chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Abnormal faeces, Diarrhoea, Dyschezia
Clinical narrative: FOC reported his daughter had loose and sometimes "jelly-like" stools every day; she was in quite a bit of pain when she had her diarrhea; FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2656445-1. The original narrative from the sender is the following:   "7/10/23 FOC, called this nurse to ask what company manufactured the RotaTeq vaccine his daughter received on 6/16/23. He explained his daughter had a "bad reaction" and was wanting to see if they could try a different rotavirus vaccine. RN asked about pts reaction and FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks, and is "just not starting to feel better" (approx. 1 month after vaccine). FOC talked to their pediatrician but would also appreciate talking to the medical director of the clinic. This RN informed Dr. who called pt. Dr. emailed RN with this summary: "I called him, and we discussed his child at some length. It turns out she was in quite a bit of pain when she had her diarrhea and so though they didn't see any blood the possibility of a spontaneous resolution of intussusception is a possibility. I advised to discuss with their pediatrician Dr. and deferred the decision to further vaccinate with rotavirus to them".  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "FOC reported his daughter had loose and sometimes "jelly-like" stools every day", " she was in quite a bit of pain when she had her diarrhea", "FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks".  Of note, these events do not concern Vaxelis, but rather Rotateq vaccine. 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, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Abnormal faeces, Diarrhoea, Malaise, Pain
Clinical narrative: FOC reported his daughter had loose and sometimes "jelly-like" stools every day; she was in quite a bit of pain when she had her diarrhea; FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2656445-1. The original narrative from the sender is the following:   "7/10/23 FOC, called this nurse to ask what company manufactured the RotaTeq vaccine his daughter received on 6/16/23. He explained his daughter had a "bad reaction" and was wanting to see if they could try a different rotavirus vaccine. RN asked about pts reaction and FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks, and is "just not starting to feel better" (approx. 1 month after vaccine). FOC talked to their pediatrician but would also appreciate talking to the medical director of the clinic. This RN informed Dr. who called pt. Dr. emailed RN with this summary: "I called him, and we discussed his child at some length. It turns out she was in quite a bit of pain when she had her diarrhea and so though they didn't see any blood the possibility of a spontaneous resolution of intussusception is a possibility. I advised to discuss with their pediatrician Dr. and deferred the decision to further vaccinate with rotavirus to them".  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "FOC reported his daughter had loose and sometimes "jelly-like" stools every day", " she was in quite a bit of pain when she had her diarrhea", "FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks".  Of note, these events do not concern Vaxelis, but rather Rotateq vaccine. 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, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Decreased appetite, Infant irritability, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: she has been cranky; There is a petechial rash to bilateral lower legs; They noticed the red dots on her lower legs shortly thereafter; Other than rash she has been cranky; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; not wanting to eat; Product administered to patient of 0.08 years (1 month); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2657009-1. The original narrative from the sender is the following:  The case is considered as off label use due to Product use issue (product use in unapproved population).  "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm, did states that it was this way especially on the bottom of her feet. This redness and warmth lasted for about 30 minutes. They noticed the red dots on her lower legs shortly thereafter. Parents report that other than the rash, she has been cranky and not wanting to eat. A little better with Tylenol on board. Still wetting diapers well. She has had no difficulty breathing or swallowing. There is a petechial rash to bilateral lower legs which may be an abnormal reaction to the vaccines or possibly mechanical in etiology. Exam is otherwise reassuring. Will report to VAERS. No need to amend future vaccine schedule. Discussed possible etiologies today with parents. Monitoring and red flags discussed in detail".  The causal relationship between Vaxelis and the reported events "she has been cranky", "There is a petechial rash to bilateral lower legs", "They noticed the red dots on her lower legs shortly thereafter", " Other than rash she has been cranky", "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm", "not wanting to eat" as related. The causal relationship between Vaxelis and the reported event " Product administered to patient of 0.08 years (1 month)" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Petechiae, Rash erythematous
Clinical narrative: she has been cranky; There is a petechial rash to bilateral lower legs; They noticed the red dots on her lower legs shortly thereafter; Other than rash she has been cranky; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; not wanting to eat; Product administered to patient of 0.08 years (1 month); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2657009-1. The original narrative from the sender is the following:  The case is considered as off label use due to Product use issue (product use in unapproved population).  "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm, did states that it was this way especially on the bottom of her feet. This redness and warmth lasted for about 30 minutes. They noticed the red dots on her lower legs shortly thereafter. Parents report that other than the rash, she has been cranky and not wanting to eat. A little better with Tylenol on board. Still wetting diapers well. She has had no difficulty breathing or swallowing. There is a petechial rash to bilateral lower legs which may be an abnormal reaction to the vaccines or possibly mechanical in etiology. Exam is otherwise reassuring. Will report to VAERS. No need to amend future vaccine schedule. Discussed possible etiologies today with parents. Monitoring and red flags discussed in detail".  The causal relationship between Vaxelis and the reported events "she has been cranky", "There is a petechial rash to bilateral lower legs", "They noticed the red dots on her lower legs shortly thereafter", " Other than rash she has been cranky", "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm", "not wanting to eat" as related. The causal relationship between Vaxelis and the reported event " Product administered to patient of 0.08 years (1 month)" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Food refusal, Irritability, Petechiae, Product use issue, Rash
