chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by Company on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005639, MCM-005641, MCM-005634, MCM-005636, MCM-005650, MCM-005643, and MCM-005644.   Further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HBP calling to report an adverse event for VAXELIS. Caller reports a 7 month old patient was administered a 4th dose of VAXELIS on 12/19/2023.; HBP calling to report an adverse event for VAXELIS. Caller reports a 7 month old patient was administered a 4th dose of VAXELIS on 12/19/2023.; This non-serious spontaneous safety report with case ID reference number: 02528682 (interaction number: 02528679) was received by the partner on 02-JAN-2024 and forwarded to agency on 03-JAN-2024 from a health professional.  Due to the nature of the event, the causality between the event "HBP calling to report an adverse event for VAXELIS. Caller reports a 7-month-old patient was administered a 4th dose of VAXELIS on 12/19/2023" and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, MMRV, PNC
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HCP called to report that a 2 month old infant was inadvertently administered PROQUAD instead of ROTATEQ.also received VAXELIS and PREVNAR at the same appointment.; This spontaneous non-serious safety report, with reference number 02529563, was received by a partner on 04-JAN-2024 and forwarded to agency on 08-JAN-2024, from a Physician.  Due to the nature of the event, the causality between the event "HCP called to report that a 2-month-old infant was inadvertently administered PROQUAD instead of ROTATEQ. Infant also received VAXELIS and PREVNAR at the same appointment." No adverse effects were reported, No additional AE/No PQC." and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by agency on 27-FEB-2024 from a HCP.  Due to the nature of the event, the causality between the event "HCP called to report that a 2 month old infant was inadvertently administered PROQUAD instead of ROTATEQ.also received VAXELIS and PREVNAR at the same appointment" and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Influenza, Influenza A virus test negative, Productive cough
Clinical narrative: I really don't think I need to file this but I am just trying to cooperate with the Vsafe system because I think it is very important due to the resistance of the public on these shots and everything else. I was asked to file it so I am. I started with a runny nose on 3/22, then started with mild cough and sneezing. I started doing home covid tests on 3/23, did two more on 3/25 and 3/27. They were all NEGATIVE. I was rapidly deteriorating, with lung congestion and productive cough with yellow green sputum. No fever.  No sore throat. Noisy respirations. We were en route to state and I went to Express Care upon arrival 3/28 and was tested for COVID, RSV, and Influenza A and B. All negative. The NP looked at my throat and was very sure I had had Influenza B as she had been dealing with this all week at the clinic. Note that I did receive the flu shot on 9/19/23 and I have also had my pneumonia shots. She felt I had also developed a bronchitis and gave me Doxycycline, Albuterol, and a steroid. I was wheezing. I actually went back to the ER two days later as I seemed to be getting worse on the lung congestion. They felt I was actually improving and made some suggestions as to cough and congestion management. No xray was indicated. They mentioned that I might have been treated for pneumonia instead of bronchitis. Things are slowly improving. I am still taking maximum cough and congestion meds and the antibiotic as ordered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test negative, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing
Clinical narrative: I really don't think I need to file this but I am just trying to cooperate with the Vsafe system because I think it is very important due to the resistance of the public on these shots and everything else. I was asked to file it so I am. I started with a runny nose on 3/22, then started with mild cough and sneezing. I started doing home covid tests on 3/23, did two more on 3/25 and 3/27. They were all NEGATIVE. I was rapidly deteriorating, with lung congestion and productive cough with yellow green sputum. No fever.  No sore throat. Noisy respirations. We were en route to state and I went to Express Care upon arrival 3/28 and was tested for COVID, RSV, and Influenza A and B. All negative. The NP looked at my throat and was very sure I had had Influenza B as she had been dealing with this all week at the clinic. Note that I did receive the flu shot on 9/19/23 and I have also had my pneumonia shots. She felt I had also developed a bronchitis and gave me Doxycycline, Albuterol, and a steroid. I was wheezing. I actually went back to the ER two days later as I seemed to be getting worse on the lung congestion. They felt I was actually improving and made some suggestions as to cough and congestion management. No xray was indicated. They mentioned that I might have been treated for pneumonia instead of bronchitis. Things are slowly improving. I am still taking maximum cough and congestion meds and the antibiotic as ordered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sputum discoloured, Wheezing
Clinical narrative: I really don't think I need to file this but I am just trying to cooperate with the Vsafe system because I think it is very important due to the resistance of the public on these shots and everything else. I was asked to file it so I am. I started with a runny nose on 3/22, then started with mild cough and sneezing. I started doing home covid tests on 3/23, did two more on 3/25 and 3/27. They were all NEGATIVE. I was rapidly deteriorating, with lung congestion and productive cough with yellow green sputum. No fever.  No sore throat. Noisy respirations. We were en route to state and I went to Express Care upon arrival 3/28 and was tested for COVID, RSV, and Influenza A and B. All negative. The NP looked at my throat and was very sure I had had Influenza B as she had been dealing with this all week at the clinic. Note that I did receive the flu shot on 9/19/23 and I have also had my pneumonia shots. She felt I had also developed a bronchitis and gave me Doxycycline, Albuterol, and a steroid. I was wheezing. I actually went back to the ER two days later as I seemed to be getting worse on the lung congestion. They felt I was actually improving and made some suggestions as to cough and congestion management. No xray was indicated. They mentioned that I might have been treated for pneumonia instead of bronchitis. Things are slowly improving. I am still taking maximum cough and congestion meds and the antibiotic as ordered.
