chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Patient reported swelling between shoulder and neck describing it as "a big ball". Patient agreed to seek medical attention. Pharmacy reached out to standing order physician for this region but doctor was not located at any of the numbers on the doctor's profile on the store's computer system. Patient has no primary physician and the clinic he claims he utilizes has no record of him.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling, Skin abrasion
Clinical narrative: Arm swollen below the shoulder, warm to touch, site pink in color, itchy.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Full blood count, Loss of consciousness
Clinical narrative: Patient reported being dizzy and passed out.  Emergency services were called and emergency room doctor determined that dizziness and fall was not result of influenza vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt broke out in large whelps on back of legs, arms, back, buttocks as well as injection site---pt took Benadryl but did not help. Went to ER on 9/19/15 pt received prednisone and vistaril which helped.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Activities of daily living impaired, Asthenia, Asthma, Bilevel positive airway pressure
Clinical narrative: Some difficulty breathing becoming impossible to breathe over the course of approximately 20 minutes.  Emergency vehicle transferred patient to ER approximately one-half hour after onset of symptoms.  Nebulizer treatments administered, BiPAP provided in ambulance.  Heart rate as high as 170, BP very low.  IV antibiotics administered over the next few days.  Physician stated it sounded like a full blown asthma attack.  BiPAP used for several hours until patient could breathe on her own.  Patient sent to a skilled nursing facility for several weeks following hospital stay due to severe weakness and inability to care for self or walk.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Chest X-ray normal, Dyspnoea, Heart rate increased, Hypotension
Clinical narrative: Some difficulty breathing becoming impossible to breathe over the course of approximately 20 minutes.  Emergency vehicle transferred patient to ER approximately one-half hour after onset of symptoms.  Nebulizer treatments administered, BiPAP provided in ambulance.  Heart rate as high as 170, BP very low.  IV antibiotics administered over the next few days.  Physician stated it sounded like a full blown asthma attack.  BiPAP used for several hours until patient could breathe on her own.  Patient sent to a skilled nursing facility for several weeks following hospital stay due to severe weakness and inability to care for self or walk.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Urine analysis normal
Clinical narrative: Some difficulty breathing becoming impossible to breathe over the course of approximately 20 minutes.  Emergency vehicle transferred patient to ER approximately one-half hour after onset of symptoms.  Nebulizer treatments administered, BiPAP provided in ambulance.  Heart rate as high as 170, BP very low.  IV antibiotics administered over the next few days.  Physician stated it sounded like a full blown asthma attack.  BiPAP used for several hours until patient could breathe on her own.  Patient sent to a skilled nursing facility for several weeks following hospital stay due to severe weakness and inability to care for self or walk.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Pt got hives all over body, redness, swelling at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Pharmacist administered Zostavax vaccine IM instead of SQ. I called the Merck info line & was told that this was not a problem.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: RED SWOLLEN PATCH AT INJECTION SITE, SWELLING OF UPPER ARM.  THE RED SWOLLEN PATCH CONTINUED TO SPREAD ON 9/20 TO A PATCH ABOUT 2.5 IN X 4 IN.  IT IS VERY TENDER AND ITCHY.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Hypersensitivity, Pruritus, Swelling face
Clinical narrative: Patient stated that they got swollen eyes and face and itched.  She said that this happened on 09/17 or 09/18 and just took Benadryl.  She said she thought it was from the flu vaccine she got on 09/11/2015.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site swelling, X-ray
Clinical narrative: Patient stated that she had the vaccine on 9/2/2015 and went to the hospital on 9/7/2015 due to pain and severe swelling at site of Prevnar 13 injection site.  She is still having pain at injection site as of 9/21/2015.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: After receiving the shot, the patient experienced a lot of pain on the arm where the shot was injected. He came to the pharmacy to tell us about it and we told him to apply ice and get some acetaminophen. He came back again to say that the pain did not go away so he was told to add some ibuprofen to his regimen. He said that the pain relievers helped but the pain is still lingering.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Neck pain, Pain, Rash erythematous
Clinical narrative: Mild pain at injection site (left arm) shooting up to neck area and tiny red dots (5) around injection area. Ibuprofen for used for pain.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Severe chills, upper back pain, body aches, weakness, fatigue, headache, fever 103.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Severe chills, upper back pain, body aches, weakness, fatigue, headache, fever 103.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus, Rash generalised
