chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Initial information was received from a health care professional on 13 Feb 2014. A 62-year-old female patient had medical history or allergy to penicillin and concomitant medication includes SYNTHROID and CYTOMEL (Route, dose site not reported) received, a dose of ADACEL intramuscularly on right arm on 24 Jan 2014 (Batch number C4432AB and Expiratory date 18 Oct 2015). It was reported that on 28 Jan 2014 patient developed rash on neck, face and hands. Laboratory investigation and corrective treatment were not reported. At the time of report outcome of event was recovered. List of documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Decreased activity, Gait disturbance, Injection site pain, Myalgia
Clinical narrative: Initial report received from a consumer (the patient) on 20 February 2014. A 40-year-old male patient had received a dose of TDAP (batch number 7734Y?) in right deltoid on 28 January 2014. The patient had no illness at the time of vaccination and pre-existing allergies and medical conditions were not reported. It was reported that the patient had initial arm soreness at injection site on an unspecified date. Then 2 days later on 30 January 2014, he experienced joint aches and muscles aches of left foot, right knee, fingers and elbows. On 03 February 2014, the patient visited own HCP for evaluation and treatment. It was stated that muscle aches and joint pain worsened and the patient had been limping due to aching of toe joints and unable to bear full weight on toes without discomfort. The patient had muscle aches all over which limited his activities. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient had no recovered. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Weight bearing difficulty
Clinical narrative: Initial report received from a consumer (the patient) on 20 February 2014. A 40-year-old male patient had received a dose of TDAP (batch number 7734Y?) in right deltoid on 28 January 2014. The patient had no illness at the time of vaccination and pre-existing allergies and medical conditions were not reported. It was reported that the patient had initial arm soreness at injection site on an unspecified date. Then 2 days later on 30 January 2014, he experienced joint aches and muscles aches of left foot, right knee, fingers and elbows. On 03 February 2014, the patient visited own HCP for evaluation and treatment. It was stated that muscle aches and joint pain worsened and the patient had been limping due to aching of toe joints and unable to bear full weight on toes without discomfort. The patient had muscle aches all over which limited his activities. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient had no recovered. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Insomnia
Clinical narrative: Initial report received from a consumer (the patient) on 20 February 2014. A 40-year-old male patient had received a dose of TDAP (batch number 7734Y?) in right deltoid on 28 January 2014. The patient had no illness at the time of vaccination and pre-existing allergies and medical conditions were not reported. It was reported that the patient had initial arm soreness at injection site on an unspecified date. Then 2 days later on 30 January 2014, he experienced joint aches and muscles aches of left foot, right knee, fingers and elbows. On 03 February 2014, the patient visited own HCP for evaluation and treatment. It was stated that muscle aches and joint pain worsened and the patient had been limping due to aching of toe joints and unable to bear full weight on toes without discomfort. The patient had muscle aches all over which limited his activities. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient had no recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Adverse drug reaction, Alopecia, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: I brought misery to myself by taking this VZV (shingles) vaccine shot.   An incessant itch comes on in the morning or after work. The itching sites are often on my hands, forearms, lower legs and feet, but can vary and spread.   Sometimes I scratch until it bleeds.  Though in the back of my mind I know I am not supposed to, it is humanly impossible to suppress.  The various steroid topical creams I have used make my skin feel like starched, cracked paper.  Anti-histamines make me feel like a zombie in the daytime.   Prednisone provided temporary relief, but caused severe dizziness and hair loss.  When I stopped taking prednisone because of the side effects, the excruciating itch returned, in different parts of my feet, legs, hands, arms, neck and face.  Recently, lesions on my legs and feet have finally dissipated somewhat, but a rush attack can occur at any moment of the day, for no apparent reason.   Sometimes the itch gets to the point that I want to disconnect the affected part of body.    In the past several weeks I have also experienced shortness of breath.  The complaint list goes on; I wish I could have an antidote for this shingles vaccination and get the past year of my life back.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus generalised, Skin haemorrhage, Skin lesion
