chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site discolouration, Injection site nodule
Clinical narrative: Case number PHHY2015US085100, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 576651) website on 07 Jul 2015, with a follow up report received from the Quality Assurance Department (QA, reference number: 1003199) on 12 Aug 2015. This report refers to a 53 year old male patient. His concurrent condition included hypertension, allergy to DEMEROL and sulfonamide drug. Concomitant medication included BYSTOLIC. He was vaccinated with FLURIVIN (batch number: 1413501) intramuscularly in left arm on 14 Oct 2014. In Nov 2014, he noticed a knot with pus at site of injection which grew from the size of quarter to dollar coin. He was taken to an emergency room. Treatment was rendered with AMOXIL on unknown date and AUGMENTIN on 26 Jan 2015. The initial event resolved but he had a black indentation at a size of a quarter. Physician told him that the event could be an infection due to the shot but could not confirm. Final outcome of the events was complete recovery. Seriousness and causality of the events were not reported. Seriousness assessment of the event infection due to the shot was upgraded based on the Novartis important medical events list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413501) vaccine was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up report received from the QA department on 12 Aug 2015: updated batch review report.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site discolouration, Injection site infection, Injection site nodule, Purulent discharge
Clinical narrative: Case number PHHY2015US085100, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 576651) website on 07 Jul 2015, with a follow up report received from the Quality Assurance Department (QA, reference number: 1003199) on 12 Aug 2015. This report refers to a 53 year old male patient. His concurrent condition included hypertension, allergy to DEMEROL and sulfonamide drug. Concomitant medication included BYSTOLIC. He was vaccinated with FLURIVIN (batch number: 1413501) intramuscularly in left arm on 14 Oct 2014. In Nov 2014, he noticed a knot with pus at site of injection which grew from the size of quarter to dollar coin. He was taken to an emergency room. Treatment was rendered with AMOXIL on unknown date and AUGMENTIN on 26 Jan 2015. The initial event resolved but he had a black indentation at a size of a quarter. Physician told him that the event could be an infection due to the shot but could not confirm. Final outcome of the events was complete recovery. Seriousness and causality of the events were not reported. Seriousness assessment of the event infection due to the shot was upgraded based on the Novartis important medical events list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413501) vaccine was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up report received from the QA department on 12 Aug 2015: updated batch review report.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Electromyogram, Hypoaesthesia
Clinical narrative: Case number PHHY2015US107909, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 581728) website on 11 Aug 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with an Influenza H1N1 vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 23 Sep 2009. On 03 Oct 2009, the patient experienced severe pain in left deltoid muscle where vaccine was given associated with sharp shooting pain up in shoulders into the neck and over to the right arm. Over next few days, the patient began experiencing numbness, tingling down arms. The patient also had severe shooting pains from both elbows and numbness in fourth and fifth finger of his hands. An electromyogram was performed at the time of the occurrence (no results given). Numbness in hands and pain in arms and neck continued on and off for approximately 10 months. The patient was given 2 courses of steroids and was seen by neurologist. The patient missed 3 weeks of work. In Apr 2014, the patient started having pain in left shoulder which progressed to back, hips and knees. Currently the patient was being treated for possible rheumatoid arthritis. But the patient has a negative rheumatoid factor. No definitive cause has been discovered other than symptoms started with pain in left arm/shoulder specifically where the patient received vaccine. Recently the patient started taking HUMIRA injections. The patient still have discomfort in left shoulder and could pinpoint where the vaccine was given even after 5.5 years of vaccination. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event possible rheumatoid arthritis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Injection site pain, Laboratory test, Neck pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US107909, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 581728) website on 11 Aug 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with an Influenza H1N1 vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 23 Sep 2009. On 03 Oct 2009, the patient experienced severe pain in left deltoid muscle where vaccine was given associated with sharp shooting pain up in shoulders into the neck and over to the right arm. Over next few days, the patient began experiencing numbness, tingling down arms. The patient also had severe shooting pains from both elbows and numbness