chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Adverse event following immunisation
Clinical narrative: This spontaneous report as received from an unspecified reporter via online media refers to unspecified female patients of unknown age. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. On an unknown date, the patients experienced unspecified side effects. The side effects were not specified by the reporter. The outcome of the side effects was unknown. The causality assessment was not provided by the reporter. The reporter considered the event to be medically significant. This is one of the two reports received from same reporter.; Sender's Comments:  US-009507513-1711USA000459:
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-SEP-2017, the patient received an adult dose of ENGERIX-B. On 19-OCT-2017, the patient received a pediatric dose of RECOMBIVAX HB 2.5/0.5 (units not provided) (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint has been filled.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Immune system disorder, Keratitis, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 04-DEC-2012 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 26-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 13-SEP-2016the patient received subsequent treatment for new and ongoing symptoms, at which time an examination revealed a herpetic infection of his eye, also known as keratoconjunctivitis, an ocular condition secondary to shingles. The patient has been prescribed antihistamine drops and an eye patch for management of his persistent and 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. Upon internal review herpetic infection of his eye was considered a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 04-DEC-2012 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 26-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 13-SEP-2016the patient received subsequent treatment for new and ongoing symptoms, at which time an examination revealed a herpetic infection of his eye, also known as keratoconjunctivitis, an ocular condition secondary to shingles. The patient has been prescribed antihistamine drops and an eye patch for management of his persistent and 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. Upon internal review herpetic infection of his eye was considered a medically significant event. Additional information has been requested.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 24-Oct-2017. This case involves a male patient (onset age not reported) who was vaccinated with a dose of FLUZONE QIV ADULT (batch number: UIV55BA) and PNEUMOVAX (batch number, expiry date and route of administration were not reported) in arm on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch and elbow to shoulder area was swollen. The patient's laboratory data and corrective treatment were not reported. The events outcome was not reported.  Upon internal review the case was considered as serious because of important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: The patient experienced cellulitis post vaccination with FLUZONE QIV Adult. Time to onset was not reported. The patient's medical history and tolerance to previous vaccinations was also not reported. The patient received Pneumovax on the same day inches apart from FLUZONE QIV Adult. The site of events was not reported. It might be possible that the infection was due to improper aseptic technique followed during vaccination which exposed inner layers of the skin to surface pathogens. There is also a possibility of alternate etiology of cellulitis being totally unrelated to vaccination and due to underlying preexisting infectious etiology. Additional information regarding latency, site of events and medical condition at the time of vaccination should be requested to assess the case. Till then the causality cannot be assessed with respect to one vaccine.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from nurse on 25-Oct-2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV and PNEUMOVAX (Batch number, expiration date, dose, route was not reported) in arm on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced severe swelling and cellulitis that was warm to touch and elbow to shoulder area was swollen. Lab data was not reported. The patient received corrective treatment with antibiotics. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a patient (age and gender not reported), who was vaccinated with FLUZONE QIV PFS (batch number: UT5954LA; expiry date, dose, dose in series not reported) and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in arm (inch a part between two vaccines) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test was not reported. Patient was prescribed with antibiotics as corrective treatment. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Lip oedema, Rash erythematous, Rash generalised, Somnolence
Clinical narrative: At approximately 12 noon, felt sleepy , then 12:30 lips were edematous, red rash all over body.  Denies any shortness of breath. She had had no meds./ food that day because she was having lab work done. Gave herself Epi pen injection and Bendaryl (25mg). She is allergic to bee stings so keeps Epi on hand.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Within less than six hours, 103 degree Fahrenheit fever and chills. High fever persisted from 2pm EST - 2am (11/3); 103 temp taken at 6pm when home from school; residual low temp continued through 12noon EST (11/3). Treated with 400 mg ibuprofen at 6pm, regular strength tylenol at 9pm, 400 mg ibuprofen at 12am, and tylenol at 8am (11/3). Used ice packs in arm pits and bilateral groin to break the 103 temp. No other adverse symptoms observed (no rash, coughing, vomitting, etc). Back to normal (expect a little tired from the night before) late Friday afternoon (for the prior year, child had not missed a single day of school due to illness).