Clinical narrative: she has been cranky; There is a petechial rash to bilateral lower legs; They noticed the red dots on her lower legs shortly thereafter; Other than rash she has been cranky; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; not wanting to eat; Product administered to patient of 0.08 years (1 month); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2657009-1. The original narrative from the sender is the following:  The case is considered as off label use due to Product use issue (product use in unapproved population).  "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm, did states that it was this way especially on the bottom of her feet. This redness and warmth lasted for about 30 minutes. They noticed the red dots on her lower legs shortly thereafter. Parents report that other than the rash, she has been cranky and not wanting to eat. A little better with Tylenol on board. Still wetting diapers well. She has had no difficulty breathing or swallowing. There is a petechial rash to bilateral lower legs which may be an abnormal reaction to the vaccines or possibly mechanical in etiology. Exam is otherwise reassuring. Will report to VAERS. No need to amend future vaccine schedule. Discussed possible etiologies today with parents. Monitoring and red flags discussed in detail".  The causal relationship between Vaxelis and the reported events "she has been cranky", "There is a petechial rash to bilateral lower legs", "They noticed the red dots on her lower legs shortly thereafter", " Other than rash she has been cranky", "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm", "not wanting to eat" as related. The causal relationship between Vaxelis and the reported event " Product administered to patient of 0.08 years (1 month)" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Skin warm
Clinical narrative: she has been cranky; There is a petechial rash to bilateral lower legs; They noticed the red dots on her lower legs shortly thereafter; Other than rash she has been cranky; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm,; not wanting to eat; Product administered to patient of 0.08 years (1 month); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2657009-1. The original narrative from the sender is the following:  The case is considered as off label use due to Product use issue (product use in unapproved population).  "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm, did states that it was this way especially on the bottom of her feet. This redness and warmth lasted for about 30 minutes. They noticed the red dots on her lower legs shortly thereafter. Parents report that other than the rash, she has been cranky and not wanting to eat. A little better with Tylenol on board. Still wetting diapers well. She has had no difficulty breathing or swallowing. There is a petechial rash to bilateral lower legs which may be an abnormal reaction to the vaccines or possibly mechanical in etiology. Exam is otherwise reassuring. Will report to VAERS. No need to amend future vaccine schedule. Discussed possible etiologies today with parents. Monitoring and red flags discussed in detail".  The causal relationship between Vaxelis and the reported events "she has been cranky", "There is a petechial rash to bilateral lower legs", "They noticed the red dots on her lower legs shortly thereafter", " Other than rash she has been cranky", "Parents state that about 2 or 3 hours after the vaccines this morning, they noticed that her legs from the upper thighs to the bottom of her feet were bright red and warm", "not wanting to eat" as related. The causal relationship between Vaxelis and the reported event " Product administered to patient of 0.08 years (1 month)" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Asthenia, Dysstasia, Fatigue, Gait inability
Clinical narrative: Mom said she wouldn't walk or stand yesterday and it is the same today; continues to not be able to stand or walk; Mom took her outside she couldn't stay standing due to weakness.; few hours later she was showing signs of increased fatigue; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2658364-1. The original narrative from the sender is the following:  "Patient received Vaxelis and PCV yesterday morning. A few hours later she was showing signs of increased fatigue but still wanted to go outside. When Mom took her outside, she couldn't stay standing due to weakness. Mom gave her Tylenol twice yesterday. Mom said she wouldn't walk or stand yesterday, and it is the same today. Today Mom gave her some Motrin but that did not help with symptoms and continues to not be able to stand or walk. Recommendation: Triaged per protocol. After more discussion about severity of symptoms with the inability to walk or stand advised Mom to take her to the Emergency Department".  The reporter assessed the causal relationship between Vaxelis and the reported events "Mom said she wouldn't walk or stand yesterday, and it is the same today"," continues to not be able to stand or walk", "Mom took her outside she couldn't stay standing due to weakness" and "few hours later she was showing signs of increased fatigue" as related  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Breath holding, Crying, Cyanosis, Pallor
