chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (for 1st dose, refer case US2018143053). On 5th August 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 5th August 2018 20:00, the patient experienced chills, fatigue and muscle pain. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the chills, fatigue and muscle pain were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the chills, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 21st June 2018 and received 2nd dose of 5th August 2018 at 15:00 hours, which led to shortening of the vaccination schedule. She received the 2nd dose because she was at the pharmacy where they were administering it and the patient could not remember when she got the 1st dose. By 8 to 9 PM, 5 hours after receiving SHINGRIX, she started experiencing the symptoms. The events were worse after the 2nd dose than the 1st dose.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Inappropriate schedule of drug administration, Myalgia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (for 1st dose, refer case US2018143053). On 5th August 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 5th August 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 5th August 2018 20:00, the patient experienced chills, fatigue and muscle pain. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the chills, fatigue and muscle pain were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the chills, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 21st June 2018 and received 2nd dose of 5th August 2018 at 15:00 hours, which led to shortening of the vaccination schedule. She received the 2nd dose because she was at the pharmacy where they were administering it and the patient could not remember when she got the 1st dose. By 8 to 9 PM, 5 hours after receiving SHINGRIX, she started experiencing the symptoms. The events were worse after the 2nd dose than the 1st dose.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX (batch number 32GR4, expiry date 1st May 2036) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced rash and unwell. The patient was treated with Valacyclovir. On an unknown date, the outcome of the rash and unwell were unknown. It was unknown if the reporter considered the rash and unwell to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right arm. The patient experienced a rash on the face, neck, and head after receiving SHINGRIX. The healthcare professional additionally reported that the patient was not feeling well and was not good according to the patient's daughter. The patient was seen by her doctor and prescribed Valacyclovir 1 gram 3 times a day for 7 days. No additional information was available.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX (batch number 32GR4, expiry date 1st May 2036) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced rash and unwell. The patient was treated with Valacyclovir. On an unknown date, the outcome of the rash and unwell were unknown. It was unknown if the reporter considered the rash and unwell to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right arm. The patient experienced a rash on the face, neck, and head after receiving SHINGRIX. The healthcare professional additionally reported that the patient was not feeling well and was not good according to the patient's daughter. The patient was seen by her doctor and prescribed Valacyclovir 1 gram 3 times a day for 7 days. No additional information was available.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX (batch number 32GR4, expiry date 1st May 2036) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced rash and unwell. The patient was treated with Valacyclovir. On an unknown date, the outcome of the rash and unwell were unknown. It was unknown if the reporter considered the rash and unwell to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right arm. The patient experienced a rash on the face, neck, and head after receiving SHINGRIX. The healthcare professional additionally reported that the patient was not feeling well and was not good according to the patient's daughter. The patient was seen by her doctor and prescribed Valacyclovir 1 gram 3 times a day for 7 days. No additional information was available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Headache within 2 hours of administration. Body aches within 4 hours. Painful, HO swelling, that spread to within 2 inches above the elbow. Swelling is 6 inches by 8 inches.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh circular raised red patch around injection site, warm to touch, afebrile
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, pain, and itching over 24-48 hour period.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, RAB, VARCEL, DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Baby boy showed with fever, irritability and rash in the face, arms and legs. It was evaluated and BENADRYL P.O was given.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, RAB, VARCEL, DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Aggression, Decreased appetite, Haematocrit normal, Haemoglobin normal, Herpes virus infection
Clinical narrative: Baby boy showed with fever, irritability and rash in the face, arms and legs. It was evaluated and BENADRYL P.O was given.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, RAB, VARCEL, DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Irritability, Platelet count normal, Pyrexia, Rash, Rash pruritic
Clinical narrative: Baby boy showed with fever, irritability and rash in the face, arms and legs. It was evaluated and BENADRYL P.O was given.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, RAB, VARCEL, DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: Rash pustular, Rash vesicular, Scab, Swelling of eyelid, Thermal burn
Clinical narrative: Baby boy showed with fever, irritability and rash in the face, arms and legs. It was evaluated and BENADRYL P.O was given.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, RAB, VARCEL, DTAPHEPBIP, MMR, PNC13, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: Baby boy showed with fever, irritability and rash in the face, arms and legs. It was evaluated and BENADRYL P.O was given.
