Age: 1.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Abnormal behaviour, Aphasia, Decreased eye contact, Depressed mood, Stereotypy
Clinical narrative: After vaccination, there were signs of injury including speech regression, loss of joy and happiness, and the development of odd behavior like arm flapping, eye contact avoidance etc.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Chest X-ray normal, Febrile convulsion, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: High fever (103.4) resulting in febrile seizure. Taken by ambulance to hospital where he was monitored for about four hours. Tests were run to determine the cause of the fever (chest x-ray, nasal swab, urinalysis), but nothing was abnormal in tests.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: High fever (103.4) resulting in febrile seizure. Taken by ambulance to hospital where he was monitored for about four hours. Tests were run to determine the cause of the fever (chest x-ray, nasal swab, urinalysis), but nothing was abnormal in tests.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I did get this vaccine, but I'm worried that I got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I did get this vaccine, but I'm worried that I got it). 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: 23-APR-2025 This case was reported by a patient via interactive digital media.  Patient did got this vaccine, but was worried that I got it. 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 Shingles vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Arthralgia, Flushing, Headache, Injection site erythema, Injection site pain
Clinical narrative: Returned to clinic for re-eval on 4/29/25. Tactile fever, headache, bodyaches 24 hours after injection. Progressed to (L) arm tenderness at injection site alongside erythema that started at 48 hours and progressed to time of visit. Unilateral left shoulder pain and bilateral cheek flushing. No angioedema, wheezing on exam concerning for anaphylaxis. Suspect delayed localized reaction. Treated with PRN hydroxizine and hydrocortisone 2.59. 6 cm of circular erythema with no induration to left deltoid. FNP-C
Age: 31.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Returned to clinic for re-eval on 4/29/25. Tactile fever, headache, bodyaches 24 hours after injection. Progressed to (L) arm tenderness at injection site alongside erythema that started at 48 hours and progressed to time of visit. Unilateral left shoulder pain and bilateral cheek flushing. No angioedema, wheezing on exam concerning for anaphylaxis. Suspect delayed localized reaction. Treated with PRN hydroxizine and hydrocortisone 2.59. 6 cm of circular erythema with no induration to left deltoid. FNP-C
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The medical assistant is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medications, past drug reactions and allergies were not reported.   On 21-APR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), 1 dosage form, administered as prophylaxis (lot number Y014436 has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date 22-FEB-2026; vaccination scheme frequency, anatomical site of injection, and route of administration were not provided), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not provided), after a temperature excursion (TE) at 5.5 degree Fahrenheit (F) up to 14.4 degree F for 40 minutes, and 14.5 degree F up to 46.4 degree F (15.8 degree F) for 10 minutes, with no previous TE (Product storage error). No additional adverse event was reported for the patient.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccine administered after temperature excursion; This spontaneous report was received from a Physician and refers to a 4-year-old female patient.   The patient's medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (DTAP), and Polio vaccine inact (IPV).   On 11-MAR-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose number 2, administered by Subcutaneous route in Left Thigh as prophylaxis (lot number Y017511 has been verified to be valid for Measles, Mumps, Rubella and Varicella [Oka-Merck] Virus Vaccine Live [PROQUAD], expiration date 15-APR-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date was not provided). The dose was administered after a temperature excursion (TE) that occurred at -9.8 degree Celsius (C) for 2 hours and 3 minutes, with no previous temperature excursion. No additional adverse event was reported for the patient.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: she had a stroke / hard for her to write now; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN INC-25-0118644-SR-01 (AMGEN INC), US-AMGEN-USASL2025083176 (AMGEN).  This serious solicited report (USASL2025083176) was reported to Amgen on 24/APR/2025 by a consumer from a commercial program  and involves a 74-year-old (Elderly) female patient who had a stroke / hard for her to write now  [PT: cerebrovascular accident] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, around three years ago, the patient had a stroke after taking a Covid vaccine injection. It was hard for her to write now due to stroke. No treatment information was received. The outcome of the events cerebrovascular accident was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event cerebrovascular accident. The causal relationship between the event cerebrovascular accident and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of "she had a stroke / hard for her to write now" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown and etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Amgen's Causality Assessment: The event Stroke was considered as unrelated to etanercept.  