Age: 14.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Pyrexia
Clinical narrative: Within less than six hours, 103 degree Fahrenheit fever and chills. High fever persisted from 2pm EST - 2am (11/3); 103 temp taken at 6pm when home from school; residual low temp continued through 12noon EST (11/3). Treated with 400 mg ibuprofen at 6pm, regular strength tylenol at 9pm, 400 mg ibuprofen at 12am, and tylenol at 8am (11/3). Used ice packs in arm pits and bilateral groin to break the 103 temp. No other adverse symptoms observed (no rash, coughing, vomitting, etc). Back to normal (expect a little tired from the night before) late Friday afternoon (for the prior year, child had not missed a single day of school due to illness).
Age: 14.0
Sex: U
Vaccine: HPV9, HPV4
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Child had a fever (103 per mom) less than 24 hours, no other symptoms of illness noted before or after.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV4
Symptoms: Pyrexia
Clinical narrative: Child had a fever (103 per mom) less than 24 hours, no other symptoms of illness noted before or after.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient has not had any adverse reaction. Wrong dosage given.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Local reaction, Skin warm, Swelling
Clinical narrative: Large local reaction with swelling, erythema and warmth.  Swelling on lateral side of arm from shoulder to elbow.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Patient came to me and showed me their arm. It was red, swollen, and tender to touch. Swollen from injection site to past elbow. Past was self treating with Benadryl and I sent them to urgent care for further examination. Patient was treated with steroid cream, and I am awaiting further details.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test abnormal, Contusion, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: On September 16, 2015 pt received the first GARDASIL vaccination. After some research we did not continue with the series. About 2 months later pt had bruising on between knee and ankles on both legs. We first noticed this at the end of October 2015. This turned into extreme bruising by the end of November 2015. In December 2015 took pt to Dr., blood test revealed ITP. Received IVIG in December. We did labs for 1 yr. He was cleared in January of 2017.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Patient called the next AM stating she had 101 fever and all over body aches. No other complaints. Patient taking OTC DAYQUIL and stated she would call back if she had any further issues.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient complains of prolonged pain at the injection site with a decrease in abduction of the affected arm (unable to reach behind head). Pain on palpation on the lateral aspect of the triceps.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling, Vaccination complication
Clinical narrative: After patient received the shot, she developed pain at the injection site an hour later. A couple of hours after that, her arm become extremely swollen which required her to go to the emergency department. It was determined that the patient was experiencing an adverse reaction to the vaccine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in left arm, swelling and redness in arm outside of injection site. Loss of mobility and increasing pain swelling, inflammation in upper portion of arm outside of injection site reaction.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reported painful, red swollen area to Left deltoid at site of vaccine on 11/1/17, ice and ibuprofen x 24 hours without good effect. Seen in office and prescribed cephalexin TID x 7 days for cellulitis.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Pt had PNEUMOVAX at workplace (school) by pharmacy on 10/16/17. Came to clinic on 10/17/17 and was diagnosed with allergic reaction--right upper arm swollen, warm with red raised rash down into axilla.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE BECAME RED, SWOLLEN AND WARM TO TOUCH. TWO DAYS AFTER THE INJECTION, THE RED AREA MEASURED 13CM BY 9CM. THE PATIENT TOOK CLARITIN AND APPLIED ICE TO THE SITE, AND 2 DAYS AFTER THAT, THE REDNESS WAS ALL GONE. THE PATIENT STATES THAT SHE HAS HAD REACTIONS LIKE THIS BEFORE, BUT THIS IS THE WORST. IT SEEMS TO GET BIGGER EVERY YEAR.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Vaccination complication
Clinical narrative: Dr. called pharmacy on 10/27/2017 at after noon to report patient reaction to the vaccine. He requested information on the vaccine patient was given he said he will report the reaction.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient is age 61 and received a high dose flu recommended for 65 and older.