Clinical narrative: Approximately 15 min after Fluzone was given, pt started experiencing itching and maybe little bumps all over her body, not just at the site of injection. Per her mom, she has received the vaccine yearly and no reaction in the past or egg allergy. No new other meds were given to the pt. Lot # is UI433AA Flu vaccine qs 2015-16. Benadryl 25 mg iv x 1 was given and symptoms improved. Plan is to discharge pt today.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Chills/fever.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient says that on the day after she received the vaccines, her right arm became swollen and hurt, and she went to the emergency room. She was given BENADRYL there and then discharged.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Blister, Cellulitis, Erythema, Rash, Skin warm
Clinical narrative: Rash with a large blister and warm redness.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Hypersomnia, Rash, Skin warm
Clinical narrative: On Saturday 9/19/2015 our daughter became really tired and slept 14 hours (which has never happened).  Then later on Sunday 9/20/2015 she was sleepy all day and around 3:30pm she woke up from her nap and started getting hives that started the size of mosquito bites and then morphed into the size of an egg. They were red and warm to the touch from her knees up to her rear.  We gave her Benadryl at 4:30 pm and the hives/rash went away.  By 7:30pm it was completely gone.  We took her to daycare and after she woke up from daycare at 1:30pm the teachers noticed the hives back again on her legs and arms.  I went to pick her up and by 2:45pm they were starting to go away without any medicine.  I went to the walk in clinic because her pediatrician could not see her and the rash/hives were all gone.  The nurse said she obviously couldn't really tell without seeing it in person (I had a picture) but to give her Benadryl again if it came but to then request allergy testing if they came again as its obviously something she is allergic too.  Neither the nurse or the pediatrician nurse thought it was related to the flu vaccine but I think it is as I saw that the reactions can be 7-10 days later.  There is just nothing else we can contribute the two episodes too where there is anything in common... Especially since she was so tired.  We think the effects just hit her later.  It would be nice to know if Benadryl is enough.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Somnolence, Urticaria
Clinical narrative: On Saturday 9/19/2015 our daughter became really tired and slept 14 hours (which has never happened).  Then later on Sunday 9/20/2015 she was sleepy all day and around 3:30pm she woke up from her nap and started getting hives that started the size of mosquito bites and then morphed into the size of an egg. They were red and warm to the touch from her knees up to her rear.  We gave her Benadryl at 4:30 pm and the hives/rash went away.  By 7:30pm it was completely gone.  We took her to daycare and after she woke up from daycare at 1:30pm the teachers noticed the hives back again on her legs and arms.  I went to pick her up and by 2:45pm they were starting to go away without any medicine.  I went to the walk in clinic because her pediatrician could not see her and the rash/hives were all gone.  The nurse said she obviously couldn't really tell without seeing it in person (I had a picture) but to give her Benadryl again if it came but to then request allergy testing if they came again as its obviously something she is allergic too.  Neither the nurse or the pediatrician nurse thought it was related to the flu vaccine but I think it is as I saw that the reactions can be 7-10 days later.  There is just nothing else we can contribute the two episodes too where there is anything in common... Especially since she was so tired.  We think the effects just hit her later.  It would be nice to know if Benadryl is enough.
Age: 86.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper extremity redness, itchiness, and swelling. Recommended to use ice pack to site, take Benadryl and ibuprofen.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Headache, Pain
Clinical narrative: Started with headache, by 10PM went to bed with severe headache and all over achie, 2 degree temp started around 12 PM. Laid in bed all day 17th, started feeling better but still ached and weak on the 18th each day a little better today 09/21/2015 just fell a little weak.
Age: 1.57
Sex: M
Vaccine: DTAP
Symptoms: Blood test normal, Dyskinesia, Electroencephalogram normal, Partial seizures, Tic
Clinical narrative: In the morning upon waking up I noticed the child's mouth become distorted (one side would stay open while the other side would be shut). This happened throughout the day. After child's nap, I contacted the doctor on call and explained the situation. They suggested that I go to the after-hours clinic. I called the clinic for an appointment. When I told them the issue they said that I should take my child to the ER. The ER doctor spoke to a neurologist and they thought that he was experiencing focal seizures. We were then transported and admitted to the main hospital. A Video EEG was set up for the night. There was also urine and blood collected. In the morning and after talking to the doctors and neurologist on call they determined that the EEG was normal along with his blood and urine specimens. They told me that he developed a tic. We are waiting on a referral for a sedated MRI as there was not a pediatric anesthesiologist available while we were at the hospital.