Age: 70.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Cerebrovascular accident
Clinical narrative: The patient states that two weeks after having the vaccines, he suffered a stroke. He consulted his physician who stated that he should have never gotten the vaccines at the same time.
Age: 1.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Patient due for DTAP vaccine, patient received Kinrix instead of DTAP. Discussed with ordering provider, order was corrected and charted.  Ordering provider has no changes to the plan of care at this time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: Patient complained of a knot forming on her upper right arm at the injection site. She said it felt warm, and the knot got bigger before subsiding after about 4 weeks.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vaccine overdose; No adverse reactions after vaccines given nor 45 min later after vaccinations.  Per mom will keep an eye on infant.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS primary ID: 2690780-1. The original narrative from the sender is as follows: No adverse reactions after vaccines given nor 45 min later after vaccinations.  Per mom will keep an eye on infant.  Case correction performed on 08-MAR-2024: Event receipt date for the events of "Overdose' and "No adverse event" updated to 05-FEB-2024.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Vaccine overdose; No adverse reactions after vaccines given nor 45 min later after vaccinations.  Per mom will keep an eye on infant.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS primary ID: 2690780-1. The original narrative from the sender is as follows: No adverse reactions after vaccines given nor 45 min later after vaccinations.  Per mom will keep an eye on infant.  Case correction performed on 08-MAR-2024: Event receipt date for the events of "Overdose' and "No adverse event" updated to 05-FEB-2024.
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day); Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day); Temporal fever for one day; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS primary ID: 2690780-1. The original narrative from the sender is as follows: Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day).
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day); Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day); Temporal fever for one day; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS primary ID: 2690780-1. The original narrative from the sender is as follows: Temporal fever for one day, blotchy erythematous rash (<24 hours, resolved by follow up next day).
Sex: M
Vaccine: DTPPVHBHPB, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inappropriate vaccine given; no adverse events; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2691882-1. The original narrative from the sender is the following:  "inappropriate vaccine given, no adverse events"  The reporter did not provide an assessment of causal relationship between Vaxelis and the event " inappropriate vaccine given".   Due to the nature of the events, the causal relationship between Vaxelis and; "inappropriate vaccine given", and "no adverse events"  was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Chest X-ray normal, Culture urine negative, Influenza virus test negative, Perioral dermatitis, Pyrexia
Clinical narrative: rash around mouth; congestion day of illness; fever of 101 given motrin taken to ER and temp 104 rectally; pt started with rash around mouth then with spread to trunk and back; Chest X-ray normal; Culture urine negative; Influenza virus test negative; Sars-cov-2 test negative; Urine analysis normal; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2692106-1. The original narrative from the sender is the following:  "pt started with rash around mouth then with spread to trunk and back with fever of 101 given motrin taken to ER and temp 104 rectally - given tylenol and monitored"  The reporter did not provide an assessment of causal relationship between Vaxelis and the event; "pt started with rash around mouth then with spread to trunk and back with fever of 101 given motrin taken to ER and temp 104 rectally - given tylenol and monitored".   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Rash, Respiratory tract congestion, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: rash around mouth; congestion day of illness; fever of 101 given motrin taken to ER and temp 104 rectally; pt started with rash around mouth then with spread to trunk and back; Chest X-ray normal; Culture urine negative; Influenza virus test negative; Sars-cov-2 test negative; Urine analysis normal; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2692106-1. The original narrative from the sender is the following:  "pt started with rash around mouth then with spread to trunk and back with fever of 101 given motrin taken to ER and temp 104 rectally - given tylenol and monitored"  The reporter did not provide an assessment of causal relationship between Vaxelis and the event; "pt started with rash around mouth then with spread to trunk and back with fever of 101 given motrin taken to ER and temp 104 rectally - given tylenol and monitored".   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1, UNK
Symptoms: Swelling of eyelid