in fourth and fifth finger of his hands. An electromyogram was performed at the time of the occurrence (no results given). Numbness in hands and pain in arms and neck continued on and off for approximately 10 months. The patient was given 2 courses of steroids and was seen by neurologist. The patient missed 3 weeks of work. In Apr 2014, the patient started having pain in left shoulder which progressed to back, hips and knees. Currently the patient was being treated for possible rheumatoid arthritis. But the patient has a negative rheumatoid factor. No definitive cause has been discovered other than symptoms started with pain in left arm/shoulder specifically where the patient received vaccine. Recently the patient started taking HUMIRA injections. The patient still have discomfort in left shoulder and could pinpoint where the vaccine was given even after 5.5 years of vaccination. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event possible rheumatoid arthritis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Paraesthesia, Rheumatoid factor negative, X-ray
Clinical narrative: Case number PHHY2015US107909, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 581728) website on 11 Aug 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with an Influenza H1N1 vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 23 Sep 2009. On 03 Oct 2009, the patient experienced severe pain in left deltoid muscle where vaccine was given associated with sharp shooting pain up in shoulders into the neck and over to the right arm. Over next few days, the patient began experiencing numbness, tingling down arms. The patient also had severe shooting pains from both elbows and numbness in fourth and fifth finger of his hands. An electromyogram was performed at the time of the occurrence (no results given). Numbness in hands and pain in arms and neck continued on and off for approximately 10 months. The patient was given 2 courses of steroids and was seen by neurologist. The patient missed 3 weeks of work. In Apr 2014, the patient started having pain in left shoulder which progressed to back, hips and knees. Currently the patient was being treated for possible rheumatoid arthritis. But the patient has a negative rheumatoid factor. No definitive cause has been discovered other than symptoms started with pain in left arm/shoulder specifically where the patient received vaccine. Recently the patient started taking HUMIRA injections. The patient still have discomfort in left shoulder and could pinpoint where the vaccine was given even after 5.5 years of vaccination. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event possible rheumatoid arthritis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Electromyogram, Electromyogram abnormal
Clinical narrative: Case number PHHY2015US107909, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 581728) website on 11 Aug 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with an Influenza H1N1 vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 23 Sep 2009. On 03 Oct 2009, the patient experienced severe pain in left deltoid muscle where vaccine was given associated with sharp shooting pain up in shoulders into the neck and over to the right arm. Over next few days, the patient began experiencing numbness, tingling down arms. The patient also had severe shooting pains from both elbows and numbness in fourth and fifth finger of his hands. An electromyogram was performed at the time of the occurrence (no results given). Numbness in hands and pain in arms and neck continued on and off for approximately 10 months. The patient was given 2 courses of steroids and was seen by neurologist. The patient missed 3 weeks of work. In Apr 2014, the patient started having pain in left shoulder which progressed to back, hips and knees. Currently the patient was being treated for possible rheumatoid arthritis. But the patient has a negative rheumatoid factor. No definitive cause has been discovered other than symptoms started with pain in left arm/shoulder specifically where the patient received vaccine. Recently the patient started taking HUMIRA injections. The patient still have discomfort in left shoulder and could pinpoint where the vaccine was given even after 5.5 years of vaccination. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event possible rheumatoid arthritis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Hypoaesthesia, Injection site discomfort, Injection site joint pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US107909, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 581728) website on 11 Aug 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with an Influenza H1N1 vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 23 Sep 2009. On 03 Oct 2009, the patient experienced severe pain in left deltoid muscle where vaccine was given associated with sharp shooting pain up in shoulders into the neck and over to the right arm. Over next few days, the patient began experiencing numbness, tingling down arms. The patient also had severe shooting pains from both elbows and numbness in fourth and fifth finger of his hands. An electromyogram was performed at the time of the occurrence (no results given). Numbness in hands and pain in arms and neck continued on and off for approximately 10 months. The patient was given 2 courses of steroids and was seen by neurologist. The patient missed 3 weeks of work. In Apr 2014, the patient started having pain in left shoulder which progressed to back, hips and knees. Currently the patient was being treated for possible rheumatoid arthritis. But the patient has a negative rheumatoid factor. No definitive cause has been discovered other than symptoms started with pain in left arm/shoulder specifically where the patient received vaccine. Recently the patient started taking HUMIRA injections. The patient still have discomfort in left shoulder and could pinpoint where the vaccine was given even after 5.5 years of vaccination. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event possible rheumatoid arthritis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia, Rheumatoid factor negative