Age: 1.57
Sex: M
Vaccine: DTAP
Symptoms: Urine analysis normal
Clinical narrative: In the morning upon waking up I noticed the child's mouth become distorted (one side would stay open while the other side would be shut). This happened throughout the day. After child's nap, I contacted the doctor on call and explained the situation. They suggested that I go to the after-hours clinic. I called the clinic for an appointment. When I told them the issue they said that I should take my child to the ER. The ER doctor spoke to a neurologist and they thought that he was experiencing focal seizures. We were then transported and admitted to the main hospital. A Video EEG was set up for the night. There was also urine and blood collected. In the morning and after talking to the doctors and neurologist on call they determined that the EEG was normal along with his blood and urine specimens. They told me that he developed a tic. We are waiting on a referral for a sedated MRI as there was not a pediatric anesthesiologist available while we were at the hospital.
Sex: U
Vaccine: HEPAB, MMR, PNC, VARCEL
Symptoms: Hypersensitivity
Clinical narrative: This is spontaneous report based on information received by Pfizer from GlaxoSmithKline, manufacturer control A0964099A from a healthcare professional. A child subject of unspecified gender and age was vaccinated with TWINRIX, (GlaxoSmithKline), varicella virus vaccines, MMR vaccine (Non-GSK), and PREVNAR on 20 June 2011. Relevant medical history and concomitant medications were not provided. After vaccination, the subject experienced allergic reaction. The healthcare professional considered the event was clinically significant (or requiring intervention). The child was treated in the emergency room and then released. At the time of reporting the event was improved. No further details were known at the time of reporting.
Age: 1.2
Sex: M
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported on behalf of her 5-year-old son. This consumer also reported similar events on her daughter, the twin of this patient. This is the second of the two reports. The patient received the first dose of PREVNAR on 06Jul2005 at the age of 2 months. The patient received the last dose of PREVNAR injection in Jul2006 at the age of 14 months, thus completing the therapy regimen. The number of total doses received was unknown. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day was unknown. At the age of 5 years, in Feb2011 and on 10Mar2011 he was diagnosed with community acquired pneumonia. Therapeutic measure taken as a result of community acquired pneumonia included treatment with ZITHROMAX. Relevant lab data was none. At the time of the report he had not recovered from community acquired pneumonia. Follow-up (28APR2011): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: U
Vaccine: PNC
Symptoms: Pneumococcal infection
Clinical narrative: This is an initial spontaneous report from a contactable physician through a Pfizer Company Representative. A 3-year-old patient (gender and race unknown) received a dose of PREVNAR. Relevant medical history and concomitant medications of the patient were unknown. It was reported that after vaccination the patient was diagnosed with pneumococcal disease on an unknown date. The physician was trying to find out the serotype of the pneumococcal disease by carrying out further studies on the patient. Relevant laboratory test results were unknown. Therapeutic measures taken in response to the event, if any, were unknown. At the time of the report, the clinical outcome of the event was unknown. Follow-up (08Jul2011): Follow-up attempts completed. No further information expected. Follow-up (28Sep2011): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective
Clinical narrative: This is an initial spontaneous report by a contactable nurse. This nurse reported a currently 5-year-old female child who was previously administered four doses of PREVNAR on unknown dates, site and time of administration. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date it was reported that PREVNAR did not work, which she explained as it was not effective. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of the report the clinical outcome of the above event was unknown. Follow-up (06Dec2011): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Blood test abnormal, Pneumococcal bacteraemia
Clinical narrative: This is an initial spontaneous report from a contactable physician via a Pfizer Sales Representative. A physician reported that a currently 5-year-old female patient received a dose of PREVNAR on an unknown date (unknown route and site). Relevant medical history and concomitant medications or vaccines were unknown. It was also unknown if any vaccines were given within four weeks. It was unknown if the patient had any siblings. On an unknown date, (at 5 years of age) the patient was diagnosed with pneumococcal bacteremia which did not require an emergency room visit. Relevant lab data included unspecified blood work on an unknown date which revealed pneumococcal bacteremia. At the time of this report the clinical outcome of the event was unknown. Follow-up (23Dec2011): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching and redness, hives.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Started itching, redness and large bump formed. Saw school nurse given BENAADRYL 50 mg. (Still hurts 9/16/15).