Age: 19.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Abdominal pain, Dyspnoea, Hyperhidrosis, Throat tightness, Vision blurred
Clinical narrative: Patient was given two vaccines roughly around 2:30pm after a physical exam. Patient left office and reported back to our office around 5pm with complaints of vomiting that started 30 mins after she left here, felt like her throat was closing and sweating. At this time, employee examined patient who also complained of ABD pain and it was determined that she should receive epi via Epi pen adult. Epi was given to patients left thigh and EMS was called due to worsening symptoms to include blurry vision and continuing of vomiting. EMS arrive roughly at 5:20 and patient was transported to emergency room for possible allergic reaction. She was given Solu-Medrol by EMS enroute and was reporting dyspnea. She was discharged from the ER few hours later with Benadryl.
Age: 19.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Vomiting
Clinical narrative: Patient was given two vaccines roughly around 2:30pm after a physical exam. Patient left office and reported back to our office around 5pm with complaints of vomiting that started 30 mins after she left here, felt like her throat was closing and sweating. At this time, employee examined patient who also complained of ABD pain and it was determined that she should receive epi via Epi pen adult. Epi was given to patients left thigh and EMS was called due to worsening symptoms to include blurry vision and continuing of vomiting. EMS arrive roughly at 5:20 and patient was transported to emergency room for possible allergic reaction. She was given Solu-Medrol by EMS enroute and was reporting dyspnea. She was discharged from the ER few hours later with Benadryl.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a female patient of unknown age. The patient's concomitant medication included sterile diluent (manufacturer unknown). The patient's pertinent medical history and drug reactions/allergies were not reported. On 17-JUL-2018 the patient was vaccinated with an expired dose of M-M-R II (route and strength unknown; lot # M028131, expiration date 02-JUN-2018; therapy type rHA) for prophylaxis. It was confirmed with nurse that dose of sterile diluent (manufacturer unknown) used for reconstitution of M-M-R II was properly stored which was already properly disposed. Confirmed with nurse that expired M-M-R II had no temperature excursions prior to being administered. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored PROQUAD for prophylaxis, albumin status rHA, lot #R003292 and expiration date 31-JUL-2019 (strength, dose, route of administration and frequency were not reported). No adverse symptoms were reported. The temperature excursion was reported as 8°F, during a time frame of 2 hours. It was reported that there was a previous temperature excursion. It was also informed by the nurse, that there was a temperature excursion reported as 8°F during a time frame of 1 hour and no previous temperature of excursion was provided (conflicting information). A digital data logger was involved.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood albumin decreased, Blood culture negative, Blood lactic acid increased, C-reactive protein increased, CSF test normal
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chapped lips, Conjunctivitis, Culture negative, Culture urine negative, Diarrhoea haemorrhagic
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Echocardiogram normal, Erythema, Haemoglobin normal, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Leukocytosis, Lip dry, Occult blood positive, Oedema, Oedema peripheral
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Peripheral swelling, Platelet count increased, Poor peripheral circulation, Pyrexia, Rash
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash erythematous, Rash macular, Respiratory viral panel, Ultrasound abdomen normal, Urine analysis normal
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Viral sepsis, White blood cell count increased
Clinical narrative: This literature report has been received from the authors of a published article. This report refers to a female infant who presented with classic Kawasaki disease (KD) shortly after receiving her routine 4 month vaccination series. The present patient was first admitted with fever, edema and erythematous-purplish rash of the extremities, 1 week after receiving PEDIARIX, Haemophilus influenza type B (Hib) (manufacturer unknown) (dose, lot# and route unknown for prophylaxis), PREVNAR 13, and ROTARIX at age 2 months. At that presentation, she had poor perfusion, elevated leukocytes, platelets, and lactate, and underwent conventional infant rule-out sepsis management. Cerebrospinal fluid panel, urinalysis, and all cultures were normal/negative; the patient quickly improved with supportive care, was suspected to have viral sepsis, and was discharged after 2 days. The patient remained well through her routine 4 months well child visit. Twelve hours after receiving vaccines (again, PEDIARIX, PREVNAR 13, and ROTARIX at that visit, she developed a fever. This persisted until presentation on day of illness (DOI) 4, at which time she had a temperature of 39.4 degree Celsius, hemoccult positive diarrhea, and an erythematous macular rash on her torso. By DOI 7 she had dry, cracked lips, intermittent non-purulent conjunctivitis, and edematous feet with red soles. KD was suspected based on standard criteria: laboratory data were notable for C-reactive protein 97.1 mg/L, hemoglobin 10.2 g/dL, and albumin 2.8 g/dL; viral respiratory screen, urine and blood cultures were negative; echocardiogram and abdominal ultrasound were normal. With ongoing flares of body rash and feet swelling, and refractory more than 39 degree Celsius fever, she was given intravenous (i.v.) immunoglobulin (IVIG) and aspirin on DOI 9. She defervesced during the IVIG infusion, the swelling resolved the next day, and besides a fading reticular rash, she was at her clinical baseline at discharge on DOI 11. Subsequently, she received all expected 6 months vaccines except ROTARIX, and received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella vaccines (manufacturer unknown) at 12 months - all with no issues - and had remained otherwise well through 15 months of age. The reporter considered the event to be related to the suspect therapies. Upon internal review, the event of Kawasaki disease was determined to be medically significant.