Clinical narrative: I brought misery to myself by taking this VZV (shingles) vaccine shot.   An incessant itch comes on in the morning or after work. The itching sites are often on my hands, forearms, lower legs and feet, but can vary and spread.   Sometimes I scratch until it bleeds.  Though in the back of my mind I know I am not supposed to, it is humanly impossible to suppress.  The various steroid topical creams I have used make my skin feel like starched, cracked paper.  Anti-histamines make me feel like a zombie in the daytime.   Prednisone provided temporary relief, but caused severe dizziness and hair loss.  When I stopped taking prednisone because of the side effects, the excruciating itch returned, in different parts of my feet, legs, hands, arms, neck and face.  Recently, lesions on my legs and feet have finally dissipated somewhat, but a rush attack can occur at any moment of the day, for no apparent reason.   Sometimes the itch gets to the point that I want to disconnect the affected part of body.    In the past several weeks I have also experienced shortness of breath.  The complaint list goes on; I wish I could have an antidote for this shingles vaccination and get the past year of my life back.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Blood test, Gait disturbance, Grip strength decreased, Impaired work ability
Clinical narrative: 3 days after receiving Anthrax vaccine patient/vaccinee complaints of pain on hands, elbows, shoulders, and hips, swollen and weakness (can't grip) both hands, trouble walking. He was brought to local hospital and was seen by local physician, diagnose with "Viral Syndrome" treated with Toradol 60mg IM and given Aleve OTC. Blood testing was performed pending result. He was given illness certificate slip for no work/duty for 2 days and follow up on 28 Jan 15. May return to duty 19 Jan 15.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Muscular weakness, Musculoskeletal pain, Pain in extremity, Peripheral swelling, Viral infection
Clinical narrative: 3 days after receiving Anthrax vaccine patient/vaccinee complaints of pain on hands, elbows, shoulders, and hips, swollen and weakness (can't grip) both hands, trouble walking. He was brought to local hospital and was seen by local physician, diagnose with "Viral Syndrome" treated with Toradol 60mg IM and given Aleve OTC. Blood testing was performed pending result. He was given illness certificate slip for no work/duty for 2 days and follow up on 28 Jan 15. May return to duty 19 Jan 15.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Autopsy, Blood sodium increased, Convulsion, Dehydration, Diet refusal
Clinical narrative: ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Ear infection, Fall, Irritability, Pyrexia, Vomiting
Clinical narrative: ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Blood sodium increased, Computerised tomogram, Death, Dehydration, Diarrhoea
Clinical narrative: ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Ear infection, Fall, Nuclear magnetic resonance imaging, Pyrexia, Seizure
Clinical narrative: ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Vomiting
Clinical narrative: ON CHRISTMAS MORNING MY SON HAD ROLLED OFF OF THE HE FUSSED BUT WAS OKAY LATER THAT DAY HE VOMITED TWO TIMES. LATER THAT MORNING OF 12/26/2014 HE URINATED AND HAD A FEVER OF 102.6 I GAVE HIM SOME TYLENOL AND THREE HOURS LATER HE STILL HAD A FEVER SO WE THE PARENTS TOOK HIM BACK TO THE DOCTORS OFFICE WHERE THE M.A WHO GAVE HIM IS VACCINES SHOT CHECKED HIS EARS AND GAVE HIM SOME TYLENOL HIS TEMP WAS 101.3. WE WAITED TO SEE A DOCTOR AND PAC CAME AND TOLD ME TO PUT HIM IN HIS BED BUT SINCE HE WAS NOT TAKING HIS BOTTLE AT THIS TIME SHE GAVE ME A CUP OF WATER AND A SYRINGE TO MAKE HIM URINATE FOR ALMOST TWO HOURS HE DID NOT URINATE BUT VOMITED SHE SAID HE HAD A EAR INFECTION THAT SHE PRESCRIBED HIM AMOXICILLIN AND TO SEE HIM BACK IN THREE WEEKS. LATER THAT AFTER NOON AFTER GIVING HIM HIS TWO DOSES OF THE TYLENOL AND AMOXICILLIN HE STARTED TO HAVE SEIZURES. WE/PARENTS RUSHED HIM TO THE HOSPITAL WERE THEY TOLD US HE WAS DEHYDRATED AND HIS SODIUM LEVELS WERE HIGH. SAYING THAT I COULD NOT HAVE CAME FROM HIS SHOT HE WAS GIVEN ON 12/22/2014 WE HAD TO HAVE GIVEN HIM SALT.