Clinical narrative: Case number PHHY2015US107909, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 581728) website on 11 Aug 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with an Influenza H1N1 vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 23 Sep 2009. On 03 Oct 2009, the patient experienced severe pain in left deltoid muscle where vaccine was given associated with sharp shooting pain up in shoulders into the neck and over to the right arm. Over next few days, the patient began experiencing numbness, tingling down arms. The patient also had severe shooting pains from both elbows and numbness in fourth and fifth finger of his hands. An electromyogram was performed at the time of the occurrence (no results given). Numbness in hands and pain in arms and neck continued on and off for approximately 10 months. The patient was given 2 courses of steroids and was seen by neurologist. The patient missed 3 weeks of work. In Apr 2014, the patient started having pain in left shoulder which progressed to back, hips and knees. Currently the patient was being treated for possible rheumatoid arthritis. But the patient has a negative rheumatoid factor. No definitive cause has been discovered other than symptoms started with pain in left arm/shoulder specifically where the patient received vaccine. Recently the patient started taking HUMIRA injections. The patient still have discomfort in left shoulder and could pinpoint where the vaccine was given even after 5.5 years of vaccination. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event possible rheumatoid arthritis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: 3 inch long rash at the site of injection.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: 3 inch long rash at the site of injection.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Pt was trying to conceive at appt 7/7/2015, with LMP of 6/20/2015. Gardasil 9 was given on 7/7/2015, and pt subsequently conceived to be currently pregnant, EDC of 3/26/2016. This is an early pregnancy exposure reporting.
Age: 1.71
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Abnormal behaviour, Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: During patient's well check on his 21 months old well check, he was given the INFs pres free 3yr-adult Influenza vaccine while he was supposed to get the INFs pres free 6-35m Influenza vaccine. Shortly after he received the over-dosed vaccine, he started acting very differently than before such as losing social skills and self-stimming.  When we found out he was over-dosed with Influenza, we talked to his pediatric, we found that doctor put the correct order but nurse might give the wrong influenza.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash that started on torso and spread to all of upper body. Treated with Diphenhydramine Hydrochloride 25mg at 8pm, which did not seem to provide relief.  Applied ice packs to worst areas to relieve itching. Itching and rash were still apparent at 10pm when patient fell asleep.  Itching and rash were gone the next morning. Patient ate eggs for dinner, which she has done many times in the past with no adverse effects.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Injection site pain, Wheezing
Clinical narrative: Wheeze/coughing/feeling like breathing obstructed. Also sore arm at injection site. Took a Benadryl at 5:00 PM. Symptoms gone next morning.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Varicella post vaccine
Clinical narrative: PROQUAD RCV'D 09/03/2015. DEVELOPED MILD CASE OF CHICKEN-POX. LOCALIZED TO THE BACK AND NECK. AFEBRILE.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: Itching and tingling all over body.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shortness of breath and rapid heart rate. 09/11/2015 7:00 AM Area where I received the injection is red, swollen, hot and tender to the touch.  Stopped at Dr. office at 9:00 AM for her to look at it.  Prescribed antibotic.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth
Clinical narrative: Shortness of breath and rapid heart rate. 09/11/2015 7:00 AM Area where I received the injection is red, swollen, hot and tender to the touch.  Stopped at Dr. office at 9:00 AM for her to look at it.  Prescribed antibotic.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV, PNC13
Symptoms: Erythema, Pruritus, Rash generalised, Rash macular, Urticaria
Clinical narrative: Broke out into rash covering entire body.  Redness, welps, itching and blotchy.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Eye pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, Fever, bilateral eye pain. No Treatment.
