chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Head injury, Pallor, Syncope
Clinical narrative: I gave the patient 2nd injection of Hep A on 11/11/17 around 12:00pm. The patient is doing fine after the injection. She stands outside waiting for her husband to have his HEP A injection. She fainted after her husband finished his injection. Her head hit the floor. Her face is pale. She feels dizzy. The pharmacy team notified the store management. We called fire department for assisting. The EMS arrived 10 minutes later. The patient is alert and responsive. However, she is still feeling dizziness. The EMS took her to the hospital. I called her husband at 2:20pm to follow up. He said she is doing fine. She is still waiting for the doctor to check her head.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site swelling, Nausea, Pain, Pruritus
Clinical narrative: On 11/8/17 pt complained on 11/7/17 he suffered from redness, itching, tenderness/pain, nausea, and swelling around the injection sites extending to the elbow and shoulder/back. Pt stated he was still suffering tenderness and redness in those areas as of early afternoon 11/8/17. Pt was advised to take BENADRYL and report further symptoms. Pharmacist suggested patient could seek treatment at local urgent care, however, patient declined and decided treat self. Right after being informed the pharmacy contacted the patient's physician about symptoms. On 11/8/17 at 6:10 pm, contact was made with patient at which point patient stated redness and swelling was much better. On 11/11/17 at 9:15 am, contact was made with patient to determine patient's well-being. Patient stated he felt much better and was nearly symptom free.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Swelling, Tenderness
Clinical narrative: On 11/8/17 pt complained on 11/7/17 he suffered from redness, itching, tenderness/pain, nausea, and swelling around the injection sites extending to the elbow and shoulder/back. Pt stated he was still suffering tenderness and redness in those areas as of early afternoon 11/8/17. Pt was advised to take BENADRYL and report further symptoms. Pharmacist suggested patient could seek treatment at local urgent care, however, patient declined and decided treat self. Right after being informed the pharmacy contacted the patient's physician about symptoms. On 11/8/17 at 6:10 pm, contact was made with patient at which point patient stated redness and swelling was much better. On 11/11/17 at 9:15 am, contact was made with patient to determine patient's well-being. Patient stated he felt much better and was nearly symptom free.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site rash, Injection site reaction, Injection site warmth, Malaise
Clinical narrative: In the morning of 11/8/2017 (3 days after the event), pt called to report that he had rash on her left arm. Pt reported heat and rash at the injection site (her deltoid) at night 11/5/17. Pt came to pharmacy on 11/8/2017 to have a consultation about the rash. The pharmacist on-duty noticed that she had a dark-red bruise on her left arm as big as the size of a quarter. A lighter red rash was also seen surrounding the bruise and spreading. There was no life threatening signs and symptoms were observed. The pharmacist recommended TYLENOL 500mg Q4H, cetirizine 10 mg daily, and hydrocortisone cream Q4H. According to record, PREVNAR 13 was suspected as the cause of the adverse reaction since she had only 1 inject at that site. 11/11/2017 pharmacist followed up with the patient again, Patient reported that she had to go to urgent care and that she was taking antibiotic. She said that her rash got better, but still sick.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: In the morning of 11/8/2017 (3 days after the event), pt called to report that he had rash on her left arm. Pt reported heat and rash at the injection site (her deltoid) at night 11/5/17. Pt came to pharmacy on 11/8/2017 to have a consultation about the rash. The pharmacist on-duty noticed that she had a dark-red bruise on her left arm as big as the size of a quarter. A lighter red rash was also seen surrounding the bruise and spreading. There was no life threatening signs and symptoms were observed. The pharmacist recommended TYLENOL 500mg Q4H, cetirizine 10 mg daily, and hydrocortisone cream Q4H. According to record, PREVNAR 13 was suspected as the cause of the adverse reaction since she had only 1 inject at that site. 11/11/2017 pharmacist followed up with the patient again, Patient reported that she had to go to urgent care and that she was taking antibiotic. She said that her rash got better, but still sick.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Herpes zoster
