chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Stool analysis normal, Urine analysis normal, Weight decreased
Clinical narrative: After getting the first of 3 scheduled shots for HPV from her pediatrician, my daughter started to feel nauseus, lethargic, and have a severe lack of appetite. This happened gradually, and we didn't connect it to the shot at first. We followed up with the 2nd shot 2 months later as we still didn't make the connection to the shot. She went in for an unrelated doctor's visit 05/26/16 where they noted she had lost 7 pounds (from 123 to 116 lbs) since her February physical. The doctor wanted us to see some specialists and get blood work done. The blood work came back normal and the subsequent visits to Cardiology and Genetics found nothing wrong. We ended up at an Adolescent Specialist who has worked with her for the past 1 1/2 years. While waiting to get an appointment with the Specialist she had her 3rd shot of HPV vaccine, as we still had not made the connection. After many visits with the Specialist and subsequent blood, urine, feces tests and many medications, he diagnosed her with an autoimmune disorder, Dysautonomia, which he said may have been brought on by the HPV vaccination. There are no other events or diseases we could connect to the sudden start of extreme symptoms. He is the one who told us to make this report. One way he helped us connect it to the vaccine was because patient's younger sister, got the same shot and started to display slightly less severe syptoms that were the same as patient had just after her shot. We stopped after only 1 shot for her sister.  After I did a lot of research on vaccinations, and the HPV vaccine in particular, I discovered that there had been reports of over 700 girls who had recieved the HPV vaccine and then all had started to experience the same symptoms patient has. The agency had supplied the vaccine and has denied any connection, but the evidence is there. Certain genetic factors make the vaccine trigger this autoimmune response.  There are many other reports of similar findings in other places, including here. I have 2 other kids who also had 1 or 2 doses of the HPV vaccine before we made the discovery that it was the likely trigger for the problems, and they did not display any symptoms. They are very different, genetically, and are both being treated for other issues, unlike the patient and her sister, who were both very healthy prior to the vaccination.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states that she felt chilled and feverish the evening of the imm.with a sore arm. The next day 3-13 chills were gone but arm still sore and her boss noted her arm was swollen and red. She came to the clinic and we measured the indurated, red area to be about 4mm by 4mm. Advised antihistamine during the day and BENADRYL at night and circumscribed the area. She returns the following day (today on 3-14-18 with an enlarged area of redness (5mm x 6mm) some swelling and soreness. She denies itching or any swelling or tingling of oral mucosa. She is continuing to take BENADRYL, ZYRTEC and apply topical BENADRYL cream.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient states that she felt chilled and feverish the evening of the imm.with a sore arm. The next day 3-13 chills were gone but arm still sore and her boss noted her arm was swollen and red. She came to the clinic and we measured the indurated, red area to be about 4mm by 4mm. Advised antihistamine during the day and BENADRYL at night and circumscribed the area. She returns the following day (today on 3-14-18 with an enlarged area of redness (5mm x 6mm) some swelling and soreness. She denies itching or any swelling or tingling of oral mucosa. She is continuing to take BENADRYL, ZYRTEC and apply topical BENADRYL cream.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: MULTIPLE RASH SITES ON UPPER ARM AND BICEP.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Central nervous system stimulation, Headache, Loss of consciousness, Lumbar puncture, Nerve block
Clinical narrative: CHRONIC HEADACHES PASSING OUT SEIZURES FOR 9 YEARS NOW.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Nerve compression, Seizure, Ventriculo-peritoneal shunt
Clinical narrative: CHRONIC HEADACHES PASSING OUT SEIZURES FOR 9 YEARS NOW.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Injection site erythema, Lethargy, Skin warm, Urticaria
