chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus generalised
Clinical narrative: I started with a headache and chest pains about hr. after shot 1:30 PM. Around 3:30 PM (3 hrs. after shot) my body got tingly, throat felt like it was tight, my tongue felt heavy and tingly, I had diarrhea continually into the evening, nausea, itching all over, hot, body aches, earache, dizziness, headache and I have been tired and weak feeling. Some of the symptoms have lessened but I continue to have a tingly tongue, body aches, headache, ear ache, I just don't feel good.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Throat tightness
Clinical narrative: I started with a headache and chest pains about hr. after shot 1:30 PM. Around 3:30 PM (3 hrs. after shot) my body got tingly, throat felt like it was tight, my tongue felt heavy and tingly, I had diarrhea continually into the evening, nausea, itching all over, hot, body aches, earache, dizziness, headache and I have been tired and weak feeling. Some of the symptoms have lessened but I continue to have a tingly tongue, body aches, headache, ear ache, I just don't feel good.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Day after injection, patient experienced a red, inflamed area at injection site. Measured approx. 3- 4 inches in basically a circle. 7 days later she still had this redness and swelling and also had a smaller area below appear, approx. 2 inch circle and commented that they were beginning to itch. Pt. purchased diphenhydramine Cream 2%.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Asthenia, Blood creatine phosphokinase normal, C-reactive protein increased, Full blood count normal, Gait disturbance
Clinical narrative: Almost 4 y/o with speech and dev. delays refused to walk after 4 y/o shots. Mother states she was weak, could not climb stairs or get in bed. After this legs were giving out. We rechecked at 48 and 72 hr. SX had resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Laboratory test normal, Loss of control of legs, Speech disorder developmental
Clinical narrative: Almost 4 y/o with speech and dev. delays refused to walk after 4 y/o shots. Mother states she was weak, could not climb stairs or get in bed. After this legs were giving out. We rechecked at 48 and 72 hr. SX had resolved.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives all over the body for days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Cellulitis, Haemoglobin decreased, Hypotension, White blood cell count increased
Clinical narrative: Developed cellulitis and hypotension the night of.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Bedridden, Hypoaesthesia, Injection site pain, Malaise, Paraesthesia
Clinical narrative: Pt describes pain at injection site as well as tingling/numbness down left arm within 1-2 hours after injection. Had malaise x 10 days causing him to be bedridden during that time. No fever/chills/sweats. Now still with soreness at injection site with numbness and tingling down left arm 2 months later. Slightly improved compared to two weeks ago.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: N/A.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported arm being swelled, warm and painful around the site of the injection about the size of her palm. Patient called her Dr. initial who said for her to take BENADRYL. Pt also took ALEVE for the pain and swelling.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Allergy test negative, Dyspnoea, Full blood count normal, Hypersensitivity, Metabolic function test
Clinical narrative: Allergic reaction, Difficulty breathing, swelling of tongue and throat.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Allergic reaction, Difficulty breathing, swelling of tongue and throat.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patient of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with VARIVAX (lot # N026070, expiry date: 20-SEP-2019; lot # N019822, expiry date: 13-JUL-2019; lot # M023380, expiry date: 11-MAY-2018) subcutaneously for prophylaxis following temperature excursion (product storage error). The temperature excursion ranged between -14 degrees Celsius (C) to -10 C for 11 hours and 35 minutes on an unknown date. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash papular
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 12-OCT-2015, the patient was vaccinated with ZOSTAVAX, (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 14-AUG-2017, the patient was treated by a physician for the onset of a painful papulo/vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX and gabapentin for management of her painful symptoms. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy (Dosage, route of administration, Lot number and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of herpes zoster, or shingles. On or about 28-MAY-2015, the patient was treated by a physician for the onset of a burning rash, which was diagnosed as shingles. The female patient was prescribed valacyclovir (VALTREX) and gabapentin for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, 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 outcomes of the events were unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information has been received on 19-FEB-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route on or about 27-APR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, rather the patient to contract a persistent strain of herpes zoster. On or about 03-SEP-2013, the patient was treated by a physician for the onset of a severe, painful vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for treatment of his painful symptoms. As a direct and proximate result of defective ZOSTAVAX, 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: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information has been received on 19-FEB-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route on or about 27-FEB-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles. On or about 26-NOV-2014, the patient was treated by a nurse practitioner for the onset of a severe and painful vesicular rash, which was diagnosed as a shingles outbreak. The patient was prescribed acyclovir, valacyclovir and prednisone for management of his painful symptoms. As a direct and proximate result of the defective ZOSTAVAX, 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: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 20-OCT-2008, the patient was inoculated with ZOSTAVAX by a physician for routine 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 01-MAR-2016, the patient was treated at a hospital for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe 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. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. The lawyer considered vaccination failure, immune system disorder, and herpes zoster to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 30-OCT-2009, the patient was inoculated with ZOSTAVAX at a physician's office for routine 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 18-MAR-2015, the patient was treated at a physician's office for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 04-APR-2015, she sought subsequent treatment at the same physician's office for ongoing and worsening symptoms related to pain, which was diagnosed as post herpetic neuralgia, a condition of chronic pain and verve damage secondary to herpes zoster infections. 