chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated a dose of with GARDASIL (dose, route, lot# and expiration date unknown) for prophylaxis. On 20-JAN-2017, the patient received a dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) for prophylaxis as the next dose in the HPV vaccination series. No adverse effects were reported. The causal relationship between the event and suspect therapies was unknown. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001972:
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No concurrent conditions, medical history and concomitant medications were reported. Approximately in 2016 (reported as one year ago), the pharmacist gave the patient a second booster shot for PNEUMOVAX 23 (dosing details, lot# and expiry date were not reported) for prophylaxis; instead of the first booster and on 22-DEC-2016 (reported as today), the patient came in for second booster and the pharmacist gave him PREVNAR 13 (dosing details, lot# and expiry date were not reported) which was supposed to be the first booster. The pharmacist mentioned that he didn't know what were the ramifications of this situation. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of ROTATEQ (lot #: L033545; expiration date: 30-MAR-2017) experienced a temperature excursion of >46F - <77F for 6 hours 30 minutes. Data logger was involved. There was no previous temperature excursion. On multiple unspecified dates, unspecified patients were administered these improperly stored doses of vaccines. No adverse effects reported. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009748.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX, subcutaneously, for prophylaxis (dose, lot # and expiration date were not reported). It was stated that the patients developed rash at injection site (no dates reported). It was stated that no treatment was given for the adverse event. At the time of reporting, the outcome of the event was unknown. A product quality complaint was not involved. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an administrator refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PNEUMOVAX 23 (intramuscularly, lot # L040178, expiration date 18-AUG-2017; dose was not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in the temperature between 0 degrees Celsius to 2 degrees Celsius for 24 hours and in the temperature range of above 8 degrees Celsius but below 25 degrees Celsius for 26 hours and for 14 hours and 10 minutes. The call was made because of a data logger. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 27-JAN-2017, the patient was vaccinated with a dose of VAQTA lot # L048460 that expired 14-JAN-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lots # M011116, M027879, M033611 with expiration dates 17-JUN-2017, 24-JAN-2018 and 02-MAR-2018 respectively, (dosages were not provided), for prophylaxis. The doses of VAQTA were exposed to a temperature > 46°F but  < 77°F and were out of range for 24 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA003012: US-009507513-1702USA003013.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated a dose of with GARDASIL (dose, route, lot# and expiration date unknown) for prophylaxis. On 20-JAN-2017, the patient received a dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) for prophylaxis as the next dose in the HPV vaccination series. No adverse effects were reported. The causal relationship between the event and suspect therapies was unknown. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009743:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lots # M000442, M026309, M037248 with expiration dates 02-MAR-2018, 11-NOV-2018 and 21-FEB-2019 respectively, (dosages were not provided),  for prophylaxis. The doses of RECOMBIVAX HB were exposed to a temperature > 46°F but  < 77°F and were out of range for 24 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001060: US-009507513-1702USA003013.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not informed. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lots # M016238, M022371 and M031553 with expiration dates 07-DEC-2017, 18-FEB-2018 and 19-MAR-2018 respectively, orally, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature > 46°F but < 77°F and were out of range for 24 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001060: US-009507513-1702USA003013.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient still contracted chickenpox. The patient did not seek medical attention. The outcome of the adverse events was reported as recovered on an unknown date. The relatedness between the adverse events and VARIVAX was not provided. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012629 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012631 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-OCT-2016, the patient was vaccinated with the first dose of ZOSTAVAX injection, subcutaneously (lot# L046295 and expiration date 17-FEB-2017, dose not provided). On 09-JAN-2017, the patient was vaccinated with the second dose of ZOSTAVAX injection, subcutaneously (lot# M033336 and expiration date 11-OCT-2017, dose not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of GARDASIL 9 lot # L037554 (dose, route of administration and expiration date were not reported). On 09-JAN-2017, the patient was vaccinated with a dose of GARDASIL lot # K004205 (dose and route of administration were not reported, expiration date 12-JAN-2017). No adverse effects were reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 months old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUN-2016, when the patient was 1 year old, he/she received the first dose of VAQTA injection (dose, route of administration, anatomical location, lot # and expiry were not specified) for prophylaxis. On 19-DEC-2016, at the age of 18 months, the patient was vaccinated with the second dose of VAQTA injection (dose, route of administration, anatomical location, lot # and expiry were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to herself, a female patient of unknown age. The patient's medical history included shingles of the jaw (herpes zoster) on an unspecified date. The patient was not taking concomitant medications. In approximately 2014, reported as about three years ago, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for prevention of shingles recurrence. On an unknown date, reported as three months after the ZOSTAVAX administration, the patient developed shingles of the jaw again but "with much less severity". No treatment was given for the adverse event. On an unknown date, the patient recovered from shingles of the jaw, reported as "she only developed a rash and then shortly after it went away on it's own". The causal relationship between the event and ZOSTAVAX was not reported. Additional information is not expected because there was no consent to contact reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a unspecified patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB, (strength, dose, frequency, and route of administration were not provided)  lot # M020100 and expiration date 07-MAR-2019 for prophylaxis. The reporter stated that the temperature range  of the vaccine  was >46°F but <77°F and the time frame was 56 minutes, also she stated that no previous temperature excursion was involved, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB injection, lot # M025192, expiration date 21-MAR-2019 (dose and route of administration were not reported). No adverse effects were reported. The vaccine experienced a temperature excursion of 33.60 Fahrenheit degrees (F) for 5 minutes. There was no previous temperature excursion. Digital data logger was not involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 27-JAN-2017: all telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003518: US-009507513-1611USA001487:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Computerised tomogram, Cough, Influenza, Mass
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, Manufacturer report number: 2015386497) on 17-JAN-2017. This case involves a 70-years-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, dose, dose in series, expiry date, route and site of administration were not reported) on an unspecified date in 2014. The patient's medical history was not reported. Concomitant medications included AFINITOR 5 mg once a day. On an unspecified date in 2014, following the vaccination, the patient experienced caught flu and dry cough. On 03-NOV-2015 computed tomography (CAT) scan revels that her tumor was shrinking from 3.7 to 3.5 and blood work was normal. The patient's corrective treatment was not reported. The events outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Computerised tomogram abnormal, Cough, Influenza, Neoplasm
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, Manufacturer report number: 2015386497) on 17-JAN-2017. This case involves a 70-years-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, dose, dose in series, expiry date, route and site of administration were not reported) on an unspecified date in 2014. The patient's medical history was not reported. Concomitant medications included AFINITOR 5 mg once a day. On an unspecified date in 2014, following the vaccination, the patient experienced caught flu and dry cough. On 03-NOV-2015 computed tomography (CAT) scan revels that her tumor was shrinking from 3.7 to 3.5 and blood work was normal. The patient's corrective treatment was not reported. The events outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer, Manufacturer report number: 2017016607) on 30 January 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient felt sick ("every time he takes it"). Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Crying, Decreased interest, Dyskinesia, Electrocardiogram normal
Clinical narrative: Mother's report: DTAP (4th dose) given at approximately 9:10am. She cried for 10-15 seconds (usual for her) and was easily distracted and consolable right away.  She was more amused by the band aid than the shot.  We gathered our belongs and put pants back on her. We had not yet left the medical exam room when her behavior suddenly changed.  After approximately 5 minutes post injection, she became very lethargic and wouldn't let me put her down.  While I was holding her, she jerked 2-3 times and then vomited. (This appeared to be a seizure)  After that episode, she became somewhat unresponsive, very lethargic, and limp.  She could barely keep her eyes open.  The MD was called in. O2 Saturation and pulse were taken. Pulse was rather low (72 bpm). O2 sat were acceptable (I cannot recall exact %). She continued to be limp, pale, not communicating or responding to verbal commands. It was decided to call an ambulance.  Once the ambulance arrived (12-15 minutes later), her color was slowing returning and she was slowing acting more alert, but remained overall fatigued. This was a complete difference from prior to the injections when she was playing with several kids in the waiting room and running from toy to toy.  After this injection she was not interested in anything.  She was like a rag doll. Appeared to be in a postictal state. She was taken to the ER. Vital signs in the ambulance revealed a stable pulse, O2, with mild hypo-tension (93/37 - R ankle).  At the ER, she was examined, EKG performed and vital signs monitored.  She was slowly returning to her baseline. Vitals signs were stable. EKG negative. She was discharged home.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Hypotension, Hypotonia, Lethargy, Pallor