Sex: M
Vaccine: VARZOS
Symptoms: Dialysis, Renal failure
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) reconstituted with sterile diluent (lot# and expiration date were not reported) and with other unspecified vaccines. On 22-OCT-2017, "shortly after" receiving ZOSTAVAX and the other vaccines, the patient went into renal failure and went to an unspecified hospital to receive dialysis. The patient was given treatment for the event. The outcome of the events was reported as "recovering". The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of renal failure was considered to be medically significant.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of currently 3 months of age and unknown gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB lot# M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 5 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB, from lot # M047666, expiration date: 24-OCT-2019 for prophylaxis (dosing details were not reported). The administered dose of the vaccine underwent a temperature excursion of 32 degree Fahrenheit (F) to 35 degree F for 6 hours. No adverse effects were reported. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient is 51 and receiving a PCV13 at this age is only recommended if immunocompromised, chronic renal failure, nephritic syndrome or asplenia. Or cochlear implants of CSF leaks which none of that patient had.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Cardiac stress test normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: The day after receiving the flu shot, BP was elevated and it was hard to breathe. Pain in chest rated 5 on scale of 0-10. Made appointment to see the doctor, and was seen 11/9/2017. Doctor performed EKG & a nuclear stress test and results of both were normal. Since that time doctor has prescribed a second BP medicine (in addition to the list of meds above).
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Left deltoid painful upon movement.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Headache, Pyrexia, Rash, Rash erythematous
Clinical narrative: A fever began of 102F on 11/2/2017 with a headache and no other symptoms. The fever continued for the next 4 days with no other accompanying symptoms. On Monday the 11/6 the fever broke and a mild red spotty rash developed all over the trunk, face, and upper extremities.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Full blood count, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Entire Arm and Hand was very Red, Hot Swollen and very Painful.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Myalgia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, severe nagging cough, chest congestion, muscle aches.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Mother of patient called approximately 2-3 hours after vaccination appointment to inform us that patient was experiencing hives "all over body" and that he is allergic to BENADRYL. Patient was referred to nearest ER.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Depressed level of consciousness, Dizziness, Dyspnoea, Feeling hot, Immediate post-injection reaction
Clinical narrative: Pt felt short of breath immediately (5-10 seconds) after administration. He began clearing his throat but did not immediately say anything to the medical assistant who was administering the vaccine, so she then gave him the influenza vaccination in the other arm (right). He continued to clear his throat and then said that he felt short of breath, hot, dizzy, nauseated, and like he might pass out. Vital signs were immediately checked and found to be normal, a portable pulse oximeter was left on his finger and O2 sats were always >98% throughout the episode. He was given a nebulizer treatment as he stated it felt like his asthma usually presents, but that did not affect his symptoms. After one hour of monitoring the patient and consistently normal vital signs he stated that he felt better and wished to return to work.  He was placed on prednisone 10 mg taper, instructed to use his albuterol MDI as directed prn and strict ER precautions were reviewed with the patient. I personally checked on him later that day, the next day, and one week later, and he reported no further issues.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Throat irritation
Clinical narrative: Pt felt short of breath immediately (5-10 seconds) after administration. He began clearing his throat but did not immediately say anything to the medical assistant who was administering the vaccine, so she then gave him the influenza vaccination in the other arm (right). He continued to clear his throat and then said that he felt short of breath, hot, dizzy, nauseated, and like he might pass out. Vital signs were immediately checked and found to be normal, a portable pulse oximeter was left on his finger and O2 sats were always >98% throughout the episode. He was given a nebulizer treatment as he stated it felt like his asthma usually presents, but that did not affect his symptoms. After one hour of monitoring the patient and consistently normal vital signs he stated that he felt better and wished to return to work.  He was placed on prednisone 10 mg taper, instructed to use his albuterol MDI as directed prn and strict ER precautions were reviewed with the patient. I personally checked on him later that day, the next day, and one week later, and he reported no further issues.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Rash maculo-papular
Clinical narrative: Maculo-papular rash over abdomen and left side. Was seen in Urgent Care and has been taking anti-histamines for one week with no improvement--2 days ago doubled dose of Zyrtec with no change in rash.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Peripheral swelling, Skin tightness