Clinical narrative: PATIENT WAS GIVEN FLU AND PNEUMONIA SHOT THEN ONE WEEK LATER SHE PRESENTED SHINGLES.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: 2015 was the first and only year that I received the high-dose trivalent flu vaccine. My Asthma manifests itself in an asthmatic cough. After receiving the high-dose trivalent flu vaccine, I had a persistent asthmatic cough that required several weeks of DELSYM inhaler until I returned to my version of normal. My Allergy and Asthma specialist said that he does not recommend the high-dose trivalent flu vaccine for his Asthma patients. The reason that I am submitting this now is that in 2016 and 2017 I needed to tell the County nurse that I could not have the high-dose trivalent flu vaccine, and that I needed the regular dose quadrivalent flu vaccine because of my previous Asthma reaction. In both years, the nurses were not aware of this. I think that this information should be part of the flu shot protocol, as a prerequisite question, so that it is commonly known. This will prevent Asthma reactions to high-dose trivalent flu vaccine, and allow Asthma patients to not be excluded from flu shots by a computer. Thank you.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Lethargy, Pain, Pyrexia, Tremor
Clinical narrative: Sudden onset of chills, shakes, then alternating fever and chills. Full body aching. Very lethargic next day with some shaking and fever and chills. Second day same symptoms, but milder. Third day able to function in house, but not comfortable enough to leave. 92% recovered by fourth day.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Ocular discomfort
Clinical narrative: Headache, severly swollen lymph nodes, muscle pain, stiff neck, pressure in eyes.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia, Vomiting
Clinical narrative: Patient complained of tingling, nausea & vomiting that occurred the night of 11/6.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Induration, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Patient's arm swelled up to twice its normal size, became very warm to the touch, and is reddish/bluish as if bruised. It spans a large diameter of approx 3.5" and is rock hard to the touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported right arm deltoid swelling, tenderness, redness, and heat at site of injection on 11/8/17 at 0840.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: Patient received flu shot and woke up about 8 hours later with diarrhea, vomiting, chills, high fever and fatigue.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient came in inquiring about side effect to PREVNAR vaccination. She stated the immunizing pharmacist informed her there could be some redness. She denies pain, swelling, etc but complains of redness that hasn't resolved but is spreading. The redness was more apparent on the inner upper left arm beneath the shoulder blade and extends to the elbow crease. She was wondering if she should expect the redness to worsen. She consulted her PCP and was told to take BENADRYL three times daily and follow up with him Monday (11/13/17) if redness does not improve.
Age: 74.0
Sex: M
Vaccine: HEPA
Symptoms: Cystitis
Clinical narrative: Patient received vaccination 9/12/17 and went to the ER 9/18/17 and stayed until 9/22/17 for a bladder infection. Patient feels it was related to vaccination.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site nodule, Nausea, Pyrexia, Rash, Retching
Clinical narrative: Had onset of fever (102 degree F), rash, dry heaves, sick to stomach and knot where immunization was given. Took BENADRYL on 11/10 for rash and it helped. Starting to feel better as of 11/10/17.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported having shoulder pain and decreased mobility that began around the day after receiving the flu vaccine. Patient denies having pain while receiving vaccine and location of vaccine is within the appropriate deltoid region of the arm. Patient is still experiencing pain and decreased mobility in shoulder while trying to move arm in certain directions. Patient has slowly gained some of the lost mobility while trying to take NSAIDS. I advised patient to add heat therapy and also to see MD about possibly starting physical therapy/further care. This is the first time patient has ever received the flu vaccine therefore an immune/allergic response could be causing the bursitis too.
Age: 88.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red circle semi rash looking around the injection site -  occurred three days after injection. No pain, no itchiness. Pt indicated that he applied some hydrocortisone cream prior to consult with RPh and the red spots have decreased.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Bacterial test negative, Fungal test negative, Impetigo, Stomatitis, Viral test negative
Clinical narrative: Within one week of injection, patient got an open sore on his mouth. We thought it was a cold sore since he had had them in the past. The cold sore did not go away after 6 weeks and was seen by his pediatrician. She deemed it Impetigo. The sore got much worse and covered both sides of his mouth, top and bottom lip, onto his cheeks and under his eyes. This went on for 5 months after 5 rounds of antibiotics, two rounds of antivirals, multiple swabs and labs run. No one ever found out what it was or how to help it. We were instructed to stay away from other children for fear that it was contagious. I have been able to get it under control with detox baths, but have to stay on top of it to keep the lesions at bay.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Cough, Fatigue, Pain
Clinical narrative: Body ache, tightness in chest, coughing, extreme fatigue, etc.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Pain right shoulder to elbow, deep.
