chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Respiratory arrest, Respiratory symptom, Resuscitation, Swelling face
Clinical narrative: Received 2 injections MMR and varicella. 1 injected in each arm. I questioned why in arm as patient's extremities were very thin. Nurse said it was ok due to little needle and given SQ. 2 days later patient started with lowgrade fever and upper respiratory symptoms. Coughing. She missed school Mon & Tuesday. On Wed she went to her reg GI Dr. She had 103 fever and still coughing. Recommended back to ped. Returned to ped on Fri. Her reg Dr wasn't in. They did a CBC which was ok but low Hgb which is her norm. O2 sat was ranging from 80 - 92. They were unsure if it worked. Dr recommended going to ER. Took her to ER. She had only 1 other complaint of rt arm hurt. They did chest xray and diagnosed bronchitis. Sent home on Zithromax, prednisone & breathing treatment. Sunday morning she woke up with left cheek swollen like mumps and a red ecchymotic area under her arm by chest. While getting her ready to go to hospital she took last breath. CPR started immediately and 911 called. Breaths did not seem to be going in. EMT took over CPR. Taken to hospital where they did get a heartbeat for less than a minute.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site haemorrhage, Injection site nodule, Injection site pain
Clinical narrative: After pulling out needle from patient's arm (deltoid area), it bled enough to trickle down the arm. The bleeding was stopped immediately when pressure was applied, but soon after administration, a quarter sized nodule appeared under the injection site.  It appeared swollen. Since bleeding had stopped, I decided to give patient an ice pack to ease swelling and pain if any.  Patient stated that there was no pain.  She returned back to pharmacy approximately 15-20 minutes later, and stated that she felt as if the swelling/lump went down.  I contacted patient around 4pm, she stated that nodule was still present and that she was starting to experience a little pain.  I advised her to apply ice for 15 minutes every few hours. Told her to contact us if any problems and will follow up with her as well.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Red place on arm approximately 5" by 2.5" retangular. Hot and firm to the touch.  Patient did not inform place of vaccination for 4 days and tried to treat with rubbing alcohol and hydrocortisone cream.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, chills, headache.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Lip swelling, Paraesthesia oral
Clinical narrative: After the Zostavax, pt was sitting in front of the pharmacy for about 15 minutes in case if there's any allergic reaction. About 20mins after the vaccination, pt came over the pharmacy and talked to me (the rph) that she's experiencing little tingling on her lips and she starts getting a bump above her lips. Her voice was deepened. We asked her to stay at the pharmacy for a little bit more and gave her a Benadryl capsule to take. After 10 minutes, pt said she felt better and wanted to go home to get the Proair because she also has asthma. We advised the pt to stay for additional check just in case if she has allergic reaction so we can give her Epipen but she wanted to go home. We advised her to call 911 if she has any swelling of the tongue, throat, rash, etc. Pt was verbalized understanding that she'll call 911 and take more Benadryl if the symptomps worsen or allergic reaction occur. Pt was gone from the pharmacy for about 2 hours, we called her at home and she said she did have the allergic reaction. Her lips were about to swell up but the Benadryl did helped calm it down and she felt fine now. She said if she it worsen, she'll take more Benadryl.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Received Fluzone IM dose at about noon on 9/27 (Lot #ui440ad). Awoke at 3am from typical sleep that night to severe chills/fever and all-over body aches. Treated with 1000 mg Tylenol. Symptoms calmed very gradually to allow sleep again after about 1.5 hrs. Much more significant chills/body aches than would have expected or have ever experienced following past flu shots. Awoke in morning with continued moderate body aches and some chills. Didn't feel well all day long.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Local swelling, Pyrexia, Swelling face
Clinical narrative: Swelling of face, neck-no troubles breathing, fever, chills.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia
Clinical narrative: I received the flu shot in my right arm. A day and a half later I couldn't walk.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Site manager of Housing reported pt had a sore arm and observed the site that was red the size of a grapefruit and swollen. Called 9/17/15, site manager reported arm feeling better.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Cough, Sputum discoloured