Clinical narrative: Patient called two days after receiving immunization to report that her arm (extending down into the hand) was red and swollen, so much so that some of her skin was described as "tight." She verified that the reaction seemed to have reached its peak and was resolving. I checked back in with her another 2 days later and she reports that the swelling had almost completely resolved. Patient states that she had only taken some Tylenol for pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Patient received vaccine in the pharmacy at about 2:15PM on 11/6/2017. She says the shot itself felt like it may have "hit a nerve", but was otherwise uneventful and she left the pharmacy without pain.  By 8pm 11/5/2017, she says her left arm hurt so badly she could not lift it away from her body. She called this am (11/6/2017) to report that her arm was still so painful, she could not lift it away from her body. She denies tenderness, but still says it hurts badly enough to cause naseau. She also says she nearly fainted while showering due to the pain. I advised her to call her Dr right away and be seen as soon as possible. I also called her Dr's office to let them know, I had spoken with her and asked them to call her and determine whether and when she should seen by physician.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Dysphonia, Electromyogram, Fatigue
Clinical narrative: Couple days after receiving flu vaccine developed flu like symptoms and fatigue. 10/4/17- developed rash on back/itchy and had tingling/burning sensation to hands and feet. 10/10/17- developed tachycardia. Went to ED and lumbar puncture and labs performed. Overall symptoms: sensory: numbness, paresthesia, burning sensation hands/feet, decrease sensation in foot. Autonomic: heart burst, sweating, palpitations, difficulty speaking in sentences, poor voice quality and weakness. Was admitted to hospital from 10/20/2017-10/23/2017 for management of variant of Guillain-Barre Syndrome (likely sensory and autonomic variant), following flu shot.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hyperhidrosis, Hypoaesthesia, Immunoglobulin therapy, Influenza like illness
Clinical narrative: Couple days after receiving flu vaccine developed flu like symptoms and fatigue. 10/4/17- developed rash on back/itchy and had tingling/burning sensation to hands and feet. 10/10/17- developed tachycardia. Went to ED and lumbar puncture and labs performed. Overall symptoms: sensory: numbness, paresthesia, burning sensation hands/feet, decrease sensation in foot. Autonomic: heart burst, sweating, palpitations, difficulty speaking in sentences, poor voice quality and weakness. Was admitted to hospital from 10/20/2017-10/23/2017 for management of variant of Guillain-Barre Syndrome (likely sensory and autonomic variant), following flu shot.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging spinal, Palpitations
Clinical narrative: Couple days after receiving flu vaccine developed flu like symptoms and fatigue. 10/4/17- developed rash on back/itchy and had tingling/burning sensation to hands and feet. 10/10/17- developed tachycardia. Went to ED and lumbar puncture and labs performed. Overall symptoms: sensory: numbness, paresthesia, burning sensation hands/feet, decrease sensation in foot. Autonomic: heart burst, sweating, palpitations, difficulty speaking in sentences, poor voice quality and weakness. Was admitted to hospital from 10/20/2017-10/23/2017 for management of variant of Guillain-Barre Syndrome (likely sensory and autonomic variant), following flu shot.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Rash, Rash pruritic, Sensory loss, Speech disorder
Clinical narrative: Couple days after receiving flu vaccine developed flu like symptoms and fatigue. 10/4/17- developed rash on back/itchy and had tingling/burning sensation to hands and feet. 10/10/17- developed tachycardia. Went to ED and lumbar puncture and labs performed. Overall symptoms: sensory: numbness, paresthesia, burning sensation hands/feet, decrease sensation in foot. Autonomic: heart burst, sweating, palpitations, difficulty speaking in sentences, poor voice quality and weakness. Was admitted to hospital from 10/20/2017-10/23/2017 for management of variant of Guillain-Barre Syndrome (likely sensory and autonomic variant), following flu shot.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Tachycardia
Clinical narrative: Couple days after receiving flu vaccine developed flu like symptoms and fatigue. 10/4/17- developed rash on back/itchy and had tingling/burning sensation to hands and feet. 10/10/17- developed tachycardia. Went to ED and lumbar puncture and labs performed. Overall symptoms: sensory: numbness, paresthesia, burning sensation hands/feet, decrease sensation in foot. Autonomic: heart burst, sweating, palpitations, difficulty speaking in sentences, poor voice quality and weakness. Was admitted to hospital from 10/20/2017-10/23/2017 for management of variant of Guillain-Barre Syndrome (likely sensory and autonomic variant), following flu shot.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, TDAP
Symptoms: Dizziness, Eyelid rash, Feeling hot, Headache, Joint range of motion decreased
Clinical narrative: The patient reported that she started to feel "faint and dizzy" about one hour after immunizations. She developed a headache later that afternoon. She also complained of limited range of motion of both arms. The next day, she said she felt "hot", but did not check her temperature. The headache persisted with soreness of both arms. On Nov. 6th, she reported a rash on the left side of her face, primarily on her left eye (both above and below the eye), cheek and forehead. She continues to complain of limited range of motion of both arms and "feeling hot".