Clinical narrative: Patient came in for 1000 appointment with primary care physician for 12 month check up. Physician deemed Patient healthy to receive recommended 12 month vaccines. Patient and parents came to Immunizations Clinic at 1030. Patient's record was verified that Patient was up to date on previous recommended vaccinations. Patient did not have any history of adverse reactions to vaccines. Patient and parents were advised that Patient was recommended to get PREVNAR, MMR, Varicella, VAQTA, and Influenza vaccines. Parents declined Influenza vaccine but consented to rest of vaccines. Vaccines were administered without difficulty or complications. Parents were educated on after vaccination care and signs of anaphylaxis. Parents were advised to stay with Patient in hospital vicinity for at least 15 minutes and to report any concerns or abnormalities in Patient behavior of health. Parents understood and complied. Parents and Patient returned to Immunizations Clinic at 1100. Parents reported that Patient was extremely lethargic and appeared to be "not normal". Parents also indicated that Patient had slight outbreak of hives on forehead; was extremely warm to the touch, and that there was significant redness on lower aspect of Patient's left thigh. Parents did not indicate that Patient was in significant distress or that Patient had any difficulty breathing. Immunizations Clinic staff observed the Patient and confirmed that Patient had no difficulties breathing and was not in significant distress, did have the indicators of hives on Patient forehead, did present significant redness on lower aspect of Patient's left thigh, and was warm to the touch. Patient and parents were referred to Emergency Department for continued observation and treatment.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site bruising, Pain, Pain in extremity
Clinical narrative: AFTER GETTING THE VACCINATION  (WITHIN 24HOURS) PATIENT REPORTED THAT SHE COULD NOT LIFT HER RIGHT ARM ABOVE HER HEAD, NOR PUT IT BEHIND HER OR PLACE IN HER POCKET WITHOUT EXTREME PAIN. PATIENT REPORTED, WHAT I WOULD CALL, NORMAL BRUISING AT THE INJECTION SITE. PATIENT REPORTED THIS TO ME TODAY 3/14/18. SHE HAS SINCE GONE TO PHYSICAL THERAPY, YESTERDAY, WHICH HELPED THE PAIN. SHE SAID WHEN SHE GOT UP THIS MORNING IT DID NOT HURT, BUT IT DOES AGAIN NOW. PATIENT IS GOING TO CONTINUE WITH PHYSICAL THERAPY.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Serious muscle soreness. Chills, nausea, headaches.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Lethargy
Clinical narrative: After getting the first shot for HPV from her pediatrician my daughter started to feel lethargic and have a lack of appetite. This happened gradually. We made the connection to the shot because her older sister had the same reactions after getting her HPV vaccine. We submitted a VAERS report for her separately (report #134951). We did not have patient get her other scheduled doses of the HPV vaccine after she showed this reaction. There are no other events or diseases we could connect to the sudden start of her symptoms. Patient's reaction was how we finally connected her sister's symptoms to the HPV shot, as that was the only common event preceding the onset of these symptoms. Sister had 3 shots and has severe symptoms, patient only had 1 shot and the symptoms were worse in the months following the vaccination, but have become less severe over the last several months, but have not disappeared completely.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Received a call from Mother stating she noticed this morning, 3/14/18, a red, hot to touch, hard lump the diameter of a baseball about 1 1/2 inches below injection site (right deltoid muscle).
Age: 22.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Rash, Swelling face
Clinical narrative: C/O "BUMPS" TO FACE AND MINOR FACIAL SWELLING.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Received a call from mother stating this morning, 3/14/18, she noticed a red, hot to touch, hard lump the diameter of a baseball 1 1/2 inches below the injection site on the right thigh.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: SHE CALLED AT 2P ON 3/14/18 AND ASKED IF LIVER PAIN IS A SIDE EFFECT OF THIS MEDICATION. SAID HER RIGHT SIDE UNDER THE RIBS IS ACHING AND HAS BEEN SINCE LAST NIGHT.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Large red hot swollen Lump.
Age: 28.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event
Clinical narrative: NO SYMPTOM EXPERIENCED.
