chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Cardiac murmur, Dizziness, Vertigo
Clinical narrative: Patient stated he started feeling dizziness/vertigo once he got to his car leaving the pharmacy. He called an ambulance once he got home and went to the emergency room. Doctor's stated it was related to the vaccines he received. They also discovered a minor heart murmur that he followup up with a cardiologist on, who said it was not severe and to come back after 2 years. He stayed at the ER for approximately 3 hours and felt better by the time he left. Patient stated he got up the next morning and felt dizzy for a short period of time and then got better. He made a follow up appointment to his Doctor who attributed vertigo to the vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Local reaction, Nausea, Pain
Clinical narrative: headache, bodyaches, chills, nausea, area with large local reaction
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Patient called 04/05 concerned about COVID vaccine he received 04/02. He said his arm is red, about 2-3 inches surrounding injection area. He's concerned since he's has no issues/reactions with his previous vaccines ( sounds like injection site reaction)
Age: 1.25
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The entire vial of the vaccine was administered instead of the 0.25 ml dose. No adverse effect noted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: facial neuralgia right forehead/scalp
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Advised MMR and varicella given around 11:15am-11:18 am on 4/03/024, in left leg with fairly immediate redness and swelling at injection site. Patient crying, moving air well, no wheeze. Erythema over left upper lateral thigh with 3 white raised lesions that blanch under pressure. No other skin lesions noted. No swelling around mouth or in throat. No drooling. Area of redness marked. Benadryl ordered. 5mL of Benadryl 12.5mg/5mL solution given by mouth x 1. Patient observed for >20 minutes. Erythema and edema significantly improved prior to discharge. Never developed any other skin lesions, difficulty breathing, wheezing, throat/facial swelling on serial examinations. Advised parent this appears more consistent with localized site reaction than anaphylaxis but did offer referral to allergist if further discussion regarding vaccination allergy desired.  Referral was declined. Also offered that Benadryl could be considered prior to such vaccinations in the future. Parent provided with printed copy of symptoms to monitor for and instruction to call EMS if these occur.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the entire vial instead of the 0.25 ml dose of the vaccine. no reported adverse effects.
Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Cold sweat, Consciousness fluctuating, Hypotension, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: Low blood pressure, thready pulse, clammy, in/out of conciousness, unresponsive at times
Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Blood test, Cardiac monitoring, Computerised tomogram head, Dizziness, Echocardiogram
Clinical narrative: Low blood pressure, thready pulse, clammy, in/out of conciousness, unresponsive at times
Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Fall, Laboratory test, Presyncope
Clinical narrative: Low blood pressure, thready pulse, clammy, in/out of conciousness, unresponsive at times
Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Blindness, Brain scan normal, Consciousness fluctuating, Cyanosis, Deafness
Clinical narrative: Low blood pressure, thready pulse, clammy, in/out of conciousness, unresponsive at times
Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Dizziness, Laboratory test normal, Nervousness, Scan normal, Sensory loss
Clinical narrative: Low blood pressure, thready pulse, clammy, in/out of conciousness, unresponsive at times
Age: 78.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Syncope
Clinical narrative: Low blood pressure, thready pulse, clammy, in/out of conciousness, unresponsive at times
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Adiposis dolorosa, Neuropathy peripheral
Clinical narrative: abdomen pain , dercums disease and neuropthy  it is on going life time condition
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given a 3rd dose of Bexsero- system flagged 2nd dose as invalid which was later discovered to be a valid dose. Pt has no adverse reactions
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is not an adverse reaction submission. Patient was given 2 doses of the RSV vaccination (Abrysvo): the 1st one on 10/4/23 and the 2nd one on 11/21/23. Patient has reported no adverse effects from this double vaccination. We are reporting this on the VAERS website at the request of the Immunization Registry.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Facial paralysis
Clinical narrative: Stroke with right sided facila droop and weakness 20 hours after vaccine
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Acne, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Father states two days after vaccination child is complaining of pain, redness, hardness on right arm. Mother states he has a pimple at injection site that looks like an abscess.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Chest pain, Headache
