chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Gait disturbance, Pain, Swelling
Clinical narrative: Client called local health department 4/18/24. Wanted to report adverse reaction to RSV vaccine given back in December. States morning after recieving the vaccine, could barely walk. full body aches,   and shoulder swollen 5 times the size it normally is. States knees have hurt for 6 weeks post vaccination. states never had sore knees before.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Abdominal pain, Arthralgia, Gait disturbance, Ligament pain, Mobility decreased
Clinical narrative: Client called local health department 4/18/24. Wanted to report adverse reaction to RSV vaccine given back in December. States morning after recieving the vaccine, could barely walk. full body aches,   and shoulder swollen 5 times the size it normally is. States knees have hurt for 6 weeks post vaccination. states never had sore knees before.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscle spasms, Myalgia, Pain, Pain in extremity, Sciatica
Clinical narrative: Client called local health department 4/18/24. Wanted to report adverse reaction to RSV vaccine given back in December. States morning after recieving the vaccine, could barely walk. full body aches,   and shoulder swollen 5 times the size it normally is. States knees have hurt for 6 weeks post vaccination. states never had sore knees before.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Swelling, Tendon pain
Clinical narrative: Client called local health department 4/18/24. Wanted to report adverse reaction to RSV vaccine given back in December. States morning after recieving the vaccine, could barely walk. full body aches,   and shoulder swollen 5 times the size it normally is. States knees have hurt for 6 weeks post vaccination. states never had sore knees before.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No reactions
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose of Engerix-B given to an adult.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Heart rate increased, Hyperhidrosis, Injection site erythema
Clinical narrative: the morning after vaccine woke up diaphoretic, with increased heart rate with movement, headache and anorexia. There was swelling and redness at the injection site. These symptoms lasted from 04/16/24 am until 04/18/24 pm. No medications or treatments given.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: the morning after vaccine woke up diaphoretic, with increased heart rate with movement, headache and anorexia. There was swelling and redness at the injection site. These symptoms lasted from 04/16/24 am until 04/18/24 pm. No medications or treatments given.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Diarrhoea, Flushing, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Mother called 4/17/24 and reported that patient's left arm had been swollen and red from injection site to the elbow. Mother also reported that patient had a fever and watery diarrhea on 4/9/24, the day after vaccines were administered. Mother reported patient was sent home from daycare on 4/17/24 due to having flushed cheeks and not feeling well and the daycare sent patinet home and told the mother to call and report symptoms to the health department since patient had vaccines the week prior. This nurse asked mother if patient currently had fever and she reported patient did not have fever and that the swelling and redness had cleared up that she only had symptoms the day following the vaccine. Patient did not require treatment. This nurse educated mom that the reactions were common, but if patient had become worse to follow up with primary care provider. Mother wanted the reaction to be listed in chart. This nurse added a note in chart and stated a Vaers report would also be submitted.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Mother called 4/17/24 and reported that patient's left arm had been swollen and red from injection site to the elbow. Mother also reported that patient had a fever and watery diarrhea on 4/9/24, the day after vaccines were administered. Mother reported patient was sent home from daycare on 4/17/24 due to having flushed cheeks and not feeling well and the daycare sent patinet home and told the mother to call and report symptoms to the health department since patient had vaccines the week prior. This nurse asked mother if patient currently had fever and she reported patient did not have fever and that the swelling and redness had cleared up that she only had symptoms the day following the vaccine. Patient did not require treatment. This nurse educated mom that the reactions were common, but if patient had become worse to follow up with primary care provider. Mother wanted the reaction to be listed in chart. This nurse added a note in chart and stated a Vaers report would also be submitted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chills, Neck pain, Thyroiditis subacute