Clinical narrative: Mother's report: DTAP (4th dose) given at approximately 9:10am. She cried for 10-15 seconds (usual for her) and was easily distracted and consolable right away.  She was more amused by the band aid than the shot.  We gathered our belongs and put pants back on her. We had not yet left the medical exam room when her behavior suddenly changed.  After approximately 5 minutes post injection, she became very lethargic and wouldn't let me put her down.  While I was holding her, she jerked 2-3 times and then vomited. (This appeared to be a seizure)  After that episode, she became somewhat unresponsive, very lethargic, and limp.  She could barely keep her eyes open.  The MD was called in. O2 Saturation and pulse were taken. Pulse was rather low (72 bpm). O2 sat were acceptable (I cannot recall exact %). She continued to be limp, pale, not communicating or responding to verbal commands. It was decided to call an ambulance.  Once the ambulance arrived (12-15 minutes later), her color was slowing returning and she was slowing acting more alert, but remained overall fatigued. This was a complete difference from prior to the injections when she was playing with several kids in the waiting room and running from toy to toy.  After this injection she was not interested in anything.  She was like a rag doll. Appeared to be in a postictal state. She was taken to the ER. Vital signs in the ambulance revealed a stable pulse, O2, with mild hypo-tension (93/37 - R ankle).  At the ER, she was examined, EKG performed and vital signs monitored.  She was slowly returning to her baseline. Vitals signs were stable. EKG negative. She was discharged home.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Postictal state, Seizure, Unresponsive to stimuli, Vomiting
Clinical narrative: Mother's report: DTAP (4th dose) given at approximately 9:10am. She cried for 10-15 seconds (usual for her) and was easily distracted and consolable right away.  She was more amused by the band aid than the shot.  We gathered our belongs and put pants back on her. We had not yet left the medical exam room when her behavior suddenly changed.  After approximately 5 minutes post injection, she became very lethargic and wouldn't let me put her down.  While I was holding her, she jerked 2-3 times and then vomited. (This appeared to be a seizure)  After that episode, she became somewhat unresponsive, very lethargic, and limp.  She could barely keep her eyes open.  The MD was called in. O2 Saturation and pulse were taken. Pulse was rather low (72 bpm). O2 sat were acceptable (I cannot recall exact %). She continued to be limp, pale, not communicating or responding to verbal commands. It was decided to call an ambulance.  Once the ambulance arrived (12-15 minutes later), her color was slowing returning and she was slowing acting more alert, but remained overall fatigued. This was a complete difference from prior to the injections when she was playing with several kids in the waiting room and running from toy to toy.  After this injection she was not interested in anything.  She was like a rag doll. Appeared to be in a postictal state. She was taken to the ER. Vital signs in the ambulance revealed a stable pulse, O2, with mild hypo-tension (93/37 - R ankle).  At the ER, she was examined, EKG performed and vital signs monitored.  She was slowly returning to her baseline. Vitals signs were stable. EKG negative. She was discharged home.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Bone pain, Spinal pain
Clinical narrative: Patient contacted pharmacy to report a feeling of "pain in her bones," primarily in her "spine." No other symptoms were reported. I contacted the patient today (2/8/17) and patient was still experiencing the pain, but it has been improving. I instructed her to contact us or her primary care provider if symptoms do not resolve in the next 48 hours or if they worsen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, warmth, edema (R) upper arm, measuring 4x3in starting 1-23-17 and lasting 6 days. Improved with BENADRYL, but would worsen when time for next dose of BENADRYL. Area covered entire upper arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Capillary nail refill test, Constipation, Culture urine negative, Dyspnoea