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a nurse practitioner who refers to her 2-month-old infant child. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with the first dose of ROTATEQ, orally (dose, lot# and expiration date were not reported) for prophylaxis as well as other unspecified vaccines, reported as "2 moth old vaccines". On an unspecified date, after the vaccination, the patient experienced seizure. The reporter also stated that the patient was placed on a modified immunization schedule for his unspecified 4 month old vaccines. On an unknown date (reported as at 4 months old), the patient was vaccinated with the second dose of ROTATEQ, orally (dose, lot# and expiration date not reported) for prophylaxis. The outcome of seizure was reported as fully recovered. The relatedness between the seizure and ROTATEQ was not reported. Upon internal review, seizure was considered as medically significant.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 09-AUG-2018, the patient was vaccinated with a properly stored but expired dose of ROTATEQ orally, for prophylaxis, lot #M039061 and expiration date 28-MAR-2018 (strength, dose and frequency were not reported). No adverse reactions were reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a pharmacist, concerning a 40 year old female patient with human immunodeficiency virus (HIV) disease as concurrent condition and no previously drug reactions or allergies. The patient's concomitant medication included dolutegravir (+) rilpivirine (JULUCA). On 22-SEP-2017, 26-APR-2018 and on unspecified date, the patient was vaccinated with RECOMBIVAX HB 40 micrograms injection, intramuscularly (dose, anatomical location, lot numbers and expiration dates were not provided) for prevention of hepatitis B; the patient completed a three-dose series of RECOMBIVAX HB, however pharmacist could not clarify whether these were the dates of administration of the first and second doses, second and third doses, or first and third doses. Pharmacist also did not clarify whether the patient was on dialysis (indication for this dose). On an unspecified date in 2018 (reported as: "recently"), the patient had titers drawn which showed the patient was negative for immunity to hepatitis B (hepatitis b surface antibody negative). At the time of report, the patient was not recovered from hepatitis b surface antibody negative and she had not been treated from the adverse event. The causal relationship between the hepatitis b surface antibody negative and  RECOMBIVAX HB was not provided.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006769:  US-009507513-1808USA006770: US-009507513-1808USA006771:  US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Lethargy, Pain
Clinical narrative: Pt had flu like symptoms (chills, lethargy, feeling generally bad/achy) the evening following the shot and for a about a full day after getting the shots.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Borrelia test negative, Eyelid function disorder, Facial paralysis, Facial paresis, Nuclear magnetic resonance imaging
Clinical narrative: Right facial Bell's palsy onset 8/9/2018 with complete paralysis on 8/12/2018. As of 8/17/2018 exam she has right facial weakness with no forehead muscle activation, limited eyelid closure, and inability to smile. She needs to drink from a straw. She also had pain. She did go to an ER on 8/11 and was prescribed prednisone and Valtrex. Steroids have been completed and last dose of Valtrex is on 8/17/2018.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Right facial Bell's palsy onset 8/9/2018 with complete paralysis on 8/12/2018. As of 8/17/2018 exam she has right facial weakness with no forehead muscle activation, limited eyelid closure, and inability to smile. She needs to drink from a straw. She also had pain. She did go to an ER on 8/11 and was prescribed prednisone and Valtrex. Steroids have been completed and last dose of Valtrex is on 8/17/2018.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, chills, dizziness, sweating, headache.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: 8/15/18 0900 mom reports patient had fever of 102 along with warm, swollen, and reddened right arm. Evaluation by pediatrician determined to be a side effect. 8/16/18 mom reports patient developed rash, continued fever, redness, and swelling of right arm. Re-evaluation by pediatrician determined to be allergic type response to vaccines given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Skin warm, Vaccination complication
Clinical narrative: 8/15/18 0900 mom reports patient had fever of 102 along with warm, swollen, and reddened right arm. Evaluation by pediatrician determined to be a side effect. 8/16/18 mom reports patient developed rash, continued fever, redness, and swelling of right arm. Re-evaluation by pediatrician determined to be allergic type response to vaccines given.