Age: 41.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Arthralgia, Crying, Eye pain
Clinical narrative: Extreme pain in left ankle, left elbow, left wrist both knees, pressure on eyes hurt to the touch, I contacted Dr. who told me that it could be an adverse reaction to the MMR, (NOTE: am not positive which HEP B vaccination I received) and was advised to take 600 mg of Ibuprofen every 8 hours. and if my condition worsened to seek immediate help at an ER, as I am out of town working. I began taking the suggested doses on Wed 11-1 @ around 6 pm, and continued to take this dose every 6-8 hours until 11-6. I also began taking ALEVE every 12 hours 11-5. As well as Turmeric. On a scale of 1-10 the pain was a 9 to the point that at times I was in tears, Ibuprofen would work after about 45 minutes. But after 6-7 hours the pain would start to return, rapidly going from a 0 on the pain scale to a 9. My condition worsened if I was lying down.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain since I received the injection 12 days ago, limited mobility, lack of sleep due to pain from arm.
Age: 63.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Colectomy, Large intestinal polypectomy, Loss of control of legs, Muscular weakness, Pain in extremity
Clinical narrative: Approximately 4 weeks I had a small rash develop on the lower portion of my rib cage, severe pain and muscle weakness in my hands, feet and lower extremities with shaking in my left arm. Treatment for the muscle weakness and was prescription of Oxycodone for pain. These pain meds were taken until from July 2016 through Sept 2016 until admitted to the Hospital for surgery to remove a large polyp and a 4 cm section of my large Colon on Sept 19th. After surgery in Oct I started to lose muscle control of my upper and lower extremities until finally paralyzed from the waist down. I am now confined to a wheelchair.
Age: 63.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Paralysis, Polypectomy, Rash, Tremor, Wheelchair user
Clinical narrative: Approximately 4 weeks I had a small rash develop on the lower portion of my rib cage, severe pain and muscle weakness in my hands, feet and lower extremities with shaking in my left arm. Treatment for the muscle weakness and was prescription of Oxycodone for pain. These pain meds were taken until from July 2016 through Sept 2016 until admitted to the Hospital for surgery to remove a large polyp and a 4 cm section of my large Colon on Sept 19th. After surgery in Oct I started to lose muscle control of my upper and lower extremities until finally paralyzed from the waist down. I am now confined to a wheelchair.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Lip swelling
Clinical narrative: Patient presented with swelling of the lips and little redness of the face. No tongue or throat involvement presented. Patient said he might have reacted to something he might have eaten or the vaccines he received on 11/10/17. Patient said he normally gets these rxns with foods. Patient pick up BENADRYL but I strongly recommended that the patient should see a physician as soon as possible and to call 911 if condition worsens.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Immediately after the shot and as I started to stand up I felt pain in my leg joints. As I walked around the store the pain quickly went away. I returned home and within about one hour I had chills all over my body. The chills were almost unbearable and soon I developed a fever of 103.4. I had chills and a fever into the evening and night. The fever and adverse feelings lasted for about 24 hours. After about two days I was fine with only some lingering fatigue.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: Immediately after the shot and as I started to stand up I felt pain in my leg joints. As I walked around the store the pain quickly went away. I returned home and within about one hour I had chills all over my body. The chills were almost unbearable and soon I developed a fever of 103.4. I had chills and a fever into the evening and night. The fever and adverse feelings lasted for about 24 hours. After about two days I was fine with only some lingering fatigue.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Haemorrhage, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Oct 30  Scab bled, a little and some deltoid pain. Nov 11 bled from bumped scab more than before. Increased pain in deltoid into brachial area. Still pains 11/12  redden area around injection site and a little raised. Took photo using cell phone.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Oct 30  Scab bled, a little and some deltoid pain. Nov 11 bled from bumped scab more than before. Increased pain in deltoid into brachial area. Still pains 11/12  redden area around injection site and a little raised. Took photo using cell phone.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Impaired work ability, Injection site pain, Neck pain
Clinical narrative: Patient is complaining that her arm still hurts at injection site and now the pain has spread to her shoulder and neck area. She said she missed 3 days of work.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthenia, Brain oedema, Cardiac function test, Electrocardiogram, Electroencephalogram abnormal