Age: 13.0
Sex: M
Vaccine: TD, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given a Td along with a Tdap. Patient asymptomatic. Physician, patient, and parent notified.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Fatigue, Pyrexia, Swelling
Clinical narrative: Patient reported having fever and chills the same day of vaccine. The next day she began to feel swelling near the injection site that traveled to underneath her right armpit. More side effects continued to include green bruising from the inner part of her underarm, all the way down to the right side of her upper lateral torso. Patient stated that she had once gotten surgery on that same arm years ago. Her husband also received the same vaccine with no unexpected side effects other than fever, chills and arm soreness. They both stated still feeling somewhat fatigued.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, and pain at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Back pain, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Severe headaches. Lower back pain. Joint pain mostly located in legs and neck.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Nausea, Pain, Swelling
Clinical narrative: Redness, swelling, pain, chills, nausea.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reaction, pt was accidentally given two doses of Polio. The KINRIX and separate Polio vaccination.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Loss of personal independence in daily activities
Clinical narrative: 1 month after vaccine patient developed bilateral upper and lower extremity weakness, blurry vision which progressed to the point of not being able to walk. She was admitted and diagnosed with Guillain-Barre which persisted despite treatment with IVIG. Now, 6 months later, she continues to have symptoms at has diagnosis of CIPD "chronic inflammatory demyelinating polyradiculopathy". She has been in and out of inpatient rehab and still requires assistance with walking and multiple ADLs. She is getting IVIG monthly which does help but after a few weeks symptoms return. She had no other illnesses that patient or family remember around the time of the development of these symptoms.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Muscular weakness, Vision blurred, Walking aid user
Clinical narrative: 1 month after vaccine patient developed bilateral upper and lower extremity weakness, blurry vision which progressed to the point of not being able to walk. She was admitted and diagnosed with Guillain-Barre which persisted despite treatment with IVIG. Now, 6 months later, she continues to have symptoms at has diagnosis of CIPD "chronic inflammatory demyelinating polyradiculopathy". She has been in and out of inpatient rehab and still requires assistance with walking and multiple ADLs. She is getting IVIG monthly which does help but after a few weeks symptoms return. She had no other illnesses that patient or family remember around the time of the development of these symptoms.
Age: 43.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient given MENACTRA vaccine in error. Patient was supposed to get Pneumococcal 23 vaccine, not Meningococcal vaccine.
Age: 1.92
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Aggression, Crying, Decreased interest, Depressed mood
Clinical narrative: Had a DTaP at his last visit 1/8/18. Had fever and irritability starting 2 hours after the vaccine. Fever got up to 102F. The next day his behavior seemed abnormal. He was fussy and unhappy. He was hitting at mom. Nursed a lot and refused to eat or drink. The next day he was really lethargic and did not have interest in things like reading books, which he normally loves. He was sleeping a lot. He seemed to be gagging some randomly, but did not vomit. He still seemed really irritable. He tried for over 24 hours solid and was inconsolable. 3 days after the vaccine he stopped nursing and would not take anything by mouth. His urine output decreased. He was inconsolable. They took him to urgent care, who then transferred him to ER, where he was diagnosed with otitis media and tachycardia.  Parents declined the amoxicillin prescribed. They gave him topical garlic mullein drops in the ears, DTaP homeopathics, and Thuia. He started nursing again the next day, and seemed to start feeling better. For two weeks after that he seemed really clingy and "like his nervous system was on edge."  Parents took him in for chiropractic treatments. It took two weeks for his behavior to return to baseline. They feel he is now recovered. His history is very concerning for encephalopathy from the pertussis component of the vaccine, which is reported as a very rare complication on the CDC website. Unfortunately I did not have the opportunity to examine him during this reaction. At his well child check on 3/12/18, his growth and development were normal. He did have a behavior where he was jutting out his chin repetitively, but not other abnormal behaviors were noted.
Age: 1.92
Sex: M
Vaccine: DTAP
Symptoms: Diet refusal, Emotional distress, Hypersomnia, Irritability, Lethargy
Clinical narrative: Had a DTaP at his last visit 1/8/18. Had fever and irritability starting 2 hours after the vaccine. Fever got up to 102F. The next day his behavior seemed abnormal. He was fussy and unhappy. He was hitting at mom. Nursed a lot and refused to eat or drink. The next day he was really lethargic and did not have interest in things like reading books, which he normally loves. He was sleeping a lot. He seemed to be gagging some randomly, but did not vomit. He still seemed really irritable. He tried for over 24 hours solid and was inconsolable. 3 days after the vaccine he stopped nursing and would not take anything by mouth. His urine output decreased. He was inconsolable. They took him to urgent care, who then transferred him to ER, where he was diagnosed with otitis media and tachycardia.  Parents declined the amoxicillin prescribed. They gave him topical garlic mullein drops in the ears, DTaP homeopathics, and Thuia. He started nursing again the next day, and seemed to start feeling better. For two weeks after that he seemed really clingy and "like his nervous system was on edge."  Parents took him in for chiropractic treatments. It took two weeks for his behavior to return to baseline. They feel he is now recovered. His history is very concerning for encephalopathy from the pertussis component of the vaccine, which is reported as a very rare complication on the CDC website. Unfortunately I did not have the opportunity to examine him during this reaction. At his well child check on 3/12/18, his growth and development were normal. He did have a behavior where he was jutting out his chin repetitively, but not other abnormal behaviors were noted.