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of phlegm discolored in a 81-year-old male patient who received FLUARIX QUADRIVALENT. Concurrent medical conditions included pneumonia (since 2014). On 14th September 2015, the patient received FLUARIX QUADRIVALENT. On 20th September 2015, 6 days after receiving FLUARIX QUADRIVALENT, the patient experienced phlegm discolored, anxiety and cough. On an unknown date, the outcome of the phlegm discolored and cough were not recovered/not resolved and the outcome of the anxiety was unknown. The reporter considered the phlegm discolored to be unrelated to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the anxiety and cough to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by patient's daughter. On 14th September 2015, about 6 days before the day of reporting, the patient received FLUARIX vaccine at local pharmacy. After vaccination, the patient started coughing up orange phlegm. The patient did not experience cough prior to the day before reporting. Therefore, the patient experienced anxiety and he thought to visit emergency room. Emergency room visit was avoided by the patient but the reporter was going to take the patient to see his pulmonary doctor later at the time of reporting.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Burning, redness, itching, rash arm and abdomen hives. Monitoring, using BENADRYL, ADVIL.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Upon injection-injection site began to swell and bleeding occurred. Bleeding stopped. Ice was applied-swelling did start to go down. Checked on patient later in afternoon. Was doing fine.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: Patient said she had a lot of pain the day of shot and is still in pain and having problems moving the arm she got the injection. She took ibuprofen, which didn't make the pain go away. She said both shots were given high on the arms felt like they hit the bone. The pain was spreading into the muscle in her neck on the side of the pneumonia shot. She has some weakness (nerve issue).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea
Clinical narrative: Patient came to me 9-28-15. Complained of nausea since the vaccination, also had fatigue. I believe she stated she missed a day or so of work.
Age: 55.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Nervous system disorder, Oedema
Clinical narrative: Radial nerve symptoms, suspect mod weakness of wrist extensor. Radial nerve edema.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Pt. states that experience nausea-diarrhea.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Pt states experience nausea/diarrhea.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Excessive swelling and redness to site and outer arm of injection lasting 2-3 days. This was accompanied with pain. Symptoms began w/in 4-6 hours of administration.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Patient received vaccine at pharmacy on 9/20/15. On 9/21/15 a dr office called to say he had presented Kw/ SOB; but we do not know which Dr office called. We have repeatedly called and no answer (from pt).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling in right pinky and ring finger.
Sex: M
Vaccine: DTAP, FLUX
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Initial report received from a healthcare professional on 18 Nov 2014. A male patient (age not reported), whose concomitant medication were not reported, had received a dose of DAPTACEL, manufacturer: Sanofi Pasteur Ltd (batch number: C4630AA, expiry date: 28-OCT-2016) dose and route of vaccination were not reported) in left thigh on an unspecified date, a dose of Flu vaccine, manufacturer: Unknown, batch number, dose and route of vaccination were not reported in right thigh, on an unspecified date and fourth dose of DTAP, manufacturer: Unknown, batch number, dose and route of vaccination were not reported on an unspecified date. Medical history of the patient was reported as, he had mild allergy to eggs and nuts. On an unspecified date, patient had papular vesicular lesions in left thigh. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patients were inadvertently administered with improperly stored, GARDASIL 9 vaccine, lot # K026246 exp: 28-JAN-2017 (dose, route therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to less than 5 patients of unspecified age and sex. The patients medical history and concurrent conditions were not reported. On an unspecified date, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) injection (lot # L004006 expiry date 05-AUG-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not provided. Since 23-JUL-2015 and on other unknown dates, an unspecified number of patients were vaccinated with an unspecified number of improperly storage doses of PEDVAXHIB lot # K025006 and expiration date 22-JUL-2017, lot # K026533 and expiration date 07-AUG-2017 and lot # L002867 and expiration date 11-NOV-2017 (dose and route of administration were not provided). There was not concomitant medication reported. The reporter referred that the vaccines were administered by an unspecified physician and no adverse experiences had been reported. Follow up information was received on 25-SEP-2015. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of three reports from the same reporter. Additional information has been requested. Narrative was updated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine 9/25/15. Pain that night at injection site. Next day (9/26/15) developed redness and swelling at site "golf ball size". Next day 9/27 increased pain, swelling and redness "softball sized", hard to move arm, warm to touch. Pain with movement. Exam: (L) upper arm/shoulder 8 x 10 cm area of redness, swollen, warm, tender. No discharge, no red streaking. Hurts to fully elevate.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pain
Clinical narrative: Received vaccine 9/25/15. Pain that night at injection site. Next day (9/26/15) developed redness and swelling at site "golf ball size". Next day 9/27 increased pain, swelling and redness "softball sized", hard to move arm, warm to touch. Pain with movement. Exam: (L) upper arm/shoulder 8 x 10 cm area of redness, swollen, warm, tender. No discharge, no red streaking. Hurts to fully elevate.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Scab
Clinical narrative: Patient had severe blisters develop a couple days after receiving vaccine, they eventually popped and scabbed over.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Skin warm, Urticaria
Clinical narrative: Patient had severe blisters develop a couple days after receiving vaccine, they eventually popped and scabbed over.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Scab
Clinical narrative: Next day (9/17/15) huge welt - hot to touch. 9/18/15 - huge blisters. 9/19/15 - blisters - one big one popped. 9/20 - blisters. 9/21 and 22 blisters and then I mailed 9/22/15 and still have blisters "see photos" and dates on back.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Skin warm, Urticaria
Clinical narrative: Next day (9/17/15) huge welt - hot to touch. 9/18/15 - huge blisters. 9/19/15 - blisters - one big one popped. 9/20 - blisters. 9/21 and 22 blisters and then I mailed 9/22/15 and still have blisters "see photos" and dates on back.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Paraesthesia
Clinical narrative: Joint pain and swelling 2 wks following MMR vaccine. Some mild tingling sensation.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Developed swelling and pain at site of injection and took > 5 days to resolve.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Adhesion, Injection site pain, Manipulation, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Severe pain at site when injection given. Pain constant, swollen -> pain/continues. 2 months given cortisone shot into subacromial space. MRI in 5 mons - SLAP tear. Surgery - pt 3/week -> adhesions - manipulation.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Surgery, Swelling
Clinical narrative: Severe pain at site when injection given. Pain constant, swollen -> pain/continues. 2 months given cortisone shot into subacromial space. MRI in 5 mons - SLAP tear. Surgery - pt 3/week -> adhesions - manipulation.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 24 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (route was not reported; lot # K005881, expiry date 14-JAN-2017). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: On 9/11/2015 patient received PREVENAR 13, the next morning patient woke up with arm swollen at site of injection. The swelling progressively got worse throughout the day. On 9/16/15 patient saw Dr. where she was prescribed cetirizine and MEDROL dose pak.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a consumer via Pfizer and refers to a male patient of unknown age. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. In 2015, reported as "a couple of weeks ago", the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, site and route of administration were not reported). Subsequently in 2015, the patient experienced reaction to PNEUMOVAX 23. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected, as no contact details were provided.