Age: 0.28
Sex: M
Vaccine: MEN
Symptoms: Crying, Diet refusal, Hyperhidrosis, Irritability, Pyrexia
Clinical narrative: Moderate fever, sweating, unusual fussiness, unusual crying, refusal to eat. Fever lasted 4 days, fussinesss lasted 8. Child fully recovered by 11/22/2014.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain upper, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Case number PHEH2014US001741, is an initial spontaneous report received from the medical assistant on 22 Jan 2014 with a follow up information received on 07 Feb 2014. This report refers to a 10-year-old male patient. His medical history and concomitant medications were not reported. His general health condition was good with normal social life. He was vaccinated with MENVEO (batch number: M13051) intramuscularly on 20 Jan 2014 at 11:33 AM. Two minutes after the vaccination, he experienced stomach pain. Shortly after that, he fainted in the arms of the nurse and remained unresponsive for 10 minutes. His vital signs appeared slightly lower than normal. Blood pressure was 80/50 mmHg and pulse was 58 at 11:55 am. On the same day, at 12:42 pm his blood pressure was normal with a value of 104/68, pulse rate was normal with a value of 88 beats per minute, body temperature was normal with a value of 36.9 degree Celsius and BMI was 15.1 (normal). His constitutional status and other examinations of eyes, ears, neck, respiratory, cardiovascular, gastrointestinal, genitourinary, musculoskeletal and skin were normal. He was given oxygen and he regained consciousness. The patient recovered and was discharged in a stable condition. The seriousness and causality of the events were not reported. Follow up information received from medical assistant on 07 Feb 2014: updated few examinations (pressure, pulse rate, body temperature, BMI) and general health condition (healthy).
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Chest discomfort, Chest pain, Dyspnoea, Increased upper airway secretion
Clinical narrative: This spontaneous report as received from a granddaughter refers to her 67 year old grandfather with none medical history. Approximately in December 2014 (also reported as some time last month and within 1 month), the patient was vaccinated with a dose of PNEUMOVAX 23 (1 shot, route of administration, lot# and expiration date were not reported). On an unknown date, the patient was feeling anxiety, he developed pneumonia-like symptoms such as chest pain, pressure on his chest, trouble breathing, a lot of mucous and was hospitalized (on an unknown date, also reported as one week after receiving the PNEUMOVAX 23 injection). It was also reported that the patient was hospitalized again on 21-JAN-2014 (also reported as two days ago). The outcome of the adverse events was not reported. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected, because there are no contact details.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a granddaughter refers to her 67 year old grandfather with none medical history. Approximately in December 2014 (also reported as some time last month and within 1 month), the patient was vaccinated with a dose of PNEUMOVAX 23 (1 shot, route of administration, lot# and expiration date were not reported). On an unknown date, the patient was feeling anxiety, he developed pneumonia-like symptoms such as chest pain, pressure on his chest, trouble breathing, a lot of mucous and was hospitalized (on an unknown date, also reported as one week after receiving the PNEUMOVAX 23 injection). It was also reported that the patient was hospitalized again on 21-JAN-2014 (also reported as two days ago). The outcome of the adverse events was not reported. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected, because there are no contact details.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the fourth of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable reporter who reported for a consumer. This 5-year-old, male consumer (race unknown) started to receive PREVNAR 13 since an unknown date at an unknown dose and frequency. The relevant medical history and concomitant medications were unknown. The consumer on an unknown date in Dec2012 experienced pneumonia for which he was hospitalized for a week in Dec2012 after taking fourth and final shot of PREVNAR 13. The relevant laboratory data was unknown. Last action taken with PREVNAR 13 in response to the reported event was unknown. Therapeutic measure taken for the reported event was unknown. The consumer had recovered from the reported event on an unknown date. Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
Age: 0.2
Sex: F
Vaccine: PNC13
Symptoms: Apnoea neonatal
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales representative. A 2-month-old female patient received the first dose of PREVNAR 13 on unknown date. After vaccination, she had an apnoeic episode. At the time of this report, the outcome of the event was unknown. Follow-up (20Dec2013): Follow-up attempts completed. No further information expected.
