chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# K012457, expiration date 04-JUN-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016").  On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of VAQTA were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects 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.; Sender's Comments:  US-009507513-1612USA007121: US-009507513-1612USA007251: US-009507513-1612USA007248: US-009507513-1612USA007249:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M029233, expiration date 09-AUG-2018 and lot# M023892, expiration date: 15-SEP-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016").  On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of RECOMBIVAX HB were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects 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.; Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007121: US-009507513-1612USA007248: US-009507513-1612USA007249:
Age: 24.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Myalgia
Clinical narrative: Injection site pain, myalgia.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: Baby has passed away. We are not sure if vaccines were the cause.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: Passed away. Not sure if vaccines were the cause?
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Myocardial necrosis marker increased, Productive cough, Vomiting
Clinical narrative: Patient reported headache and went to lie down around 5:00 pm.  Started experiencing shortness of breath and vomited once so husband called for an ambulance. ER visit at 6:30pm with shortness of breath, headache and productive cough.  Physician saw elevated cardiac enzymes and patient was transferred at 21:30.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: Red, Pain, Hard.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dry mouth, Fatigue, Headache, Pain
Clinical narrative: Patient reports of pain all over body, fatigue, chills, dry mouth, severe pain in arms and legs, and headaches. Pain started 2 hours after vaccine was administered.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports of pain all over body, fatigue, chills, dry mouth, severe pain in arms and legs, and headaches. Pain started 2 hours after vaccine was administered.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: I was bruised where the shot was given, plus to the left and below the shot I had swelling with bruising and pain. I also have a lot of pain and trouble raising my arm up and out. I get a flu shot every year and have never had any problems before. Now I have trouble getting things from a cupboard, refrigerator, driving, doing my hair and many other things, all of which cause excruciating pain. I went to the doctor 11-10-16 he gave me a prescription for methylprednisolone 4mg Dospak 21s. The pain was less, but still there and still couldn't raise my arm without the pain. When the medication ended, the next day the pain was from my shoulder to my neck and down to my elbow and my shoulder was the size of a half of a softball. I still cannot use my right arm without pain. I live alone and need my arm. I want to know what's going on and what can be done to help me. Please help. Do I have SIRVA?
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Angiogram, Arthralgia, Back pain, Blood test, Cardiac monitoring
Clinical narrative: Our son was given a Tdap shot on Friday, November 25th at approximately 3:15 p.m. during a physical he was undergoing. He seemed okay that night except for his injection site (right deltoid) which was quite sore. That appointment was at the clinic with CNP. The next day (Saturday, 11/26/16) he slept late and felt achy and generally under the weather. On Sunday (11/27/16) he was feverish along with body aches. His temperature was 102.0 at 4:22 a.m. He had 600 mg Ibuprofen at 9 a.m. just for comfort. He is a college student and had finals coming up. The highest fever we recorded that day was at 10:40 p.m. when it was 102.2. We didn't medicate at that point. Monday (11/28/16) he had a low-grade fever of 99.6 at 9:12 a.m. He took Ibuprofen 600 mg about an hour-and-a-half later so he could function at school. Tuesday (11/29/16) around midnight patient was taking his temperature-it was 99.2. (He had 600 mg Ibuprofen and one TUMS tablet at this time.) He was feeling chest pain that caused him to breathe shallowly. He also had injection site pain that radiated down his right arm, a flat red spot an inch or two below that site (about 3/4" in diameter), a headache (front, back and other areas), sinus pain, all his teeth hurt, joint pain (especially his knees and ankles), neck and back pain. This lasted more than 2 hours. At 2:00 a.m. he said it was about a "5 out of 10" and he was very sweaty. At 3:00 a.m. he said he was "fine" and was still very sweaty. He had another episode lasting probably 30 minutes around 7:00 p.m. that night-similar to above. Wednesday (11/30/16) morning around 7:00 a.m. he had another episode with the same symptoms. We decided to go in to the walk-in clinic. The symptoms had subsided by then. Around 9:30 a.m. we went there: He had a chest x-ray, EKG and blood work done there. Since the Troponin level was high they sent him to the hospital as a direct admission. He had more blood work, a heart monitor, echocardiogram, angiogram. He spent the night for observation and tests. Thursday (12/1/16) early afternoon he was discharged. Wednesday (12/7/16) he was seen post-hospitalization by CNP at clinic.