Age: 0.5
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 6 month old patient of unknown gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 18-SEP-2015, the patient was inadvertently, subcutaneously vaccinated with the initial 0.5 ml dose of PROQUAD (Merck) lot # L005297, expiry date 17-AUG-2016. No adverse effects were reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Whelps/hives on legs and arms within 60 minutes after injection. Reported to Pediatrician, was evaluated that day. BENADRYL x 3 doses in 24 hours. Also reported a fever on 102, TYLENOL given and fever resolved along with hives.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to "less than 10" patients of unspecified age and sex. The patients medical history and concurrent condition were not reported. On an unspecified date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) injection (lot # K002918 expiry date 26-FEB-2016). No adverse effects were reported. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Malaise, Syncope
Clinical narrative: Shot 3 PM on the 9th felt ill 8:30-10:00 AM the next day during that time (8:50) fainted out for only a short time for 5 days- muscle soreness in the arm at the site of the shot.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Malaise
Clinical narrative: Itchy red blisters around injection site. Daughter said she hasn't feel well for day or two.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On 17-SEP-2015 (reported as within the last two days of receiving ZOSTAVAX, the patient developed a red welt (1-1.5 inches) at the injection site (injection site erythema), which was painful (injection site pain). The patient sought medical attention by calling the pharmacist. Ice to the site was reported as treatment for the patient. At the time of the report, the outcome of the patient developed a red welt (1-1.5 inches) at the injection site which was painful was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm SQ - redness, swelling, soreness, warm to touch, 2 days with headache, 1 day with temp 99.5: cool compresses and BENADRYL and monitor and notified PCP.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Face oedema, Orbital oedema, Scan with contrast normal, Urine analysis normal
Clinical narrative: Vaccine given 9-2-15. On 9-7-15 at 1600, pt developed severe (R) side facial edema from jawline into eye socket. Went to urgent care on 9-7-15, went to ER on 9-8-15. Began KEFLEX, steroids, NSAIDS.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, X-ray normal
Clinical narrative: Knee swollen, warm and red. Fever.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Culture throat, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt. had a reaction to MENACTRA injection given in the left deltoid 0.5 ml on 9/3/2015. Was seen in office - hospital for redness, swelling, hardness at site. Temperature 99.9 degrees F. Swelling the size of a baseball. 6x6.5 in.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Oropharyngeal pain
Clinical narrative: Pt. had a reaction to MENACTRA injection given in the left deltoid 0.5 ml on 9/3/2015. Was seen in office - hospital for redness, swelling, hardness at site. Temperature 99.9 degrees F. Swelling the size of a baseball. 6x6.5 in.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Eyelid oedema, Lacrimation increased, Lethargy, Swelling
Clinical narrative: His eyes were swollen shut and watery, especially his left eye. He acted like he was in a lot of pain because he screamed all day if he wasn't napping. He was very lethargic. He wouldn't hold his head up for about 3-4 hours after the shot. He acted dizzy. He would not sit up. His whole left side was swollen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dyspnoea, Enlarged uvula, Pain, Pyrexia
Clinical narrative: Large welt, body aches, fevers, chills, uvula swelling, difficulty breathing, treated with prednisone.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Large welt, body aches, fevers, chills, uvula swelling, difficulty breathing, treated with prednisone.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3x3 in redness around injection site, soreness reported with movement. Advised by MD to apply warm packs and monitor.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Fainted, within 1-2 minutes after vaccine administered. Cold compress to neck and cold water.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Pt. told dad she was dizzy and had syncopal event x 2 seconds- was pale and sweaty- had pt lie down w/HOB elevated- gave water, took vitals, and monitored x 20-25 min and checked by Dr.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Dizziness, Fear, Immediate post-injection reaction