Clinical narrative: Patient turned Greenish blue and fell face first into the floor within a few minutes of having these vaccines. I tried to get the vaccines as close as possible with the information on her vaccine records. Patient continued to feel weak and have nausea and frequent headaches in the weeks following these vaccines. Patient had severe weakness also that seemed to grow in strength over the next few months. On January 29th 2016, patient had a seizure and All of the symptoms worsened after this. An EEG showed swelling on her brain. An MRI done after that did not show the swelling anymore. Patient was diagnosed with POTS after a visit with the head of Pediatric Cardiology. Patient still suffers from POTS today.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Face injury, Fall, Headache, Nausea, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Patient turned Greenish blue and fell face first into the floor within a few minutes of having these vaccines. I tried to get the vaccines as close as possible with the information on her vaccine records. Patient continued to feel weak and have nausea and frequent headaches in the weeks following these vaccines. Patient had severe weakness also that seemed to grow in strength over the next few months. On January 29th 2016, patient had a seizure and All of the symptoms worsened after this. An EEG showed swelling on her brain. An MRI done after that did not show the swelling anymore. Patient was diagnosed with POTS after a visit with the head of Pediatric Cardiology. Patient still suffers from POTS today.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Postural orthostatic tachycardia syndrome, Seizure, Skin discolouration, Tilt table test
Clinical narrative: Patient turned Greenish blue and fell face first into the floor within a few minutes of having these vaccines. I tried to get the vaccines as close as possible with the information on her vaccine records. Patient continued to feel weak and have nausea and frequent headaches in the weeks following these vaccines. Patient had severe weakness also that seemed to grow in strength over the next few months. On January 29th 2016, patient had a seizure and All of the symptoms worsened after this. An EEG showed swelling on her brain. An MRI done after that did not show the swelling anymore. Patient was diagnosed with POTS after a visit with the head of Pediatric Cardiology. Patient still suffers from POTS today.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Noticed arm pain starting at the shoulder going all the way down to the elbow on the evening of vaccination. After 2 days on 11/12 the patient noted the symptoms were significantly resolving (slight pain at injection site area only).
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Pt got 3 imzs. ZOSTAVAX and FLUZONE HD in right arm. PNEUMOVAX 23 in left arm. These were administered on 11/10/17. Pt came into pharmacy on 11/12/17 with a rash on her left arm above and below the injection site. I told pt to take BENADRYL, NSAID, and use ice to reduce swelling / allergic reaction. Pt said the rash had gotten better since the first day when she got the imz. Told her to monitor it and if it gets worse to go in to the doctor.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Throat Tightness, tingling in fingers/Toes, Flushing/ Sweating, headache, itching, Lightheadedness--gave 2 BENADRYL, water, monitored. Checked blood pressure pulse (135/85, 65) monitored for 30 minutes. Patient left was advised to continue BENADRYL every 4 hours. Called and checked on patient 1 day post reaction---just soreness at injection site.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus, Throat tightness
Clinical narrative: Throat Tightness, tingling in fingers/Toes, Flushing/ Sweating, headache, itching, Lightheadedness--gave 2 BENADRYL, water, monitored. Checked blood pressure pulse (135/85, 65) monitored for 30 minutes. Patient left was advised to continue BENADRYL every 4 hours. Called and checked on patient 1 day post reaction---just soreness at injection site.
Age: 29.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I discovered the MA gave a PREVNAR 13 instead of PPSV 23. No adverse outcome. No treatment to patient. Education to MA.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Lethargy, Vomiting
Clinical narrative: Lethargy in the morning, vomiting by late afternoon.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Back pain, Chest pain, Dyspepsia, Flatulence
Clinical narrative: Gas, dyspepsia, pain in chest and back, weakness, general malaise since getting vaccinations.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Malaise
Clinical narrative: Gas, dyspepsia, pain in chest and back, weakness, general malaise since getting vaccinations.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm has remained sore, has trouble lifting above the shoulder, has pain from mid deltoid down to midway on front edge of arm, is trying ADVIL, will let us know.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain, which initiated within few days after vaccination and still present, a few week out after vaccine was administered. Especially pain in the shoulder.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient reported diarrhea and vomiting for 3 days after admin.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Severe headache which has lasted for three days now.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Patient had swelling of right eye.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: She stated her arm swelled up and was discolored yellow and painful. She came in today and said she still had swelling at her elbow but the pain is gone now.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt is experiencing swollen left arm where injection took place.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient had a visible red rash area at the injection site of the left arm (deltoid). Patient's son explained that it started a few days after the injection and had progressively gotten worse. On the day reported, the rash was about 3 inches tall and 2 inches wide. Patient reported pain/tenderness at the site, but no visible sign of major swelling noted. Patient was advised to seek treatment with a physician for the inflammation if necessary.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in next day and complained her left arm was painful and swollen. She could not lift her arm much.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Patient received PNEUMOVAX and FLUVIRIN injection site was warm and red to touch had to go to ER next day after vaccine. (Arm was also swollen).