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Our son was given a Tdap shot on Friday, November 25th at approximately 3:15 p.m. during a physical he was undergoing. He seemed okay that night except for his injection site (right deltoid) which was quite sore. That appointment was at the clinic with CNP. The next day (Saturday, 11/26/16) he slept late and felt achy and generally under the weather. On Sunday (11/27/16) he was feverish along with body aches. His temperature was 102.0 at 4:22 a.m. He had 600 mg Ibuprofen at 9 a.m. just for comfort. He is a college student and had finals coming up. The highest fever we recorded that day was at 10:40 p.m. when it was 102.2. We didn't medicate at that point. Monday (11/28/16) he had a low-grade fever of 99.6 at 9:12 a.m. He took Ibuprofen 600 mg about an hour-and-a-half later so he could function at school. Tuesday (11/29/16) around midnight patient was taking his temperature-it was 99.2. (He had 600 mg Ibuprofen and one TUMS tablet at this time.) He was feeling chest pain that caused him to breathe shallowly. He also had injection site pain that radiated down his right arm, a flat red spot an inch or two below that site (about 3/4" in diameter), a headache (front, back and other areas), sinus pain, all his teeth hurt, joint pain (especially his knees and ankles), neck and back pain. This lasted more than 2 hours. At 2:00 a.m. he said it was about a "5 out of 10" and he was very sweaty. At 3:00 a.m. he said he was "fine" and was still very sweaty. He had another episode lasting probably 30 minutes around 7:00 p.m. that night-similar to above. Wednesday (11/30/16) morning around 7:00 a.m. he had another episode with the same symptoms. We decided to go in to the walk-in clinic. The symptoms had subsided by then. Around 9:30 a.m. we went there: He had a chest x-ray, EKG and blood work done there. Since the Troponin level was high they sent him to the hospital as a direct admission. He had more blood work, a heart monitor, echocardiogram, angiogram. He spent the night for observation and tests. Thursday (12/1/16) early afternoon he was discharged. Wednesday (12/7/16) he was seen post-hospitalization by CNP at clinic.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hypopnoea, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Our son was given a Tdap shot on Friday, November 25th at approximately 3:15 p.m. during a physical he was undergoing. He seemed okay that night except for his injection site (right deltoid) which was quite sore. That appointment was at the clinic with CNP. The next day (Saturday, 11/26/16) he slept late and felt achy and generally under the weather. On Sunday (11/27/16) he was feverish along with body aches. His temperature was 102.0 at 4:22 a.m. He had 600 mg Ibuprofen at 9 a.m. just for comfort. He is a college student and had finals coming up. The highest fever we recorded that day was at 10:40 p.m. when it was 102.2. We didn't medicate at that point. Monday (11/28/16) he had a low-grade fever of 99.6 at 9:12 a.m. He took Ibuprofen 600 mg about an hour-and-a-half later so he could function at school. Tuesday (11/29/16) around midnight patient was taking his temperature-it was 99.2. (He had 600 mg Ibuprofen and one TUMS tablet at this time.) He was feeling chest pain that caused him to breathe shallowly. He also had injection site pain that radiated down his right arm, a flat red spot an inch or two below that site (about 3/4" in diameter), a headache (front, back and other areas), sinus pain, all his teeth hurt, joint pain (especially his knees and ankles), neck and back pain. This lasted more than 2 hours. At 2:00 a.m. he said it was about a "5 out of 10" and he was very sweaty. At 3:00 a.m. he said he was "fine" and was still very sweaty. He had another episode lasting probably 30 minutes around 7:00 p.m. that night-similar to above. Wednesday (11/30/16) morning around 7:00 a.m. he had another episode with the same symptoms. We decided to go in to the walk-in clinic. The symptoms had subsided by then. Around 9:30 a.m. we went there: He had a chest x-ray, EKG and blood work done there. Since the Troponin level was high they sent him to the hospital as a direct admission. He had more blood work, a heart monitor, echocardiogram, angiogram. He spent the night for observation and tests. Thursday (12/1/16) early afternoon he was discharged. Wednesday (12/7/16) he was seen post-hospitalization by CNP at clinic.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Sinus pain