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Immediate post-injection reaction, Nausea, Pain, Pyrexia
Clinical narrative: (R) arm immediate pain, nausea-fever during night to 101 degrees. Redness soreness, vomiting, 4"x4" area. Had 2 bad days ill. Rx KEFLEX.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vomiting
Clinical narrative: (R) arm immediate pain, nausea-fever during night to 101 degrees. Redness soreness, vomiting, 4"x4" area. Had 2 bad days ill. Rx KEFLEX.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Rash, Skin reaction
Clinical narrative: Pt. had delayed reaction to H.D. Flu shot (FLUZONE HD) 10 days after spot. Looked "spotted", more like band-aid rash. Flu shot area had redness (1/4" circle) from edge to edge. Gave ice pk, generic CLARITIN and hydrocortisone crm 1%.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Peripheral swelling
Clinical narrative: Patient had cold chills and sweats evening of vaccine 9/18/15. Next day noticed swelling in right arm which continued to get worse and go down patients arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: PREVNAR 13 1st dose on 8-28-15 lt deltoid Flu shot 0n 8-28-15 rt deltoid pain lt deltoid persisted till 5th day (9-1-15) and became swollen rt upper arm with redness, induration and tender, warm , spread to axilla, and down forearm and back to scapula. Requiring medical treatment with prednisone x 5 dy and antibiotic x 3 day resolved 3rd week 9/21.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Injection site warmth, Skin warm, Swelling, Tenderness
Clinical narrative: PREVNAR 13 1st dose on 8-28-15 lt deltoid Flu shot 0n 8-28-15 rt deltoid pain lt deltoid persisted till 5th day (9-1-15) and became swollen rt upper arm with redness, induration and tender, warm , spread to axilla, and down forearm and back to scapula. Requiring medical treatment with prednisone x 5 dy and antibiotic x 3 day resolved 3rd week 9/21.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Erythema
Clinical narrative: Possible cellulitis; Md prescribed cephalexin; Pt noticed  red circle getting bigger.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pruritus
Clinical narrative: She developed rash on site of injection, and it itched alot.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient called 4:30 pm 9-21-15 to ask about a facial numbness above lip and circling around cheek to chin which she said had started on Sunday afternoon around 5 pm.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Lethargy, Meningitis pneumococcal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 9 month old male patient who experienced pneumococcal meningitis. The patient received the third dose on an unspecified date. The patient was taken to the walk in patient clinic and was lethargic in May 2010. The patient was admitted to the hospital with a diagnosis of pneumooccal meningitis. It is unknown if any treatment was given. Outcome was unknown. No additional information was available at the time of this report.
Age: 12.0
Sex: M
Vaccine: PNC
Symptoms: Meningitis pneumococcal, Streptococcus test positive
Clinical narrative: This was created to reflect the correct country of origin. The cancelled # was UR-WYE-H15177110. Follow-up information was received regarding recovery status. Information regarding PREVNAR was received from a healthcare professional regarding a 12-year-old male patient who experienced pneumococcal meningitis and drug ineffective. The patient received a dose on an unspecified date at the age of three. In 2010, the date unknown, the patient experienced pneumococcal meningitis and was hospitalized. The patient recovered. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I, MedWatch or VAERS report may indicate in the appropriate field that it is an initial report. Follow-up (13Dec2010): This contactable physician reported that the patient recovered.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Antibody test negative, Full blood count, Inappropriate schedule of drug administration, Pneumonia
Clinical narrative: This is an initial spontaneous report from a contactable nurse. This nurse reported that her daughter, a 5-year-old, female child, received PREVNAR. The nurse reported the event of pneumonia on three different occasions. This is the third of three reports of pneumonia occurring in Sep2010. The child received 4 doses of PREVNAR, beginning on 04AUG2005 (first dose) through 31MAY2006 (fourth dose). A total of 4 injections were given at the appropriate and designated times as per the pediatric immunization schedule. The fourth dose was received at 12-months. The patient developed bilateral pneumonia in Sep2010 (at age 5 years). The patient was treated as an outpatient for pneumonia in September 2010. Titers were drawn to check immunity of pneumococcal injection. As reported, it was shown that she does not have immunity. The child's relevant medical history included neurocardiogenic syncope since an unknown date for which she was hospitalized. The child is not on any medications for this. The patient has no drug allergies. The patient also has a history of hospitalization for pneumonia in June 2008 and November 2008. The relevant laboratory tests included CBC, results not reported, on an unknown date, a few weeks ago. The nurse stated the patient did not get immunity with the PREVNAR injections and believes there is a causal relationship with the event pneumonia. At the time of this report, the patient has recovered from pneumonia. The therapeutic measures taken as a result of the event included administration of the first dose of PREVNAR 13 0.5 mL on an unknown date, 4 weeks ago. According to her pulmonologist, the child should receive another dose. Her pediatrician suggested that she should receive two additional doses of PREVNAR 13. Follow-up (15FEB2011): New information was reported from a contactable nurse regarding a 5-year-old female patient. This nurse reported the event of pneumonia on three different occasions. This is the third of three reports. Additional information included, medical history, dates of vaccine administration.