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warm at injection site. Area measured at 2 inches x 2 inches (at 6pm 11/11/16). Patient took BENADRYL before she got to pharmacy today.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Both vaccines were given in left deltoid, flu toward front, pneumo - rear. Pt stopped in 2 days later to show site - flu - red, swollen (slightly), itching.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Whole arm swollen for 5 days. Rash in arm. Fever for 2 days.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Hypotension, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm pain, hard to lift arm. Low blood pressure noted later that day / next day - started resolving following day. (Noted in PREVNAR 13 arm).
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported pain in her right arm which radiated to her fingers. She had trouble lifting items and moving her arm. The patient lasted four plus weeks. The pain decreased with time. Patient reported that she also spoke to her physician.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: 1 hour after vaccination swelling in the hand, left hand, continued to increase and decreased over night - customer notified pharmacy morning after vaccination. Recommended doctor visit.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site vesicles
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received on 21Oct2017 4:10 pm PREVNAR 13 (lot s06030, expiration date 01Aug2018, NDC number: 00005197105) at 0.5 ml single in the left deltoid for immunization and on 19Oct201 FLUZONE (NDC number 49281040165, lot: ui892aa, expiry: 06Jun2019) in the left deltoid for immunization. Medical history and concomitant medications were none. In Oct2017 the patient experienced cellulitis and returned to the pharmacy on 28Oct2017 for treatment that included BACTRIM double strength 800/160mg, 1 tablet q12 hours for 10 days. The outcome was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received on 21Oct2017 4:10 pm PREVNAR 13 (lot s06030, expiration date 01Aug2018, NDC number: 00005197105) at 0.5 ml single in the left deltoid for immunization and on 19Oct201 FLUZONE (NDC number 49281040165, lot: ui892aa, expiry: 06Jun2019) in the left deltoid for immunization. Medical history and concomitant medications were none. In Oct2017 the patient experienced cellulitis and returned to the pharmacy on 28Oct2017 for treatment that included BACTRIM double strength 800/160mg, 1 tablet q12 hours for 10 days. The outcome was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Cough, Disorientation, Dysphagia, Dyspnoea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient with seasonal allergy. Concomitant therapies included ZYRTEC. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 (dose, route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) administered on the same day. Sterile diluent (manufacturer unknown) and PROQUAD both did not undergo a temperature excursion. On 02-NOV-2017, the patient experienced lip swelling, cough and hives. The patient was given EPIPEN, BENADRYL CHILDRENS ALLERGY, DECADRON and albuterol nebulizer as treatment at the office. The patient sought for medical attention and also went to the Emergency Room for an unknown treatment. The outcome of urticaria, lip swelling and cough was reported as recovering. The causality assessment was not provided. Upon internal review, the events of lip swelling, cough and urticaria were considered to be medically significant due to the treatment required to prevent serious outcomes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Face oedema, Lip swelling, Somnolence, Urticaria, Wheezing
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient with seasonal allergy. Concomitant therapies included ZYRTEC. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 (dose, route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) administered on the same day. Sterile diluent (manufacturer unknown) and PROQUAD both did not undergo a temperature excursion. On 02-NOV-2017, the patient experienced lip swelling, cough and hives. The patient was given EPIPEN, BENADRYL CHILDRENS ALLERGY, DECADRON and albuterol nebulizer as treatment at the office. The patient sought for medical attention and also went to the Emergency Room for an unknown treatment. The outcome of urticaria, lip swelling and cough was reported as recovering. The causality assessment was not provided. Upon internal review, the events of lip swelling, cough and urticaria were considered to be medically significant due to the treatment required to prevent serious outcomes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Cough, Lip swelling, Urticaria
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient with seasonal allergy. Concomitant therapies included ZYRTEC. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 (dose, route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) administered on the same day. Sterile diluent (manufacturer unknown) and PROQUAD both did not undergo a temperature excursion. On 02-NOV-2017, the patient experienced lip swelling, cough and hives. The patient was given EPIPEN, BENADRYL CHILDRENS ALLERGY, DECADRON and albuterol nebulizer as treatment at the office. The patient sought for medical attention and also went to the Emergency Room for an unknown treatment. The outcome of urticaria, lip swelling and cough was reported as recovering. The causality assessment was not provided. Upon internal review, the events of lip swelling, cough and urticaria were considered to be medically significant due to the treatment required to prevent serious outcomes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Face oedema, Lip swelling, Rash, Somnolence, Swelling face