Clinical narrative: Our son was given a Tdap shot on Friday, November 25th at approximately 3:15 p.m. during a physical he was undergoing. He seemed okay that night except for his injection site (right deltoid) which was quite sore. That appointment was at the clinic with CNP. The next day (Saturday, 11/26/16) he slept late and felt achy and generally under the weather. On Sunday (11/27/16) he was feverish along with body aches. His temperature was 102.0 at 4:22 a.m. He had 600 mg Ibuprofen at 9 a.m. just for comfort. He is a college student and had finals coming up. The highest fever we recorded that day was at 10:40 p.m. when it was 102.2. We didn't medicate at that point. Monday (11/28/16) he had a low-grade fever of 99.6 at 9:12 a.m. He took Ibuprofen 600 mg about an hour-and-a-half later so he could function at school. Tuesday (11/29/16) around midnight patient was taking his temperature-it was 99.2. (He had 600 mg Ibuprofen and one TUMS tablet at this time.) He was feeling chest pain that caused him to breathe shallowly. He also had injection site pain that radiated down his right arm, a flat red spot an inch or two below that site (about 3/4" in diameter), a headache (front, back and other areas), sinus pain, all his teeth hurt, joint pain (especially his knees and ankles), neck and back pain. This lasted more than 2 hours. At 2:00 a.m. he said it was about a "5 out of 10" and he was very sweaty. At 3:00 a.m. he said he was "fine" and was still very sweaty. He had another episode lasting probably 30 minutes around 7:00 p.m. that night-similar to above. Wednesday (11/30/16) morning around 7:00 a.m. he had another episode with the same symptoms. We decided to go in to the walk-in clinic. The symptoms had subsided by then. Around 9:30 a.m. we went there: He had a chest x-ray, EKG and blood work done there. Since the Troponin level was high they sent him to the hospital as a direct admission. He had more blood work, a heart monitor, echocardiogram, angiogram. He spent the night for observation and tests. Thursday (12/1/16) early afternoon he was discharged. Wednesday (12/7/16) he was seen post-hospitalization by CNP at clinic.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Toothache, Troponin increased
Clinical narrative: Our son was given a Tdap shot on Friday, November 25th at approximately 3:15 p.m. during a physical he was undergoing. He seemed okay that night except for his injection site (right deltoid) which was quite sore. That appointment was at the clinic with CNP. The next day (Saturday, 11/26/16) he slept late and felt achy and generally under the weather. On Sunday (11/27/16) he was feverish along with body aches. His temperature was 102.0 at 4:22 a.m. He had 600 mg Ibuprofen at 9 a.m. just for comfort. He is a college student and had finals coming up. The highest fever we recorded that day was at 10:40 p.m. when it was 102.2. We didn't medicate at that point. Monday (11/28/16) he had a low-grade fever of 99.6 at 9:12 a.m. He took Ibuprofen 600 mg about an hour-and-a-half later so he could function at school. Tuesday (11/29/16) around midnight patient was taking his temperature-it was 99.2. (He had 600 mg Ibuprofen and one TUMS tablet at this time.) He was feeling chest pain that caused him to breathe shallowly. He also had injection site pain that radiated down his right arm, a flat red spot an inch or two below that site (about 3/4" in diameter), a headache (front, back and other areas), sinus pain, all his teeth hurt, joint pain (especially his knees and ankles), neck and back pain. This lasted more than 2 hours. At 2:00 a.m. he said it was about a "5 out of 10" and he was very sweaty. At 3:00 a.m. he said he was "fine" and was still very sweaty. He had another episode lasting probably 30 minutes around 7:00 p.m. that night-similar to above. Wednesday (11/30/16) morning around 7:00 a.m. he had another episode with the same symptoms. We decided to go in to the walk-in clinic. The symptoms had subsided by then. Around 9:30 a.m. we went there: He had a chest x-ray, EKG and blood work done there. Since the Troponin level was high they sent him to the hospital as a direct admission. He had more blood work, a heart monitor, echocardiogram, angiogram. He spent the night for observation and tests. Thursday (12/1/16) early afternoon he was discharged. Wednesday (12/7/16) he was seen post-hospitalization by CNP at clinic.