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 patient was caused to suffer severe and permanent injuries, pain, and mental anguish, including diminished enjoyment of life. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. The lawyer considered vaccination failure, weakened immune symptoms, herpes zoster, and post herpetic neuralgia to be disabling. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Pt called on 2/9/18- states that she developed pain in her joints since receiving her vaccines on 1/23/18. Nursing supervisor called her back on 2/9/18 and discussed the adverse events that could occur after the MMR vaccine and that she was within the time frame of the side effects. She was also instructed to call her MD for follow up. Pt called us back on 2/20/18 and was still having symptoms. Nursing supervisor spoke with her again and discussed issues. I called pt on 2/22/18 and discussed situation with her- she is still having joint pain in her hands and left knee. She states that the pain started in her knees and went to her ankles and then to her hands. She stated that she felt achy and tired also after receiving the vaccines. Pt. did call her MD and he advised her to not receive the second dose of MMR vaccine. I advised her to call her MD and maybe he would order a titer to check her antibody titers for Rubella which was low or that he could write her a medical exemption for the MMR vaccine. Pt was needing vaccine for immigration. She will call Regulatory Authority if she has further questions.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Feeling hot, Lethargy, Posture abnormal, Somnolence
Clinical narrative: Patient received vaccine and within minutes father found patient slumped over. Father unsure if patient lost consciousness or not. Father thinks that the patient may have lost consciousness for a "couple seconds" and when patient came to he appeared to be coughing as if he was choking.  The patient then felt very drowsy with a hot feeling to face. Patient looked lethargic upon first observation from RN.
Age: 0.5
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Erythema
Clinical narrative: 6 month old child accidently given GARDASIL vaccine by medication assistant. No adverse reactions noted other than localized redness. Child observed for 15 minutes. No additional reactions to medication.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Pyrexia, Vaccination complication
Clinical narrative: Patient went into Emergency department 4 days after receiving vaccines. Patient presented with low grade fever and redness and swelling of Left thigh injection site. Emergency department diagnosed adverse reaction and cellulitis of left thigh.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram, Erythema, Oxygen saturation decreased, Rash, Respiratory distress
Clinical narrative: Respiratory distress, rhinorrhea, rash, reddened skin on arms, face, neck, chest. O2 Sat dropped. Was given inhaler, oxygen and 911 called. Patient was transported via ambulance to the ER.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea
Clinical narrative: Respiratory distress, rhinorrhea, rash, reddened skin on arms, face, neck, chest. O2 Sat dropped. Was given inhaler, oxygen and 911 called. Patient was transported via ambulance to the ER.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Sleep disorder
Clinical narrative: Redness, swelling, heat from injection site, irritable, sleep patterns have changed.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-FEB-2018, the patients were vaccinated with dose of improperly stored PROQUAD injection (strength, dose, frequency and route of administration were not reported) (lot # N021726, expiration date 06-FEB-2019) for prophylaxis. On 16-FEB-2018, the patients were vaccinated with dose of improperly stored VARIVAX (strength, dose, frequency and route of administration were not reported) (lot # N020014, expiration date 17-JUL-2019) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M034582, expiration date 27-APR-2019). The vaccines were stored in between -14 degrees of Celsius to -10 degrees of Celsius for 2 hours 25 minutes. The previous temperature excursion was between -14 degrees of Celsius to -10 degrees of Celsius for 18 hours 25 minutes and from -9 degrees of Celsius to 8 degrees of Celsius for 1 hour 25 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an unspecified reporter via company representative refers to a 78 year old female patient. The patient's concurrent conditions included diabetes. The patient's medical history was not reported. The patient's concomitant therapies included JANUVIA and LYRICA. It was unknown if the patient had any drug reactions/allergies. On an unknown date in 2013 (also reported as, at an unspecified time five years ago), the patient was vaccinated with ZOSTAVAX, (dose, units, frequency, lot number, expiration date not reported) as an injection. On 12-FEB-2018, the patient developed shingles on her left arm (herpes zoster). The patient was given treatment for the event. It was unknown if any lab diagnostics/studies were performed. The patient sought medical attention for the event. The patient was not given any intervention. The event did not lead to significant disability or incapacity, neither resulted in hospitalization. No further information was provided. The outcome of herpes zoster was not recovered. The reporter did not provide the causality of herpes zoster with ZOSTAVAX. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
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 09-MAY-2013, the patient was vaccinated with ZOSTAVAX, (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 10-MAR-2016, the patient was treated at a Dermatology facility for the onset of a severe painful rash diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash pruritic
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 08-MAR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy (Dosage, route of administration, Lot number and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On or about 23-SEP-2015, the patient was treated at an urgent care facility (by an unspecified healthcare professional) for the onset of a painful and pruritic rash, which was diagnosed as shingles. The female patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, 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, pain and suffering, and other damages. The outcomes of the events were unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Cardiovascular disorder, Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other health professional via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date in Oct2017, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site/pain on her arm and circulation problem both on an unspecified date with outcome of unknown. The patient went to the emergency room because of the events and called the doctor's office and asking for some information about Prevnar 13.