Enbrel is under agreement with Amgen.; Sender's Comments: There is not a reasonable possibility that the event stroke was related to the suspect drugs considering the products safety profile and pharmacokinetic characteristics. The event could most likely be due to patient underlying contributory factors. Detailed clinical course and complete medical history with any other concomitant medication would aid in comprehensive medical assessment. This case will be reassessed upon receipt of additional information.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Electric shock sensation, Hypoaesthesia, Malaise
Clinical narrative: Flare up of Rheumatoid Arthritis; Electrical shocks running down her arms and legs; Numbness/ Hands felt numb; Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them; Swollen hands and feet; Sick all over; Had no energy; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on unknown date). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   In FEB-2021, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (Verbatim: Flare up of Rheumatoid Arthritis) (serious criteria GSK medically significant), electric shock sensation (Verbatim: Electrical shocks running down her arms and legs), numbness in hand (Verbatim: Numbness/ Hands felt numb), tremor (Verbatim: Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them), peripheral swelling (Verbatim: Swollen hands and feet), sickness (Verbatim: Sick all over) and loss of energy (Verbatim: Had no energy). The outcome of the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy were resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix.     The company considered the rheumatoid arthritis aggravated to be unrelated to Shingrix. It was unknown if the company considered the electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix.   Linked case(s) involving the same patient:  US2021253751   Additional Information: GSK Receipt Date: 17-APR-2025 The reporter reported that within 12 hours of receiving the second dose of Shingrix, she began to experience a bad immune response.  The second dose of Shingrix was in February, 2021. Shingrix had triggered a flare up of her Rheumatoid Arthritis (RA). The patient experienced electrical shocks running down her arms and legs, her hands felt numb and she had no control over them.  Her legs would also shake uncontrollably.  Her hands and feet became swollen. The patient also reported she was sick all over, and had no energy.  The patient stated it took almost 1 year for her joints to be back to where they were before receiving Shingrix.; Sender's Comments: Rheumatoid arthritis aggravated  is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GLAXOSMITHKLINE-US2021253751:same patient saperet case is created due to time gap
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rheumatoid arthritis, Tremor
Clinical narrative: Flare up of Rheumatoid Arthritis; Electrical shocks running down her arms and legs; Numbness/ Hands felt numb; Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them; Swollen hands and feet; Sick all over; Had no energy; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on unknown date). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   In FEB-2021, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (Verbatim: Flare up of Rheumatoid Arthritis) (serious criteria GSK medically significant), electric shock sensation (Verbatim: Electrical shocks running down her arms and legs), numbness in hand (Verbatim: Numbness/ Hands felt numb), tremor (Verbatim: Uncontrollable shaking/ Legs would shake uncontrollably/she had no control over them), peripheral swelling (Verbatim: Swollen hands and feet), sickness (Verbatim: Sick all over) and loss of energy (Verbatim: Had no energy). The outcome of the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy were resolved.   It was unknown if the reporter considered the rheumatoid arthritis aggravated, electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix.     The company considered the rheumatoid arthritis aggravated to be unrelated to Shingrix. It was unknown if the company considered the electric shock sensation, numbness in hand, tremor, peripheral swelling, sickness and loss of energy to be related to Shingrix.   Linked case(s) involving the same patient:  US2021253751   Additional Information: GSK Receipt Date: 17-APR-2025 The reporter reported that within 12 hours of receiving the second dose of Shingrix, she began to experience a bad immune response.  The second dose of Shingrix was in February, 2021. Shingrix had triggered a flare up of her Rheumatoid Arthritis (RA). The patient experienced electrical shocks running down her arms and legs, her hands felt numb and she had no control over them.  Her legs would also shake uncontrollably.  Her hands and feet became swollen. The patient also reported she was sick all over, and had no energy.  The patient stated it took almost 1 year for her joints to be back to where they were before receiving Shingrix.; Sender's Comments: Rheumatoid arthritis aggravated  is an unlisted event which is considered unrelated to GSK vaccine Shingrix. US-GLAXOSMITHKLINE-US2021253751:same patient saperet case is created due to time gap