Age: 1.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Varicella
Clinical narrative: Varicella infection.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Infection, Injection site pain
Clinical narrative: Within hours, patient had soreness in the shoulder where the flu immunization was administered.  The pain continued to get worse.  Two weeks later she went to the doctor.  He stated she had an infection in the bursa and the pain was related to the immunization being administered in the bursa.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Client called this nurse Saturday 12/10/16 to said, "she had a small knot on (R) shoulder but can move it. Explained side effects per via statement client voiced understood. Client called again 12/11/16 arm swollen to elbow. Using cool compresses and BENADRYL.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Dizziness that started after injection 2 days post injection. No current illness. Fever, chills. VSS
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to less than 10 patients of unknown age and gender. There was no information about the patients' pertinent medical histories, drug reactions or allergies and concomitant medications provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, injection, lot # L044058, expiration date 02-MAY-2017; lot # M007962, expiration date 15-AUG-2017 and lot # M031942, expiration date 27-DEC-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effect was reported. The administered doses of vaccine underwent the temperature excursion of 23 degrees Fahrenheit for 40 hours, which was detected by a data logger. No product quality complaint was involved. There were no previous temperature excursions reported. Recombinant human albumin (rHA) has been verified to be the albumin status for PROQUAD lot # L044058, M007962 and M031942. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA004054: MERCK 1611USA007551:  mfr number.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple, unspecified patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. The Pharmacist reported that multiple unspecified patients were administered improperly stored varicella VARIVAX (dose, route were not reported) and PROQUAD.  Information regarding vaccines involved as follows:  PROQUAD (lot# M002055, expiration date 7/11/2017) or VARIVAX (lot#L048463, expiration date 12/2/2017).  Temperature/Time frame: -2 degrees Celsius for 1 hour 36 minutes, 2.9 degrees Celsius for 3 hours 42 minutes, -8.l degrees Celsius for 1 hour 36 minutes, -11.5 degrees Celsius 30 minutes, -7.4 degrees Celsius 2 hours 12 minutes, -7.5 degrees Celsius 48 minutes.  Names of vaccines involved: PROQUAD (lot # M007965, expiration date 15-AUG-2017) or VARIVAX (lot#M004663, expiration date 27-JAN-2018). Temperature/Time frame:  -2 degrees Celsius 1 hour 36 minutes, 2.9 degrees Celsius 3 hours 42 minutes, -8.1 degrees Celsius 1 hour 36 minutes, -7.5 degrees Celsius 48 minutes, -13.4 for 18 minutes, -13.7 12 for minutes.  No adverse effects were reported.  No additional information was available. Follow-up information has been received on 28-NOV-2016 from the pharmacist via phone call providing new stability data and an additional lot number to add to the case.  Names of vaccines involved:  VARIVAX (lot # L048463, expiration date 02-DEC-2017, lot #M004663, expiration date 27-JAN-2018).  Temperature 2.9 degrees Celsius:  time frame: 1 hour; cumulative time frame: 11 hours 54 minutes.  PROQUAD, (lot# M007961, expiration date 15-MAY-2017), temperature: 2.9 Celsius, time frame: 1 hour; cumulative timeframe: 11 hours 24 minutes.  The time frames and temperatures were double checked with the pharmacist.  No adverse effects were reported by patients.  No further information provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown gender and age. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# M025871, expiration date 24-MAY-2018, subcutaneously (dose was not reported) for prophylaxis. Administered doses of VARIVAX were stored in -11.96 degrees Celsius for 15 hours, -11.5 degrees Celsius for 15 hours and in - 14.61 degrees Celsius for 15 hours. There was no previous temperature excursion. No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA011250:
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 40 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately 2011 (reported as "5 years ago on an unspecified date"), the patient was vaccinated with his first dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported). On 05-DEC-2016, the patient came to the pharmacy and requested the second dose of VARIVAX that was not administered. There was no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, strength, vaccination site, route unspecified). On an unknown date, the patient experienced injection site rash, injection site warmth and injection site swelling following the administration of ZOSTAVAX. The patient sought medical attention and contacted pharmacist. The outcome of the events was reported as not recovered. Product quality complaint (PQC) was not involved. No further information was provided. Varicella Zoster Virus Identification Program (VZVIP) packet was offered and declined.     Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to 2 patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) for prevention of shingles. On unknown dates, after receiving the ZOSTAVAX, the patients developed shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route of administration, lot# and expiry date were unknown) for prophylaxis. On an unspecified date, reported as over a year after the first dose, the patient was administrated with the second dose of ZOSTAVAX, lot# M035691, expiry date 07-NOV-2017 (dose and route of administration were not reported) for prophylaxis. The lot of the sterile diluent used was M023649 with an expiry date of 14-DEC-2018. There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chronic lymphocytic leukaemia, Expired product administered
Clinical narrative: Information has been received from a Nurse Practitioner (also reported as nurse prescriber), referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Since an unknown date (reported as every 5 years), the patient had been vaccinated with PNEUMOVAX23 (dose, strength, anatomical location, lot number, expiration date were not reported) for prophylaxis. On an unspecified date, the patient experienced chronic lymphocytic leukaemia (reported as her condition, from an unspecified date). On 10-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L022795 (dose, strength, anatomical location, expiration date were not reported) for prophylaxis. At the time of this report, the outcome of chronic lymphocytic leukaemia was unknown and the causality assessment between the event and the PNEUMOVAX23 was not provided by the reporter. Upon internal review, chronic lymphocytic leukaemia was considered as a medically significant event. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender started to receive PREVNAR 13, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced experienced burning when vaccine was administered on an unspecified date with outcome of unknown. The action taken in response to the event for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse (patient) through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced fever and pain. Clinical outcome of the events was unknown at time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for him/herself. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose in Nov2016 (3 weeks before this report) for immunisation. The patient medical history and concomitant medications were not reported. In 2016, after I received Prevnar 13, he caught a cold, although not initially. He was in a closed car with a guy that was sneezing all over me. He got a fever but he was getting stronger now. The outcome was unknown. He queried when can it get the flu vaccine and the Shingles vaccine.
Sex: U
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Swelling
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A pharmacist reported a patient of unspecifed age and gender received PREVNAR 13 on an unspecified date at single dose for immunization. The patient had a big tattoo so the vaccination was given in higher than normally to avoid the tattoo however the patient had swelling at the site of injection. The vaccination might be administered in the different muscle and not deltoid muscle and might have hit the pectoral muscle of shoulder. The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events on three patients. This is the first of three reports. A patient of an unspecified age and gender received PREVNAR 13, (lot N97935, exp. date 12Jan2017, NDC number 0005-1971-01) on the right deltoid muscle at single dose on 12Sep2016 for immunization. Relevant medical history and concomitant medication were not specified. On an unknown date the patient experienced warm, red and swollen at administration site and they turned red like cellulitis. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586404 same reporter, same events, different patients. US-PFIZER INC-2016586398 same reporter, same events, different patients.
Age: 49.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Axillary mass, Injection site pain, Myalgia, Tenderness
Clinical narrative: States upon awakening 12/17/16 noticed a tender lump in (R) armpit size of half an orange. States (R) shoulder sore and has muscle aches. Tenderness and size of lump has not increased or decreased. Denies fever. Took ADVIL-provided some relief.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events on three patients. This is the second of three reports. A patient of an unspecified age and gender received PREVNAR 13, )lot N97935, exp. date 01Dec2017, NDC number 0005-1971-01) on the right deltoid muscle at single dose on 12May2016 for immunization. Relevant medical history and concomitant medication were not specified. On an unknown date the patient experienced warm, red and swollen at administration site and they turned red like cellulitis. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586404 same reporter, same events, different patients. US-PFIZER INC-2016586397 same reporter, same events, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events on three patients. This is the third of three reports. A patient of an unspecified age and gender received PREVNAR 13, (lot N47827, exp. date 01Nov2017, NDC number 0005-1971-01) on the right deltoid muscle at single dose on 11Nov2016 for immunization. Relevant medical history and concomitant medication were not specified. On an unknown date the patient experienced warm, red and swollen at administration site and they turned red like cellulitis. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586398 same reporter, same events, different patients. US-PFIZER INC-2016586397 same reporter, same events, different patients.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 64 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13, lot M88543, expiry date Jul2017, NDC 00005197105) intramuscular in the left arm on 06Dec2016 for  immunization.  The patient medical history and concomitant medications were not reported. On 08Dec2016 the patient's arm was red, warm to touch and there was swelling. Redness was about half a cm below the site of vaccination and it continued three or four inches down the arm. The patient went to her allergy specialist and the doctor said it was an infection and prescribed oral antibiotics, a topical antibiotic, and a steroid cream. The allergy doctor wanted to dispense the next dose of pneumococcal 13-val conj vac (dipht crm197 protein)  at the office to see if the reaction was due to the vaccine itself. At the time of this report the patient was not recovered from the reported events, redness and swelling were worsened.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 75-year-old female patient received the first dose of  PREVNAR 13, intramuscular on 15Nov2016 at 4 pm at left upper arm for pneumonia prevention, and first dose of FLUZONE HD, intramuscular from 15Nov2016 at 4 pm at left upper arm to prevent the flu. Medical history included asthma and cough. Concomitant medication included  Q-40 inhalant at 1DF 2x/day for asthma, montelukast 1 DF 1x/day (at night) for asthma and benzonatate 100 mg as needed (at night) for cough, all from 2014 and ongoing. On 15Nov2016 at around 7-8 pm, patient  felt sick for a couple of day and she also had chills, fever, diarrhea, headache and shoulder pains; she felt like she had the flu. She felt really bad for 24 hours and then for 2-3 days. Patient recovered from all the events on 19Nov2016.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 75-year-old female patient received the first dose of  PREVNAR 13, intramuscular on 15Nov2016 at 4 pm at left upper arm for pneumonia prevention, and first dose of FLUZONE HD, intramuscular from 15Nov2016 at 4 pm at left upper arm to prevent the flu. Medical history included asthma and cough. Concomitant medication included  Q-40 inhalant at 1DF 2x/day for asthma, montelukast 1 DF 1x/day (at night) for asthma and benzonatate 100 mg as needed (at night) for cough, all from 2014 and ongoing. On 15Nov2016 at around 7-8 pm, patient  felt sick for a couple of day and she also had chills, fever, diarrhea, headache and shoulder pains; she felt like she had the flu. She felt really bad for 24 hours and then for 2-3 days. Patient recovered from all the events on 19Nov2016.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. This pharmacist reported similar events for 2 patients. This is the second of 2 reports. A patient of unspecified age, race, ethnicity and gender received for immunization on an unspecified date a single dose of PREVNAR 13)and a high dose of influenza vaccine.  The patient medical history and concomitant medications were not reported.  The two vaccines were co-administered on the same arm about one inch apart. On an unspecified date the patient experienced redness from the injection site all the way down to the elbow, it was red, swollen and hot. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016586887 same reporter/product/event, different patient.
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. This pharmacist reported similar events for 2 patients. This is the first of 2 reports. A patient of unspecified age, race, ethnicity and gender received for immunization on an unspecified date a single dose of PREVNAR 13 and a high dose of influenza vaccine.  The patient medical history and concomitant medications were not reported.  The two vaccines were co-administered on the same arm about one inch apart. On an unspecified date the patient experienced redness from the injection site all the way down to the elbow, it was red, swollen and hot. Outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586886 same reporter/product/event, different patient.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Pt came in to have her arm looked at. It had redness size of golf ball (flat).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Electrocardiogram, Heart rate increased, Respiratory tract congestion, Throat tightness