Clinical narrative: Eyelid swelling; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2692350-1.  The original narrative from the sender is the following:  "Patient received Beyfortus (RSV mAb nirsevimab, 0.5mL) LOT: 2022829 in the Left thigh at 0900. Mother called post visit at 1600 and states she noticed eyelid swelling at 1500. No other symptoms reported. Mother was advised to have patient seen in urgent care"  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event; "Eyelid swelling".   Of note, these events do not concern Vaxelis, but rather the Beyfortus vaccine. Vaxelis should have been considered as a co-suspect. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, HIBV, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I gave a Vaxelis and a HIB both. I had forgotten that HIB was in the vaxelis; Overdose; There was no adverse reaction; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2693527-1. The original narrative from the sender is the following:  "I gave a Vaxelis and a HIB both. I had forgotten that HIB was in the vaxelis. There was no adverse reaction".  Due to the nature of the event, the causal relationship between Vaxelis and the events; "I gave a Vaxelis and a HIB both. I had forgotten that HIB was in the vaxelis", Overdose, and "There was no adverse reaction" was not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood electrolytes normal, Blood glucose normal, Chest X-ray, Crying, Electrocardiogram
Clinical narrative: breathing shallowly; Mom consoled baby and began to place him in his car seat 5-7 minutes after vaccines given. Mom immediately noted that he was becoming very pale, limp, and poorly responsive (not apneic); Blood glucose normal; Blood electrolytes normal; he was becoming very pale; minimally responsive; Patient cried immediately following injections; very hypotonic; Electrocardiogram; Chest X-ray; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2696114-1 The original narrative from the sender is the following:  "Patient cried immediately following injections but had no breath-holding spells. Mom consoled baby and began to place him in his car seat 5-7 minutes after vaccines given. Mom immediately noted that he was becoming very pale, limp, and poorly responsive (not apneic) and brought him out of the exam room to the Nurses' station calling for help. The nurses and I saw him at that time. He was (1) diffusely very pale, including his lips, (2) breathing shallowly, (3) eyes were open mostly, (4) very hypotonic, and (5) minimally responsive.. We took him back to the exam room. Heart rate was 60-80. No resuscitation needed. Color and tone slowly improved over a 30-minute period and he was transferred to a local pediatric ED for evaluation.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events: "breathing shallowly", "Mom consoled baby and began to place him in his car seat 5-7 minutes after vaccines given. Mom immediately noted that he was becoming very pale, limp, and poorly responsive (not apneic)", Blood glucose normal, Blood electrolytes normal, "he was becoming very pale",  "minimally responsive", "Patient cried immediately following injections", and very hypotonic. Due to the nature of the events, the causal relationship between Vaxelis  and Electrocardiogram, and Chest X-ray was assessed as not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Hypopnoea, Hyporesponsive to stimuli, Hypotonia, Immediate post-injection reaction, Pallor
Clinical narrative: breathing shallowly; Mom consoled baby and began to place him in his car seat 5-7 minutes after vaccines given. Mom immediately noted that he was becoming very pale, limp, and poorly responsive (not apneic); Blood glucose normal; Blood electrolytes normal; he was becoming very pale; minimally responsive; Patient cried immediately following injections; very hypotonic; Electrocardiogram; Chest X-ray; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2696114-1 The original narrative from the sender is the following:  "Patient cried immediately following injections but had no breath-holding spells. Mom consoled baby and began to place him in his car seat 5-7 minutes after vaccines given. Mom immediately noted that he was becoming very pale, limp, and poorly responsive (not apneic) and brought him out of the exam room to the Nurses' station calling for help. The nurses and I saw him at that time. He was (1) diffusely very pale, including his lips, (2) breathing shallowly, (3) eyes were open mostly, (4) very hypotonic, and (5) minimally responsive.. We took him back to the exam room. Heart rate was 60-80. No resuscitation needed. Color and tone slowly improved over a 30-minute period and he was transferred to a local pediatric ED for evaluation.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events: "breathing shallowly", "Mom consoled baby and began to place him in his car seat 5-7 minutes after vaccines given. Mom immediately noted that he was becoming very pale, limp, and poorly responsive (not apneic)", Blood glucose normal, Blood electrolytes normal, "he was becoming very pale",  "minimally responsive", "Patient cried immediately following injections", and very hypotonic. Due to the nature of the events, the causal relationship between Vaxelis  and Electrocardiogram, and Chest X-ray was assessed as not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gardasil not indicated for 5 mo. baby, inadvertently given in place of Prevnar; Gardasil not indicated for 5 mo. baby, inadvertently given in place of Prevnar; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID. The original narrative from the sender is the following:  none noted - no obvious signs/symptoms Gardasil not indicated for 5 mo. baby, inadvertently given in place of Prevnar.  