Age: 18.0
Sex: F
Vaccine: HPV9, MMRV
Symptoms: Incorrect product formulation administered
Clinical narrative: Client received MMRV vaccination; only needed Varivax.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: There are no adverse events, no treatment or outcome to report. It was an expired vaccine, and the Health Dept was contacted for guidance, as well as the company - Pfizer. Both recommending re vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Acute myeloid leukaemia, Contusion, Ear infection, Fungal skin infection, Injection site mass
Clinical narrative: A few days after vaccines, my son had two huge lumps in his thigh, then he developed an ear infection, a cold that lasted two weeks, bruising, and a fungal rash only to find out on June 14,2018 he had an aggressive form of blood cancer, Acute Myeloid Luekemia .
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Nasopharyngitis, White blood cell count increased
Clinical narrative: A few days after vaccines, my son had two huge lumps in his thigh, then he developed an ear infection, a cold that lasted two weeks, bruising, and a fungal rash only to find out on June 14,2018 he had an aggressive form of blood cancer, Acute Myeloid Luekemia .
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Fever for 4-5 hours, chills,  achy ness, pain in joints and all over.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Discomfort, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: 24 hours after injection, at injection site left arm, swollen, red and hot to touch. Low grade fever of 99.7 for 3 days following injection. Left upper back pain, left neck pain, left jaw pain and pressure. Extreme fatique, whole body aches. Today is day 4 following vaccine and symptoms are slowly residing however the arm is still red, swollen and hot to touch.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site warmth, Neck pain, Pain, Pain in jaw, Pyrexia
Clinical narrative: 24 hours after injection, at injection site left arm, swollen, red and hot to touch. Low grade fever of 99.7 for 3 days following injection. Left upper back pain, left neck pain, left jaw pain and pressure. Extreme fatique, whole body aches. Today is day 4 following vaccine and symptoms are slowly residing however the arm is still red, swollen and hot to touch.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: 24 hours after injection, at injection site left arm, swollen, red and hot to touch. Low grade fever of 99.7 for 3 days following injection. Left upper back pain, left neck pain, left jaw pain and pressure. Extreme fatique, whole body aches. Today is day 4 following vaccine and symptoms are slowly residing however the arm is still red, swollen and hot to touch.
Age: 48.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Myalgia, Pyrexia, Trismus
Clinical narrative: 24 hours after injection, at injection site left arm, swollen, red and hot to touch. Low grade fever of 99.7 for 3 days following injection. Left upper back pain, left neck pain, left jaw pain and pressure. Extreme fatique, whole body aches. Today is day 4 following vaccine and symptoms are slowly residing however the arm is still red, swollen and hot to touch.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: 1st shot mild fever, headache, body aches. 2nd shot approx 3 months later, severe headache, muscle aches and nausea. Fever at least 101. Diarrhea the morning after shot. Other symptoms lasted 24 hours. Couldn't take MOTRIN, too sick with nausea. Never had an adverse reaction to any other vaccine including original shingles vaccine shot over 6 years ago. No allergies or illness at time of these injections.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Injection site warmth
Clinical narrative: General malaise with headache starting about an hour after injection. Eight hours after injection muscle and joints ache and started to run a fever. Took naproxen 220 mg at 1800 hrs. Woke up next day feeling like I had the flu and running a temp. of 101F. Took Acetaminophen 500mg. 0800 hr and 1400 hr and remained in bed still running a fever. By 1700 hr fever gone and felt much better. Injection site remains painful and warm to touch at 1000 hr 8/17/18. (No signs of infection).