Clinical narrative: Patient receive immunizations 1200 after eating lunch. Hep A, Varicella, Tdap, MCV-4 and HPV-9. Immediately after receiving immunizations listed above patient complained of dizziness and nausea. Patient feet was elevated and a ice pack was applied to the back of his neck.  Patient started feeling sleepy with sinking episodes. Patient was placed in a supine trendelenburg position. 1225 Vitals 124/76 Pulse 85 Temp 98.1 Resp 16. Patient was alert, orientated to name, place and time. Skin dry and warm to touch. Resp even and unlabored. Denies SOB, chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints, everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eyes, patient not recovering after 30 minutes and having symptoms of anxiety/panic attack, Dr notified and agree to call "911". Mother agreed with the plan of care. 1230 BP 150/107 HR 82 Resp 16 Temp 98.0. Attempted to distract patient with the phone and he dropped the phone. He stated "My arms are weak". 1235 EMS at the bedside, transported to stretcher and sent to ER with his mother. Vitals 114/42 HR 65 Resp 16 Temp 98.0 oral. Patient was alert. Patient symptoms remain the same but visions was clear. Patient was alert, OX3 and stable at time of transfer. Instructed mother to follow-up with EMS as directed by the ER, mother verbalize good understanding and agree with the plan of care. Report given to EMS using SBAR.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Lacrimation increased, Muscular weakness, Nausea, Panic attack, Somnolence
Clinical narrative: Patient receive immunizations 1200 after eating lunch. Hep A, Varicella, Tdap, MCV-4 and HPV-9. Immediately after receiving immunizations listed above patient complained of dizziness and nausea. Patient feet was elevated and a ice pack was applied to the back of his neck.  Patient started feeling sleepy with sinking episodes. Patient was placed in a supine trendelenburg position. 1225 Vitals 124/76 Pulse 85 Temp 98.1 Resp 16. Patient was alert, orientated to name, place and time. Skin dry and warm to touch. Resp even and unlabored. Denies SOB, chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints, everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eyes, patient not recovering after 30 minutes and having symptoms of anxiety/panic attack, Dr notified and agree to call "911". Mother agreed with the plan of care. 1230 BP 150/107 HR 82 Resp 16 Temp 98.0. Attempted to distract patient with the phone and he dropped the phone. He stated "My arms are weak". 1235 EMS at the bedside, transported to stretcher and sent to ER with his mother. Vitals 114/42 HR 65 Resp 16 Temp 98.0 oral. Patient was alert. Patient symptoms remain the same but visions was clear. Patient was alert, OX3 and stable at time of transfer. Instructed mother to follow-up with EMS as directed by the ER, mother verbalize good understanding and agree with the plan of care. Report given to EMS using SBAR.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Visual impairment
Clinical narrative: Patient receive immunizations 1200 after eating lunch. Hep A, Varicella, Tdap, MCV-4 and HPV-9. Immediately after receiving immunizations listed above patient complained of dizziness and nausea. Patient feet was elevated and a ice pack was applied to the back of his neck.  Patient started feeling sleepy with sinking episodes. Patient was placed in a supine trendelenburg position. 1225 Vitals 124/76 Pulse 85 Temp 98.1 Resp 16. Patient was alert, orientated to name, place and time. Skin dry and warm to touch. Resp even and unlabored. Denies SOB, chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints, everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eyes, patient not recovering after 30 minutes and having symptoms of anxiety/panic attack, Dr notified and agree to call "911". Mother agreed with the plan of care. 1230 BP 150/107 HR 82 Resp 16 Temp 98.0. Attempted to distract patient with the phone and he dropped the phone. He stated "My arms are weak". 1235 EMS at the bedside, transported to stretcher and sent to ER with his mother. Vitals 114/42 HR 65 Resp 16 Temp 98.0 oral. Patient was alert. Patient symptoms remain the same but visions was clear. Patient was alert, OX3 and stable at time of transfer. Instructed mother to follow-up with EMS as directed by the ER, mother verbalize good understanding and agree with the plan of care. Report given to EMS using SBAR.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tenderness
Clinical narrative: Patient reports lingering pain, tenderness from Tdap vaccine on 8/11/15. Patient states that she experiences pain when lifting heavy objects or lift arm.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 82 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date (reported as "a few years ago"), the patient was vaccinated with a ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unknown date (reported as recently), the patient presented with a case of shingles. At the time of the report, the outcome of shingles was unknown. No product quality complaint was involved. Additional information is not expected as no further information can be obtained from the physician.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Nausea after 2nd shot resolved. Intermittent nausea after 3rd shot for 6m-12m. Parent just reported this to us on 9/19/2015.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: High fever, rash.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Pt. rec'd Hep B vaccine instead of Hep A No treatment required. Pt. contacted to return to correct Hep A vaccine.