Clinical narrative: This event was historical at age 2 months; I find no record of previous report. The patient received 2 month vaccines. MOP reports decreased responsiveness, "limp" and fever. She was seen in ER and admitted with negative eval. Discharge summary as follows: "HPI: Patient is a 2 month old female who presented to the ED 2 days ago for "breathing weird after shots". She had been a healthy full-term infant born SVD at 40+3 to G3P2 mom and had a normal well baby check the day of admission. At the WBC, she received her 2 month scheduled immunizations at 1030 and was subsequently dropped off at daycare. When picked up, mom noticed breathing concerns and then presented to ED. There she had a rectal temp 103.7, tachypnea to 80s, and tachycardia to 190s, given 50 mg of MOTRIN and admitted for observation. Hospital Course: Since admission, mom reports she has been tolerating bottle well; she exclusively receives SIMILAC q2-3 hours up to 4 oz. She has been producing urine adequately but no stool since day of admission. She has had no acute events through the nights and sleeps well per parents. On the morning of day 2 of hospital stay she had significant nasal congestion that brought on increased breathing effort and subcostal retractions. This resolved promptly after saline and suction and she has had only one mild episode requiring suction since. She has remained afebrile with no O2 requirements or need for fluid support, with stable vitals. PE: Vitals: Temp 97.8-98.8F, HR 128-132, RR 40-42, Pulse ox 100% on RA, Admit weight 5300g General: Resting comfortably, mildly fussy but consolable on arousal Head: Atraumatic/normocephalic, Anterior fontanel open, soft, and flat Nose: No secretions noted, adequate air movement Mouth: Moist Mucosa Lungs: CTA with mild upper airway sounds transmitting nasal congestion but good air movement Heart: RRR, no murmurs appreciated Abdomen: Soft, NT/ND, no hepatosplenomegaly; normal BS Pulses: Femoral 2+ bilat Extremities: Symmetric appropriate tone throughout; cap refill <2 sec Skin: No rashes or discoloration A/P: This is a 2 month old previously healthy, full term female infant who presented with fever, tachycardia, tachypnea, and fussiness. This is a very common reaction to DTaP vaccine, with 1/4 children experiencing fever and 1/3 of children experiencing prolonged fussiness. This adverse reaction typically occurs several hours after the vaccine and resolves without sequelae. Patient was counseled no need to deviate from immunization schedule. Her nasal congestion may represent a concurrent viral URI that is resulting in secretions and stuffiness. Her decreased H&H likely represents the physiologic nadir known to occur around 2 months of life but should be followed up by PCM. Her stable vital signs and improvement on the ward are reassuring that she can be discharged to home with outpatient follow up Friday."
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hyporesponsive to stimuli, Hypotonia, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: This event was historical at age 2 months; I find no record of previous report. The patient received 2 month vaccines. MOP reports decreased responsiveness, "limp" and fever. She was seen in ER and admitted with negative eval. Discharge summary as follows: "HPI: Patient is a 2 month old female who presented to the ED 2 days ago for "breathing weird after shots". She had been a healthy full-term infant born SVD at 40+3 to G3P2 mom and had a normal well baby check the day of admission. At the WBC, she received her 2 month scheduled immunizations at 1030 and was subsequently dropped off at daycare. When picked up, mom noticed breathing concerns and then presented to ED. There she had a rectal temp 103.7, tachypnea to 80s, and tachycardia to 190s, given 50 mg of MOTRIN and admitted for observation. Hospital Course: Since admission, mom reports she has been tolerating bottle well; she exclusively receives SIMILAC q2-3 hours up to 4 oz. She has been producing urine adequately but no stool since day of admission. She has had no acute events through the nights and sleeps well per parents. On the morning of day 2 of hospital stay she had significant nasal congestion that brought on increased breathing effort and subcostal retractions. This resolved promptly after saline and suction and she has had only one mild episode requiring suction since. She has remained afebrile with no O2 requirements or need for fluid support, with stable vitals. PE: Vitals: Temp 97.8-98.8F, HR 128-132, RR 40-42, Pulse ox 100% on RA, Admit weight 5300g General: Resting comfortably, mildly fussy but consolable on arousal Head: Atraumatic/normocephalic, Anterior fontanel open, soft, and flat Nose: No secretions noted, adequate air movement Mouth: Moist Mucosa Lungs: CTA with mild upper airway sounds transmitting nasal congestion but good air movement Heart: RRR, no murmurs appreciated Abdomen: Soft, NT/ND, no hepatosplenomegaly; normal BS Pulses: Femoral 2+ bilat Extremities: Symmetric appropriate tone throughout; cap refill <2 sec Skin: No rashes or discoloration A/P: This is a 2 month old previously healthy, full term female infant who presented with fever, tachycardia, tachypnea, and fussiness. This is a very common reaction to DTaP vaccine, with 1/4 children experiencing fever and 1/3 of children experiencing prolonged fussiness. This adverse reaction typically occurs several hours after the vaccine and resolves without sequelae. Patient was counseled no need to deviate from immunization schedule. Her nasal congestion may represent a concurrent viral URI that is resulting in secretions and stuffiness. Her decreased H&H likely represents the physiologic nadir known to occur around 2 months of life but should be followed up by PCM. Her stable vital signs and improvement on the ward are reassuring that she can be discharged to home with outpatient follow up Friday."