The causal relationship between Vaxelis and the events of "Gardasil not indicated for 5 mo. baby, inadvertently given in place of Prevnar" was assessed as Not applicable due to the nature of the reported events.  No further information is expected.  RA notes: Based on the available information, the events were not related to Vaxelis but to the Gardasil 19. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Mild varicella-like rash that developed on her legs, chest and back; Mild varicella-like rash that developed on her legs, chest and back; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2701446-1. The original narrative from the sender is the following:  mild varicella-like rash that developed on her legs, chest and back.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "mild varicella-like rash that developed on her legs, chest and back".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Accidently given the flu shot; This non-serious case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2709487-1. The original narrative from the sender is the following:  Child did not experience an adverse effect, she was accidently given the flu shot. Nurse realized the mistake after administration and the DR was quickly made aware. DR spoke to the parent and the baby was fine before leaving the clinic.  The causal relationship between Vaxelis and the reported events of "Child did not experience an adverse effect and she was accidently given the flu shot" was assessed as not applicable due to the nature of the events.  No further information is expected.  Regulatory Authority notes: Based on the available information, the events were not related to Vaxelis but to the Flulaval quadrivalent (Influenza) (seasonal) vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Area of injection was bruised; resulted in rash; This spontaneous safety report, with reference number 2709561 (VAERS ID # 2709561-1) was received by the partner on 19-JAN-2024 and forwarded to Health Authority on 24-JAN-2024, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Area of injection was bruised" and " resulted in rash."  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt came in for 6 month check but, is currently 8 months; Pt was normal after Vaccine was given, no side effects reported; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2710771-1. The original narrative from the sender is the following:  Pt came in for 6 month check but, is currently 8 months, pt had already received 2 rotas in the past and was behind on well check up. Pt was normal after Vaccine was given, no side effects reported.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Pt came in for 6 month check but, is currently 8 months and Pt was normal after Vaccine was given, no side effects reported".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Asthenia, Decreased appetite, Rash
Clinical narrative: Decreased energy; He developed poor appetite; Rash on his face; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2712011-1. The original narrative from the sender is the following:  Shortly after Vaxelis, PCV20, Rota AND Beyfortus given for pt.'s 2 month well check (all on the same day) -- he developed poor appetite, decreased energy and a rash on his face (later that day). Symptoms lasted for about 4-5 days. Benadryl used once and seemed to have helped with the rash. No worsening symptoms and managed with supportive care at home.    The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Decreased energy, He developed poor appetite, Rash on his face".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Abnormal behaviour, Decreased activity, Pyrexia
Clinical narrative: Mother noted change in behavior; Less active; Fever started after WCC visit, Tmax 103.0; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2712461-1. The original narrative from the sender is the following:  Fever started after WCC visit, Tmax 103.0 On 11/8, fever did not resolve and mother noted change in behavior and less active so they went to UC Treatments tried: Gave a fever reducer (80 mg Acetaminophen chew tablets) Warm-cool bath, cool wash cloths with temp decrease from 103-102.  The causal relationship between Vaxelis and the reported events of "Mother noted change in behavior, Less active, and Fever started after WCC visit, Tmax 103.0" was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Red and painful; Red/Redness; Leg hurting little swollen; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2712481-1. The original narrative from the sender is the following:  Pt mom called on 11/8/23 stating her son had vaccines on Monday 11/6/23 woke up Tuesday 11/7/23 with leg hurting little swollen not wanting to walk but mom didn't think much of it at the time and gave him Motrin which got him throughout the day. Then on Wednesday 11/8/23 his leg is more swollen red and painful. Mom was concerned it may be from vaccines. Senn Dr. on 11/9/23 and per note "Swelling of left lower extremity - Fever, leg swelling and redness are most likely due to vaccines (vaxelis, PCV) - Reassured, can use ice/cool packs, tylenol/motrin PRN - Low concern for infectious cause of rash/swelling at this point - Reviewed red flag symptoms and when to seek care - Recommended daily photo documentation in case swelling worsens."  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.   No further information is expected.