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: knocked her on butts out /noticed a weird sensation on my right thigh; sort of a vague areal pain. not an itch, more like a burning sensation; This non-serious case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   In APR-2025, the patient received the 2nd dose of Shingrix (right arm). In APR-2025, less than a week after receiving Shingrix, the patient experienced weird feeling (Verbatim: knocked her on butts out /noticed a weird sensation on my right thigh) and pain burning (Verbatim: sort of a vague areal pain. not an itch, more like a burning sensation). The outcome of the weird feeling was not resolved and the outcome of the pain burning was not reported.   It was unknown if the reporter considered the weird feeling and pain burning to be related to Shingrix.     It was unknown if the company considered the weird feeling and pain burning to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2025 The patient received the second dose of the Shingrix vaccine about two weeks ago in their right arm. It knocked him on the butt for 2 days, but got better.  About 5 days later the patient noticed a weird sensation on right thigh that has been persistent for 8 days now.  The patient had a sensation felt like a stinging pain whenever the hair follicles moved, which was very distracting. The patient had been trying to figure out if  he was bitten by a spider, (no visible bite), or if this is a side effect associated with the vaccine.  The pharmacist stated it feels like what his whole body felt like when he had just gotten the shot. The pharmacist enquired about the stinging kind of pain, the patient described sort of a vague areal pain and not an itch, more like a burning sensation. The pharmacist stated that any discussions should not be taken as medical advice, and individuals were referred to their healthcare provider as the primary resource for patient care.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I don't know when I got my first dose of the shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient had received 1st dose on unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I don't know when I got my first dose of the shingles shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 27-APR-2025 Patient reported via chatbot and stated that he/she don't know when they got first dose of the shingles shot. Also asked what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose? Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If it's been over 6 months since my first shingles shot, do I have to start over with 2 shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose over 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: If it's been over 6 months since my first shingles shot, do I have to start over with 2 shots). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 25-APR-2025 The patient reported that it had been over 6 months since the patient's first shingles shot and asked do he/she had to start over with 2 shots. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: had an itchy rash on his chest; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a 80-year-old male 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 itchy rash (Verbatim: had an itchy rash on his chest). The outcome of the itchy rash was not reported.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2025 The patient's wife reported this case. The patent (husband) and reporter were scheduled for second Shingrix shot in the next week and he had an itchy rash on his chest for more than a year.
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Higher than Approved Dose (Overdose); Extra dose administered; 2nd dose administered at longer interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received HBV (Engerix B) (batch number CT3Z7, expiry date 13-FEB-2027) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis and HBV (Engerix B) (batch number 4H297, expiry date 06-APR-2026) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 12-OCT-2023 with lot number-XS278, expiry date-17-Mar-2025) and Engerix B (3rd dose received on 05-SEP-2024 with lot number 92NK2, expiry date- 29-SEP-2026).   On 11-APR-2025, the patient received the 5th dose of Engerix B. On 05-MAR-2025, the patient received the 4th dose of Engerix B. On 12-MAR-2024, the patient received the 2nd dose of Engerix B. On 12-MAR-2024, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered at longer interval). On 05-MAR-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered). On 11-APR-2025, the patient experienced extra dose administered (Verbatim: Higher than Approved Dose (Overdose)). The outcome of the extra dose administered, extra dose administered and drug dose administration interval too long 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 : 21-APR-2025 Physician Assistant reported he/she had a patient who was given five vaccines for Hepatitis B, Engerix B and just wanted to go over any potential actions that should be take in place for any potential side effects from this. The patient received 2nd dose at longer interval than recommended which led to lengthening of vaccination schedule. The patient received 4th and 5th dose not as per schedule which led extra dose administered. The reporter did not consent to follow-up.