Age: 21.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Periarthritis
Clinical narrative: Intense debilitating shoulder pain. Stiff rotator cuff, frozen shoulder, unable to lift arm without severe pain.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Dizziness, Headache, Mycoplasma test
Clinical narrative: Dizziness, prolong head ache, chest pain.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Colonoscopy normal, Diarrhoea, Endoscopy upper gastrointestinal tract normal, Injection site pain
Clinical narrative: Diarrhea started 5AM 4/24/15-ran day and night. Took KAOPECTATE and IMODIUM no results to stop. Saw Dr's 5/5 and 5/11/15 no relief. So bad was hospitalized 4 days, many tests done also a colonoscopy and upper GI endoscopy. All tests negative. I still have pain where the shot was given. 6/9/15 Emergency room hospital.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Initial solicited case received from the investigator in a trial on 02 September 2015. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This case involves a 24-year-old male subject who developed non-specific myocarditis during the study participation. The subject had medical history of elevated cholesterol and headaches. The subject received a first dose of anthrax vaccine concomitantly on 01 July 2015. On 12 July 2015, 11 days after receiving a dose of ACAM2000 on 01 July 2015 (batch number, route and site of administration not reported), the subject had non-specific myocarditis. The subject's blood test done on 12 July 2015 recorded the highest value of troponin I as 2.82 which was abnormal. The subject's ECG done on 12 July 2015 was normal. The subject's echocardiogram, MRI (brain, spinal cord and heart) and lumbar puncture was not performed. The subject's corrective treatment was not reported. Outcome of the event non-specific myocarditis was not reported. Relationship to investigational product according to company: associated. Whether the serious adverse event led to the termination of the subject from the study or not was not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Paraesthesia oral
Clinical narrative: Tingling in tongue, tightness in jaw. Oral liquid Benadryl self-administered at 10:00 AM, Personal EPI pen self-administered at 10:10 AM.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Injection site nodule, Injection site warmth, Middle insomnia
Clinical narrative: I felt fine until I rubbed the knot at injection site around 6 PM. (somewhere I had heard you should do that.)  In 15 minutes I became dizzy, weak and nauseous. My blood pressure was 141/85 P60.  (BP was 120/62 at Dr. Office earlier in the day) The dizziness persisted until around 2:30 am. I went to bed at 8 pm, awoke at midnight still dizzy, but awoke at 2:30 completely well but with a feverish knot at injection site.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: I felt fine until I rubbed the knot at injection site around 6 PM. (somewhere I had heard you should do that.)  In 15 minutes I became dizzy, weak and nauseous. My blood pressure was 141/85 P60.  (BP was 120/62 at Dr. Office earlier in the day) The dizziness persisted until around 2:30 am. I went to bed at 8 pm, awoke at midnight still dizzy, but awoke at 2:30 completely well but with a feverish knot at injection site.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Nausea, Swelling, Tenderness
Clinical narrative: Nausea, extreme shoulder pain, limited arm motion.  Swollen and very tender to the touch.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: 4 inch x 6 inch raised hard red area, warm to touch below left deltoid injection site.  Intense itching all over body.  BP 116/74 Itch not relieved with Benadryl.