Sex: M
Vaccine: COVID19, DTPPVHBHPB, PNC20, RV5
Symptoms: Product preparation error, Pyrexia, Vomiting
Clinical narrative: Patient developed a fever of 104; Vomiting; Patient received undiluted vaccine of the multidose vial (yellow top); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2713335-1. The original narrative from the sender is the following:  Patient received undiluted vaccine of the multidose vial (yellow top). Patient and mother were informed. Patient developed a fever of 104 and vomiting but recovered the after administration.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: It was discovered that vaccine expired on 11/17/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2716222-1. The original narrative from the sender is the following:  RotaTeq was given on 11/20/2023 and upon medical assistant documenting the vaccine it was discovered that vaccine expired on 11/17/2023.  The causal relationship between Vaxelis and the reported event of "It was discovered that vaccine expired on 11/17/2023" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Product administered to patient of inappropriate age; Product use in unapproved population; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2718442-1. The original narrative from the sender is the following:  "Product Administered to patient of inappropriate age"  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Product Administered to patient of inappropriate age".  Due to the nature of the events, the causal relationship between Vaxelis and "Product Administered to patient of inappropriate age" was not applicable.  No further information is expected.  Case correction performed on 08-Mar-2024: The event receipt date for the "Product use issue" has been updated to 05-Feb-2024, which was previously missed.
Sex: F
Vaccine: DTAPHEPBIP, DTPPVHBHPB, RV5
Symptoms: Burning sensation, Contusion, Vision blurred
Clinical narrative: One received there was screaming crating burning; There is still a massive mark of burning under the skin which is now bruised; Vision get blurred on and off since then; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2719509-1. The original narrative from the sender is the following:  "One received there was screaming crating burning there is still a massive mark of burning under the skin which is now bruised . Vision get blurred on and off since then and the quality of life is not the same . So upset."  The causal relationship between Vaxelis and the reported events "One received there was screaming crating burning, There is still a massive mark of burning under the skin which is now bruised, and Vision get blurred on and off since then", was assessed as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC15, VARCEL
Symptoms: Product preparation issue
Clinical narrative: MMR Priorix given separately, syringe diluent given and vial containing powder vaccine found to be left in vaccine box and reconstituted; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2720573-1. The original narrative from the sender is the following:  "MMR Priorix given separately, syringe diluent given and vial containing powder vaccine found to be left in vaccine box and reconstituted"  The causal relationship between Vaxelis and the event "MMR Priorix given separately, syringe diluent given and vial containing powder vaccine found to be left in vaccine box and reconstituted" was assessed as not applicable due to the nature of these reported event.  Of note, these events do not concern Vaxelis, but rather MMR (Priorix) vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC15, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: May have received diluent syringe of vaccine and did not receive vial containing powder vaccine of MMR Priorix; Did not have any s/sx of adverse reaction after vaccines on 11/16/23,; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2720581-1. The original narrative from the sender is the following:  "May have received diluent syringe of vaccine and did not receive vial containing powder vaccine of MMR Priorix, did not have any s/sx of adverse reaction after vaccines on 11/16/23, per mom"  The causal relationship between Vaxelis and the event "May have received diluent syringe of vaccine and did not receive vial containing powder vaccine of MMR Priorix" and " Did not have any s/sx of adverse reaction after vaccines on 11/16/23,"was assessed as not applicable due to the nature of these reported events.  Of note, these events do not concern Vaxelis, but rather MMR (Priorix) vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RSV, RV5
Symptoms: Wrong product administered
Clinical narrative: ABRYSVO (Adult dose RSV) administered instead of BEYFORTUS for PEDS; ABRYSVO (Adult dose RSV) administered instead of BEYFORTUS for PEDS; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2720863-1. The original narrative from the sender is the following:  "ABRYSVO (Adult dose RSV) administered instead of BEYFORTUS for PEDS"  The causal relationship between Vaxelis and the events "ABRYSVO (Adult dose RSV) administered instead of BEYFORTUS for PEDS " was assessed as not applicable due to the nature of these reported events.  Of note, these events do not concern Vaxelis, but rather RSV (ABRYSVO) vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Diarrhoea, Vomiting, Vomiting projectile