Age: 1.92
Sex: M
Vaccine: DTAP
Symptoms: Otitis media, Pyrexia, Retching, Tachycardia, Urine output decreased
Clinical narrative: Had a DTaP at his last visit 1/8/18. Had fever and irritability starting 2 hours after the vaccine. Fever got up to 102F. The next day his behavior seemed abnormal. He was fussy and unhappy. He was hitting at mom. Nursed a lot and refused to eat or drink. The next day he was really lethargic and did not have interest in things like reading books, which he normally loves. He was sleeping a lot. He seemed to be gagging some randomly, but did not vomit. He still seemed really irritable. He tried for over 24 hours solid and was inconsolable. 3 days after the vaccine he stopped nursing and would not take anything by mouth. His urine output decreased. He was inconsolable. They took him to urgent care, who then transferred him to ER, where he was diagnosed with otitis media and tachycardia.  Parents declined the amoxicillin prescribed. They gave him topical garlic mullein drops in the ears, DTaP homeopathics, and Thuia. He started nursing again the next day, and seemed to start feeling better. For two weeks after that he seemed really clingy and "like his nervous system was on edge."  Parents took him in for chiropractic treatments. It took two weeks for his behavior to return to baseline. They feel he is now recovered. His history is very concerning for encephalopathy from the pertussis component of the vaccine, which is reported as a very rare complication on the CDC website. Unfortunately I did not have the opportunity to examine him during this reaction. At his well child check on 3/12/18, his growth and development were normal. He did have a behavior where he was jutting out his chin repetitively, but not other abnormal behaviors were noted.
Age: 74.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Fall, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: PATIENT'S WIFE CALLED APPROX 5:45PM 3/9/18 TO SAY PATIENT WAS EXPERIENCING NUMBNESS IN LEFT HAND AND NUMBNESS IN TONGUE. PATIENT WAS TOLD TO GO TO HOSPITAL, BUT REFUSED.  PATIENT FELL DOWN FLIGHT OF STAIRS THE FOLLOWING DAY (3/10/18) AND WAS HOSPITALIZED UNTIL 3/12/18. TREATMENT RECEIVED AT HOSPITAL NOT KNOWN TO REPORTER OF THIS FORM.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, body ache, headache.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient claim that when the shot was given she felt pain in the area of the shot. She received the shot on 10/19/2016 but later called today 03/14/18 to say that the shooting pain went down to her elbow and it's bothering her and wants to find out if the injection is causing this pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash pruritic
Clinical narrative: 30 minutes after vaccination, started to feel itching on back of head. By the time she got home 30 minutes later, noticed had itchy rash on legs and back. Rash spread to trunk, arms, face throughout the rest of the day, no new lesions 12 hours after vaccination. Seen in clinic 2 days later, rash still present, still very pruritic. No reaction at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Incomplete course of vaccination, Pain, Pruritus