Clinical narrative: patient went cyanotic; experienced a breath-holding spell; patient became pale; continued crying; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2658510-1. The original narrative from the sender is the following:  "Gave patient Prevnar 13 vaccination in left thigh and then immediately gave Vaxelis in right thigh and patient went cyanotic and experienced a breath-holding spell and then shortly after took a breath, recovered and then continued crying, then 5-7 minutes later patient became pale. Continuous oxygen saturations were monitored and stayed above 97%. Patient's color returned to normal within 30 minutes after episode. After discussion with doctor, it has been decided that future vaccinations will be given individually at different times for this patient".  The reporter assessed the causal relationship between Vaxelis and the events "patient went cyanotic ", "experienced a breath-holding spell ", "patient became pale" and " continued crying" as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HPV9, PNC15, DTPPVHBHPB, HPV9, PNC15
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administration error, Product packaging confusion, Wrong product administered
Clinical narrative: Pt received an HPV by accident; looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance; looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance; This was an error in administration.; No adverse reactions seen yet; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2644045-1. The original narrative from the sender is the following:  "Pt received an HPV by accident since it looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance. This was an error in administration. No adverse reactions seen yet".  Reporter assessed the causal relationship between Vaxelis and the events "Pt received an HPV by accident", " looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance"," looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance", " This was an error in administration." and " No adverse reactions seen yet" as not applicable due to the nature of this events.  Of note, these events do not concern Vaxelis, but rather Vaxneuvance vaccine. 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, HPV9, PNC15, DTPPVHBHPB, HPV9, PNC15
Symptoms: No adverse event, Product label issue, Wrong product administered
Clinical narrative: Pt received an HPV by accident; looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance; looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance; This was an error in administration.; No adverse reactions seen yet; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2644045-1. The original narrative from the sender is the following:  "Pt received an HPV by accident since it looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance. This was an error in administration. No adverse reactions seen yet".  Reporter assessed the causal relationship between Vaxelis and the events "Pt received an HPV by accident", " looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance"," looked like Vaxneuvance and a box of HPV vaccine was misplaced into the box for Vaxneuvance", " This was an error in administration." and " No adverse reactions seen yet" as not applicable due to the nature of this events.  Of note, these events do not concern Vaxelis, but rather Vaxneuvance vaccine. 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, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever with maximum temperature 102 F; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2658893-1. The original narrative from the sender is the following:  "Fever with maximum temperature 102 F"  The reporter did not provide an assessment of causal relationship between Vaxelis and the event " Fever with maximum temperature 102 F".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2658921-1. The original narrative from the sender is the following:  " I administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early and did not realize until the end of the visit. Explained to mom what happened. Mother of patient did not return to clinic with any questions, concerns, or complaints of child feeling or having any reaction".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2658921-1. The original narrative from the sender is the following:  " I administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early and did not realize until the end of the visit. Explained to mom what happened. Mother of patient did not return to clinic with any questions, concerns, or complaints of child feeling or having any reaction".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Administered Vaxelis and PCV13 to catch up patient with immunizations, but it was too early".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Eye swelling, Rash
Clinical narrative: Rash and eye swelling; Rash and eye swelling; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2660591-1. The original narrative from the sender is the following:  "Rash and eye swelling"  The reporter did not provide an assessment of causal relationship between Vaxelis and the event " Rash and eye swelling"  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given outside of age range. Vaxelis is approved through age five, patient is six years old.; Patient has not had any s/s of adverse reaction; Vaccine given outside of age range. Vaxelis is approved through age five, patient is six years old; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2644045-1. The original narrative from the sender is the following:  The case is classified as off label use due to Product use issue (product use in unapproved population).  "Vaccine given outside of age range. Vaxelis is approved through age five, patient is six years old. No adverse s/s reported. Nurse called mother who states patient has not had any s/s of adverse reaction "  The reporter assessed the causal relationship between Vaxelis and the events " Vaccine given outside of age range. Vaxelis is approved through age five, patient is six years old", " Patient has not had any s/s of adverse reaction", " Vaccine given outside of age range. Vaxelis is approved through age five, patient is six years old " as not applicable due to the nature of this event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Irritability