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, TDAP
Symptoms: Pain in extremity, Rash
Clinical narrative: The patient reported that she started to feel "faint and dizzy" about one hour after immunizations. She developed a headache later that afternoon. She also complained of limited range of motion of both arms. The next day, she said she felt "hot", but did not check her temperature. The headache persisted with soreness of both arms. On Nov. 6th, she reported a rash on the left side of her face, primarily on her left eye (both above and below the eye), cheek and forehead. She continues to complain of limited range of motion of both arms and "feeling hot".
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Odd rash. Possible allergic reaction 2 inches below the injection sight.
Age: 37.0
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I had two sore arms the same after receiving my three vaccinations. I also had a small fever of 100.3 degrees. The effects were very mild and completely expected after having three vaccinations administered at once.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Pt reported a knot, redness and swelling near the injection site of the ZOSTAVAX immunization.  She has taken a benadryl and will use hydrocortisone and keep area cool.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: No symptoms, or reaction but vaccine was given without being mixed with the ACTHIB component can you please let me know if this should have been reported on VAERS.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient received vaccinations and immediately felt dizzy. Laid patient down on exam table for 5-10 minutes and he began to feel better he stated. BP 125/59. Patient sat up and stated he felt fine. He then stood up BP 116/75. Walked with patient to car and notified parent if he got any worse to go to ER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Rash, Secretion discharge
Clinical narrative: This is a spontaneous report from a contactable Nurse reporting for herself. A 65-year-old female patient received PREVNAR 13 at single dose at right upper arm on an unspecified date in 2017 (2 months before this report) at 12:00 pm for immunization, at physician office. The patient stated she had 2 vaccines that day. She did not have any medications, medical history or investigations to add to this report. Sher did not have any vaccines in the previous 4 weeks, any medical history that was relevant or previous reactions. The patient experienced swollen and discolored, half of her arm in Aug2017 with outcome of recovering, tingling feeling in 2 fingers in Aug2017 with outcome of not recovered, skin is rashy and flaking / her skin was rashed in Sep2017 with outcome of recovering, they are still kind of numb feeling on an unspecified date with outcome of unknown. The shot discolored her arm, caused swelling, and her skin was rashed and skin was dark. She did not know when the events started.  She stated that she has pictures. She states that it looks kind of like her arm was burned. She states that her arm is still discolored and flaking. The AEs required a visit to  physician office: at that time there was fluid draining from it. She had to go back to the doctor and who gave her a steroid cream for her arm. She states that the rash and flaking started three weeks after the swelling went down. She had the tingling in two fingers and they are still kind of numb feeling. The swelling was gone. She didn't read in the pamphlet that it was normal.  The Nurse considered events of swollen and discolored, half of her arm, tingling feeling in 2 fingers are serious due to medically significant.  The reporter assessed the events skin is rashy and flaking, swollen and discolored, half of her arm and tingling feeling in 2 fingers related to PREVNAR 13. Sender's Comments: Based on a drug event temporal association,  a causal association between administration of PREVNAR 13 and the onset of "swollen and discolored, half of her arm, tingling feeling in 2 fingers" cannot be fully excluded. 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: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin discolouration, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable Nurse reporting for herself. A 65-year-old female patient received PREVNAR 13 at single dose at right upper arm on an unspecified date in 2017 (2 months before this report) at 12:00 pm for immunization, at physician office. The patient stated she had 2 vaccines that day. She did not have any medications, medical history or investigations to add to this report. Sher did not have any vaccines in the previous 4 weeks, any medical history that was relevant or previous reactions. The patient experienced swollen and discolored, half of her arm in Aug2017 with outcome of recovering, tingling feeling in 2 fingers in Aug2017 with outcome of not recovered, skin is rashy and flaking / her skin was rashed in Sep2017 with outcome of recovering, they are still kind of numb feeling on an unspecified date with outcome of unknown. The shot discolored her arm, caused swelling, and her skin was rashed and skin was dark. She did not know when the events started.  