Sex: F
Vaccine: PNC
Symptoms: Bronchiolitis
Clinical narrative: This is a spontaneous report from a contactable reporter via a call center. A mother reported on behalf of her daughter. A female patient (age and race unknown) received a dose of PREVNAR on an unknown date. Relevant medical history, concomitant medications and past product history were unknown. It was reported that the patient developed bronchiolitis within 48 hours after being administered the PREVNAR. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported event were unknown. The clinical outcome of the reported event was unknown at the time of report. Follow-up information was received by a second call center from the same reporter on the same day, 24Jan2011. This contactable female consumer reported that her daughter began on PREVNAR unknown dose injection for an unknown reason on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Other vaccines given to her was unknown. Vaccine given on the same day was unknown. Vaccines taken within the last four weeks were unknown. On an unknown date while on PREVNAR unknown dose she experienced bronchiolitis within 48 hours of administration of injection. Relevant lab data was unknown. At the time of the report it was unknown if the patient was taking PREVNAR. At the time of the report the clinical outcome of the above event was unknown. Follow-up (16MAR 2011): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC
Symptoms: Gastritis, Gastrointestinal inflammation, Vomiting
Clinical narrative: This is an initial spontaneous report by a contactable consumer. A male infant (age unknown) received PREVNAR on an unknown date. Relevant medical history and concomitant medications were unknown. On an unknown date (two and half days after immunization), the patient experienced vomiting after he had solids in his stomach. It was noted that they thought that the symptoms were due to stomach and intestinal inflammation. Relevant laboratory data was unknown. At the time of report the clinical outcome of the events was unknown. Follow-up (10MAR2011): Follow-up attempts completed. No further information is needed.
Sex: M
Vaccine: PNC
Symptoms: Pneumonia pneumococcal
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer, the grandmother of a 5 month old male patient who experienced pneumococcal pneumonia. The patient possibly received a dose on an unspecified date. On an unspecified date, the patient experienced pneumococcal pneumonia. The patient's outcome was unknown. The reporter stated she did not know if the patient had received PREVNAR vaccinations prior to the event. No additional information was available at the time of this report.
Age: 0.05
Sex: M
Vaccine: PNC
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a consumer regarding a 28 day old male patient who was administered the first dose of PREVNAR at 14 days old and then at 28 days old experienced a body temperature of 104. At 14 days of age, the patient received the first dose on an unspecified date. The patient was administered the first dose of PREVNAR at 14 days old. When he was 28 days old, the patient was admitted to the hospital for a body temperature of 104. The fever resolved within a few hours, however remained hospitalized for 3 days because the mother refused a spinal tap. See related case(s): US WYE H17382110 (Adverse event, expedited).
Sex: F
Vaccine: PNC
Symptoms: Laboratory test abnormal, Meningitis pneumococcal, Pyrexia, Vomiting
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 13 month old female patient who experienced vomiting, pneumococcal meningitis and fever. The patient received three doses in six months on unspecified dates. The patient experienced vomiting, pneumococcal meningitis and fever in Mar 2010 and was hospitalized for five days. The patient recovered. No additional information was available at the time of this report.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: 2 vaccines on 9-10-15 PREVNAR and FLUZONE. Pt returns 7 days later. Arm is hot and swollen. Rph on duty explained possible cellulitis. Pt was referred to urgent care. Doc on duty reports an infection but did not use the word cellulitis according to pt. Pt prescribed clindamycin 150mg.