Clinical narrative: When returning for dose #2 on 3/29/24, client reported that she had a bad headache about 1 hour after vaccine. She reported she also  had intermittent "chest tightness" and an intermittent pain in the center of her chest. She reports the symptoms resolved that evening. She also reported that she usually wears a breast/chest binder, that she did not wear it the day she was vaccinated or since through the date she reported symptoms on 3/29/24. Instructed client to call her PCP on 3/29/24.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient is a 20 year old female that was requesting Hep B 3-dose series for school purposes. Patient received first dose on 01/12/2024 (pediatric dose mistakenly), second dose on 03/05/2024 (adult dose correctly), and came in today (04/03/2024) for the 3rd dose, which was not administered since it had not been 6 months since the second dose. The Hep B schedule is 0,1,6 month intervals. It was found that the first dose was invalidated by system since it was a pediatric dose, but we need to verify it is safe to give the 3rd vaccine and how we should proceed regarding this situation since the first dose was incorrect.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Paraesthesia, Sleep disorder
Clinical narrative: Couldn'tsleep onarmand achey for a week then joints sore and crazy painful barelygetting in and out of car. did go away.  not sore or residual to touch now 3 weeks later but tingly and numb from jaw to traps to arm on same side as vaccine. lasts for a couple minutes then gone.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Cardio-respiratory arrest, Death, Resuscitation
Clinical narrative: The Nursing Supervisor was called to the Resident's Room at 12:55am for a Code.   CPR was immediately initiated, and EMS notified. EMS arrived at 1:05am, and continued CPR.  Resident pronounced deat at 1:42am.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Chest discomfort, Cough, Dyspnoea
Clinical narrative: patient presented to the Emergency Department on 4/5/2024 after being diagnosed with a viral upper respiratory tract infection in the Clinic on 4/3/24.  Chief complaint in the ED is cough.  Tested negative for COVID on morning of 4/5/24 with home test, but tested positive same day in the ED.   ED provider's note:" 7-year-old young lady with past medical history significant for wheeze which is required albuterol in the past but never steroid treatment and has not been formally diagnosed as asthma, who presents to the emergency department with approximately 1 week of cough which is substantially worse at night and which is associated with some increased work of breathing.  Patient was seen in clinic approximately 2 days ago at which time she was treated as an asthma cough and was begun on albuterol.  Mom has been giving albuterol but the patient's symptoms were refractory this evening and she had visibly increased work of breathing.  Additionally, the child has now began to have fevers which mom reports are new.  Mom gave some ibuprofen approximately 10 hours ago.  Patient does complain of some chest tightness with her cough.  She is visibly tachypneic and is belly breathing a bit.  She does not have any visible retractions at this time.  She has never required hospitalization for asthma.  She is still eating and drinking.  She did have an episode of posttussive emesis tonight."  Patient is still admitted to the unit but note says she is looking much better and will likely be discharged tomorrow (4/6/24.)
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test negative, Pyrexia, SARS-CoV-2 test positive, Tachypnoea
Clinical narrative: patient presented to the Emergency Department on 4/5/2024 after being diagnosed with a viral upper respiratory tract infection in the Clinic on 4/3/24.  Chief complaint in the ED is cough.  Tested negative for COVID on morning of 4/5/24 with home test, but tested positive same day in the ED.   ED provider's note:" 7-year-old young lady with past medical history significant for wheeze which is required albuterol in the past but never steroid treatment and has not been formally diagnosed as asthma, who presents to the emergency department with approximately 1 week of cough which is substantially worse at night and which is associated with some increased work of breathing.  Patient was seen in clinic approximately 2 days ago at which time she was treated as an asthma cough and was begun on albuterol.  Mom has been giving albuterol but the patient's symptoms were refractory this evening and she had visibly increased work of breathing.  Additionally, the child has now began to have fevers which mom reports are new.  Mom gave some ibuprofen approximately 10 hours ago.  Patient does complain of some chest tightness with her cough.  She is visibly tachypneic and is belly breathing a bit.  She does not have any visible retractions at this time.  She has never required hospitalization for asthma.  She is still eating and drinking.  She did have an episode of posttussive emesis tonight."  Patient is still admitted to the unit but note says she is looking much better and will likely be discharged tomorrow (4/6/24.)