Age: 21.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Anaemia, Condition aggravated, Rash
Clinical narrative: MMR vaccination 6/5/15 - Develop rash on feet and hands on 6/6. Seen in urgent care 6/8 - sent to Emergency dept - Admitted 3 days. IV fluids, BENADRYL.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Cataplexy, Guillain-Barre syndrome, Viral infection
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of cataplexy in a 57-year-old male patient who received FLULAVAL (batch number AFLLA687AA, expiry date unknown). Previously administered products included FLULAVAL vaccine (batch number AFLLA591BA). Concurrent medical conditions included multiple allergies (a lot of), pneumonia (issues) and blood pressure high. Concomitant products included Potassium. On an unknown date, the patient received FLULAVAL. In March 2012, an unknown time after receiving FLULAVAL, the patient experienced cataplexy (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization and GSK medically significant), Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant) and viral infection (serious criteria hospitalization). On an unknown date, the outcome of the cataplexy was not recovered/not resolved and the outcome of the unable to walk, Guillain Barre syndrome and viral infection were unknown. It was unknown if the reporter considered the cataplexy, unable to walk, Guillain Barre syndrome and viral infection to be related to FLULAVAL. Additional details were provided as follows: This case was previously reported to a doctor. The patient had an aggressive immune system. Concomitant medication also included high blood pressure medication. The patient received a FLULAVAL vaccine. In March 2012, he had a very rapid onset of symptoms that progressed over 6 months and that incapacitated him. The symptoms required several hospitalizations for several weeks and numerous numbers of tests were done. In March of 2012, he developed a viral severe cataplexy and Guillain-Barre syndrome. It was a viral infection that made him lose the ability to walk. He had to go through rehabilitation to learn to walk and received treatment. He was disabled and could not walk more than 10 feet. The patient had received some vaccines other than FLULAVAL and suffered from pneumonia issues in general but he did not have that information with him at the time of reporting. The reporter wanted to get more details about the H1N1 nuclear protein used within the FLULAVAL, as he believed that activated the viral infection. He also mentioned a vaccine made by different manufacturer that he received afterward, 2013-2014 MPV injector 94ZN4; expiry date 30th June 2014, a different set of expiration that he was not sure what it meant (26 July 2013). However, as per our sales data the batch number 94ZN4, corresponded to FLULAVAL.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea, Unresponsive to stimuli
Clinical narrative: Patient slumped down in chair, was non-responsive. 911 called immediately, was moved carefully to horizontal position on floor. Patient was able to nod head in response to questions, and swallowed 2 Benadryl and some water at around 04:12 PM. Patient's breathing became more labored, and lips started to become a blue color, and she was increasingly non-responsive. A dose of Epi-pen 0.3mg was administered at 04:15 PM. EMS arrived shortly thereafter and took patient to hospital.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient was given Afluria influenza injection. As bandaid was being applied to injection site patient slouched over in chair and lost consciousness for approximately 10-15 seconds. Patient was given water to drink and cold compresses were applied to forehead and both wrists. Patient appeared pale after event with some perspiration on forehead. Prior to immunization patient reported no reaction in past to immunizations. After adverse event patient reported that he had passed out before during a blood draw and thought he had experienced a seizure during that episode. Patient was held in immunization area and supervised for 20 minutes and then walked off on his own after he confirmed that he was doing fine.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood test, Chills, Dehydration, Exposure during pregnancy, Pyrexia
Clinical narrative: Woke up at 3:30 AM on 9/2/15 with chills and shaking but no fever. Woke back up at 10:00AM on 9/2/15 with 100.5 degree fever, went to OBGYN because I was 37 weeks pregnant and they admitted me to Medical Center because I still had a fever, my heart rate was 130 bpm and the baby's was around 200 bpm. At hospital received an IV drip for dehydration and stayed for observation. Fevers continued until 4am 9/3/15 and I was released from the hospital at 12:00PM on 9/3/15 after having normal temperature since 6am.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Tremor
Clinical narrative: Woke up at 3:30 AM on 9/2/15 with chills and shaking but no fever. Woke back up at 10:00AM on 9/2/15 with 100.5 degree fever, went to OBGYN because I was 37 weeks pregnant and they admitted me to Medical Center because I still had a fever, my heart rate was 130 bpm and the baby's was around 200 bpm. At hospital received an IV drip for dehydration and stayed for observation. Fevers continued until 4am 9/3/15 and I was released from the hospital at 12:00PM on 9/3/15 after having normal temperature since 6am.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Full blood count, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Muscle aches, joint pains, fatigue.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Headache, Joint stiffness
Clinical narrative: On 9/10/15, started with headache, tiredness and general malaise.  On 9/11/15, symptoms worsened to include lack of focus, dizziness, and joint pain and stiffness in neck, shoulders, back along spinal column, and right elbow.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Musculoskeletal stiffness
Clinical narrative: On 9/10/15, started with headache, tiredness and general malaise.  On 9/11/15, symptoms worsened to include lack of focus, dizziness, and joint pain and stiffness in neck, shoulders, back along spinal column, and right elbow.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient told that he was feeling dizzy after he recived the shot.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives noted starting at site of MMR injection and spreading over body over next 24 hours. Patient happy and playful, no anaphylaxis.