Clinical narrative: Subacute thyroiditis following Shingrix vaccination, with chills, elevated CRP and anterior neck pain
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Covid 19 moderna vaccine 12 years and above was given 0.5ml to 11 year old patient in error. Correct dosage was not given of 0.25ml. The patient did not have any adverse symptoms
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave patient moderna vaccine 12 years  and up 0.5ml instead of the 6-11years old 0.25ml, no adverse symptoms
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Lethargy, Nausea, Peripheral swelling
Clinical narrative: arm swollen; lethargic, Nausea, fatigue
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Injection site pain, Lethargy
Clinical narrative: arm swollen; lethargic, Nausea, fatigue
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: arm swollen; lethargic, Nausea, fatigue
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Pain, Purulent discharge, Pyrexia
Clinical narrative: Patient states she had fever, chills, body aches right after vaccine and within 24 hours developed sinus congestion/infection, thick green mucus in lungs and sinuses. Patient saw provider and was prescribed antibiotics for sinus infection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinitis, Sinus congestion, Sinusitis
Clinical narrative: Patient states she had fever, chills, body aches right after vaccine and within 24 hours developed sinus congestion/infection, thick green mucus in lungs and sinuses. Patient saw provider and was prescribed antibiotics for sinus infection.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received the TDAP vaccine on 4/16/24 on the left arm. The next day, 4/17/24, pt stated that her arm was swollen. On 4/18/24, the pt came into clinic to receive her Hepatitis B vaccine and clinic noticed that the L arm was still red and swollen (compared to a softball)-pt felt tingling in her left arm. Pt stated that she felt that she could not feel her arm and had pain radiate from the tip of her thumb up to her neck. Today, the arm is not as painful or swollen as yesterday though feels itchy and really hot at the insertion area. Pt can move left arm. Pt denies loss of feeling in the L arm. Pt denies SOB/chest pain/throat closing/hives. Pt sent picture to RN and insertion area is red and slightly swollen (circular) about the size of a small orange. Pt's vaccine looks to be given below anterior axillary line.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Pt received the TDAP vaccine on 4/16/24 on the left arm. The next day, 4/17/24, pt stated that her arm was swollen. On 4/18/24, the pt came into clinic to receive her Hepatitis B vaccine and clinic noticed that the L arm was still red and swollen (compared to a softball)-pt felt tingling in her left arm. Pt stated that she felt that she could not feel her arm and had pain radiate from the tip of her thumb up to her neck. Today, the arm is not as painful or swollen as yesterday though feels itchy and really hot at the insertion area. Pt can move left arm. Pt denies loss of feeling in the L arm. Pt denies SOB/chest pain/throat closing/hives. Pt sent picture to RN and insertion area is red and slightly swollen (circular) about the size of a small orange. Pt's vaccine looks to be given below anterior axillary line.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered at inappropriate site
Clinical narrative: Pt received the TDAP vaccine on 4/16/24 on the left arm. The next day, 4/17/24, pt stated that her arm was swollen. On 4/18/24, the pt came into clinic to receive her Hepatitis B vaccine and clinic noticed that the L arm was still red and swollen (compared to a softball)-pt felt tingling in her left arm. Pt stated that she felt that she could not feel her arm and had pain radiate from the tip of her thumb up to her neck. Today, the arm is not as painful or swollen as yesterday though feels itchy and really hot at the insertion area. Pt can move left arm. Pt denies loss of feeling in the L arm. Pt denies SOB/chest pain/throat closing/hives. Pt sent picture to RN and insertion area is red and slightly swollen (circular) about the size of a small orange. Pt's vaccine looks to be given below anterior axillary line.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt did not have an adverse reaction to vaccine. Pt was administered  an expired vaccine.  The vaccine had expired a day prior to being administered. Pt has been notified and the recommendation is to repeat dose.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received a pediatric dose of this vaccine instead of an adult dose.