Vaccine: MMR
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: received second dose of Priorix intramuscularly instead of subcutaneous; Adult patient received Priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a adult patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 28-APR-2025, the patient received the 2nd dose of Priorix (intramuscular). On 28-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received second dose of Priorix intramuscularly instead of subcutaneous) and inappropriate age at vaccine administration (Verbatim: Adult patient received Priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration 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: 28-APR-2025 The pharmacist reported that an adult patient received second dose of Priorix intramuscularly instead of subcutaneous, which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration
Age: 78.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Night sweats, Rash
Clinical narrative: Woke up in morning with severe fatigue, next day develop fever of 100, then rash appeared all over my body and I developed diarrhea.  I still am ver fatigued, rash is still present and stomach still painful.  Also have had night sweats
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Condition aggravated
Clinical narrative: arm swollen, red and pain spread to elbow and armpit.  Fever, chills, bodyaches, shaky, back, pain, shoulder pain, vomit, dizzy,  extreme fatigue, insomnia, muscle and joint pain more pronounced than usual.  Symptoms started 4 hours after injection on April 1st and still having pain and fatigue.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Erythema, Fatigue, Insomnia, Myalgia
Clinical narrative: arm swollen, red and pain spread to elbow and armpit.  Fever, chills, bodyaches, shaky, back, pain, shoulder pain, vomit, dizzy,  extreme fatigue, insomnia, muscle and joint pain more pronounced than usual.  Symptoms started 4 hours after injection on April 1st and still having pain and fatigue.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: arm swollen, red and pain spread to elbow and armpit.  Fever, chills, bodyaches, shaky, back, pain, shoulder pain, vomit, dizzy,  extreme fatigue, insomnia, muscle and joint pain more pronounced than usual.  Symptoms started 4 hours after injection on April 1st and still having pain and fatigue.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Vomiting
Clinical narrative: arm swollen, red and pain spread to elbow and armpit.  Fever, chills, bodyaches, shaky, back, pain, shoulder pain, vomit, dizzy,  extreme fatigue, insomnia, muscle and joint pain more pronounced than usual.  Symptoms started 4 hours after injection on April 1st and still having pain and fatigue.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Unnecessary vaccines given due to receiving vaccines 4/22/2025. Paperwork (work-up) done before 4/22/2025, student needing all vaccines. Database not checked again, gave all "needed" vaccines. Educated CNA that paperwork cannot be done more than a week in advance due to students receiving vaccines at other places. All vaccines entered into database. This all took place at a school vaccine clinic via the immunization team.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Student was administered unnecessary doses of Pediarix (Dtap, Hep B, Polio). Nurse completed the record review of student and missed a vaccine record in student education profile. the vaccine record was not entered into database or EHR. Nurse then entered vaccine records from profile into database and EHR. the Dtap vaccine was flagged "age too young," Hep B, Polio, and MMR was not flagged, however they were extra doses.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 12/11/2024
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC20, VARCEL
Symptoms: Product preparation error
Clinical narrative: A Hib vaccine was administered to a patient using sterile water as a diluent instead of the manufacturer -supplied - Hib specific diluent. The parent of the child will be contacted and advised to return to the clinic for proper revaccination. No adverse events were observed or reported at the time of submission.