She stated that she has pictures. She states that it looks kind of like her arm was burned. She states that her arm is still discolored and flaking. The AEs required a visit to  physician office: at that time there was fluid draining from it. She had to go back to the doctor and who gave her a steroid cream for her arm. She states that the rash and flaking started three weeks after the swelling went down. She had the tingling in two fingers and they are still kind of numb feeling. The swelling was gone. She didn't read in the pamphlet that it was normal.  The Nurse considered events of swollen and discolored, half of her arm, tingling feeling in 2 fingers are serious due to medically significant.  The reporter assessed the events skin is rashy and flaking, swollen and discolored, half of her arm and tingling feeling in 2 fingers related to PREVNAR 13. Sender's Comments: Based on a drug event temporal association,  a causal association between administration of PREVNAR 13 and the onset of "swollen and discolored, half of her arm, tingling feeling in 2 fingers" cannot be fully excluded. 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: 87.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 87-year-old male patient received the 1st dose of PREVNAR 13 (Lot# S58702, Exp date Aug2019, NDC 0005-1971-01), intramuscular in right arm, on 21Oct2017 at 12:20 PM, at 0.5 ml single, for immunisation. Relevant medical history included ongoing enlarged prostate, ongoing acid reflux (esophageal), blood disorder, sleep disorder. Concomitant medications included the 5th dose of FLUZONE on 21Oct2017 for immunisation, finasteride (unspecified trade name) from an unspecified date and ongoing for Enlarged prostate, tamsulosin (unspecified trade name) from an unspecified date and ongoing for enlarged prostate, omeprazole (unspecified trade name) from an unspecified date and ongoing for reflux, apixaban (ELIQUIS) from an unspecified date and ongoing for blood disorder, nortriptyline (unspecified trade name) from an unspecified date and ongoing for sleep disorder. Previously the patient received 4 doses of FLUZONE for immunisation, with no adverse effect. Patient got flu vaccine every year. The patient experienced arm hurting on 21Oct2017 at 12:20 PM with outcome of not recovered. The pharmacist reported that she thinks patient's arm is still sore from the needle stick, unknown if it is related to the actual vaccine or not. She thinks it's just muscle soreness the patient is still having. Patient complains his arm has been hurting since he received the vaccine. The event arm hurting was considered serious as per medically significant. Patient's doctor recommended ibuprofen and use compresses for arm hurting. Patient was unable to take ibuprofen so he took Tylenol.; Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of event cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Extra dose administered, Mobility decreased, Pain, Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist.  A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13 lot S35324 Expiry date: 01Aug2018, intramuscular on 19Oct2017 12:35 at 0.5ml intramuscular into left arm for immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing. Concomitant medication included FLUZONE HD, Lot number: UI840AC Intramuscular in left arm on 14Sep2017. The anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm. Patient had injection on 19Oct2017 and is still having soreness and cannot lift arm above shoulder from Oct2017. The outcome of the events was not recovered. Also the patient stated that has had PREVNAR 13 before, resulting in inappropriate vaccine dose administered (outcome was unknown). The reporter assessed the events soreness and cannot lift arm above shoulder medically significant and related to PREVNAR 13. The pharmacist wanted to know if it is normal to experience pain this long after injection. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of events of "soreness and cannot lift arm above shoulder " cannot be excluded, considering the temporal association. 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: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist.  A 72-year-old female patient of an unspecified ethnicity received PREVNAR 13 lot S35324 Expiry date: 01Aug2018, intramuscular on 19Oct2017 12:35 at 0.5ml intramuscular into left arm for immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing. Concomitant medication included FLUZONE HD, Lot number: UI840AC Intramuscular in left arm on 14Sep2017. The anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm. Patient had injection on 19Oct2017 and is still having soreness and cannot lift arm above shoulder from Oct2017. The outcome of the events was not recovered. Also the patient stated that has had PREVNAR 13 before, resulting in inappropriate vaccine dose administered (outcome was unknown). The reporter assessed the events soreness and cannot lift arm above shoulder medically significant and related to PREVNAR 13. The pharmacist wanted to know if it is normal to experience pain this long after injection. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of events of "soreness and cannot lift arm above shoulder " cannot be excluded, considering the temporal association. 