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Monocyte percentage increased, Nasal congestion, Pyrexia, Respiration abnormal
Clinical narrative: This event was historical at age 2 months; I find no record of previous report. The patient received 2 month vaccines. MOP reports decreased responsiveness, "limp" and fever. She was seen in ER and admitted with negative eval. Discharge summary as follows: "HPI: Patient is a 2 month old female who presented to the ED 2 days ago for "breathing weird after shots". She had been a healthy full-term infant born SVD at 40+3 to G3P2 mom and had a normal well baby check the day of admission. At the WBC, she received her 2 month scheduled immunizations at 1030 and was subsequently dropped off at daycare. When picked up, mom noticed breathing concerns and then presented to ED. There she had a rectal temp 103.7, tachypnea to 80s, and tachycardia to 190s, given 50 mg of MOTRIN and admitted for observation. Hospital Course: Since admission, mom reports she has been tolerating bottle well; she exclusively receives SIMILAC q2-3 hours up to 4 oz. She has been producing urine adequately but no stool since day of admission. She has had no acute events through the nights and sleeps well per parents. On the morning of day 2 of hospital stay she had significant nasal congestion that brought on increased breathing effort and subcostal retractions. This resolved promptly after saline and suction and she has had only one mild episode requiring suction since. She has remained afebrile with no O2 requirements or need for fluid support, with stable vitals. PE: Vitals: Temp 97.8-98.8F, HR 128-132, RR 40-42, Pulse ox 100% on RA, Admit weight 5300g General: Resting comfortably, mildly fussy but consolable on arousal Head: Atraumatic/normocephalic, Anterior fontanel open, soft, and flat Nose: No secretions noted, adequate air movement Mouth: Moist Mucosa Lungs: CTA with mild upper airway sounds transmitting nasal congestion but good air movement Heart: RRR, no murmurs appreciated Abdomen: Soft, NT/ND, no hepatosplenomegaly; normal BS Pulses: Femoral 2+ bilat Extremities: Symmetric appropriate tone throughout; cap refill <2 sec Skin: No rashes or discoloration A/P: This is a 2 month old previously healthy, full term female infant who presented with fever, tachycardia, tachypnea, and fussiness. This is a very common reaction to DTaP vaccine, with 1/4 children experiencing fever and 1/3 of children experiencing prolonged fussiness. This adverse reaction typically occurs several hours after the vaccine and resolves without sequelae. Patient was counseled no need to deviate from immunization schedule. Her nasal congestion may represent a concurrent viral URI that is resulting in secretions and stuffiness. Her decreased H&H likely represents the physiologic nadir known to occur around 2 months of life but should be followed up by PCM. Her stable vital signs and improvement on the ward are reassuring that she can be discharged to home with outpatient follow up Friday."