Age: 51.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Ultrasound abdomen
Clinical narrative: After receiving the vaccination patient developed swelling, redness and warmth to her left upper extremity.  This continued to worsen over 1 to 2 days.  It did not seem to improve and then worsened again and is spreading towards the inner arm. She presented to my clinic and it appeared she had a vaccine reaction and then developed a superimposed cellulitis.  Point-of-care ultrasound demonstrated cobble stoning consistent with cellulitis. She was treated with BActim.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Peripheral swelling, Skin warm
Clinical narrative: redness, warmth, swelling over left arm; worsening over last 2d; fatigue
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Headache, Seizure like phenomena, Staring, Tremor
Clinical narrative: Around 30 seconds after she got her HPV and Menquadfi vaccines (in that order) , she fell back on the exam table and had a brief episode of general shakiness, seizure -like, had a blank look in her eyes. This spell was witnessed by her mother and the medical assistant who is the one that gave the vaccines. It lasted around 2-3 seconds as per both observants, after which she made eye contact and stated that her head hurt. At that time, I was called to the room, checked vitals at 4:17 pm (4/30/25), were stable. Observed her for around 20 min, in that process her vitals were checked again, they were still normal. She stated she felt fine, walked in the room.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given adult Hep A instead of Pedi Hep A
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Ear pain, Pain in extremity, Pain in jaw
Clinical narrative: I had my Tdap given by our associate health on 4/23/25. Next morning noted mild left side jaw pain and arm pain yet I thought this was all normal. I took Aleve which helped. The arm pain lessened yet left jaw pain has worsen and now hurting into my left ear. No teeth pain just the jaw. taking Aleve helps a bit yet opening mouth causes more pain to jaw.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Large area of edema to L shoulder at injection site extending to mid-arm , skin tense and hot w/overlying erythema extending from shoulder to elbow, but w/o fluctuance or induration. Pt treated with cephalexin to cover for cellulitis.
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Erythema, Fatigue, Myalgia, Pyrexia
Clinical narrative: FEVER, JOINT AND MUSCLE PAIN, FATIGUE, PAINFUL SWOLLEN RED AREA ON LEFT SIDE OF NECK THAT MIGRATES DOWN TO LEFT CHEST MEASURING 6X8 INCHES.  BEGAN TREATING SYMPTOMS WITH TYLENOL 1000MG BID - TID.  BEGAN AUGMENTIN 875MG BID X 10DAYS,  BEGAN ZYRTEC 10MG DAILY ON 04/30/2025.
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Swelling
Clinical narrative: FEVER, JOINT AND MUSCLE PAIN, FATIGUE, PAINFUL SWOLLEN RED AREA ON LEFT SIDE OF NECK THAT MIGRATES DOWN TO LEFT CHEST MEASURING 6X8 INCHES.  BEGAN TREATING SYMPTOMS WITH TYLENOL 1000MG BID - TID.  BEGAN AUGMENTIN 875MG BID X 10DAYS,  BEGAN ZYRTEC 10MG DAILY ON 04/30/2025.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Electrocardiogram normal, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Pt reported dizziness about 7 min s/p injection. Had tolerated previous vaccination without difficulty. Hadn't eaten breakfast, no other variables that were suspicious. Pt reported ringing in ears, nausea, vomited x1, darkened/starry vision, appeared pale with dusky lips and appeared diaphoretic. Responded to laying down, time. EKG WNL. Initially BP 60/37 HR 101, improved to WNL s/p laying down and eating snack.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Photopsia, Skin discolouration, Tinnitus, Visual impairment, Vomiting
Clinical narrative: Pt reported dizziness about 7 min s/p injection. Had tolerated previous vaccination without difficulty. Hadn't eaten breakfast, no other variables that were suspicious. Pt reported ringing in ears, nausea, vomited x1, darkened/starry vision, appeared pale with dusky lips and appeared diaphoretic. Responded to laying down, time. EKG WNL. Initially BP 60/37 HR 101, improved to WNL s/p laying down and eating snack.