Age: 22.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness at the injection site that is painful. It is a huge bump. Taking benadryl and prednisone
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt had no adverse effect. Wrong dose was administered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Flushing, Headache, Hypoaesthesia
Clinical narrative: Big red blith 2 inch below injection sight. Feels like a bad burn. Painful to touch. 3 days later the blisters popped up in the red area and became very sick. Vomiting.  Headache.  Body aches. Diarrhea.  Fever. Pain in rash area. Chills. Numbness and pin like needles tingling in hands. Flush. Went to pharmacy and then doctor.  Taking steroids and .deep pain at rash sight.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Malaise, Pain
Clinical narrative: Big red blith 2 inch below injection sight. Feels like a bad burn. Painful to touch. 3 days later the blisters popped up in the red area and became very sick. Vomiting.  Headache.  Body aches. Diarrhea.  Fever. Pain in rash area. Chills. Numbness and pin like needles tingling in hands. Flush. Went to pharmacy and then doctor.  Taking steroids and .deep pain at rash sight.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Rash, Vomiting
Clinical narrative: Big red blith 2 inch below injection sight. Feels like a bad burn. Painful to touch. 3 days later the blisters popped up in the red area and became very sick. Vomiting.  Headache.  Body aches. Diarrhea.  Fever. Pain in rash area. Chills. Numbness and pin like needles tingling in hands. Flush. Went to pharmacy and then doctor.  Taking steroids and .deep pain at rash sight.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Gastroenteritis viral, Herpes zoster, Swelling, Tenderness
Clinical narrative: Big red blith 2 inch below injection sight. Feels like a bad burn. Painful to touch. 3 days later the blisters popped up in the red area and became very sick. Vomiting.  Headache.  Body aches. Diarrhea.  Fever. Pain in rash area. Chills. Numbness and pin like needles tingling in hands. Flush. Went to pharmacy and then doctor.  Taking steroids and .deep pain at rash sight.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site bruising, Injection site reaction, Injection site scab, Injection site streaking, Injection site vesicles
Clinical narrative: Patient mother reached out to provider to report that she developed a red rash with blisters and fever after receiving MMR-V vaccine at 4 year well child check.  Mother noted fever is not unusual but there was a red streak going towards anterior thigh. Provider directed to stay course and offer Tylenol/ibuprofen for comfort and to follow up for new or worsening symptoms.  Patient mom later notes that site was bruised but blisters scabbed and healed.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Patient mother reached out to provider to report that she developed a red rash with blisters and fever after receiving MMR-V vaccine at 4 year well child check.  Mother noted fever is not unusual but there was a red streak going towards anterior thigh. Provider directed to stay course and offer Tylenol/ibuprofen for comfort and to follow up for new or worsening symptoms.  Patient mom later notes that site was bruised but blisters scabbed and healed.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Swelling, Vomiting
Clinical narrative: Adverse reaction to DTaP. Started within hours of encounter yesterday, Nausea , vomiting, large swelling (of 4 cm circular with some raising.) I sent the patient to the ER (4/19/24). Patient breathing well.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: arm swelling, face swelling
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Pain in extremity, Swelling
Clinical narrative: A patient, presents with soreness in their arm. They report that the soreness is located around the area where they received a an imunization on Tuesday. The patient denies experiencing hives, fevers, difficulty swallowing, or any other concerning symptoms. They mention feeling fine overall, but the affected area feels hot and swollen. Allergies:  No known allergies
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Feeling hot, Injection site pain, Injection site warmth
Clinical narrative: A male patient, presents with pain and heat in one arm. The other arm is also reported to be hot but without issues. The patient's father confirms the presence of pain and heat in the affected arm. The patient's mother states that she can see the pain in the patient's face. The current symptoms may be related to a recent vaccination or a skin infection. The patient denies any other symptoms or discomfort. No fevers.  Allergies:  No known allergies
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash, Varicella virus test positive
Clinical narrative: Rash, multiple blisters
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: PATIENT RECIVED VACCINE IN CLINIC ROOM AND APPROXIMATELY 5 MINTES LATER WAS CALLED TO CHECK OUT WINDOW DUE TO PATIENT PASSING OUT/FAINTED.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt injection site became swollen, warm and red over the first two days after vaccine. She said it was painful and went to Dr. office on 4/19/23 Where they marked red area and are monitoring its growth. She also received and Antibiotic incase of cellulitis
Age: 62.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Cellulitis, Erythema, Injection site reaction, Oedema peripheral, Tenderness
Clinical narrative: L arm erythema, edema, tenderness x 4 days. No systemic symptoms. Suspect cellulitis vs injection site reaction. Treated with Cephalexin 500mg  QID x 5 days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Oedema peripheral
Clinical narrative: Patient was administered Comirnaty on 4/15/2024. Patient came back on 4/19/2024 to the pharmacy reporting swelling of the injection site and swelling underneath by the armpit. Patient stated side effects started to occur 48 hours after administration. Patient counseled that swollen lymph nodes by the armpit are a reported side effect by the CDC for the COVID vaccination. Patient said she has been taking Tylenol but not working. Asked patient to see reaction but did not show me. Referred patient to primary care provider for additional treatment/questions.