Clinical narrative: Tightening of throat, rapid heartbeat, congestion, unsettled stomach. Treated w/BENADRYL. Felt fetter two days later.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abdominal pain, Crying, Decreased appetite, Discomfort, Emotional distress
Clinical narrative: On Wednesday, October 19th, patient received the oral rotavirus vaccine.  Immediately after the dose was given, patient nursed and then fell asleep.  Typically at this time of day he naps for about two hours. On this day he slept for six hours and woke suddenly.  He began screaming until he was dark red in the face. He drew his knees to belly and couldn't be soothed. He would not eat either. After 20 minutes of this behavior I gave him a full dose of Children's Tylenol. Another 40 minutes of this intense screaming past and he finally exhausted himself to sleep.  He slept for about an hour and woke very fussy and seemed uncomfortable. The fussiness and soft cries continued through the next evening. Throughout this period I continued to give him does of Tylenol.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Erythema, Fatigue, Irritability, Screaming
Clinical narrative: On Wednesday, October 19th, patient received the oral rotavirus vaccine.  Immediately after the dose was given, patient nursed and then fell asleep.  Typically at this time of day he naps for about two hours. On this day he slept for six hours and woke suddenly.  He began screaming until he was dark red in the face. He drew his knees to belly and couldn't be soothed. He would not eat either. After 20 minutes of this behavior I gave him a full dose of Children's Tylenol. Another 40 minutes of this intense screaming past and he finally exhausted himself to sleep.  He slept for about an hour and woke very fussy and seemed uncomfortable. The fussiness and soft cries continued through the next evening. Throughout this period I continued to give him does of Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash to right thigh about site of administration, fever on day 1, no further fever, no treatment other than clinical monitoring.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Atrophy, Coordination abnormal, Cytogenetic analysis abnormal, Demyelination, Differential white blood cell count normal
Clinical narrative: 20 yo male with S and S (B) hand numbness, atrophy, decreased coordination after receipt of adenovirus (lot# 34600212 BRR), hep A (#9M57P SKB), IIV (#U55306), IPV (K1694-1), MCV4P (U580AA CSL), Tdap (AH4LF SKB), varicella (L050957 Merck) vaccines. Per neuro notes symptoms included numbness and weakness of his hands, 1 week after vaccine receipt; progressing to feet two weeks later (week 3). Symptoms were constant, difficulty with fine motor skills, grasp, (R) foot drop, left foot weakness. Vaccine receipt was 20 May 2016, PT note on 31 May notes thenar and hypothenar atrophy and Ape hand appearance (intrinsic weakness). He was admitted on 27 June 16 and discharged 03 July 16. He received IVIG for presumed GBS with symptom improvement. He did not have an LP. EMG-NCS. Abnormal study with electrical evidence of slowing of multiple motor and sensory nerves most consistent with the diagnosis of peripheral polyneuropathy and most likely a diffuse demyelinating process like Guillain-Barre Syndrome. No evidence any specific peripheral nerve impingement although there was extra slowing of the median nerve. There is no evidence of radiculopathy on needle exam. There was no evidence of myopathy on needle exam. Patient was referred for vaccine causality. Genetic testing for PMP22 demonstrated deletion confirming HNPP diagnosis.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Electromyogram abnormal, Fine motor skill dysfunction, Full blood count, Gene mutation identification test positive, Grip strength decreased
Clinical narrative: 20 yo male with S and S (B) hand numbness, atrophy, decreased coordination after receipt of adenovirus (lot# 34600212 BRR), hep A (#9M57P SKB), IIV (#U55306), IPV (K1694-1), MCV4P (U580AA CSL), Tdap (AH4LF SKB), varicella (L050957 Merck) vaccines. Per neuro notes symptoms included numbness and weakness of his hands, 1 week after vaccine receipt; progressing to feet two weeks later (week 3). Symptoms were constant, difficulty with fine motor skills, grasp, (R) foot drop, left foot weakness. Vaccine receipt was 20 May 2016, PT note on 31 May notes thenar and hypothenar atrophy and Ape hand appearance (intrinsic weakness). He was admitted on 27 June 16 and discharged 03 July 16. He received IVIG for presumed GBS with symptom improvement. He did not have an LP. EMG-NCS. Abnormal study with electrical evidence of slowing of multiple motor and sensory nerves most consistent with the diagnosis of peripheral polyneuropathy and most likely a diffuse demyelinating process like Guillain-Barre Syndrome. No evidence any specific peripheral nerve impingement although there was extra slowing of the median nerve. There is no evidence of radiculopathy on needle exam. There was no evidence of myopathy on needle exam. Patient was referred for vaccine causality. Genetic testing for PMP22 demonstrated deletion confirming HNPP diagnosis.