Clinical narrative: Received Rotateq #1 on 09--2023.Had persistent vomiting, received Rotateq#2 11-21-2023 had projectile vomiting and diarrhea 24 hrs after which resolved after 24hours.; Received Rotateq #1 on 09--2023. Had projectile vomiting and diarrhea 24 hrs after which resolved after 24hours; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2720901-1. The original narrative from the sender is the following:  "Received Rotateq #1 on 09--2023. Had persistent vomiting 8 hrs later and resolved after 12 hours Received Rotateq #2 11-21-23. Had projectile vomiting and diarrhea 24 hrs after which resolved after 24hours On both occasions, vomiting and diarrhea were NOT accompanied by fever exposure to other ill persons spread of disease to family members persistent symptoms Child does not attend day care and had no other outside contacts prior to these 2 vaccine dates"  The reporter did not provide an assessment of causal relationship between Vaxelis and the events " Received Rotateq #1 on 09--2023.Had projectile vomiting and diarrhea 24 hrs after which resolved after 24hours"   Of note, these events do not concern Vaxelis, but rather Rotateq vaccination. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Cyanosis, Diarrhoea, Haematochezia, Infant irritability, Mucous stools
Clinical narrative: Specs of blood in poop with a large mucus, loose stool; Fussy and irritable; Lips turned blue for about an hour; he was chattering his gums, hands and feet were cold; Hands and feet were cold; Specs of blood in poop with a large mucus, loose stool; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2721214-1. The original narrative from the sender is the following:  5 hours after vaccines given, he was fussy and irritable. Lips turned blue for about an hour, he was chattering his gums, hands and feet were cold. He never stopped breathing. Specs of blood in poop with a large mucus, loose stool. He was taken to ED.   The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Peripheral coldness
Clinical narrative: Specs of blood in poop with a large mucus, loose stool; Fussy and irritable; Lips turned blue for about an hour; he was chattering his gums, hands and feet were cold; Hands and feet were cold; Specs of blood in poop with a large mucus, loose stool; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2721214-1. The original narrative from the sender is the following:  5 hours after vaccines given, he was fussy and irritable. Lips turned blue for about an hour, he was chattering his gums, hands and feet were cold. He never stopped breathing. Specs of blood in poop with a large mucus, loose stool. He was taken to ED.   The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC20
Symptoms: Cyanosis, Lethargy, Oedema peripheral, Pyrexia
Clinical narrative: CENTRAL ACROCYANOSIS; PERIPHERAL EXTREMITY EDEMA; Lethargy; Fever; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2721376-1. The original narrative from the sender is the following:  Peripheral extremity edema, central acrocyanosis, fever, lethargy.   The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC20
Symptoms: Condition aggravated, Eczema, Erythema, Periorbital swelling, Pruritus
Clinical narrative: pt had flare up of his eczema with swelling around his eyes, intense erythema and itching; pt had flare up of his eczema; intense erythema; swelling around his eyes; itching; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2721727-1. The original narrative from the sender is the following:  2 days after vaccination, mom states pt had flare up of his eczema with swelling around his eyes, intense erythema and itching. The mom took to the Hospital ER who treated pt with 5 days of oral steroid.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: his legs were sore for a few days; Patient was given an adult Hep A Vaqta vaccine instead of the pediatric; Patient was given an adult Hep A Vaqta vaccine instead of the pediatric; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2723121-1. The original narrative from the sender is the following:  Patient was given an adult Hep A Vaqta vaccine instead of the pediatric. Per report of mother the only problem he experienced was his legs were sore for a few days.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.  RA notes: Based on the available information, the events were not related to Vaxelis but to Vaqta vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Immediate post-injection reaction, Retching, Vomiting
Clinical narrative: Vomiting; Gagging; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2723592-1. The original narrative from the sender is the following:  Gagging, vomited immediately after given 1/4 dose. reattempted with same results by mouth. 17. vaccines given on same date (vaxelis and pcv20) were administered 15 minutes after the rotavirus was given and vomiting occurred.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC20, RV5