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Rash, Varicella virus test positive
Clinical narrative: Rash, multiple blisters
Age: 72.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: patient presented 4/19 in afternoon (1 day following vaccinations) with redness and itchiness throughout the body, but declined symptoms of throat swelling/difficulty breathing. injection sites appeared red and raised, but denied painful. patient planned to take zyrtec and follow-up with primary. patient aware to take benadryl and report to hospital if symptoms of throat swelling start to appear
Age: 48.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I TALKED TO PATIENT SHE SAID SHE DID  NOT HAVE ANY ADVERSE EFFECT I HAD TO FILL OUT THIS FORM PER MY DISTRIC MANAGER BECAUSE VACCINES WAS GIVEN TO A PATIENT AT THE AGE OF 48 REQUIREMENT FOR THIS VACCINE IS AGE 60
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: MA Pulled Dtap instead of TDAP for patient
Age: 36.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction.  The vaccination is recommended for ages 12 months -12 years.  The vaccination was given to a 36 year old.   Merck was contacted today, 04/19/2024.  Merck Advised that this was a Misuse of Vaccination, rather than an Adverse Reaction and that , although this is considered off-label use, the CDC recommends that the vaccine may be counted towards completion of the vaccine series and does not need to be repeated.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC15
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: HIB was administered and mixed with sterile diluent.  Only 0.75ml given of 1ml mixture. Patient did not experience any adverse outcomes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash
Age: 16.0
Sex: M
Vaccine: COVID19, MENB
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 16 year old patient received covid vaccine designated for patients 6 months old through 11yrs old instead of receiving covid vaccine designated for patients 12yrs and older. Consulted with Regional Immunization Nurse for DPH, who advised patient to have a second dose of covid vaccine for patients 6mos through 11yrs old today or receive the covid vaccine for 12yrs and older on any other day. Called patient's mother, informed her of incident, and explained DPH recommendations to her. Mother said patient is not available today but she will have patient come to clinic next week for the one dose of covid vaccine for patients 12yrs and older.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, X-ray limb
Clinical narrative: righ upper arm pain at approx 2 weeks and 5 weeks after shot.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third dose of Hib vaccine administered on 07-MAY-2002 at the age of 7 months; This spontaneous report has received from an other health professional, via medical records (immunization records) from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (2402USA007091), concerning a 7-month-old female patient. The patient's medical history and current conditions were not provided. Her concomitant vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV), hepatitis b vaccine (HEPATITIS B [HEPATITIS B VACCINE]), and pneumococcal vaccine conj 7v (crm197) (PREVNAR).  On 15-NOV-2001 and 24-JAN-2002, respectively, the patient was vaccinated with the first and second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (reported as Hib (Hib1) vaccine; dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis at a clinic.  On 07-MAY-2002, at the age of 7 months, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (reported as Hib (Hib1) vaccine; dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis at a clinic (Inappropriate age at vaccine administration).  This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2402USA007091:
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hepatitis B vaccine administration: first dose on 15-NOV-2001, second dose on 24-JAN-2002, third dose on 09-SEP-2002; hepatitis B vaccine administration: first dose on 15-NOV-2001, second dose on 24-JAN-2002, third dose on 09-SEP-2002; This spontaneous report has received from an other health professional, via medical records (immunization records) from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (2402USA007091), concerning a 4-month-old female patient. The patient's medical history and current conditions were not provided. Her concomitant vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), hib vaccine (HIB), polio vaccine inact (IPV), and pneumococcal vaccine conj 7v (crm197) (PREVNAR).  On 15-NOV-2001, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as hepatitis B (hep B) ped/adol vaccine; dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis at a pediatric clinic.  On 24-JAN-2002, she was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as hepatitis B (hep B) ped/adol vaccine; dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis at a pediatric clinic (Inappropriate schedule of vaccine administered).  On 09-SEP-2002, she was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as hepatitis B (hep B) ped/adol vaccine; dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis at a pediatric clinic (Inappropriate schedule of vaccine administered).  This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2402USA007091:
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Rubella antibody positive, Thyroid function test abnormal