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a Consumer on 11 March 2015. A male patient, whose medical history and concomitant medications were not reported, had received a dose of Tdap (batch number, dose in series, route and site of administration were not reported) on an Unspecified date. It was reported that the patient had experienced sore arm 6 weeks post vaccination and patient stated he discussed this with the pharmacist and he believes the wrong length of needle was used. Laboratory investigations were not reported. It was reported that patient had used Ibuprofen, topical preparations of Icy Hot and Ben Gay as corrective treatments, but which were ineffective. It was reported that the patient required ER/doctor visits. At the time of this report the patient outcome was unknown. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Night sweats, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever up to 102 degrees for about 4 days. Arm swelled to size of softball for 7 days. Body aches for 7 days. Night sweats.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Initial unsolicited report received from a physician on 17 February 2015. A 2-month old male patient, medical history and concomitant medications were not reported, had received the intramuscular dose of DTP manufacturer unknown, (batch number, expiry date and site of administration were not reported) on an unspecified date. It was reported the patient had never received another pertussis containing vaccine. On an unknown date, after vaccination the patient had 4 hour crying spell and was diagnosed with a possible neurologic reaction to pertussis vaccine. The patient required ER/doctor visit. Laboratory investigation and corrective treatments were not reported. On an unspecified date patient was recovered from the events. It was also reported that the patient was 25 and has had no issues with Dt or other vaccines. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were reported as unknown. At the time of this report, outcome of the event was resolved on an unspecified date. Documents held by sender: none.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Initial unsolicited report received from a physician on 17 February 2015. A 2-month old male patient, medical history was unknown and concomitant medications were not reported, had received first dose of DTAP manufacturer unknown, (batch number, route of administration, site of administration were unknown) on an unspecified date. It was reported the patient had never received another Pertussis contacting vaccine. On an unknown date after vaccination the patient had 4 hour crying spell and was diagnosed with a possible neurologic reaction to pertussis vaccine. The patient required ER/doctor visit. Laboratory investigations was unknown and corrective treatment were not reported. On an unspecified date patient was recovered from the events. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Initial unsolicited report received from a non healthcare professional (corrected) on 09 January 2015. A female patient (details not provided), whose medical history and concomitant meidcation was not reported, had received a dose of TDAP, (batch number, dose number, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, patient experienced localized reaction. Illness at the time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies were reported as environmental. Corrective treatment was not reported and laboratory investigations were reported as unknown. At the time of this report, the outcome of the patient was reported as recovered. Documents held by sender: none. Follow up information received from a non healthcare professional (Medical Assistant) on 09-Apr-2015. The patient age was provided as 31 years. The pre-existing physician diagnosed allergies were reported as unknown. There were no laboratory investigations done. It was reported that the information of the reaction was passed on to the facility and they did not administer the vaccine to the patient who had a noted reaction. There was no additional information provided.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional on 09 January 2015. A 24-month-old female patient, whose medical history and concomitant medication was not reported, had received a first dose of DTaP, (batch number, dose number, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, patient experienced redness and swelling at the injection site. Illness at the time of vaccination and pre-existing physician diagnosed allergies were reported as unknown. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the patient was reported as unknown. Documents held by sender: none. Follow up information received from a non-healthcare professional on 11 March 2015. No new information was reported. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Initial report received from a healthcare professional 07-NOV-2014. A pediatric patient whose age, gender, medical history and concomitant medications were not reported, had received a dose of TDAP (manufacturer; unknown, batch number, expiration date, dose in series, route and site of vaccination was not reported, on an unspecified date. On an unspecified date, the patient had a reaction to Tdap vaccine. At the time of this report, the outcome of the event was not reported. Laboratory investigations and corrective treatment were not reported. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Headache, Photophobia, Sleep disorder
Clinical narrative: Initial unsolicited report received from a healthcare professional (patient's parent) on 01 October 2014. An 11-year-old male patient, had received a dose of MENOMUNE, (batch number, dose in series and site of vaccination was not reported) subcutaneously on 30 September 2014. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 30 September 2014, few hours after vaccination, the patient developed headache. Headache became severe and interfered with his sleep. The patient also experienced photophobia. The patient was awake much of the night. Corrective treatments were not reported. No laboratory tests were performed. Documents held by sender: none. Follow-up information received from healthcare professional on 02 April 2015. Patient was vaccinated with a dose of TDAP and manufacturer: UNKNOWN (batch number, dose of vaccine and route of vaccination were not reported) in left deltoid on an unspecified date. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: C-reactive protein normal, Chest X-ray normal, Disturbance in attention, Dyspnoea, Epstein-Barr virus antibody negative