Age: 0.94
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting on afternoon & evening that received immunization. Fever during night received immunization and the following day.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vision blurred
Clinical narrative: Patient felt fainty and sweaty. Patient felt nauseous and could not focus eyes.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Local injection site reaction with reddness, itching, pain, and swelling.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Shot was administered in my left rotator cuff.  Immediate pain, followed by SIX MONTHS of pain, inability to use arm, and physical therapy.  One year later, rotator cuff and arm are still painful.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Computerised tomogram abdomen normal, Haematochezia, Mucous stools, X-ray normal
Clinical narrative: Bloody stools with mucus w/i 24hrs of Rotateq given withOUT clinical or radiographical evidence of intussusception.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, Vomiting, Diarrhea, low grade fever.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Left arm swollen, red, and hot to touch (full length of arm). Pt has had fever, light headed, has been in bed since Wednesday. (day of shot)
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Tenderness
Clinical narrative: Swelling, redness and tenderness down the arm. Not at injection site cellulitis like reaction.
Age: 16.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: Leg Pain, weakness cannot walk well.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling hot, Headache, Injection site pruritus, Injection site swelling
Clinical narrative: Began with swelling, fever spot, and itching at injection sight.  On Sept. 9 achy joints in hip, head to toe rash,  face feels very hot, severe headache. At this point, no relief.  I am curious how long this is expected to last.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash generalised
Clinical narrative: Began with swelling, fever spot, and itching at injection sight.  On Sept. 9 achy joints in hip, head to toe rash,  face feels very hot, severe headache. At this point, no relief.  I am curious how long this is expected to last.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Swelling and redness with itch in hands and feet along with pain at injection site.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Feeling cold, Feeling hot, Hypoaesthesia
Clinical narrative: Shivering, chills, freezing feeling after a few hours started feeling burning hot all over body with violent joint and muscle pain and numbing sensation fingertips. Unbelievable injection site pain and swelling. Felt like going to die!
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Shivering, chills, freezing feeling after a few hours started feeling burning hot all over body with violent joint and muscle pain and numbing sensation fingertips. Unbelievable injection site pain and swelling. Felt like going to die!