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient inadvertently received undiluted Covid 19 vaccine; Medical assistant did not use diluent, filled syringe from vial.; Mother denies adverse effects from the vaccine.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2724432-1. The original narrative from the sender is the following:  Patient inadvertently received undiluted Covid 19 vaccine. Medical assistant did not use diluent, filled syringe from vial. Mother notified on 12/13 when error was identified. Mother denies adverse effects from the vaccine.  The causal relationship between Vaxelis and the events " Patient inadvertently received undiluted Covid 19 vaccine. Medical assistant did not use diluent, filled syringe from vial. Mother notified on 12/13 when error was identified. Mother denies adverse effects from the vaccine." was assessed as not applicable due to the nature of the reported events.  No further information is expected.  Regulatory Authority notes: Based on the available information, the events were not related to Vaxelis but to the Covid-19 vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml.; NO ADVERSE EVENTS MEDICATION ERROR RSVNirsevimab( Beyfortus); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2724886-1. The original narrative from the sender is the following:  NO ADVERSE EVENTS MEDICATION ERROR RSV-Nirsevimab(Beyfortus) is based on weight  Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml. DOS - Patient weignt was 11 lbs 4 oz = to 5.1 kgs. Patient's correct dosage should of be 1.0 ml for > 5 kgs.  Will give additional dose of Beyfortus 0.5 ml at next OV (12/19/23) per CDC guidelines.  The causal relationship between Vaxelis and the events " NO ADVERSE EVENTS MEDICATION ERROR RSV-Nirsevimab(Beyfortus) is based on weight  Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml. DOS - Patient weignt was 11 lbs 4 oz = to 5.1 kgs. Patient's correct dosage should of be 1.0 ml for > 5 kgs.  Will give additional dose of Beyfortus 0.5 ml at next OV (12/19/23) per CDC guidelines." was assessed as not applicable due to the nature of the reported events.  No further information is expected.  MAH notes: Based on the available information, the events were not related to Vaxelis but to Nirsevimab (beyfortus) vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC15
Symptoms: Excessive eye blinking
Clinical narrative: Two days after last visit pt started blinking a lot. Blinking appears to be getting worse.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2725467-1. The original narrative from the sender is the following:  Two days after last visit pt started blinking a lot. Blinking appears to be getting worse.  The causal relationship between Vaxelis and the events " Two days after last visit pt started blinking a lot. Blinking appears to be getting worse." was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site rash, Rash, Rash papular, Urticaria
Clinical narrative: Urticarial rash surrounding injection site.; Urticarial rash surrounding injection site.; Papular rash on abdomen, back, chest, upper extremities, and lower extremities approximately 10 minutes after vaccines given.; Urticarial rash surrounding injection site. Ice pack applied. Papular rash on abdomen, back, chest, upper extremities, and lower extremities approximately 10 minutes after vaccines given.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2726303-1. The original narrative from the sender is the following:  Urticarial rash surrounding injection site. Ice pack applied. Papular rash on abdomen, back, chest, upper extremities, and lower extremities approximately 10 minutes after vaccines given. Attempted to use Benadryl however patient vomited right after. 8mg methylprednisolone IM injection. Rapid improvement in rash.  The causal relationship between Vaxelis and the events "Urticarial rash surrounding injection site. Ice pack applied. Papular rash on abdomen, back, chest, upper extremities, and lower extremities approximately 10 minutes after vaccines given. Attempted to use Benadryl however patient vomited right after. 8mg methylprednisolone IM injection. Rapid improvement in rash." was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Error recognized and parent informed, as well as escalation up to the chain of command; Vaccine overdose; No adverse event reported, patient tolerated the vaccines.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2726321-1. The original narrative from the sender is the following:  "extra dose administered", "no adverse event"  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "extra dose administered", and "no adverse event".  Per MD confirmation, "vaccine overdose" was added.  Due to the nature of the events, the causal relationship between Vaxelis and "extra dose administered", "Vaccine overdose" and "no adverse events" was not applicable.  No further information is expected.