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Use of accessory respiratory muscles, Viral upper respiratory tract infection, Vomiting
Clinical narrative: patient presented to the Emergency Department on 4/5/2024 after being diagnosed with a viral upper respiratory tract infection in the Clinic on 4/3/24.  Chief complaint in the ED is cough.  Tested negative for COVID on morning of 4/5/24 with home test, but tested positive same day in the ED.   ED provider's note:" 7-year-old young lady with past medical history significant for wheeze which is required albuterol in the past but never steroid treatment and has not been formally diagnosed as asthma, who presents to the emergency department with approximately 1 week of cough which is substantially worse at night and which is associated with some increased work of breathing.  Patient was seen in clinic approximately 2 days ago at which time she was treated as an asthma cough and was begun on albuterol.  Mom has been giving albuterol but the patient's symptoms were refractory this evening and she had visibly increased work of breathing.  Additionally, the child has now began to have fevers which mom reports are new.  Mom gave some ibuprofen approximately 10 hours ago.  Patient does complain of some chest tightness with her cough.  She is visibly tachypneic and is belly breathing a bit.  She does not have any visible retractions at this time.  She has never required hospitalization for asthma.  She is still eating and drinking.  She did have an episode of posttussive emesis tonight."  Patient is still admitted to the unit but note says she is looking much better and will likely be discharged tomorrow (4/6/24.)
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Localized erythema and swelling (~20cm x 10cm) complicated to cellulitis infection that occurred 3 days after her vaccination. No fevers, chills, or other systemic symptoms
Age: 12.0
Sex: F
Vaccine: DTAPIPVHIB, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Pentacel (DTaP-Hib-IPV) dose. No adverse side effects noted expected per PCP. Patient advised to return to clinic for viable dose of Tdap.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She is out of the age rage to receive this combo vaccine. GSK and state were both contacted. These vaccines need to be given separate in 4 weeks. We have notified the patients mother letting her know this and to schedule a visit to come in to get these vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Localized redness and mild pain
Age: 12.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She is out of age range to receive this combo vaccine. GSK and state were both contacted. The vaccines need to be given separate in 4 weeks. We have notified the patients mother letting her know this and schedule a time to come in and have these done.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Nodule, Peripheral swelling, Skin mass
Clinical narrative: arm swelling, with subsequent subcutaneous painful nodule at injection site still present after >1 month
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong age administration of vaccine. Vaccine age is for 12+ years. Patient is 11yrs and 9 months. Patient waited 15 minutes. No adverse reaction. Provider notified of vaccine administration error.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She is out of age range to receive this combo vaccine. GSK and state were both contacted. The vaccines need to be given separate in 4 weeks. We have notified the patients mother letting her know this and schedule a time to come in and have these done.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AE; Caller states a 24 year old patient was inadvertently administered a fourth dose on 03/06/2024; This spontaneous report was received from a medical assistant referring to a 24-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-MAR-2024, the patient was inadvertently vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X025115, expiration date: 19-MAY-2026, administered for prophylaxis (strength, dose and route of administration were not provided) (Extra dose administered). No symptoms reported and no additional details provided. No other adverse event (AE) (No adverse event).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administering a dose of PROQUAD after experiencing a temperature excursion.; This spontaneous report was received from a nurse and refers to a 5-year-old male patient.  The patient's medical history and concurrent conditions were not reported.  On 07-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #X024915, expiration date: 14-APR-2025, administered subcutaneously in the left arm (dose was not provided) for prophylaxis, after experiencing a temperature excursion (product storage error). On the same day, he was also vaccinated with diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).  On 07-MAR-2024, the vaccine was put into freezer. Freezer temperature went to 5.6 degrees Fahrenheit (F), 5 minutes later the temperature was 5.1 F, and at 10 minutes temperature marked 3,5 F. The temperature went to 5,6 F (above 5 F for 10 minutes). Therefore, the medication error occurred during storage in clinical practice. No additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event).
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Underdose
Clinical narrative: No side effects reported; Patient receiving a smaller than recommended dose of VAQTA and MMRII; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-FEB-2023, the patient received a smaller than recommended dose of (VAQTA) intramuscular injection (dose, lot #, expiry date, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose, lot #, expiry date, and route of administration were not provided); both administered for prophylaxis (underdose). The vaccines were administered at a different office. No side effects were reported.  This is one of two reports received concerning the same patient.