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Culture throat, Erythema, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: I really don't know time of injection, ask patient.  Severe headache, body aches, fever 102, red and tender L deltoid 12 x 7 cm size, sore throat.  Rapid strep neg.  Swollen tender glands in sup cervical areas.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Pain, Pyrexia, Streptococcus test negative, Tenderness
Clinical narrative: I really don't know time of injection, ask patient.  Severe headache, body aches, fever 102, red and tender L deltoid 12 x 7 cm size, sore throat.  Rapid strep neg.  Swollen tender glands in sup cervical areas.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Neck pain
Clinical narrative: I really don't know time of injection, ask patient.  Severe headache, body aches, fever 102, red and tender L deltoid 12 x 7 cm size, sore throat.  Rapid strep neg.  Swollen tender glands in sup cervical areas.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Pain, Pyrexia
Clinical narrative: I really don't know time of injection, ask patient.  Severe headache, body aches, fever 102, red and tender L deltoid 12 x 7 cm size, sore throat.  Rapid strep neg.  Swollen tender glands in sup cervical areas.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching, Redness, Slight swelling reported to pharmacy 9/11/2015 at 11:00 AM.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm
Clinical narrative: Per patient she is experienced bronchospasms around 8pm and saw PCP today who gave her a breathing treatment and prescribed the following: Ventolin, Medrol dose pack, and Benadryl. She also stated that her blood pressure may have been elevated but is uncertain as she did not check her levels and also did not take her regular blood pressure medication once she experienced symptoms.  Patient stated that she felt better today especially after breathing treatment administered at doctor's visit but is not 100% recovered.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Deafness, Dizziness, Vision blurred
Clinical narrative: Dizziness, Partial hearing loss, blurred vision.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Neck pain, Night sweats, Pyrexia
Clinical narrative: Chills, fever, night sweats severe, neck pain, overall complete fatigue for 5 days, then just complete fatigue for another week.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Patient got a FLUZONE HD shot on 9/9/15. Patient came to pharmacy to inquire about reaction to shot site. Patient proceeded to primary care doctor. Antibiotics given for cellulitis.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Patient got a FLUZONE HD shot on 9/9/15. Patient came to store to inquire about reaction to arm. Patient proceeded to primary care for treatment. Antibiotics given to patient for cellulitis.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Pt. returned to clinic 5 hours after vaccination. Reporting nausea, headache, fatigue, rapid heart beat dizziness and weakness. Patient advised to go to emergency room and inform of receiving vaccine.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Pt. returned to clinic 5 hours after vaccination. Reporting nausea, headache, fatigue, rapid heart beat dizziness and weakness. Patient advised to go to emergency room and inform of receiving vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large, red, swollen right upper arm to elbow on 8/3/15. Very sore. BENADRYL/ice.
Age: 79.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Headache, Mobility decreased, Pain in extremity, Somnolence
Clinical narrative: 8/27/15 pneumonia vaccine - arm sore & red (spot size of tennis ball) for approximately 10 days-1st 2 days could not raise arm above shoulder-applied ice after calling dr on 6th day-was Okay after approximately 12 days-had bad headache first 24 hrs and very sleepy.
Age: 56.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Pt developed hives, looked like poison ivy. No medical treatment at this time. Had previous rash on other arm before vaccine.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Less than 24 hours after injection - pt. reported rash from neck to thigh area - completely cover - bright red - whelps - c/o itching and burning.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old male patient. The patient had no pertinent medical history, drug reactions or allergies. On 04-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX 19.400 PFU (plaque forming units), lot # K024034, expiration date 20-FEB-2016 (dose and route of administration were not reported). Concomitant therapies included CRESTOR, meloxicam (manufacturer unknown) and amitriptyline (manufacturer unknown). On an unknown date in approximately September 2015, the patient experienced swelling, redness, soreness, and itchiness at the injection site. There was also a separate spot below the injection site that also was red, itchy, sore and swollen. Pharmacist reported that patient thought it could be shingles. The patient sought medical attention, he contacted a pharmacist. No treatment was given to the patient for the events. No lab diagnostics studies were performed. Varicella-zoster virus (VZV) packet was faxed. Outcomes of the events were reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old male patient. The patient had no pertinent medical history, drug reactions or allergies. On 04-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX 19.400 PFU (plaque forming units), lot # K024034, expiration date 20-FEB-2016 (dose and route of administration were not reported). Concomitant therapies included CRESTOR, meloxicam (manufacturer unknown) and amitriptyline (manufacturer unknown). On an unknown date in approximately September 2015, the patient experienced swelling, redness, soreness, and itchiness at the injection site. There was also a separate spot below the injection site that also was red, itchy, sore and swollen. Pharmacist reported that patient thought it could be shingles. The patient sought medical attention, he contacted a pharmacist. No treatment was given to the patient for the events. No lab diagnostics studies were performed. Varicella-zoster virus (VZV) packet was faxed. Outcomes of the events were reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician via company representative referring to a 16 year old female patient. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unspecified date in approximately February 2015 (about six months ago), the patient was vaccinated with the first dose of GARDASIL injection (lot#, dose, frequency and route were not provided). On an unspecified date in 2015 after receipt of the vaccine, the patient came for an office visit complaining of joint pain. The physician did not administer any further dose of the GARDASIL. The outcome of joint pain was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. Medical history and concurrent condition of the patient were not reported. On an unknown date the patient was vaccinated with her first dose of GARDASIL (lot#, expiry date, dose, frequency and route not reported). Then the patient administered her second dose of GARDASIL three weeks after the first dose on an unknown date. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a nurse, via other company (Pfizer # 2015293822) refers to some patients of unknown demography. The patient's concurrent conditions and medical history were not reported It was reported that PREVNAR 13 was administered to a lot of adults and about 8 adults have experienced local reactions. On an unknown date, patients were vaccinated with PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). Nurse reported that they saw more local reactions with PREVNAR 13 compared to PNEUMOVAX 23. The outcome of the event was unknown. The reporter's causality for the event was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a nurse, via other company (Pfizer # 2015293822) refers to a patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On an unspecified date, the patient experienced her entire arm painful and swollen. The outcome of the events was unknown. The reporter's causality for the events was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP, HPV4, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown demographics. On multiple unspecified dates, the patients were administered improperly stored with ROTATEQ (K004795; 11-FEB-2016). Other suspect therapies included GARDASIL (J006236; 25-FEB-2016; K005881; 14-JAN-2017) and RECOMBIVAX HB (K010535; 27-AUG-2016) (dose, route unspecified). No adverse effect reported. It was reported that during her previous call on 10-AUG-2015, the same nurse also inquired about the stability of a particular lot number and expiration date of M-M-R II (J016235; 19-DEC-2015), but none of that particular M-M-R II, was administered and was included in this AE. In addition, this nurse also inquired about the stability of another lot number and expiration date of M-M-R II, (K012473; 26-AUG-2016) on her call from today (09/09/2015); however, this particular lot number and expiration date of M-M-R II did not under go a temperature excursion and is not included in this AE. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer referring to her daughter, a female patient of unknown age. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unspecified date in November 2014 and 28-AUG-2015, the patient was respectively administered her first and second dose of GARDASIL (strength, dose, frequency and route were not provided). No adverse effect was reported. Additional information is not expected as the reporter did not wish further contact.
Age: 46.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 46 year old adult female patient. No information about medical history, concurrent conditions was reported for the patient. On 01-SEP-2015 46 year old adult patient was vaccinated with PROQUAD, (Lot L010140, expiration date 24-SEP-2016) 0.5 ml, subcutaneously. The reporter documented that first digit in the lot number L010140 could be read as I or lower case 'L' and was unable to confirm the lot number at the time of call. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patent of unknown demographics. No information about medical history, concurrent conditions was reported for the patient. On 09-SEP-2015 the patient was inadvertently administered with expired dose of MMR II lot # J008534, expiration date 12-JUL-2015 (dose strength, route unspecified). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-APR-2014 the patient was given a dose of GARDASIL (the first dose, route: injection; strength, lot#, dosage and frequency unspecified) instead of a hepatitis B vaccine (manufacturer unknown). No adverse events occurred. Additional information is not expected because no contact details were available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with oral, ROTATEQ (lot # K010222, expiration date 12-MAY-2016). It was reported that the vaccine administered underwent an temperature excursion which occurred on 15-AUG-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.