Clinical narrative: Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; including fussiness; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2662655-1. The original narrative from the sender is the following:  "Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site the next morning after the vaccine was given, including fussiness. Mother was asked if any, difficulty breathing, fever or any other symptoms. No other symptoms. Mother gave fever reducing oral liquid drops for any discomfort. Mother claimed she (mother) also has adverse reaction in her medical history to Dtap"  The causal relationship between Vaxelis and the reported events" Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site"; " including fussiness" was assessed as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Irritability, Urticaria
Clinical narrative: Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site; including fussiness; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2662655-1. The original narrative from the sender is the following:  "Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site the next morning after the vaccine was given, including fussiness. Mother was asked if any, difficulty breathing, fever or any other symptoms. No other symptoms. Mother gave fever reducing oral liquid drops for any discomfort. Mother claimed she (mother) also has adverse reaction in her medical history to Dtap"  The causal relationship between Vaxelis and the reported events" Mother describe a "bouncy ball size" welt with redness and rash around the right upper leg at injection site"; " including fussiness" was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, UNK, UNK, DTPPVHBHPB, UNK, UNK
Symptoms: Erythema, Pyrexia
Clinical narrative: red spots on skin appeared 48 hours after receiving vaccines. (not sure if either symptom is related to vaccines); fever persisting for 5 days; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2663495-1. The original narrative from the sender is the following:  "fever persisting for 5 days; red spots on skin appeared 48 hours after receiving vaccines. (not sure if either symptom is related to vaccines)"   The reporter did not provide an assessment of causal relationship between Vaxelis and the events, "fever persisting for 5 days" and "red spots on skin appeared 48 hours after receiving vaccines. (not sure if either symptom is related to vaccines)".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Erythema, Immediate post-injection reaction, Infant irritability, Pallor, Peripheral swelling
Clinical narrative: erythema after receiving Vaxelis vaccine in Left leg.; Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg.; patient very fussy; Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg.; Face and trunk became very pale; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2663996-1. The original narrative from the sender is the following:  "Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg. Got PCV 15 in Right leg right ager. Face and trunk became very pale, patient very fussy. No mouth swelling or audible wheezing, no respiratory distress. Vitals stable (BP, HR, pulse ox), given IM EpiPen Jr x 1, leg swelling resolved immediately. Vitals remained stable, taken to ED via ambulance. Will need allergist clearance before receiving any future vaccines. Will follow up recommendations from ED."  The reporter assessed the "Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg", "Face and trunk became very pale" and "patient very fussy"  as Related  to Vaxelis as the patient experienced these events immediately after vaccination with Vaxelis as a co-suspect vaccine with RotaTeq and Vaxneuvance to suggest a causal relationship.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Erythema, Immediate post-injection reaction, Irritability, Pallor, Peripheral swelling
Clinical narrative: erythema after receiving Vaxelis vaccine in Left leg.; Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg.; patient very fussy; Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg.; Face and trunk became very pale; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2663996-1. The original narrative from the sender is the following:  "Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg. Got PCV 15 in Right leg right ager. Face and trunk became very pale, patient very fussy. No mouth swelling or audible wheezing, no respiratory distress. Vitals stable (BP, HR, pulse ox), given IM EpiPen Jr x 1, leg swelling resolved immediately. Vitals remained stable, taken to ED via ambulance. Will need allergist clearance before receiving any future vaccines. Will follow up recommendations from ED."  The reporter assessed the "Patient experienced immediate L leg swelling, erythema after receiving Vaxelis vaccine in Left leg", "Face and trunk became very pale" and "patient very fussy"  as Related  to Vaxelis as the patient experienced these events immediately after vaccination with Vaxelis as a co-suspect vaccine with RotaTeq and Vaxneuvance to suggest a causal relationship.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC13, DTPPVHBHPB, HEPA, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2664212-1. The original narrative from the sender is the following:  "Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early."  Due to the nature of the event, the causal relationship between Vaxelis  and "Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early." was Not Applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC13, DTPPVHBHPB, HEPA, PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2664212-1. The original narrative from the sender is the following:  "Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early."  Due to the nature of the event, the causal relationship between Vaxelis  and "Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early." was Not Applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV, RV5, DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: EXTRA DOSE ADMINISTERED; Overdose; No Adverse Event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2668702-1 and ADDITIONAL INFORMATION RECEIVED ON 12-OCT-2023 with the following VAERS Primary 2665702-1. The original narrative from the sender is the following:  "was accidentally administered with acthib and vaxelis at the same time with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid nonserious case received from a other health professional. This case involves a 6 months old male patient who was accidentally administered with Hib (Prp/T) Vaccine [Act-Hib] And Vaxelis [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] at the same time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination. On 31-Jul-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: Once; Strength: Standard, expiry date: 06-May-2024 and lot UJ801AA) via intramuscular route in Left Vastus Lateralis for Immunization; on the same day received a unknown dose of suspect VAXELIS not produced by Sanofi Pasteur (formulation Strength, expiry date and lot number: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and was accidentally administered at the same time (Extra dose administered) (latency: same day). Information on the batch number was reuqested. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error"  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Extra dose administered", "No adverse event" and "Overdose".   Due to the nature of the event, the causal relationship between Vaxelis and "Extra dose administered", "No adverse event" and "Overdose" was Not Applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV, RV5, DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: EXTRA DOSE ADMINISTERED; Overdose; No Adverse Event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary 2668702-1 and ADDITIONAL INFORMATION RECEIVED ON 12-OCT-2023 with the following VAERS Primary 2665702-1. The original narrative from the sender is the following:  "was accidentally administered with acthib and vaxelis at the same time with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid nonserious case received from a other health professional. This case involves a 6 months old male patient who was accidentally administered with Hib (Prp/T) Vaccine [Act-Hib] And Vaxelis [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] at the same time with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination. On 31-Jul-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: Once; Strength: Standard, expiry date: 06-May-2024 and lot UJ801AA) via intramuscular route in Left Vastus Lateralis for Immunization; on the same day received a unknown dose of suspect VAXELIS not produced by Sanofi Pasteur (formulation Strength, expiry date and lot number: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and was accidentally administered at the same time (Extra dose administered) (latency: same day). Information on the batch number was reuqested. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error"  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Extra dose administered", "No adverse event" and "Overdose".   Due to the nature of the event, the causal relationship between Vaxelis and "Extra dose administered", "No adverse event" and "Overdose" was Not Applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, UNK, VARCEL, VARCEL, DTPPVHBHPB, HEPA, MMR, UNK, VARCEL, VARCEL
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.; Adminstration issue; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667006-1. The original narrative from the sender is the following:  "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit."  This case was classified as a PQC to be databased given that the reported event was "Syringe issue" in which Vaxelis was reported as to a patient as a co-suspect vaccine.   The reporter did not provide an assessment of causal relationship between Vaxelis and the events; "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.)" and " Syringe issue".  Due to the nature of the event, the causal relationship between Vaxelis and "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.)" and " Syringe issue" was Not Applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, UNK, VARCEL, VARCEL, DTPPVHBHPB, HEPA, MMR, UNK, VARCEL, VARCEL
Symptoms: Syringe issue, Underdose
Clinical narrative: Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.; Adminstration issue; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667006-1. The original narrative from the sender is the following:  "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit."  This case was classified as a PQC to be databased given that the reported event was "Syringe issue" in which Vaxelis was reported as to a patient as a co-suspect vaccine.   The reporter did not provide an assessment of causal relationship between Vaxelis and the events; "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.)" and " Syringe issue".  Due to the nature of the event, the causal relationship between Vaxelis and "Needle/syringe came out when child moved resulting in vaccination not being administered. The vaccination was repeated during the same visit.)" and " Syringe issue" was Not Applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB
Symptoms: Balance disorder, Body temperature increased, Coordination abnormal, Crying, Decreased appetite
Clinical narrative: difficulty with balance and corrdenation; weight loss (1.5 pounds),; continued severe diarrhea; Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in; redness in face, neck; 100.3 temp, 103 temp; screaming in tears, unable to be consoled late into the next morning; screaming in tears, unable to be consoled late into the next morning; difficulty with balance and corrdenation; discomfort; sweating; sleepiness; loss of appetite; drowsy; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2667026-1. The original narrative from the sender is as follows.  "8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"  The reporter assessed the casual relationship between Vaxelis and the events " 8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"as related.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB
Symptoms: Diarrhoea, Discomfort, Erythema, Hyperhidrosis, Screaming
Clinical narrative: difficulty with balance and corrdenation; weight loss (1.5 pounds),; continued severe diarrhea; Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in; redness in face, neck; 100.3 temp, 103 temp; screaming in tears, unable to be consoled late into the next morning; screaming in tears, unable to be consoled late into the next morning; difficulty with balance and corrdenation; discomfort; sweating; sleepiness; loss of appetite; drowsy; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2667026-1. The original narrative from the sender is as follows.  "8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"  The reporter assessed the casual relationship between Vaxelis and the events " 8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"as related.   No further information is expected.