Clinical narrative: SHOT WAS ADMINISTERED ON 3/1/18. PATIENT EXPERIENCED CHILL, ACHE AND HEADACHE  ON 3/2/18. SHE DEVELOPED RASH ON 3/3/18. THEN SHE HAD ITCHING ON 3/4/18. SHE BROKE OUT IN A RASH THAT SHE THOUGHT IT LOOKED LIKE CHICKEN POX ON 3/5/18. SHE SAW HER PCP THAT DAY AND WAS TOLD THAT HER SIGNS AND SYMPTOMS WERE VERY LIKELY A REACTION TO SHINGRIX. SHE WAS NOT GIVEN ANY MEDICATION TO TREAT HER RASH. HER SYMPTOMS IMPROVED BY THE END OF THE WEEK. PCP ADVISED HER NOT TO GET THE SECOND SHINGRIX SHOT. SHE WAS HERE TODAY AND DISCUSSED HER REACTION WITH ME AND HAD COMPLETELY RECOVERED FROM THE ADVERSE REACTION.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Vaccination complication
Clinical narrative: SHOT WAS ADMINISTERED ON 3/1/18. PATIENT EXPERIENCED CHILL, ACHE AND HEADACHE  ON 3/2/18. SHE DEVELOPED RASH ON 3/3/18. THEN SHE HAD ITCHING ON 3/4/18. SHE BROKE OUT IN A RASH THAT SHE THOUGHT IT LOOKED LIKE CHICKEN POX ON 3/5/18. SHE SAW HER PCP THAT DAY AND WAS TOLD THAT HER SIGNS AND SYMPTOMS WERE VERY LIKELY A REACTION TO SHINGRIX. SHE WAS NOT GIVEN ANY MEDICATION TO TREAT HER RASH. HER SYMPTOMS IMPROVED BY THE END OF THE WEEK. PCP ADVISED HER NOT TO GET THE SECOND SHINGRIX SHOT. SHE WAS HERE TODAY AND DISCUSSED HER REACTION WITH ME AND HAD COMPLETELY RECOVERED FROM THE ADVERSE REACTION.
Age: 61.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Malaise, Vomiting
Clinical narrative: Patient reports becoming violently ill and profusely vomiting within 24 hours of receiving the vaccine.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Acute disseminated encephalomyelitis, Guillain-Barre syndrome, Lumbar puncture, Mental status changes, Muscular weakness
Clinical narrative: Guillain Barre and ADEM. Respiratory failure, altered mental status, muscle weakness.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Respiratory failure
Clinical narrative: Guillain Barre and ADEM. Respiratory failure, altered mental status, muscle weakness.
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Oropharyngeal pain, Pyrexia, Vaccination failure
Clinical narrative: This is a serious spontaneous case, initially received on 06-Mar-2018, from a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (prefilled syringe, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195210, expiry date: 31-Mar-2018, dose: not reported). On 05-Mar-2018, patient experienced sore throat and low grade fever but there was no body ache. The patient thought it was a sinus infection. However, on 06-Mar-2018, after 5 months 8 days of vaccination, the patient was diagnosed with type A influenza (positive) (considered as vaccination failure). She took TAMIFLU. It was reported that, the patient felt well (recovering) at the time of this report and would go to work from 11-Mar-2018.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, FLU4, MMRV, PNC13
Symptoms: Incorrect route of drug administration
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash macular, Swelling
Clinical narrative: Patient received PNEUMOVAX 23 on 3/12/18. Within 24 hours the arm that was vaccinated developed a blotchy inconsistent red rash and became swollen. She had to go to the doctor on 3/14/18 where she received a steroid shot and received an antibiotic.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Localized swollen Bil. thighs about at the vaccine site min redness bil. lump (right thigh).