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient with seasonal allergy. Concomitant therapies included ZYRTEC. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 (dose, route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) administered on the same day. Sterile diluent (manufacturer unknown) and PROQUAD both did not undergo a temperature excursion. On 02-NOV-2017, the patient experienced lip swelling, cough and hives. The patient was given EPIPEN, BENADRYL CHILDRENS ALLERGY, DECADRON and albuterol nebulizer as treatment at the office. The patient sought for medical attention and also went to the Emergency Room for an unknown treatment. The outcome of urticaria, lip swelling and cough was reported as recovering. The causality assessment was not provided. Upon internal review, the events of lip swelling, cough and urticaria were considered to be medically significant due to the treatment required to prevent serious outcomes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria, Vaccination complication, Wheezing
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient with seasonal allergy. Concomitant therapies included ZYRTEC. The patient did not have any known drug reactions or allergies. On 02-NOV-2017, the patient was vaccinated with a dose of PROQUAD lot # N019251, expiration date 20-DEC-2018 (dose, route of administration were not reported). Other suspect therapies included sterile diluent (manufacturer unknown) administered on the same day. Sterile diluent (manufacturer unknown) and PROQUAD both did not undergo a temperature excursion. On 02-NOV-2017, the patient experienced lip swelling, cough and hives. The patient was given EPIPEN, BENADRYL CHILDRENS ALLERGY, DECADRON and albuterol nebulizer as treatment at the office. The patient sought for medical attention and also went to the Emergency Room for an unknown treatment. The outcome of urticaria, lip swelling and cough was reported as recovering. The causality assessment was not provided. Upon internal review, the events of lip swelling, cough and urticaria were considered to be medically significant due to the treatment required to prevent serious outcomes.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Eye haemorrhage, Joint swelling, Pain, Pyrexia, Rash
Clinical narrative: Lacey rash, joint swelling and intense pain all over body, high fever that last months. Bleeding under the eyes.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning to 5 patients (ages and genders not reported) who on an unknown date were vaccinated with improperly stored doses of GARDASIL 9 (Lot No. N017697, exp date 21-JAN-2020) for prophylaxis. No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. Follow-up information was received from medical assistant on 03-NOV-2017. On 27-SEP-2017, a 15 year old male patient was vaccinated with GARDASIL 9 from lot N015087 expiry date 20-OCT-2019 by intramuscular route for prophylaxis. No adverse events reported. This is one of the several reports linked via same reporter link.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Aphthous ulcer, Cold sweat, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous report was received from a 77 year old female patient with contrast dyes allergy, reporting on herself. The patient had no medical history. On 13-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly (lot#, expiration date and dose were not reported) as recommended vaccine. The patient had no concomitant therapies. On 13-OCT-2017, 6 hours after vaccination, the patient develop soreness in the left arm (where the vaccine was provided) . An hour after the soreness started, she developed a cold sweat and her arm from her shoulder to just below the elbow was red, inflamed, painful, and swelled to almost twice it's size. During the night, she could not sleep because of the pain and attempted to ice the arm. On 14-OCT-2017, the swelling started to go down, the arm became pink, and she slept on and off through out the day. She only drank fluids all day. On 15-OCT-2017, the patient developed canker sores in her mouth and on 16-OCT-2017, her arm was sore. No laboratory diagnostic tests were performed. The patient sought medical attention by talking with her physician. Unspecified treatment was give for the events.  On 17-COT-2017, the patient was completely recovered (also reported as recovering) from the events except the canker sores in her mouth from which she did not recover at the time of this report.  The causality between the events and PNEUMOVAX 23 was not provided. Product quality complaint was not involved.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: This spontaneous report was received from a 77 year old female patient with contrast dyes allergy, reporting on herself. The patient had no medical history. On 13-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly (lot#, expiration date and dose were not reported) as recommended vaccine. The patient had no concomitant therapies. On 13-OCT-2017, 6 hours after vaccination, the patient develop soreness in the left arm (where the vaccine was provided) . An hour after the soreness started, she developed a cold sweat and her arm from her shoulder to just below the elbow was red, inflamed, painful, and swelled to almost twice it's size. During the night, she could not sleep because of the pain and attempted to ice the arm. On 14-OCT-2017, the swelling started to go down, the arm became pink, and she slept on and off through out the day. She only drank fluids all day. On 15-OCT-2017, the patient developed canker sores in her mouth and on 16-OCT-2017, her arm was sore. No laboratory diagnostic tests were performed. The patient sought medical attention by talking with her physician. Unspecified treatment was give for the events.  On 17-COT-2017, the patient was completely recovered (also reported as recovering) from the events except the canker sores in her mouth from which she did not recover at the time of this report.  The causality between the events and PNEUMOVAX 23 was not provided. Product quality complaint was not involved.