Age: 1.42
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no other AE occurred; An expired dose of diluent was used to reconstitute PROQUAD and the dose was administered to a patient.; An expired dose of diluent was used to reconstitute PROQUAD; This spontaneous report was received from a nurse and refers to a 17-month-old patient of unknown gender. The patient medical history, concurrent conditions, concomitant therapies, drug allergies or reactions were not reported.  On 29-MAR-2024, the patient was vaccinated with a dose (1 dose) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot # X025093, which had been confirmed to be a valid lot number; expiration date reported and confirmed as 16-APR-2025) (strength, exact dose, route of administration, and anatomical location were not provided) administered as prophylaxis. The suspect vaccine was reconstituted with an expired dose (1 dose) of sterile diluent (STERILE DILUENT) solution for injection/infusion lot # W013828, which had been verified to be a valid lot number, expiration date reported and confirmed as 28-JAN-2024) (strength, dose, route of administration, and anatomical location were not provided) (expired product administered/product preparation issue). No additional information or adverse event (AE) reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test positive, Blood test, Incomplete course of vaccination, Laboratory test, Middle ear effusion
Clinical narrative: fever; some fluid in her ears; This spontaneous report was received from a patient's mother referring to her daughter, a currently 18-year-old female patient. The patient was allergic to cefalexin (KEFLEX) with reaction of hives. The patient's other medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2006 when the patient was 1 years old, the patient was vaccinated with her first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prevention.   6 days after the vaccination, the patient developed a fever of 105 degrees. The patient was sent to the hospital but was not admitted. The patient had bloodwork and testing done, details of which are not known. The patient also had some fluid in her ears but that she had a history of it that had not caused this prior. The patient's fever kept climbing at hospital and they put her on ice bath and gave ibuprofen and acetaminophen. The patient's body temperature reached 107 degrees and the reporter believed it climbed higher because they pushed her out of the room and would not tell her about the fever at that point. The patient came down and she was able to go home. The outcome of the fever was recovered. The outcome of the middle ear effusion was unknown. The patient was planned to receive the second dose; however, titers were tested, and she was positive for immunity, so they did not administer the second dose. The causal relationship between the events above and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was unknown.  Lot# is being requested and will be submitted if received.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: fever; some fluid in her ears; This spontaneous report was received from a patient's mother referring to her daughter, a currently 18-year-old female patient. The patient was allergic to cefalexin (KEFLEX) with reaction of hives. The patient's other medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2006 when the patient was 1 years old, the patient was vaccinated with her first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prevention.   6 days after the vaccination, the patient developed a fever of 105 degrees. The patient was sent to the hospital but was not admitted. The patient had bloodwork and testing done, details of which are not known. The patient also had some fluid in her ears but that she had a history of it that had not caused this prior. The patient's fever kept climbing at hospital and they put her on ice bath and gave ibuprofen and acetaminophen. The patient's body temperature reached 107 degrees and the reporter believed it climbed higher because they pushed her out of the room and would not tell her about the fever at that point. The patient came down and she was able to go home. The outcome of the fever was recovered. The outcome of the middle ear effusion was unknown. The patient was planned to receive the second dose; however, titers were tested, and she was positive for immunity, so they did not administer the second dose. The causal relationship between the events above and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was unknown.  Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: RV5
Symptoms: Dyschezia, Haematochezia, Rotavirus test positive
Clinical narrative: painful, bloody stool; painful, bloody stool; Stool PCR showed 'ROTAVIRUS A'; This spontaneous report was received from a company representative and physician and refers to an infant (baby) patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the breast fed patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose description, lot #, expiry date and route of administration were not provided) for prophylaxis.  On an unknown date, two weeks after the vaccination, the patient developed painful, bloody stool (haematochezia) (dyschezia). Additionally, stool polymerase chain reaction (PCR) showed: rotavirus A (rotavirus test positive). No further information was provided. No additional adverse event (AE) or product quality complaint (PQC) was noted. The outcome of the events was not provided.  The causal relationship between the adverse events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.  Upon internal review, the events of haematochezia and dyschezia were determined to be medically significant.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A administered on 11-SEP-2013 and on 04-SEP-2015; This spontaneous report has been received from a physician, via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (2402USA009921), concerning a 7-year-old female patient.   The patient's medical history and concurrent conditions were not reported. Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis b vaccine (HEP B), hib vaccine (HIB PRP-T), pneumococcal conjugate vaccine 13-valent (PCV13), polio vaccine (IPV), rotavirus vaccine pentavalent, varicella vaccine (VARIVAX). Concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis b vaccine (HEP B), measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR) and polio vaccine inact (IPV).   On 11-SEP-2013, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 04-SEP-2015, the patient received second dose of hepatitis a vaccine, inactivated (manufacturer unknown) (inappropriate schedule of product administration).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2402USA009921:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep B administered on 11-JAN-2008, 13-FEB-2008 and 11-SEP-2013; Hep B administered on 11-JAN-2008, 13-FEB-2008 and 11-SEP-2013; This spontaneous report has been received from a physician, via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS # 2402USA009921), concerning a 5-week-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-JAN-2008, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 13-FEB-2008, the patient received second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration). On 11-SEP-2013, the patient received third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2402USA009921:
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MMR administered on 11-SEP-2013; This spontaneous report has been received from a physician, via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (2402USA009921), concerning a 5year-old female patient.   The patient's medical history and concurrent conditions were not reported. Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis b vaccine (HEP B), hib vaccine (HIB PRP-T), pneumococcal conjugate vaccine 13-valent (PCV13), polio vaccine (IPV), rotavirus vaccine pentavalent, varicella vaccine (VARIVAX). Concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis b vaccine (HEP B), hepatitis a vaccine (HEP A) and polio vaccine inact (IPV).   On 11-SEP-2013, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). On 30-JUL-2014, the patient received second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2402USA009921:
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4th dose of Hib vaccine given; 3rd dose of Hib vaccine on 14-JAN-2003 (at the age of 6 months 11 days); This spontaneous report has been received from an an other health care professional via a medical records (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (MARRS # 2402USA008515), concerning a 6-month-old patient. The patient's historical vaccines included hepatitis B vaccine. His concurrent conditions and medical history were not provided.   On 05-SEP-2002, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). On 06-NOV-2002, he received the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). On 14-JAN-2003, at the age of 6 months and 11 days, the patient received the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) (inappropriate age at vaccine administration). He concomitantly received diphteria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid, hepatitis B vaccine and polio vaccine. On 01-OCT-2003, he was administered the fourth dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) (extra dose administered).  This is one of 4 reports created for the same patient.; Sender's Comments:  US-009507513-2402USA008515: US-009507513-2402USA008405: US-009507513-2404USA001266: US-009507513-2404USA001267:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was accidently administered an expired dose of PROQUAD on Apr 2, 2024; This spontaneous report was received from a Nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 02-APR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), once, lot #W028564, expiration date: 06-MAR-2024 (Expired product administered), administered for prophylaxis (anatomical location, strength and route of administration were not provided). Operator of device was health professional. Product had no prior temperature excursions. No further information provided. No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Quadriplegia
Clinical narrative: Paralyzed completely from the neck down; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: Paralyzed completely from the neck down) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   The reporter considered the paralysis to be related to Shingles vaccine.     The company considered the paralysis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that do not to ask your pharmacist about the risk of guillain barre syndrome associated with the vaccine.  The patient was paralyzed completely from the neck down because of that vaccine. Remember to ask guillain barre syndrome. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: Had shingles after vaccination/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 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: 29-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that shingles was something that the patient would not wish on the worst enemy and he/she had the vaccines. 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Ended up with shingles after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Ended up with shingles after vaccination/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 resolving.   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: 31-MAR-2024 This case was reported by patient's spouse via interactive digital media. The reporter state that you could still get shingles with the vaccine. The patient and the reporter both got the vaccines about 3 years ago. The patient ended up with shingles about 2 years before reporting. He was put on an antiviral medication and did fine. The reporter asked the pharmacist about it, and he confirmed you still could get shingles but probably would not be as severe. The reporter was shocked because they were under the impression that it would keep them from getting it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: I am having joint pain; I have arthritis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arthralgia aggravated in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included joint pain and arthritis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced arthralgia aggravated (Verbatim: I am having joint pain) and arthritis aggravated (Verbatim: I have arthritis). The outcome of the arthralgia aggravated and arthritis aggravated were not reported.   It was unknown if the reporter considered the arthralgia aggravated and arthritis aggravated to be related to Arexvy.     It was unknown if the company considered the arthralgia aggravated and arthritis aggravated to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The case was received from the patient via interactive digital media. The patient has joint pain and arthritis but feel vaccine triggered.