Age: 8.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Pneumonia, Rales
Clinical narrative: This is a spontaneous report from a non-clinical-study program from a non-contactable consumer. This is a spontaneous report from a non-contactable consumer or other non HCP. A 8-year-old male patient of an unspecified ethnicity received PREVNAR 13, on an unspecified date, and PREVNAR, on an unspecified date to an unspecified date. Medical history and concomitant medications were not reported. The patient experienced pneumonia last year in Jan2012 in both lungs with crackling in chest. Lab data included x-ray on unknown date. Unspecified antibiotics, nebulizer were prescribed as a result of the events and the patient recovered after 2 weeks. No follow up attempts possible. No further information expected.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-clinical-study program from a non-contactable consumer. A 2-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced "mild pneumonia" at 23 months in Nov2013 and was visited at the ER. Therapeutic measures were taken as a result of the event includes unspecified antibiotics. The patient recovered after 7 days. No follow-up attempts possible. No further information expected.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Computerised tomogram, Fall, Headache, Intensive care, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received on 04 February 2014 from an investigator participating in a study. A 33-year-old male subject, with no reported medical history, was diagnosed with lapses of consciousness on 02 November 2013, after receiving the unknown dose of Purified Vero Rabies Vaccine - Serum Free on an unspecified date (lot number, site and route of administration were not reported). Concomitant medications were not reported. The subject was hospitalized for the diagnosis of lapses of consciousness on an unspecified date. Complementary investigations and corrective treatment were not reported. The event of lapses of consciousness was resolved on an unspecified date. According to the investigator, the event was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 21 February 2014. The event term lapses of consciousness was changed to seizure. The subject was diagnosed with seizure on 02 November 2013 i.e. 239 days after receiving the third dose of IMOVAX Rabies on 08 March 2013 (batch number, site and route of administration not reported). The subject had received a first dose of IMOVAX Rabies on 08 February 2013 (lot number not reported) and second dose on 15 February 2013. The subject had concomitant medications but the details were not reported. The subject was hospitalized on 02 November 2013. The diagnosed event seizure was resolved on 04 November 2013. The subject was discharged from the hospital on 04 November 2013. This study was unblinded on 26 September 2013. Follow up information received on 25 February 2014. The details of concomitant medication were reported as, Tramadol of dose 50mg orally from September 2013 for treating pain, and NORCO of dose 10/325 orally from 04 November 2013 to 30 November 2013 for treating pain. Follow up information received on 04 March 2014. The subject had medical history of back pain and depression. The subject had third suspect dose of study drug by intramuscular route at deltoid right side. The subject had experienced symptom headache on 02 November 2013. Subject fell and had a seizure lasting 2-3 minutes. Subject was brought into hospital, and admitted to ICU. Subject was discharged in stable condition. Treatment details include KEPPRA 500mg orally twice a day. The lab details include CAT scan and MRI were performed. The symptom headache was resolved on 02 November 2013.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Seizure
Clinical narrative: Initial report received on 04 February 2014 from an investigator participating in a study. A 33-year-old male subject, with no reported medical history, was diagnosed with lapses of consciousness on 02 November 2013, after receiving the unknown dose of Purified Vero Rabies Vaccine - Serum Free on an unspecified date (lot number, site and route of administration were not reported). Concomitant medications were not reported. The subject was hospitalized for the diagnosis of lapses of consciousness on an unspecified date. Complementary investigations and corrective treatment were not reported. The event of lapses of consciousness was resolved on an unspecified date. According to the investigator, the event was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 21 February 2014. The event term lapses of consciousness was changed to seizure. The subject was diagnosed with seizure on 02 November 2013 i.e. 239 days after receiving the third dose of IMOVAX Rabies on 08 March 2013 (batch number, site and route of administration not reported). The subject had received a first dose of IMOVAX Rabies on 08 February 2013 (lot number not reported) and second dose on 15 February 2013. The subject had concomitant medications but the details were not reported. The subject was hospitalized on 02 November 2013. The diagnosed event seizure was resolved on 04 November 2013. The subject was discharged from the hospital on 04 November 2013. This study was unblinded on 26 September 2013. Follow up information received on 25 February 2014. The details of concomitant medication were reported as, Tramadol of dose 50mg orally from September 2013 for treating pain, and NORCO of dose 10/325 orally from 04 November 2013 to 30 November 2013 for treating pain. Follow up information received on 04 March 2014. The subject had medical history of back pain and depression. The subject had third suspect dose of study drug by intramuscular route at deltoid right side. The subject had experienced symptom headache on 02 November 2013. Subject fell and had a seizure lasting 2-3 minutes. Subject was brought into hospital, and admitted to ICU. Subject was discharged in stable condition. Treatment details include KEPPRA 500mg orally twice a day. The lab details include CAT scan and MRI were performed. The symptom headache was resolved on 02 November 2013.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Asthma, Condition aggravated