Age: 66.0
Sex: M
Vaccine: PNC21
Symptoms: Abdominal discomfort, Blood pressure increased, Feeling abnormal
Clinical narrative: Patient says he felt sick to his stomach , and had elevated blood pressure for over an hour.  He says he felt he was going to die.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Loss of consciousness, Pain in extremity, Pyrexia
Clinical narrative: 4/28/2025 at 0830 Moderna COVID-19 Spikevax administered to L deltoid. Later that same day L arm soreness developed with progression to fever in the evening.  4/29/2025 at 0500 woke feeling lightheaded, disoriented, blacking out with hives present on L wrist. At 0700 woke for work- hives present systemically. Presented to urgent care and was directed to the ED. Caregiver reports passing out at check-in. Admitted through ED for 1 night observation.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 4/28/2025 at 0830 Moderna COVID-19 Spikevax administered to L deltoid. Later that same day L arm soreness developed with progression to fever in the evening.  4/29/2025 at 0500 woke feeling lightheaded, disoriented, blacking out with hives present on L wrist. At 0700 woke for work- hives present systemically. Presented to urgent care and was directed to the ED. Caregiver reports passing out at check-in. Admitted through ED for 1 night observation.
Age: 1.75
Sex: F
Vaccine: DTPPVHBHPB, HEPA, HIBV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Administered Dtap Vaxelis(combination) instead of Dtap only. Also administered HIB, HepA, pneumococcal (prevnar 20) during visit. Failed to scan vaccine out before administering.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, warmth
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Heavy menstrual bleeding, Impaired work ability, Polymenorrhoea, Pruritus
Clinical narrative: I've had two reactions: within a day of getting the vaccine I got my period over a week early, and it as extremely heavy (filling tampons more than twice as fast as usual), and period lasted twice as long as normal.  Second reaction a week and a half later (April 28) was full body hives that bruised, swelled, and itched terribly. I got hives anywhere something rubbed against my skin, requiring a trip to urgent care, a prescription medication, and I haven't been able to work for three days and counting.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: I've had two reactions: within a day of getting the vaccine I got my period over a week early, and it as extremely heavy (filling tampons more than twice as fast as usual), and period lasted twice as long as normal.  Second reaction a week and a half later (April 28) was full body hives that bruised, swelled, and itched terribly. I got hives anywhere something rubbed against my skin, requiring a trip to urgent care, a prescription medication, and I haven't been able to work for three days and counting.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient given pediatric dose of Vaqta Hep A vaccine. Patient to return to practice 5/2/25 to receive remainder of adult dose. No reactions noted.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth
Clinical narrative: Patient called reporting quarter sized red warm spot where injection site occurred. Pharmacist counseled patient to monitor area and have doctor evaluate arm to determine reaction to vaccine or infection. Patient will call doctor today 5/1/2025
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm injection from 4/21/25 when received the pneumococcal vaccine.  Pt reports area swelling, redness and occasional itching.  Onset 4/28/25  Patient evaluated by provider on 5/30/25. There is a 5 x 7 area of mild erythema left deltoid region with mild centralized tenderness and no palpable abnormality, induration or fluctuance.  No significant edema or increased warmth.  Patient advised to observe for any other changes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: painful arm and unable to lift arm after vaccine
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Full blood count normal, Injection site rash, Injection site scab, Pyrexia
Clinical narrative: Parent reports onset of facial redness, rash and swelling around 1300 the day of vaccine. Progressive into the evening. Parent recorded fever of 101F at 8:00pm day of vaccines. Woke morning after, 5/1/25, with fever 103.8F and up to 105F, progressive facial rash, swelling, rash to right arm and abdomen. Parent provided with oral dose ibuprofen at home. Parent called clinic to make same day visit. Child presented to clinic 5/1/2025 at 8:20 am with red diffuse, fine papular facial rash with swelling.  Fever 101.f, ibuprofen 1 hour prior at home. Tachycardic. Normotensive.  Rash to right arm distal to injection site surrounding previously healing small scab/wound present prior to vaccines. Scattered streaky fine red papular rash to abdomen.  No airway or acute circulatory compromise.  Mild clear rhinorrhea on exam.  Sent home with monitoring instructions, supportive cares with antipyrectics and cetirizine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash papular, Rhinorrhoea, Swelling face