Sex: U
Vaccine: RSV
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Cough; Cold symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced cough (Verbatim: Cough) and cold symptoms (Verbatim: Cold symptoms). The outcome of the cough and cold symptoms were not reported.   It was unknown if the reporter considered the cough and cold symptoms to be related to Arexvy.     It was unknown if the company considered the cough and cold symptoms to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 The patient came down with a cough and cold symptoms after the injection the next day.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: very tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: very tired). The outcome of the tiredness was not reported.   It was unknown if the reporter considered the tiredness to be related to Arexvy.     It was unknown if the company considered the tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-MAR-2024 The patient was very tired and glad to know it was a side effect,  The patient asked how long did it usually last.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administered vaccine after temp excursions; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 53-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 27BN7, expiry date 30-JUN-2024) for prophylaxis.   On 19-MAR-2024, the patient received Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: administered vaccine after temp excursions). The outcome of the incorrect storage of drug 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: 25-MAR-2024 The nurse reported that they had Fluarix quadrivalent 2023-2024 that they experienced vaccine temperature excursions well below freezing to 24.3 Fahrenheit probably they do not had sophisticated data logger so they cannot say how long, they cannot assure anything so they were wasting the vaccine, which led to incorrect storage of drug. However 3 patients that received that day during the 8 hours time period. They asked that they would like to know how to advise them on next step revaccination or not. The reporter consented to follow up. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024038022:Different patient US-GSK-US2024038021:Different patient
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: we experienced vaccine temperature excursions well below freezing to 24.3F; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 27BN7, expiry date 30-JUN-2024) for prophylaxis.   On 19-MAR-2024, the patient received Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: we experienced vaccine temperature excursions well below freezing to 24.3F). The outcome of the incorrect storage of drug 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: 25-MAR-2024 The nurse reported that they had Fluarix quadrivalent 2023-2024 that they experienced vaccine temperature excursions well below freezing to 24.3 Fahrenheit probably they do not had sophisticated data logger so they cannot say how long, they cannot assure anything so they were wasting the vaccine, which led to incorrect storage of drug. However 3 patients that received that day during the 8 hours time period. They asked that they would like to know how to advise them on next step revaccination or not. The reporter consented to follow up. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024038022:Different patient/Same Reporter US-GSK-US2024038020:Different patient/Same Reporter
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: uarix that experienced  vaccine temperature excursions well below freezing to 24.3 Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 27BN7, expiry date 30-JUN-2024) for prophylaxis.   On 19-MAR-2024, the patient received Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: uarix that experienced  vaccine temperature excursions well below freezing to 24.3 Fahrenheit). The outcome of the incorrect storage of drug 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: 25-MAR-2024 The nurse reported that they had Fluarix quadrivalent 2023-2024 that they experienced vaccine temperature excursions well below freezing to 24.3 Fahrenheit probably they do not had sophisticated data logger so they cannot say how long, they cannot assure anything so they were wasting the vaccine, which led to incorrect storage of drug. However 3 patients that received that day during the 8 hours time period. They asked that they would like to know how to advise them on next step revaccination or not. The reporter consented to follow up. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024038020:Different patient US-GSK-US2024038021:Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he received 1st dose of Shingrix about 4 or 5 years ago and wants to get 2nd dose of Shingrix now; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 4 or 5 years ago ).   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: he received 1st dose of Shingrix about 4 or 5 years ago and wants to get 2nd dose of Shingrix now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-MAR-2024 The patient self-reported this case. He received 1st dose of Shingrix vaccine about 4 or 5 years ago, pre pandemic.  He wanted to get 2nd dose of Shingrix now and asked if he needs to restart the series.  The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.58
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 7 year old patient received Infanrix; Inappropriate schedule of vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa (Infanrix) (batch number TX77L, expiry date 01-DEC-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (DTPa-HBV-IPV) for prophylaxis.   On 15-MAR-2024, the patient received Infanrix. On 23-MAY-2017, the patient received the 3rd dose of DTPa-HBV-IPV. On 23-MAY-2017, not applicable after receiving Infanrix and an unknown time after receiving DTPa-HBV-IPV, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). On 15-MAR-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 year old patient received Infanrix). The outcome of the inappropriate age at vaccine administration and drug dose administration interval too long were 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: 25-MAR-2024. The 3 dose series of dTap-IPV-Hep B vaccines administered by patient (could not confirm if the series was Pediarix). Patient received 1st dose of dTap-IPV-Hep B vaccines on 23-DEC-2016 and 2nd dose on 23-FEB-2017. The nurse practitioner stated that 7 year old patient received Infanrix which led to inappropriate age at vaccine administration. The patient received 3rd dose of dTap-IPV-Hep B, later than the recommended interval, which led to lengthening of vaccination schedule.