Clinical narrative: Headache - started one hour after vaccination. Feeling of "unwellness", "not feeling like himself". Shortness of breath approx. 10 days after vaccination. Poor concentration, difficulty focusing. Light bothering eyes.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Feeling abnormal, Full blood count normal, Headache, Malaise, Metabolic function test normal
Clinical narrative: Headache - started one hour after vaccination. Feeling of "unwellness", "not feeling like himself". Shortness of breath approx. 10 days after vaccination. Poor concentration, difficulty focusing. Light bothering eyes.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Photophobia, Red blood cell sedimentation rate normal, Spirometry abnormal
Clinical narrative: Headache - started one hour after vaccination. Feeling of "unwellness", "not feeling like himself". Shortness of breath approx. 10 days after vaccination. Poor concentration, difficulty focusing. Light bothering eyes.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: Initial report received from healthcare professional on 8 September 2014. A 5-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of DTaP which might be DAPTACEL (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date of 2007. It was reported that on an unspecified date of 2007, after receiving DTaP or DAPTACEL vaccine, the patient experienced "severe" local reaction. The patient's corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient was recovered. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Headache, Nausea, Pyrexia
Clinical narrative: Initial report from healthcare professional on 25 August 2014. A female patient in her 30's, whose concomitant medications were not reported, had received injection of first dose of IMOVAX rabies (batch number, route and anatomical site of administration were not reported) on an unspecified date as pre-exposure prophylaxis. Patient has "allergy" to eggs (that is why IMOVAX chosen) with reaction of severe GI distress. The patient didn't have significant other medical history. Rabies was the only vaccine given that day. A prescription for oral typhoid vaccine was provided, but not yet started. It was reported that on an unspecified date, on next day after receiving IMOVAX rabies vaccine, the patient experienced dull headache which was resolved within 24 hours. On day 2 after vaccination, the patient developed fever, diffuse joints and also nausea without improving. The patient could take OTC MOTRIN PRN as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 27 March 2015. The patient and responsible physician's details were updated. It was reported that a 31 year old patient had received a dose of IMOVAX RABIES (batch number J-1724-1) intramuscularly in left deltoid on 18 August 2014. Previously patient had also received a dose of TDAP (batch number, route and site of administration not reported) and had also a dose of HEPATITIS A VACCINE (batch number, route and site of administration not reported) approximately 1-2 weeks before IMOVAX RABIES, dates not specified. The patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased through hospital. The patient's medical history included egg allergy, PCOS, kidney stones, migraine headache and PUD. The patient's concomitant medication includes bystolic, DHEA, vitamins and metformin. It was reported that on 21 August 2014 the patient had fever (102 Degree Celsius) and also experienced joint pain and had nausea. The patient was prescribed oral typhoid which she had not started at that time and was also instructed to take MOTRIN as corrective treatment. It was reported that the headache had resolved on 21 August 2014. The final outcome of the event was unknown. Documents held by Sender: None.
Sex: U
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SAS092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA09512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092725 (same vaccine). Objective: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. Methods: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. Results: Since 2013, 7, 378 women who were offered the Tdap vaccine antenatally developed at our institution: 7, 152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.77 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4, 159). Conclusion: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Ad Tdap vaccine was exposure in utero, out of total 2, 093 number of neonate patients out of which 206 (3 percentage) patients birth weight was observed less than the third percentile, 364 (5 percentage) patients birth weight was observed less than the fifth percentile, 714 (10 percentage) patients birth weight was observed less than tenth percentile and 809 (11 percentage) patients birth weight was observed greater than the ninetieth percentile. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA09509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Objective: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. Methods: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. Results: Since 2013, 7, 378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7, 152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were adminsitered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). Conclusion: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7, 378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7, 152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposed in utero, thus 12 (0.2 percentage) neonate patients had developed 5 minute Apgar less than 4. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.