Sex: M
Vaccine: PNC
Symptoms: Lethargy, Meningitis pneumococcal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 9 month old male patient who experienced pneumococcal meningitis. The patient received the third dose on an unspecified date. The patient was taken to the walk in patient clinic and was lethargic in May 2010. The patient was admitted to the hospital with a diagnosis of pneumococcal meningitis. It is unknown if any treatment was given. Outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored doses of VAQTA injection (lot #K007827 with expiration date 09-DEC-2016, Lot# K008254 with expiration date 12-NOV-2015 and Lot# K005323 with expiration date 10-FEB-2017; dose and route were not provided). There was no concomitant medication reported. It was unknown if the patient sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 13-SEP-2015, the patient was inadvertently vaccinated with a dose of GARDASIL (lot number and dosing details were not reported) which expired on 26-JUN-2015. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: This spontaneous report was received from a healthcare worker via an unspecified pharmacist refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # was not reported) along with unspecified flu vaccine. On an unknown date, the patient experienced flue like symptoms and they had a blood red injection site reaction. The outcome of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Papule
Clinical narrative: Information has been received from a nurse practitioner via company representative  referring to a female patient of unknown age. On an unspecified date the patient was vaccinated with ZOSTAVAX vial (lot #, dose and route were not provided). On an unspecified date the patient was diagnosed with shingles. The shingles lesions were papular and painless. The distribution of the lesions was not provided. The patient visited the office to seek medical attention. No treatment was given for the events. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Information has been received from a pharmacist via a field employee referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with  a dose of ZOSTAVAX 19400 PFJU (strength, dosage frequency and route unspecified. On an unknown date  the patient stated that she/he felt like they had bug bites and experienced tingling on her/his arms and legs after receiving ZOSTAVAX. The patient sought medical attention via contacting pharmacist. The outcome of the events was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old female patient. Information concerning medical history and concurrent condition was not reported. The patient had no drug reactions and allergies. On 13-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and strength were unknown, lot # L021606, expiry date: 10-SEP-2016) subcutaneously. There was no concomitant therapy reported. On 14-SEP-2015 the patient told the pharmacist that she began to have some itching around the injection site and then on 16-SEP-2015 the patient has some blisters developing at the injection site. The patient went back to pharmacy for medical attention. There was no treatment for the events. There was no lab diagnostics studies performed. The patient was recovering from the events at the time of the report. Additional information  has been requested.
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 10-JUL-2015, the pharmacist gave VAQTA (dose, lot# and route unknown), Tdap (dose, lot# and route unknown) and MENACTRA (dose, lot# and route unknown) all three vaccines to the patient. On an unspecified date in 2015, the patient complained of elbow pain. The patient sought medical attention by speaking with the pharmacist. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a healthcare student referring to a patient of unknown age and gender. Information about medical history and concomitant conditions were unspecified. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX23 (lot number, dose and route were unknown). On an unknown date, the patient experienced a fully body rash. The patient sought medical attention via visiting a physician. The outcome the event was unknown. The causality between the event and PNEUMOVAX23 was unspecified. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a patient (who is also a field representative) of unknown age concerning herself. On an unknown date in June 2013 the patient was first vaccinated with RECOMBIVAX HB, intramuscular in the left arm (dose and lot # unspecified). On 17-SEP-2015 (reported as "today") the patient was vaccinated with second dose of RECOMBIVAX HB, intramuscular in the left arm (dose and lot# unspecified) (Inappropriate schedule of vaccine administered). No adverse effects reported. No further details provided. There was no PQC involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 10 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with the improperly stored does of (Oka/Merck) VARIVAX (lot number L016125 and expiration date 06-MAY-2017)(dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown date, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were vaccinated with GARDASIL that was improperly stored  (dose, strength and route of administration were not provided). Co-suspect or concomitant therapies were not reported. The lot number reported for GARDASIL were: L012190 with expiration date on 13-APR-2017, K006960 with expiration date on 19-FEB-2017 and K023432 with expiration date on 18-JUN-2016. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Blood test abnormal, Body temperature increased, Headache, Muscular weakness