Clinical narrative: Initial report received on 24 January 2014 and follow up information received on 28 January 2014 from an investigator participating in a study. A 33-year-old female subject had worsening of asthma on 10 December 2013 i.e. 146 days after receiving fifth intramuscular dose of IMOVAX rabies in the left deltoid on 17 July 2013 (batch number not reported). The subject received first dose of IMOVAX rabies on 19 June 2013, second dose on 22 June 2013, third dose on 27 June 2013 and fourth dose on 03 July 2013. The subject had medical history of migraine headaches, asthma and anemia. The subject had concomitant therapies with SINGULAIR from unknown date in 2000 Per OS, 10 mg, QD indicated in asthma, Multivitamins from unknown date in 2003, Per OS 2 Tabs QD indicated in anemia and Ibuprofen from unknown date in 2003, Per OS 800 mg PRN indicated in Migraine. The subject reported on 24 January 2014 at 09:00am that on 10 December 2013, she was admitted at the hospital due to a severe asthma attack. Medical records will be requested today for more details. Lab investigations were unknown as the medical records were pending to receive. The corrective treatment details were not reported because medical records were pending to receive to provide requested information. The event of worsening of asthma resolved on 15 December 2013 and the subject was discharged from the hospital on the same day i.e. on 15 December 2013. The event of worsening of asthma was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to termination of the subject from the study. List of documents held by sender: None. Unblinding information received on 31 January 2014. Follow up information received on 03 March 2014: It was reported that the records were requested on 24 January 2014, 05 February 2014 and 27 February 2014. The records were not available for date of service and no records would be provided. This case is linked with 2014SA012490 (SAE# 1: multiple traumatic fractures secondary to motor vehicle accident from 07 October 2013 to 10 October 2013).
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Convulsion
Clinical narrative: Initial report was received on 19 March 2014 from a non health care professional. A five-month old male patient with an unknown past medical history had received on 06 March 2014 the following vaccines: an intramuscular right thigh injection of PENTACEL, lot number C4637AA; Rotavirus (manufacturer, lot number, route and site of administration not reported), and PREVNAR (manufacturer, lot number, route and site of administration not reported). The patient had previously received a dose of PENTACEL. Unspecified amount of time later the night of the vaccine also reported as 07 March 2014, the patient had a seizure and was hospitalized. Treatments were not reported. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: none
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Autopsy, Bacterial sepsis, Immunodeficiency, Otitis media acute
Clinical narrative: Initial report received on 12 September 2013 from an investigator participating in a study under the reference number M5A11. A four-month-old female subject with no reported past medical history had received on 04 December 2009 the following vaccines: dose 2 of PENTACEL, Lot number C38481AA (route and site of administration not reported), dose 3 of Hep B, MSD lot number 1251Y (route and site of administration not reported), dose 2 of PNCV7, Pfizer lot number D92436 (route and site of administration not reported), and RV5, MSD lot number 0534Y (route and site of administration not reported) and 25 days later was found to have a bacterial sepsis due to acute otitis media. The subject has been napping at daycare and original workup was for SIDS. According to physician reviewing autopsy results states "rapidity of this overwhelmingly sepsis in an otherwise perfectly normal appearing child is quite unusual: speculated that it may have been secondary to an unknown immune deficiency which will probably never be known." The subject had received dose one of PENTACEL, lot number C3385AA on 13 October 2009. According to the investigator, discussion of potential consultation with immunology department and potential genetic testing but it was unknown whether either of these were pursued. If so, results were unavailable. No further information was available at the time of the report. The subject's outcome was fatal. The event of bacterial sepsis due to acute otitis media was not related to the trial product. Follow-up information was received on 08 October 2013 from the investigator. The subject had a past medical history of a URI on 15 December 2009 which lasted a week, nasal congestion at 20 day visit and cradle cap at 2 month well visit. According to the report, at the 20 day visit the subject had cold symptoms over the prior 3 days, no fever, not much coughing and the subject was still feeding ok and having wet diapers and stools. "Dx: congestion of nasal sinus (primary encounter diagnosis) Note: may be secondary to Upper respiratory infection". The subject had received on 13 October 2009 an intramuscular left thigh injection of PENTACEL. On 04 December 2009, the subject had received an intramuscular right thigh injection of PENTACEL, and intramuscular left thigh injection of Hep B, an intramuscular left thigh injection of PCV7 and RV5 orally. Documents held by sender: medical records and autopsy report.