Age: 0.92
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mother reported child had vaccine Monday and Tues. AM noted (R) leg to have quarter sized area of redness and warm to touch. Mom reports today area is getting smaller without any treatment. She wanted to report she is concerned this is allergic reaction and she does not want child to receive any further doses of PCV.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right upper thigh with erythema, induration and warmth within 24 hours of vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Large red raised area (like a single hive) about 4" in diameter around injection site. Starting itching 2/21/2018, but did not look at site. Work up 2/22/2018 and it was very tender, red and swollen along with itchy.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, Pyrexia
Clinical narrative: 2 INCH AREA REDNESS AND SORENESS OF RT ARM, LOW FEVER DAY AFTER VACCINATION. DIFFICULTY MOVING RT ARM WITH DIFFICULTY PERFOMRING DAILY ACTIVIES. FATHER ADVISED TO TAKE CHILD TO PRIMARY CARE PROVIDER.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient and guardian came to clinic with complaint of redness, warmth and swelling at the site of injection. Guardian was informed that this appeared to be a normal reaction. Guardian was advised to follow up at primary care physician.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Mild redness that has persisted for several days at site of injection. Redness approximately the size of the palm of a hand and patient reports not getting better.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm red, swollen, warm to touch after getting shot. Patient given antibiotic for cellulitis.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Monoplegia, Pain in extremity
Clinical narrative: FLUZONE HD was administered to the patient on 9/14/2017. The patient reports that he suffered some arm pain later that evening, prompting him to call the pharmacy, where he was told it is normal to have some injection site pain after a vaccination.  Six days after the vaccination, on 9/20/2017, the patient was treated for herpes zoster. He states that he had spent some time in the hospital due to illness. He came to the pharmacy today, February 22, 2018, starting that his arm is now paralyzed from the vaccination.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose was administered when adult dose was needed. No problems with vaccine dose that was administered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Woke up on second morning after injection to a rash on upper chest going down to stomach area and on upper back and neck. No other symptoms.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Ear pain, Hypoaesthesia, Hypoaesthesia oral, Lip injury, Mobility decreased
Clinical narrative: Woke up this AM and had notable numbness on the right side of my face. Including the tongue and throat. Had pain in the right ear and temporal mandibular joint 4/10. As I was consuming my breakfast I bit my lip. It was then that I noted my face on the right was not moving much. No marked facial droop, but when I smiled the right side was not moving as much as the left.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Pharyngeal hypoaesthesia, Temporomandibular joint syndrome
Clinical narrative: Woke up this AM and had notable numbness on the right side of my face. Including the tongue and throat. Had pain in the right ear and temporal mandibular joint 4/10. As I was consuming my breakfast I bit my lip. It was then that I noted my face on the right was not moving much. No marked facial droop, but when I smiled the right side was not moving as much as the left.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Rash erythematous, Swelling, Vaccination complication
Clinical narrative: Patient had red swollen rash.
Age: 14.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Burning sensation, Injection site rash
Clinical narrative: Patient C/O of Left arm feeling like a burning sensation and broke out in a rash around injection site starting on 02/19/2018 around 12:48 PM.