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Myalgia, Nausea, Swelling
Clinical narrative: Swelling, fatigue, nausea, and severe muscle aches of L side. Ibuprofen, acetaminophen, icing have not helped. Patient followed up 3-2-18 and there was some improvement. No fever. No previous reaction.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Client inadvertently administered HPV9 at approximately 20 weeks gestation.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: Client inadvertently administered HPV9 at approximately 20 weeks gestation.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, MNQ, TDAP, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Oth complications following immunization, NEC, init on 2018-03-09.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, MNQ, TDAP, UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, NEC, init on 2018-03-09.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Agitation, Cough, Discomfort, Inflammation, Insomnia
Clinical narrative: Son developed high fever, inflamed ears, severe rash, agitation, sleeplessness, soreness, runny nose and a cough 5 days following shot. Fever lasted 3-4 days, followed by rash 2-3 days. 3 weeks following son now has swollen lymph nodes in neck and groin region. Mild agitation from discomfort. Son still will not sleep more than 45 mins at a time and now snores since receiving injection.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Son developed high fever, inflamed ears, severe rash, agitation, sleeplessness, soreness, runny nose and a cough 5 days following shot. Fever lasted 3-4 days, followed by rash 2-3 days. 3 weeks following son now has swollen lymph nodes in neck and groin region. Mild agitation from discomfort. Son still will not sleep more than 45 mins at a time and now snores since receiving injection.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Snoring, White blood cell count normal
Clinical narrative: Son developed high fever, inflamed ears, severe rash, agitation, sleeplessness, soreness, runny nose and a cough 5 days following shot. Fever lasted 3-4 days, followed by rash 2-3 days. 3 weeks following son now has swollen lymph nodes in neck and groin region. Mild agitation from discomfort. Son still will not sleep more than 45 mins at a time and now snores since receiving injection.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: MMR II was administered at 3:00pm. About 5 minutes after receiving the MMR II vaccine subcutaneously in the right thigh, a single hive developed right below the injection site. Observed infant for 30 minutes post-vaccines, observed only a local response and no diffuse or widespread hives, no signs of respiratory or GI symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. Information regarding patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021719, expiry date: 10-AUG-2019 for prophylaxis (dose and route was not reported). It was reported that VARIVAX was exposed to a temperature of 6 degree F to 14 degree F for one hour and 15 degree F to 46 degree F for 7 hours. It was reported that there  was no previous temperature excursion. The sterile diluent used for reconstitution of VARIVAX was properly stored. No adverse effects were reported. There was no product quality complaint (PQC) involved. It was reported that  call was because of a data logger.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient received an improperly stored dose of M-M-R II (lot # N002337, expiry date: 20-JAN-2019) for prophylaxis which was reconstituted with a properly stored sterile diluent (STERILE DILUENT) (lot # N013282, expiry date: 23-AUG-2019). The temperature excursion ranged between 32 degrees Fahrenheit (°F) to 35°F (35.4F) on an unknown date for a time frame of 2 minutes. There was a previous temperature excursion which ranged 32°F to 35°F (35.2 F) for 11 minutes and 47°F to 77°F (51.9F) for 17 minutes. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1803USA004144: US-009507513-1803USA004145:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's husband concerning a pregnant female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy outcome was outcome pending.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient received an improperly stored dose of M-M-R II (lot # N002337, expiry date: 20-JAN-2019) for prophylaxis which was reconstituted with a properly stored sterile diluent (STERILE DILUENT) (lot # N013282, expiry date: 23-AUG-2019). The temperature excursion ranged between 32 degrees Fahrenheit (°F) to 35°F (35.4F) on an unknown date for a time frame of 2 minutes. There was a previous temperature excursion which ranged 32°F to 35°F (35.2 F) for 11 minutes and 47°F to 77°F (51.9F) for 17 minutes. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1803USA004145: US-009507513-1803USA002996:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to an 82 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 08-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly for vaccination (strength, dose, lot # and expiration date were not reported).  On the same date, reported as "almost immediately", the patient developed severe pain at the injection site (injection site pain). The patient sought medical attention and went to emergency room where she was given unspecified medications for the pain and was sent to home. At the reporting time, the patient was not recovered from injection site pain. The causality assessment between the event and  PNEUMOVAX 23 was not provided. Injection site pain was considered to be disabling by the pharmacist.