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: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is spontaneous report from a Pfizer sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose on an unknown date for pneumonia. The patient medical history and concomitant medications were not reported. The patient previously took PREVNAR 13 for immunisation. Patient had a 2nd PREVNAR 13 dose approximately 3 years before this report. Then she developed great deal of pain in her left arm and limited movement. She stated it got very painful and the she believed it was from the PREVNAR 13. She had a free dose of PREVNAR 13, 8 years before this report. She then went back to her HCP (she thought about 3 years before this report) and they said she could have another dose. She said the nursing staff were saying she did not get a shot 3 years before this report. She stated that the pain was so bad, on a scale of 1-10 it is sometimes a 10. The outcome of the events was unknown. All the dates were unknown as the caller had no record. She was not sure of the start date for her symptoms.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Arthralgia, Headache, Malaise, Myalgia
Clinical narrative: Initial unsolicited report received from consumer on 22-Sep-2017. This case involves 39-year-old male patient who was vaccinated with 1 ml dose (5 doses) of Imovax and PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 15 Sep 2017. The patient's medical history and concomitant medications were not reported. On 16 Sep 2017, one day following the vaccination, the patient experienced headache stomach pain some pains in his joints and muscles he felt sick. Lab data and corrective treatment were not reported. On 17 Sep 2017 (reported as events lasted a day and feels better next day), the patient recovered from the events. Since then he has had 2 more injections without issue he has one more to go. It was reported taht, tthe patient was happy now. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Asthenia, Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: Within 2 minutes after the injection had a sharp pain go down (R) arm. My hand had a tremor, lost feeling in last 2 fingers of hand and sharp constricting pain to my medial and lateral wrist. Had a burning pins and needles feeling from upper arm down to wrist. Lost strength to (R) hand.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Sensory loss, Tremor
Clinical narrative: Within 2 minutes after the injection had a sharp pain go down (R) arm. My hand had a tremor, lost feeling in last 2 fingers of hand and sharp constricting pain to my medial and lateral wrist. Had a burning pins and needles feeling from upper arm down to wrist. Lost strength to (R) hand.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced arm soreness after vaccine was given, then gradual arm pain the next few days. Patient stated that the arm was difficult to move in an "up" motion. Currently the pain comes and goes, it still lingers and he has made an appointment to see his PCP.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: 2 days after injection, patient's right arm became warm to touch and swollen, she went to a nurse practitioner, on 11/2/17. Nurse practitioner said patient had mild cellulitis and prescribed an antibiotic. On 11/6/17, the pharmacy manager contacted patient and nurse practitioner to follow up with incident.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 11/2/17 PM PPT noted redness and warmth at injection site that was the width of the arm. She applied a cold pack to area and denied fever. 11/3/17 PPT reported reaction to facility by phone call. PPT reports was advised to take TYLENOL by staff member. PPT also applied cold pack to injection site. 11/6/17 PPT came to facility, injection site assessed. Area slightly reddened, 5cm in diameter. No warmth or swelling noted.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Swelling face, Urticaria, Vomiting
Clinical narrative: Approximately 30 minutes after the administration the patient had facial swelling, hives and vomiting. Later that day patient also had ran a fever.
Age: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Crying, Electrocardiogram abnormal, Muscle contractions involuntary, Posture abnormal, Sinus tachycardia
Clinical narrative: Vaccine given on 10/20/17. On 10/21/17, patient woke up crying with arms abducted and flexed. She was lying supine. Was not holding posture. Eyes were fixed. Lasted 2-3 mins. No postictal symptoms. Flu given 36 hrs prior to event.
Age: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Staring
Clinical narrative: Vaccine given on 10/20/17. On 10/21/17, patient woke up crying with arms abducted and flexed. She was lying supine. Was not holding posture. Eyes were fixed. Lasted 2-3 mins. No postictal symptoms. Flu given 36 hrs prior to event.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Biopsy skin, Measles
Clinical narrative: Measles rash and symptoms.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Pain and decreased ROM in right shoulder. Has been seen by family doctor twice and has been referred on to orthopedic doctor.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Nausea
Clinical narrative: Fatigue, upper abdominal pain-lasting 3 days, mild headache, moderate pain in arm of injection, weakness, mild nausea. Due date-Jan 11th 2018.