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Guillain-Barre syndrome, Haemoglobin normal, Hereditary neuropathy with liability to pressure palsies, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 20 yo male with S and S (B) hand numbness, atrophy, decreased coordination after receipt of adenovirus (lot# 34600212 BRR), hep A (#9M57P SKB), IIV (#U55306), IPV (K1694-1), MCV4P (U580AA CSL), Tdap (AH4LF SKB), varicella (L050957 Merck) vaccines. Per neuro notes symptoms included numbness and weakness of his hands, 1 week after vaccine receipt; progressing to feet two weeks later (week 3). Symptoms were constant, difficulty with fine motor skills, grasp, (R) foot drop, left foot weakness. Vaccine receipt was 20 May 2016, PT note on 31 May notes thenar and hypothenar atrophy and Ape hand appearance (intrinsic weakness). He was admitted on 27 June 16 and discharged 03 July 16. He received IVIG for presumed GBS with symptom improvement. He did not have an LP. EMG-NCS. Abnormal study with electrical evidence of slowing of multiple motor and sensory nerves most consistent with the diagnosis of peripheral polyneuropathy and most likely a diffuse demyelinating process like Guillain-Barre Syndrome. No evidence any specific peripheral nerve impingement although there was extra slowing of the median nerve. There is no evidence of radiculopathy on needle exam. There was no evidence of myopathy on needle exam. Patient was referred for vaccine causality. Genetic testing for PMP22 demonstrated deletion confirming HNPP diagnosis.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Neuropathy peripheral, Peroneal nerve palsy, Polyneuropathy
Clinical narrative: 20 yo male with S and S (B) hand numbness, atrophy, decreased coordination after receipt of adenovirus (lot# 34600212 BRR), hep A (#9M57P SKB), IIV (#U55306), IPV (K1694-1), MCV4P (U580AA CSL), Tdap (AH4LF SKB), varicella (L050957 Merck) vaccines. Per neuro notes symptoms included numbness and weakness of his hands, 1 week after vaccine receipt; progressing to feet two weeks later (week 3). Symptoms were constant, difficulty with fine motor skills, grasp, (R) foot drop, left foot weakness. Vaccine receipt was 20 May 2016, PT note on 31 May notes thenar and hypothenar atrophy and Ape hand appearance (intrinsic weakness). He was admitted on 27 June 16 and discharged 03 July 16. He received IVIG for presumed GBS with symptom improvement. He did not have an LP. EMG-NCS. Abnormal study with electrical evidence of slowing of multiple motor and sensory nerves most consistent with the diagnosis of peripheral polyneuropathy and most likely a diffuse demyelinating process like Guillain-Barre Syndrome. No evidence any specific peripheral nerve impingement although there was extra slowing of the median nerve. There is no evidence of radiculopathy on needle exam. There was no evidence of myopathy on needle exam. Patient was referred for vaccine causality. Genetic testing for PMP22 demonstrated deletion confirming HNPP diagnosis.
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Red blood cell count normal, White blood cell count normal
Clinical narrative: 20 yo male with S and S (B) hand numbness, atrophy, decreased coordination after receipt of adenovirus (lot# 34600212 BRR), hep A (#9M57P SKB), IIV (#U55306), IPV (K1694-1), MCV4P (U580AA CSL), Tdap (AH4LF SKB), varicella (L050957 Merck) vaccines. Per neuro notes symptoms included numbness and weakness of his hands, 1 week after vaccine receipt; progressing to feet two weeks later (week 3). Symptoms were constant, difficulty with fine motor skills, grasp, (R) foot drop, left foot weakness. Vaccine receipt was 20 May 2016, PT note on 31 May notes thenar and hypothenar atrophy and Ape hand appearance (intrinsic weakness). He was admitted on 27 June 16 and discharged 03 July 16. He received IVIG for presumed GBS with symptom improvement. He did not have an LP. EMG-NCS. Abnormal study with electrical evidence of slowing of multiple motor and sensory nerves most consistent with the diagnosis of peripheral polyneuropathy and most likely a diffuse demyelinating process like Guillain-Barre Syndrome. No evidence any specific peripheral nerve impingement although there was extra slowing of the median nerve. There is no evidence of radiculopathy on needle exam. There was no evidence of myopathy on needle exam. Patient was referred for vaccine causality. Genetic testing for PMP22 demonstrated deletion confirming HNPP diagnosis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Arthralgia, Drooling, Emotional distress, Hypotonia, Lymphadenopathy
Clinical narrative: High pitched screaming/inconsolable 1-2+ hrs. Fever (5 days, TYLENOL every 4-6 hrs). Drooling/limp body. Swollen lymph nodes/joint pain. Back arching/pain. Startle reflex returned.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Opisthotonus, Pyrexia, Screaming
Clinical narrative: High pitched screaming/inconsolable 1-2+ hrs. Fever (5 days, TYLENOL every 4-6 hrs). Drooling/limp body. Swollen lymph nodes/joint pain. Back arching/pain. Startle reflex returned.