Age: 15.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 31-JUL-2017, the patient was vaccinated with a first dose of improperly stored GARDASIL 9 lot # N001533, expiry date: 16-OCT-2019, intramuscularly in left deltoid for prophylaxis. Concomitant therapies included VARIVAX. The dose of GARDASIL 9 was stored at a temperature between 47 degree Fahrenheit to 77 degree Fahrenheit for 10 minutes. No adverse effects were reported. The call was because of a data logger. No product quality complaint was involved. This is one of two reports form the same reporter. Sender's Comments: US-009507513-1708USA000698.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported.  On an unknown date the patient was vaccinated with M-M-R II intramuscular, lot # M045394, expiration date 14-NOV-2018, for prophylaxis (strenght, dose and frequency were not reported). Concomitant therapies included sterile diluent (STERILE DILUENT).
Age: 1.0
Sex: F
Vaccine: FLUX, HEPA, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 1 year old female patient. The patient's concomitant medications included influenza virus vaccine (unspecified) given in the left leg, PREVNAR 13 given in the left leg and hepatitis A virus vaccine (unspecified) given in the right leg. The patient had no known allergies. On 01-NOV-2017, the patient was administered with the PROQUAD (lot # N015623 and expiry date: 15-NOV-2018) at a dose of 0.5 ml once subcutaneously in the right leg to vaccinate against measles, mumps, rubella and varicella viruses. On the same day, the patient was accidentally administered with M-M-R II (lot# M045391 and expiry date: 14-NOV-2018) at a dose of 0.5ml once subcutaneously in the left leg for prophylaxis (inappropriate schedule of drug administration). On 01-NOV-2017, the patient was accidentally given both the PROQUAD and M-M-R II vaccine, when she should have only received the PROQUAD vaccine (drug administration error). The patient's parents did not report any adverse events to the facility thus far. The patient's laboratory data was unknown. As of 01-NOV-2017, it was unknown, if the patient would receive the PROQUAD or M-M-R II vaccines in the future.
Sex: M
Vaccine: PPV
Symptoms: Chronic myeloid leukaemia
Clinical narrative: This spontaneous report was received from a 75-year-old male patient and refers to himself. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. In January 2012, the patient was vaccinated with dose of PNEUMOVAX23 injection (dose, frequency, lot# and expiration date were not reported) for prevention from pneumococcal disease. On an unspecified date (reported as recently), the patient was checked for chronic myeloid leukaemia. The patient sought for medical attention. Upon internal review, the event of chronic myeloid leukaemia was determined as medically significant. The outcome of chronic myeloid leukaemia was not reported. Causality assessment was not provided.
Age: 1.33
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 16-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 26-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N008823, and expiration date: date 26-MAY-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 19-JUL-2017 until 12-AUG-2017, the vaccine was exposed to various temperature excursions ranging from 34 degrees Fahrenheit (F) to 48F for the period of up to 46 hours at a time. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA007325:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 11-JAN-2008 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JUL-2012 the patient was treated at a community hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 05-DEC-2014, administered by the physician at a health facility, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Only a few days after being vaccinated, on or about 08-DEC-2014, the patient was treated by the physician (same one who administered vaccination) at the same health facility (where he received vaccination) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The male patient has been prescribed valacyclovir (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 17-OCT-2013, the patient was inoculated with ZOSTAVAX by an unspecified person at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-DEC-2015 the patient was treated by a physician/MD for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient has been prescribed Acyclovir and pregabalin (LYRICA) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.