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to two children patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On 23-FEB-2018, also reported as "26-FEB-2018", the patients were vaccinated with an improperly stored dose of VAQTA injection 25/0.5 (units not provided), lot number N023953 with expiration date on 05-NOV-2018  (dose and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion as listed, as recorded by a data logger. On 21-FEB-2018,  in the range between 32°F at 29 °F, worst case 1 hour. On 22-FEB-2018, in the range between 32°F at 30 °F , worst case 1 hour . On 26-FEB-2018, in the range between 32°F up to 35°F (32.44F), worst case 3 hours. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1803USA006071:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding four unspecified patients of unknown age and gender. The patients' concomitant medications included sterile diluent (MERCK STERILE DILUENT) lot# N026286, expiration date 06-FEB-2020. The patients' medical history, historical drugs and drug reactions/allergies were not provided. On 08-MAR-2018 and 09-MAR-2018, the patients were vaccinated with  an improperly stored doses of VARIVAX injection, lot # N028711, expiration date 13-OCT-2019 for prophylaxis (route and antomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between -9°C to 8°C during 8 hours. The vaccines had not had any previous temperature excursions. There was no adverse effect reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (Strength, route, dose, frequency, and anatomical location were unknown) with lot # N027618 and expiration date 04-OCT-2019, and lot # reported as N026082 and  expiration date 20-SEP-2019; and an improperly stored dose of ROTATEQ per oral (strength, dose, frequency, and anatomical location were unknown) with lot # N032565 and expiration date 30-MAR-2019; and lot # N021094 and expiration date 12-MAR-2019; for prophylaxis. The administered dose of vaccines experienced the temperature excursion of 47°F to 77°F  (47.8F) degrees Fahrenheit  for 21 hours. There was a digital data logger involved, and a previous temperature excursion of  47°F to 77°F (51F) degrees Fahrenheit  for 209 Minutes.  No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product quality issue
Clinical narrative: This spontaneous report was received from an unspecified reporter, and refers to a child patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown dates, the patient was vaccinated with two doses of GARDASIL 9 injection, for prophylaxis, (strength, dose, frequency, lot number and expiration date was not provided). Furthermore, it was reported that the patient was injected with GARDASIL 9, the product injected  was limpid transparency liquid, but was a little bit turbid translucent liquid. Moreover, it was also reported that after thorough agitation, GARDASIL 9 should appear as a white, cloudy solution. Product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant referring to a currently 76 year old female patient. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included atenolol. On an unknown date (reported as "recently"),  the patient was vaccinated with PNEUMOVAX 23 (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date (reported as "a day after receiving PNEUMOVAX 23"), the patient experienced arm swelling, as well as pain and warmth at the injection site after receiving PNEUMOVAX 23 at an unknown pharmacy. The medical assistant stated that the patient reports she had previously received a dose of what was reported to be "plain PNEUMOVAX " not PNEUMOVAX 23 several years ago but the date and details of the prior vaccination were unknown by the reporter. No laboratory diagnostics or studies were performed. The patient sought for medical attention, she called to the pharmacy and saw a physician. At the time of the report, the outcome of injection site swelling, injection site warmth and injection site pain was unknown. The  medical assistant did not mention the causality assessment between the events of injection site swelling, injection site warmth and injection site pain, and PNEUMOVAX 23.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to six children patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On 21-FEB-2018, also reported as "22-FEB-2018, 23-FEB-2018 and 27-FEB-2018", the patients were vaccinated with an improperly stored dose of ROTATEQ orally, lot number N013989 with expiration date on 30-JAN-2019 and lot number N021101 with expiration date on 28-FEB-2019 (strength and dose were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion as listed, as recorded by a data logger. On 21-FEB-2018,  in the range between 32°F at 29 °F, worst case 1 hour. On 22-FEB-2018, in the range between 32°F at 30 °F , worst case 1 hour. On 26-FEB-2018, in the range between 32°F up to 35°F (32.44F), worst case 3 hours. On 27-FEB-2018, in the range between 32°F up to 35°F (32.46 F) worst case 3 hours. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1803USA004988:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Contusion, Rash generalised, Rash pruritic
Clinical narrative: Bruising, itchy rash everywhere, blistering.