Clinical narrative: Parent reports onset of facial redness, rash and swelling around 1300 the day of vaccine. Progressive into the evening. Parent recorded fever of 101F at 8:00pm day of vaccines. Woke morning after, 5/1/25, with fever 103.8F and up to 105F, progressive facial rash, swelling, rash to right arm and abdomen. Parent provided with oral dose ibuprofen at home. Parent called clinic to make same day visit. Child presented to clinic 5/1/2025 at 8:20 am with red diffuse, fine papular facial rash with swelling.  Fever 101.f, ibuprofen 1 hour prior at home. Tachycardic. Normotensive.  Rash to right arm distal to injection site surrounding previously healing small scab/wound present prior to vaccines. Scattered streaky fine red papular rash to abdomen.  No airway or acute circulatory compromise.  Mild clear rhinorrhea on exam.  Sent home with monitoring instructions, supportive cares with antipyrectics and cetirizine.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Autoantibody negative
Clinical narrative: The patient had a negative titer drawn on 02/11/22. She was then given the Heplisav- 2 shot series which was completed 05/09/22. She should have had another titer drawn a month after her last dose, however, she did not. Today the nurse interpreted the information that the patient had her series completed and the titer came back as negative. The nurse was going to repeat the Hep B (Heplisav) series and have a titer redrawn. After administering the first dose of the second inoculation series the nurse noticed that the first series was given after the negative titer. Therefore, the patient received a booster when all she needed was another titer drawn to determine immunity.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Severe diarrhea, started 15 hours after I got the vaccine.   Very weak, no appetite.   Was up about 25 times during the night to the bathroom.  I?m  forcing myself to eat.  Dull headache.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Electrocardiogram normal, Electroencephalogram normal, Full blood count
Clinical narrative: On 3/4/25, he was not feeling well.  Caretaker heard a scream, and found sitting on the toilet, stiff.  He seemed unresponsive for a few minutes, and then was groggy.  He was seen in the ER, where an EKG showed sinus rhythm.  CBC with diff, CMP, TSH on 3/5/25 did not reveal a cause.  Video EEG on 3/6/25 did not show seizure activity.  No further episodes happened after the one described.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Malaise, Metabolic function test, Musculoskeletal stiffness, Screaming, Somnolence
Clinical narrative: On 3/4/25, he was not feeling well.  Caretaker heard a scream, and found sitting on the toilet, stiff.  He seemed unresponsive for a few minutes, and then was groggy.  He was seen in the ER, where an EKG showed sinus rhythm.  CBC with diff, CMP, TSH on 3/5/25 did not reveal a cause.  Video EEG on 3/6/25 did not show seizure activity.  No further episodes happened after the one described.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Thyroxine free, Unresponsive to stimuli
Clinical narrative: On 3/4/25, he was not feeling well.  Caretaker heard a scream, and found sitting on the toilet, stiff.  He seemed unresponsive for a few minutes, and then was groggy.  He was seen in the ER, where an EKG showed sinus rhythm.  CBC with diff, CMP, TSH on 3/5/25 did not reveal a cause.  Video EEG on 3/6/25 did not show seizure activity.  No further episodes happened after the one described.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Dehydration, Full blood count, Metabolic function test, Pain
Clinical narrative: Patient had severe body aches and weakness at the end of the day following vaccines. Patient was taken to the emergency room by her mother. In the emergency room patient was diagnosed with dehydration and body aches. Patient received toradol and 1 L NS. Patient's symptoms improved while in the ER and was discharged.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pregnancy test, Urine analysis
Clinical narrative: Patient had severe body aches and weakness at the end of the day following vaccines. Patient was taken to the emergency room by her mother. In the emergency room patient was diagnosed with dehydration and body aches. Patient received toradol and 1 L NS. Patient's symptoms improved while in the ER and was discharged.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Muscle Pains and Headache
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Immediately after receiving the vaccination, patient felt lightheaded and needed to lie down. Shortly after lying down, the patient had a brief loss of consciousness with seizure activity. After about 30 seconds, patient regained consciousness and complained of headache and nausea. Clinic Triage nurses and patient Primary care provider were called in to assist patient. Patient mother agreed to take the patient to the local hospital ER for stabilization and further evaluation.