Clinical narrative: This spontaneous report was received from a patient's mother via company representative and refers to her 4 year old male son with Kawasaki's disease. The patient did not have drug reactions or allergies. On 28-AUG-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot#, expiration date, dose, site and route of administration were not reported) as preschool vaccinations. Concomitant therapies included IPV (unspecified) and Hep A (manufacturer unknown). On 03-SEP-2015, the patient experienced headache. Then on 06-SEP-2015, he had a temperature of up to 103.5 (units not provided), was sent to an unspecified emergency room (ER) and released on the same day. On 08-SEP-2015, the patient complained of leg weakness. Unspecified blood work was performed and it was reported that the "UBC" was low (on unknown date). On 08-SEP-2015, the patient complained of leg weakness. The treatment was given and included MOTRIN, TYLENOL (also reported as "Tylernol") and unspecified intravenous (IV) antibiotic. The outcome of the events was reported as not recovered. The relatedness between the events and PROQUAD (Merck) was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Arm pain within an our or two of administration which continues to worsen 8 days out from when vaccine was given.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Herpes zoster, Hypersensitivity, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer and a pharmacist who refers to herself, a 79 year old female patient with diabetes and PCN allergy. ON 31-JUL-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous. Concomitant therapies included JANUVIA, glimepiride, PLAVIX, NITRO and COREG. The patient reported two days after receiving ZOSTAVAX, she developed a red rash on her right arm from the injection site to her elbow. The injection site had become swollen and site began running a low grade fever. (Specific temperature not provided). The patient has since visited a dermatologist and received a skin biopsy, although she has been diagnosed with "shingles" and was rather diagnosed with an allergic reaction. The patient was treated with prednisone and tetracycline (manufacturer and dose unspecified). The rash has since moved to both of her arms, both legs, upper thighs, and shin area. She also has a rash on her buttocks. The patient reported she was recovering from her allergic reaction and rash. The patient was also stated that her husband has visited the local hospital emergency room with a red rash across his chest. He husband was not admitted. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer and a pharmacist who refers to herself, a 79 year old female patient with diabetes and PCN allergy. ON 31-JUL-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous. Concomitant therapies included JANUVIA, glimepiride, PLAVIX, NITRO and COREG. The patient reported two days after receiving ZOSTAVAX, she developed a red rash on her right arm from the injection site to her elbow. The injection site had become swollen and site began running a low grade fever. (Specific temperature not provided). The patient has since visited a dermatologist and received a skin biopsy, although she has been diagnosed with "shingles" and was rather diagnosed with an allergic reaction. The patient was treated with prednisone and tetracycline (manufacturer and dose unspecified). The rash has since moved to both of her arms, both legs, upper thighs, and shin area. She also has a rash on her buttocks. The patient reported she was recovering from her allergic reaction and rash. The patient was also stated that her husband has visited the local hospital emergency room with a red rash across his chest. He husband was not admitted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: IPV, MNQ, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Upper extremity mass
Clinical narrative: Pt has a large swollen lump on L arm. Area as per grandmother is red and swollen and the size of the bottom of a coffee mug.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site infection
Clinical narrative: Injection site skin infection.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown gender and age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB, (dose, route, anatomical location, lot number and expiration date were not reported) before transplant. There was no concomitant medication reported. On an unknown date, the titers were drawn on an unspecified date and were negative (Hepatitis B surface antibody negative). It was unknown if the patient sought medical attention. No product quality complaint was involved. At the time of the report, the outcome of the Hepatitis B surface antibody negative was unknown. The relatedness between the event and therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple number of patients of unknown aeg and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of VAQTA (dose and route of administration not reported) lot # L009445, expiration date 01-JUN-2017, that were improperly stored. There were no adverse effects reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age. On 17-SEP-2015, the patient was vaccinated with (Oka/Merck) VARIVAX in error. No known effects reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot numbers were reported as: lot# K004205, expiration date 12-JAN-2017; lot# K005881, expiration date 14-JAN-2017; lot# K006960, expiration date 19-FEB-2017; lot# K008931, expiration date 04-MAR-2017; doses, route and site of administration were not reported). There were no adverse symptoms reported. The lot numbers: K004205, K005881, K006960, K008931 had been verified to be invalid lot numbers for GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL lot # K006117, expiry date 14-JAN-2017, dose, route and site of administration were not reported. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site discomfort, Injection site swelling, Swelling
Clinical narrative: Swelling and discomfort to injection site and armpit area. Swelling and redness over left axillary lymph node. Treated with 10 day CEFZIL course.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: Pt received immunization HPV #3 on 08/31/15. On 09/02/15, pt called Health Dept stating (L) arm very sore, so sore to raise or lay on it. Pt states she feels very weak, not herself.
Age: 20.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to Lt upper arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 10 unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of PROQUAD (Merck) (lot number reported as L024122 and expiration date 30-DEC-2016; lot number L023113 and expiration date 24-DEC-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: 2 x 2 red hot itchy localized reaction at Tdap 9/15/15 site which started 1 day after injection.