Age: 0.75
Sex: F
Vaccine: DTAP, IPV
Symptoms: Extra dose administered, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: That day in the afternoon my daughter was feverish, I gave her 2.5ml of TYLENOL so she could sleep better. Several days later, red spots appeared on her two thighs, similar to mosquito bites. Two red spots on one thigh and one on the other.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Gait disturbance, Headache, Pain
Clinical narrative: It started with a headache right after the shot around 7:00; continued to feel pain in left arm after the shot and sluggish into the night around 9:00 pm; woke up with chest pains and difficulty walking normally; having significant pain joints, chest and head. Overall body Aches.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sluggishness
Clinical narrative: It started with a headache right after the shot around 7:00; continued to feel pain in left arm after the shot and sluggish into the night around 9:00 pm; woke up with chest pains and difficulty walking normally; having significant pain joints, chest and head. Overall body Aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram, Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden L Hearing Loss.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 9th March 2018 03:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2018 03:30, immediately after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria other: as per reporter), injection site bruising (serious criteria other: as per reporter), injection site pain (serious criteria other: as per reporter) and injection site erythema (serious criteria other: as per reporter). The patient was treated with Ice Pack (NOS). On an unknown date, the outcome of the injection site swelling, injection site bruising, injection site pain and injection site erythema were recovering/resolving. The reporter considered the injection site swelling, injection site bruising, injection site pain and injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacist for herself. The patient received SHINGRIX on left arm. The events were immediately treated with the intervention of an ice pack.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Urticaria
Clinical narrative: Weal.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Poor quality sleep, Swelling face
Clinical narrative: On the night of the shot, or early morning of next day (3/8), patient had swelling, pain, and redness at the injection site, and "uncomfortable sleep". Woke on 03/08/2018 with left facial swelling, cheek only. No swelling of eye, lips, or tongue. Also had one episode of non bilious, non bloody emesis. Being referred to allergy/immunology to identify further etiology. Appointment will be made for next injection due with Allergy, in September.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: On the night of the shot, or early morning of next day (3/8), patient had swelling, pain, and redness at the injection site, and "uncomfortable sleep". Woke on 03/08/2018 with left facial swelling, cheek only. No swelling of eye, lips, or tongue. Also had one episode of non bilious, non bloody emesis. Being referred to allergy/immunology to identify further etiology. Appointment will be made for next injection due with Allergy, in September.
Sex: U
Vaccine: MENB
Symptoms: Eye swelling, Myalgia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after use of product, the patient experienced severe swelling in both eyes and muscle general pain. Outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable other-healthcare professional via a Pfizer sales representative. A 20-year-old female patient of an unspecified ethnicity received first dose of TRUMENB (lot#: R56659, expiry date: 31Jan2019), via an unspecified route of administration on an unspecified date in 2017 (reported as 8 months ago) at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very tired/fatigue, headache, dizziness on an unspecified date in 2017 after given meningococcal group b rlp2086. 8 months later she still experienced occasional dizziness and fatigue most of the time. The provider stated the fatigue started when she received the 1st dose of meningococcal group b rlp2086 and it continued. The outcome of headache was unknown, the outcome of other events was not recovered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Concurrent medical conditions included atrial fibrillation (Diagnosed prior to taking SHINGRIX) and immunodeficiency (Diagnosed prior to taking SHINGRIX). Concomitant products included Warfarin and Metoprolol. On 20th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injected limb mobility decreased and fever. On 20th January 2018, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the extensive swelling of vaccinated limb, shingles, injected limb mobility decreased and fever were recovered/resolved and the outcome of the injection site erythema and injection site induration were unknown. The reporter considered the extensive swelling of vaccinated limb, shingles, injected limb mobility decreased and fever to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient started to have swelling at the injection site about an hour after receiving the vaccine, and by the time she got home, she could not lift her arm. By that night the swelling was about the size of a grapefruit (7 inches, 7 diameter) and was red and hard. She stated that she also felt feverish. She stated that it took about 2 weeks for the swelling to go away completely. Before she received the vaccine she would have shingles outbreaks often as she had an immunodeficiency. She stated that she also had a shingles recurrence since receiving the vaccine, but it was not nearly as painful and could tell a huge difference since taking the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Concurrent medical conditions included atrial fibrillation (Diagnosed prior to taking SHINGRIX) and immunodeficiency (Diagnosed prior to taking SHINGRIX). Concomitant products included Warfarin and Metoprolol. On 20th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injected limb mobility decreased and fever. On 20th January 2018, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the extensive swelling of vaccinated limb, shingles, injected limb mobility decreased and fever were recovered/resolved and the outcome of the injection site erythema and injection site induration were unknown. The reporter considered the extensive swelling of vaccinated limb, shingles, injected limb mobility decreased and fever to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient started to have swelling at the injection site about an hour after receiving the vaccine, and by the time she got home, she could not lift her arm. By that night the swelling was about the size of a grapefruit (7 inches, 7 diameter) and was red and hard. She stated that she also felt feverish. She stated that it took about 2 weeks for the swelling to go away completely. Before she received the vaccine she would have shingles outbreaks often as she had an immunodeficiency. She stated that she also had a shingles recurrence since receiving the vaccine, but it was not nearly as painful and could tell a huge difference since taking the vaccine.