Age: 0.75
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Inadvertently administered vaccine to a 9 month old individual.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left arm pain and redness for 2 days after vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a physician, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-FEB-2018, the patient was inadvertently administered with a dose of ZOSTAVAX 19400 PFU, for prophylaxis, by the intramuscular route (anatomical location was not reported). The product lot number was reported as M020938 with expiration date on 31-JUL-2018. Lot number M020938 is an invalid lot number for Zoster Vaccine Live.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Coma, Contusion, Death, Dyspnoea
Clinical narrative: This spontaneous report was received from a medical assistant (patient's mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she'd have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn't know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn't gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor's office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren't allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient's condition got deteriorated and they couldn't tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, General physical health deterioration, Haemoglobin decreased, Injection site haemorrhage, Lethargy
Clinical narrative: This spontaneous report was received from a medical assistant (patient's mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she'd have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn't know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn't gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor's office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren't allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient's condition got deteriorated and they couldn't tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Leukaemia, Life support, Lymphadenopathy, Meningitis, Menorrhagia
Clinical narrative: This spontaneous report was received from a medical assistant (patient's mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she'd have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn't know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn't gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor's office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren't allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient's condition got deteriorated and they couldn't tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pallor, Petechiae
Clinical narrative: This spontaneous report was received from a medical assistant (patient's mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she'd have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn't know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn't gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor's office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren't allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient's condition got deteriorated and they couldn't tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Sepsis, Swelling, Transfusion, White blood cell count decreased
Clinical narrative: This spontaneous report was received from a medical assistant (patient's mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she'd have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn't know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn't gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor's office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren't allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient's condition got deteriorated and they couldn't tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying after vaccines patient re-evaluated in office at 4:40. Per Dr. will administer 2 vaccines only at next well baby visit, no indication that we should not vaccinate child at all.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash macular, Skin warm, Tenderness
Clinical narrative: Left arm tenderness, red blotchy patches on left arm, itching, warm to touch.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site discolouration
Clinical narrative: Patient continues to have a pinpoint superficial gray discoloration of skin at injection sites on right thigh several months s/p vaccination.
Age: 19.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Medication error, No adverse event
Clinical narrative: Pt was given the influenza Adjuvanted (FLUAD) vaccine instead of the regular Influenza vaccine. Pt was fine no adverse reaction tolerated fine. Notified Provider FNP of the error. Provider noted that is okay no additional orders needed. F/u with Patient on 2/22/2018 pt notified of the error and pt stated she is fine no problems.
Age: 19.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt was given the influenza Adjuvanted (FLUAD) vaccine instead of the regular Influenza vaccine. Pt was fine no adverse reaction tolerated fine. Notified Provider FNP of the error. Provider noted that is okay no additional orders needed. F/u with Patient on 2/22/2018 pt notified of the error and pt stated she is fine no problems.
Age: 78.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events observed. But due to miscommunication patient was given FLUAD. He wanted to get pneumonia shot. Patient already had one flu shot for the season 2017/2018.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Usually I have no adverse effects from the flu shot; however, last October after the shot I commented that it ached somewhat. I had the shot at our local store and have already recycled the paperwork, so I don't have much of the information requested on this form. The continuing discomfort is not debilitating, but occasionally my arm aches at night and requires a heating pad to sleep. During the day, it only rarely is uncomfortable. I would like to know if it will eventually heal and intend to speak to my doctor when I have a physical which is not scheduled until May.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Dizzy patient. Felt faint. Sweating. Gave water and juice and held upright. Needed about 15 minutes of care. Then color came back to face and stated he would be okay.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram normal, Dizziness, Pain, Pain in extremity
Clinical narrative: Began as bad arm pain despite taking 600mg of ibuprofen after the injection. At 0500, woke up with chills, body aches, and dizziness.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Facial paralysis, Lethargy
Clinical narrative: Had impressive lethargy then droop on R side of face for about 24h after shots last time.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Patient complained that she is been experiencing bad muscle pain and arm weakness since she has took the shot.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Conjunctivitis
Clinical narrative: Left eye conjunctivitis.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient called today (2/22/18) stating that she still had intense pain in the area that she had the above vaccines.  This is the first time that she had contacted anyone regarding the discomfort.  She stated that she did not have any redness/swelling/warmth at the vaccine sites, but pain in the muscle significant enough that it was causing her to wake at night sometimes and it was difficult to perform some daily activities. The pain was not getting better or worse since the day after her vaccines. I suggested that she should call her doctor for further evaluation. Patient came in later today with 2 prescriptions after talking with her doctor. Patient will be following up with her doctor for monitoring and further treatment, if necessary.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient states she started having severe pains in her neck 3 days after receiving the flu shot. The next day the pain spread to her shoulder blade and down to her wrist. She states the pain was severe however she didn't lose any motor function of her arm or her shoulder. The pain mostly resolved about 2 to 3 weeks after it began. She says she still has a little pain in the back of her arm in the mornings.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAP, HEP, IPV, RV1
Symptoms: Pyrexia
Clinical narrative: The girl had high fever (38-40 degrees C). The pediatrician prescribed TYLENOL every 4 hours. Since I'm a new mother, I thought that it was normal although the fever lasted a little more than 1 week.
Age: 0.67
Sex: F
Vaccine: HEP, PNC13
Symptoms: Blood culture, Cough, Diarrhoea, Pyrexia, Respiratory distress
Clinical narrative: Resp distress. Given diphenhydramaine and albuterol. Pt was transferred to higher level of care facility.