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients age and gender. On an unknown dates the patients were vaccinated with doses of ROTATEQ orally (dose, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a non-clinical-study-program from a contactable consumer. A 14-months-old male patient of an unspecified ethnicity received PREVNAR 13, on an unspecified date, via an unspecified route of administration. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. The patient was hospitalized for two days. It was reported that the patient had received three doses of PREVNAR 13 at the time of the event. Therapeutic measures included antibiotics and albuterol. The patient recovered. Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
Age: 0.6
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from Non-Clinical-Study-Program from a contactable consumer. A 7-months-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were unknown. In Mar2013 the patient experienced pneumonia and was hospitalized for 4 days. Therapeutic measures were taken as a result of the event included unspecified antibiotics. The patient recovered after several weeks. Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the first of four patients. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Lobar pneumonia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer vaccine representative. A 72-year-old female patient of unknown race received PREVNAR 13 at single dose. Relevant medical history and concomitant medications were unknown. On an unknown date in 2013 the patient had significant rash on trunk and chest area and developed upper lobe pneumonia. Relevant laboratory data was unknown. Therapeutic measures taken for the reported event were unknown. Clinical outcome of the reported events was unknown at the time of the report. Follow-up (31Dec2013): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypersomnia, Injection site pain, Malaise, Muscular weakness
Clinical narrative: Pain at injection site, body weakness, malaise, sleeping for five days, extreme muscle pain on day four and five, legs very weak on day three four and five.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Pain at injection site, body weakness, malaise, sleeping for five days, extreme muscle pain on day four and five, legs very weak on day three four and five.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/Itching. No respiratory problem. Given Benadryl.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Herpes simplex encephalitis, Lethargy, Pyrexia, Rhinovirus infection
Clinical narrative: Lethargic, seizures, 105.7 fever.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site erythema, Injection site swelling, Pain, Screaming
Clinical narrative: Red and Swollen thigh (site of shot), uncontrollable screaming crying, pain and tenderness.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Tenderness
Clinical narrative: Red and Swollen thigh (site of shot), uncontrollable screaming crying, pain and tenderness.
Age: 0.3
Sex: F
Vaccine: PNC13
Symptoms: Apnoeic attack, Cyanosis
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales representative. A 4-month-old female patient received the second dose of PREVNAR 13 on unknown date. After vaccination, within 48 hours, had an apnoeic episode at home and she turned blue. When she had received the first dose of PREVNAR 13, at the age of 2 months, she also had had an apnoeic episode. At the time of this report, the outcome of the events was unknown. Follow-up (20Dec2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Productive cough
Clinical narrative: This is a spontaneous report from a non-clinical study program. A contactable 74-year-old female consumer received PREVNAR 13 on unknown date. The consumer stated that she had pneumonia 13 times. She stated that health was not good still getting over the pneumonia from 6 months ago, still coughing up stuff from her chest. Consumer stated that when she was in the fifth grade she had a severe allergic reaction to Diphtheria shot. At the time of reporting, the patient was recovering. Follow-up (13Sep2013) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar adverse event for two different patients. This is the second of two reports. A patient (age, gender and Ethnicity unknown) received PREVNAR 13 (Lot Number: H07344, Expiration Date: Apr2015, NDC Number: 0005197101) single dose, on an unspecified date. Relevant medical history and concomitant medications were unknown. Illness at the time of vaccination was unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On an unspecified date, while on PREVNAR 13, the patient experienced rash