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory syncytial virus test negative, Tachycardia, Tachypnoea, Use of accessory respiratory muscles
Clinical narrative: This event was historical at age 2 months; I find no record of previous report. The patient received 2 month vaccines. MOP reports decreased responsiveness, "limp" and fever. She was seen in ER and admitted with negative eval. Discharge summary as follows: "HPI: Patient is a 2 month old female who presented to the ED 2 days ago for "breathing weird after shots". She had been a healthy full-term infant born SVD at 40+3 to G3P2 mom and had a normal well baby check the day of admission. At the WBC, she received her 2 month scheduled immunizations at 1030 and was subsequently dropped off at daycare. When picked up, mom noticed breathing concerns and then presented to ED. There she had a rectal temp 103.7, tachypnea to 80s, and tachycardia to 190s, given 50 mg of MOTRIN and admitted for observation. Hospital Course: Since admission, mom reports she has been tolerating bottle well; she exclusively receives SIMILAC q2-3 hours up to 4 oz. She has been producing urine adequately but no stool since day of admission. She has had no acute events through the nights and sleeps well per parents. On the morning of day 2 of hospital stay she had significant nasal congestion that brought on increased breathing effort and subcostal retractions. This resolved promptly after saline and suction and she has had only one mild episode requiring suction since. She has remained afebrile with no O2 requirements or need for fluid support, with stable vitals. PE: Vitals: Temp 97.8-98.8F, HR 128-132, RR 40-42, Pulse ox 100% on RA, Admit weight 5300g General: Resting comfortably, mildly fussy but consolable on arousal Head: Atraumatic/normocephalic, Anterior fontanel open, soft, and flat Nose: No secretions noted, adequate air movement Mouth: Moist Mucosa Lungs: CTA with mild upper airway sounds transmitting nasal congestion but good air movement Heart: RRR, no murmurs appreciated Abdomen: Soft, NT/ND, no hepatosplenomegaly; normal BS Pulses: Femoral 2+ bilat Extremities: Symmetric appropriate tone throughout; cap refill <2 sec Skin: No rashes or discoloration A/P: This is a 2 month old previously healthy, full term female infant who presented with fever, tachycardia, tachypnea, and fussiness. This is a very common reaction to DTaP vaccine, with 1/4 children experiencing fever and 1/3 of children experiencing prolonged fussiness. This adverse reaction typically occurs several hours after the vaccine and resolves without sequelae. Patient was counseled no need to deviate from immunization schedule. Her nasal congestion may represent a concurrent viral URI that is resulting in secretions and stuffiness. Her decreased H&H likely represents the physiologic nadir known to occur around 2 months of life but should be followed up by PCM. Her stable vital signs and improvement on the ward are reassuring that she can be discharged to home with outpatient follow up Friday."
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Rash macular, Skin warm
Clinical narrative: Day after pain, "couldn't bend elbow because it hurt:. Day after that red, warm splotchy rash from elbow to shoulder.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Rotator cuff syndrome
Clinical narrative: Pain, weakness and limited mobility on right arm/shoulder since 2 days after receiving the hepatitis B vaccine. 6 sessions of physical therapies.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram head normal, Excessive eye blinking, Hypersomnia, Hypertonia, Musculoskeletal stiffness
Clinical narrative: Head turned to the right, tonic stiffening or right arm, and eyes blinking. Stated that event lasted for around 5 min, but not longer than. Afterwards slept for several hours.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Posture abnormal
Clinical narrative: Head turned to the right, tonic stiffening or right arm, and eyes blinking. Stated that event lasted for around 5 min, but not longer than. Afterwards slept for several hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Patient reported itching on 2/2/17. On 2/3/17 swelling at injection site and a rash.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient administered DTaP/HepB/IPV and DTap/HIB/IPV at visit on 2/8/17.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic, Varicella virus test negative
Clinical narrative: Noticed rash to trunk and facial skin, appeared like mosquito bites, about 2 weeks after taking the VZV vaccine.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient had pain in her lower right arm from vaccine administered.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Pain LUE within one hour within 48 Hrs LUE into shoulder painful with limited motion into (L) shoulder. Slight improvement over one month-motion still limited motion, pain, lack of ability to sleep.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012635 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012636 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012656 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012662 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012663 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for her daughter via a Pfizer sales representative. This 23 year-old female patient of an unspecified race and ethnicity received the second single dose of TRUMENBA via an unspecified route of administration on 01Feb2017 for immunization.  No other vaccine was administered the same day. The patient had previously received for immunization the first single dose of meningococcal group b rlp2086 on an unspecified date. The patient medical history and concomitant medications were not reported. On 01Feb2017 two hours after the vaccination the patient experienced vomiting and severe chills. Outcome of events was unknown.