Clinical narrative: She received SHINGRIX, an unspeciifed time after receiving "MMR", she experienced an injection site reaction characterized by redness, swelling, and the area being warm to touch.; She received SHINGRIX, an unspeciifed time after receiving "MMR", she experienced an injection site reaction characterized by redness, swelling, and the area being warm to touch.; She received SHINGRIX, an unspeciifed time after receiving "MMR", she experienced an injection site reaction characterized by redness, swelling, and the area being warm to touch.; Unspecified thyroid level drawn on 01-MAR-2024 and her level was a "little over".; This spontaneous report has been received from the patient referring to herself, a 72-year-old female patient.  The patient's medical history and concurrent conditions were not reported. It was reported that since unspecified date (reported as "for the past five years"), she had been on an unspecified thyroid medication, however, she did not provide the reason for the start of the thyroid medication.   On an unspecified date in 2014, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiration date, route of administration and anatomical location were not provided); and with varicella zoster vaccine rge (cho) (SHINGRIX), (formulation, strength, dose, frequency, indication, lot #, expiration date, route of administration and anatomical location were not provided).  On an unspecified date, the patient experienced injection site reaction characterized by redness (vaccination site erythema), swelling (vaccination site swelling) and the area was too warm to touch (vaccination site warmth). Additionally, it was stated that on 01-MAR-2024, the patient recently had an unspecified thyroid level drawn which showed her levels "a little over" (thyroid hormones increased); thus, she was advised to take her unspecified thyroid medication four pills per day (on Monday, Wednesday and Friday), and three pills per day on the remaining days due to her thyroid level being a "little over". Before her dosage adjustment, she was taking three pills per day of the unspecified thyroid medication. It was unknown by the reporter if the patient sought medical attention or if any laboratory diagnostics or study procedures were performed. On 27-MAR-2024, she had titers drawn which revealed immunity to measles, mumps and rubella. The outcome of the events were not provided.  The action taken regarding thyroid hormones increased, vaccination site erythema, vaccination site swelling and vaccination site warmth with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella zoster vaccine rge (cho) (SHINGRIX) was not reported.   The causal relationship between all the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella zoster vaccine rge (cho) (SHINGRIX) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient was inadvertently administered a dose of PROQUAD that suffered a Temperature Excursion (TE); This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant medications included diluent.  On 09-APR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), 0.5 milliliter, lot #X021754, expiration date: 23-FEB-2025, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) after a temperature excursion (TE): temperature 37.9F, time frame 8 hours 42 minutes 0 seconds (Product storage error) (diluent was not involved). No symptomatic events were reported. No further information was provided. No additional adverse events.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Physician reported that a 17 years old patient received PROQUAD on 3/19/2024; Tired; This initial spontaneous report was received from a physician and refers to a 17-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-MAR-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, 1 dose, lot #X021754, which had been verified to be a valid lot number, expiration date reported and confirmed as 23-FEB-2025, administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided) (product administered to patient of inappropriate age).  It was reported that the patient developed 2 days of fever (pyrexia) and body aches (pain) starting on 28-MAR-2024. On an unspecified day in 2024, the patient felt tired (fatigue) for 2 weeks. At the time of reporting, the outcome of the events was not provided. No further information provided.  The action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) regarding the events of pyrexia, pain, and fatigue was reported as not applicable.   The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: So far patient has not experienced any adverse events/No additional AE reported; Gardasil 9 first dose: 11-OCT-2023, second dose: 12-APR-2024, third dose: 16-APR-2024; This spontaneous report was received from a registered nurse and refers to a 11-year-old male patient. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies or reactions provided.  On 11-OCT-2023, at the age of 11 years old, the patient was vaccinated with the first  dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiry date were not provided), for prophylaxis.  On 16-APR-2024, the patient was vaccinated with another hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957405 confirmed to be valid with expiration date: 11-NOV-2025 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis. The reporter explained that after administration, she was documenting the dose in the immunization system, and noticed that last week on 12-APR-2024, the patient was administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at his family doctor (exact dose, route of administration, anatomical location, lot # and expiry date were not reported). This was not disclosed by the patient or the patient's family. The dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) she administered on 16-APR-2024 (reported as today), was intended to be the second dose, but technically was the third dose (Inappropriate schedule of product administration). So far the patient has not experienced any adverse events.  