and due to the adverse event was hospitalized. Relevant sibling information was unknown. At time of this report, clinical outcome of the event was unknown. Follow-up (24Jan2014): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable reporter who reported on behalf of her mother. An 81-year-old female patient received a dose of PREVNAR-13 at 0.5 ml single dose in the upper arm on 14Feb2013 in the morning, using a prefilled syringe as she was immune-compromised. The vaccine was administered in a public health clinic. The relevant medical history included ongoing immune-compromised and ongoing chronic obstructive pulmonary disease (COPD) both since an unknown date. The relevant concomitant medications were unknown. The consumer was diagnosed with pneumonia on 14Mar2013 in her chest X-Ray. The relevant laboratory data included chest X-ray on 14Mar2013 and the patient was diagnosed with pneumonia. Therapeutic measures taken for the reported event included albuterol inhaler (dose unknown) as needed, AUGMENTIN or amoxicillin since an unknown date at an unknown dose and frequency and breathing treatment, all since an unknown date. The consumer was still suffering from pneumonia at the time of report. Follow-up (17May2013): Follow-up attempts completed. No further information expected.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Apnoea neonatal
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales representative. This physician reported for a female patient (infant). The patient's mom reported that at 2 months in the NICU initial PREVNAR 13 vaccines were given and she had an apneic episode. She gave the 4 month vaccines separately and within 48 hours from the PREVNAR 13 administration the patient had an apneic episode at home where she turned blue. At 6 months the vaccines were given separately again and she was on an apnea monitor this time, the monitor alarmed but the patient did not turn blue within 48 hours from the PREVNAR 13 administration. Follow-up (13Dec2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia, Rash
Clinical narrative: This is a spontaneous report by a non-contactable physician. This male physician reported on behalf of a patient (age and gender unknown) who received on an unknown date PREVNAR 13 on an unknown site, at single dose. Relevant medical history and concomitant medications were unknown. Vaccines taken within the last four weeks were unknown. Vaccines taken on the same day were unknown. Illness at the time of vaccination was unknown. In Oct2013 the patient experienced rash and pneumonia and mentioned that the rash was full grown. Relevant sibling information was unknown. Relevant lab data was unknown. At the time of the report the clinical outcome of the above mentioned events was unknown. No follow-up attempts possible. No further information expected.
Age: 0.2
Sex: F
Vaccine: DTP, HEP, HIBV, OPV
Symptoms: Biopsy skin abnormal, Blister, Blood fibrinogen normal, Blood immunoglobulin A normal, Blood immunoglobulin G increased
Clinical narrative: This case was retrieved via a search of scientific literature on 22 October 2013. Verbatim from the article: "A 3-month-old healthy female infant presented to the dermatology clinic with a 1 month history of blisters which began on her feet. The blisters developed 3 days after she received her routine 2 month immunizations (oral polio, DPT, HIB, and hepatitis B). The blisters had been increasing in both number and size and had spread to the patient's hands. She had no prior history of skin disorders and no family history of atopy. Physical examination revealed a well-appearing infant girl who was noted to have multiple 0.25 to 1 cm tense bullae on erythematous bases. The lesions were clustered most intensely on the ventral surfaces of the palms and soles, but also were present on the lateral digits and the dorsal hands and feet. Solitary lesions were also noted on her arms and legs. No lesions were noted on the patient's trunk, face, or perineum. Punch biopsies were performed of the lesional and perilesional skin from the dorsal right foot for both standard histologic analysis and for immunofluorescence studies. Laboratory evaluation including a complete blood count with differential was within normal limits, with the exception of a mild peripheral eosinophilia (8%). Hematoxylin and eosin staining clearly demonstrated a subepidermal bullous dermatosis with an intense mixed inflammatory infiltrate containing numerous eosinophils within the dermis. Periodic acid-Schiff stain for fungi was negative. Gram's stain was negative. Direct immunofluorescence of perilesional skin revealed linear staining of IgG along the basement membrane zone. Staining of complement component C3 was also seen in the same distribution. Staining for IgA, IgM, and fibrinogen was negative, and no circulating anti-basement membrane zone antibodies were detected in the patient's serum. The mother's serum was tested and found to be devoid of circulating anti-basement membrane zone antibodies. Neither salt-split skin testing or immunoblot assay was performed. After a potent CYCLOCRT ointment was applied, her blisters resolved completely at 6 weeks with only mild postinflammatory hyperpigmentation and no textural changes. One year after resolution of her lesions the patient has had no further outbreaks and has continued the recommended schedule for routine childhood immunizations." Documents held by sender: none.