Lot # is being requested and will be submitted if received.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported; HCP called to report that a patient had been inadvertently administered an expired dose of MMR II.  The expiration date was 4/12/2024 and it was administered today, 4/16/2024.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-APR-2024, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, 0.5 milliliter, lot #W028733, which had been verified to be a valid lot number, expiration date reported and confirmed as 12-APR-2024 administered for prophylaxis (strength, route of administration, and anatomical location were not provided) (expired product administered). Operator of device was a health professional. No other adverse effects were reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; expired dose of ROTATEQ was inadverntly administered to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-APR-2024, the patient was inadvertently administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1932210, expiration date: 28-MAR-2024, administered orally for prophylaxis (strength was not provided) (Expired product administered). The reporter did not report any side effects from the administration of the expired dose (no adverse event). The vaccine did not experience any temperature excursions during its lifetime.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received her first GARDASIL 9 in January 2022 (specific date unknown) and second GARDASIL 9 in April 2022 (specific date unknown). Patient is now wanting to get her third dose; No additional AE; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies provided.  On an unknown day in January 2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, and on an unspecified day in April 2022, with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiry date was not provided for both), for prophylaxis.  The patient wanted to be vaccinated with the third dose (Inappropriate schedule of product administration). The reporter stated that the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at an "alternate dosing interval". No additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Vaccination failure, Wrong technique in product usage process
Clinical narrative: I've got it now/, suspected vaccination failure; I can't use my arm; I've got it now; 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.   Co-suspect products included Influenza vaccine (Influenza vaccin) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In DEC-2023, the patient received Influenza vaccin. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've got it now/, suspected vaccination failure) (serious criteria GSK medically significant), arm discomfort (Verbatim: I can't use my arm) and shingles (Verbatim: I've got it now). The outcome of the vaccination failure was unknown and the outcome of the arm discomfort and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, arm discomfort and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, arm discomfort and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-APR-2024 The case was received from the patient via interactive digital media. The patient was reporter. The reported that patient received Shingles shot and patient had diagnosed Monday. The reported that patient also got Flu shot in an 4th December. The patient cannot use arm because the nurse jabbed the needle too far. The reported that the symptom heal in a couple more month. 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
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at least ten times throughout her life). Previously administered products included Zostavax (received older shingles vaccine on an unknown date).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 12-APR-2024 The patient's children reported that the patient was vaccinated with old Shingels vaccine as well as Shingrix vaccine. The Shingrix vaccines were administered approximately 1 to 2 years prior and now had a case of shingles (a new case bene) requiring medication to treat them. The reporter was asking that it was common to get shingles even though a vaccine was received in the past, it would be beneficial to take a second round of Shingrix. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had shingles worse since then; 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've had shingles worse since then). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-APR-2024 The case was received from the patient via interactive digital media. The patient was reporter The reporter reported that, don't count on the vaccine, he/she took the new one with the booster. The reporter had shingles worse since then. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This non-serious case was reported by a consumer via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 10-APR-2024, the patient received the 1st dose of Bexsero (left deltoid). On 10-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired vaccine used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-APR-2024 This report was submitted via the online direct entry reporting system.  The Bexsero manufacturer was unspecified. The patient received an expired dose of Bexsero vaccine, which led to expired vaccine used. The consent to contact initial reporter was given but the consent to contact the practice manager healthcare professional was not given.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness
Clinical narrative: shoulder is still aching/ shoulder soreness; experienced dizziness; This non-serious case was reported by a consumer via patient support programs and described the occurrence of shoulder soreness in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-FEB-2024, the patient received the 1st dose of Shingrix. On 06-FEB-2024, less than a day after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: shoulder is still aching/ shoulder soreness) and dizziness (Verbatim: experienced dizziness). The outcome of the shoulder soreness and dizziness were not resolved.   It was unknown if the reporter considered the shoulder soreness and dizziness to be related to Shingrix.     It was unknown if the company considered the shoulder soreness and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2024 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine, and his shoulder was still aching. Patient also stated he experienced dizziness.  The shoulder soreness and dizziness was still ongoing. No additional information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Had a sore arm; Then it affected the tendon in the elbow all the way down to knees; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included stroke (On 10th May 2022, the patient experienced stroke and recovered with sequel on the same day) and tendonitis (had tendonitis a year ago). Previously administered products included Covid 19 vaccine (received 1st dose of Covid-19 vaccine in fall of 2021 intramuscular in right arm and unknown batch/lot number), Covid 19 vaccine (received 2nd dose of Covid-19 vaccine in January 2022 intramuscular on right arm batch/lot number unknown), Covid 19 vaccine (received 3rd dose of Covid-19 vaccine in April 2022) and Eliquis with an associated reaction of carpal tunnel syndrome (in 2023, received Eliquis batch/lot number 1958032 expiry date May 2025 (Carpel tunnel in hands),5mg 1 tablet by mouth twice daily).   In FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Had a sore arm) and tendonitis (Verbatim: Then it affected the tendon in the elbow all the way down to knees). The outcome of the pain in arm was resolved and the outcome of the tendonitis was not reported.   It was unknown if the reporter considered the pain in arm and tendonitis to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and tendonitis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter reported that patient was received shingles shot that affected the tendon on right side where got the shot. The caller verified the information provided by the transferring agent and clarified that it was after received the shingles shot that affected the tendon on right side. The body must not absorb drugs quickly, got tendonitis that started about 3 weeks after got the shingles shot.  At first just had a sore arm for few days.  Then it affected the tendon in the elbow all the way down to knees. The reporter did not know the name of the shingles vaccine and did not get a vaccination card or anything.  The patient received a total of 3 Covid-19 vaccines. The patient had the initial 2 and then a booster. The patient had no real bad effects from the strokes, said that they took a piece of skull out. The physician told to start Eliquis to see if it was what was causing the carpal tunnel and when restarted it, the carpal tunnel came back and the physician took off of it. Carpal tunnel went away after stopped eliquis and switched to a different medication. The heart physician was shocked because they had never seen that side effect and had never heard of it before. The heart physician with heart group Shingles vaccine, Shingles shot made arm hurt for a few days.  The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Body temperature increased, Headache, Injection site induration, Injection site swelling
Clinical narrative: Injection site is swollen; joints painful; Hurts to move, pain with movement; headache; sore arm; running grade tempreture; too hard; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extensive swelling of vaccinated limb in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-APR-2024, the patient received Arexvy. In APR-2024, an unknown time after receiving Arexvy, the patient experienced extensive swelling of vaccinated limb (Verbatim: Injection site is swollen), joint pain (Verbatim: joints painful), pain (Verbatim: Hurts to move, pain with movement), headache (Verbatim: headache), pain in arm (Verbatim: sore arm), body temperature increased (Verbatim: running grade tempreture) and injection site induration (Verbatim: too hard). The outcome of the extensive swelling of vaccinated limb, joint pain, pain, headache, pain in arm, body temperature increased and injection site induration were not reported.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, joint pain, pain, headache, pain in arm, body temperature increased and injection site induration to be related to Arexvy.     It was unknown if the company considered the extensive swelling of vaccinated limb, joint pain, pain, headache, pain in arm, body temperature increased and injection site induration to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-APR-2024 The case was received from the patient via interactive digital media. The patient was reporter. The reported that patient had received the Arexvy vaccine. The reported that after the vaccination patient had hurt all over, joint painful, hurt to move, injection site swollen and patient had almost elbow and very hard running grade temperature and headache. Till the time of reporting reported that patient vaccination was 2 days ago. The patient had usually had a reaction to vaccine except a sore arm. The reported that this one causing paint with movement.