chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: According to the patient: "I just wanted to let you know that I had a reaction to the shingles vaccine. I woke up in the middle of the night shivering, and running a fever. I had a headache, a sore throat, and every joint in my body hurt. I could not even turn sideways because I could not stand the pain in my knee. I slept the whole day Saturday (2/10/18), as I had a fever the whole day. I woke up Sunday (2/11/18) much better, but my left knee is still hurting today, and the pain goes up my inner thigh to my groin."
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: C-reactive protein, Dyskinesia, Eye movement disorder, Full blood count, Metabolic function test
Clinical narrative: On eve of d10 after vaccination patient developed right sided eye deviation and focal arm movements associated with fever and new popular rash concerning for seizure, seizure resolved without intervention. Pt regained neurologic baseline. Patient admitted to hospital for overnight observation with no further events. Rash resolving at discharge.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash papular, Seizure, Urine analysis
Clinical narrative: On eve of d10 after vaccination patient developed right sided eye deviation and focal arm movements associated with fever and new popular rash concerning for seizure, seizure resolved without intervention. Pt regained neurologic baseline. Patient admitted to hospital for overnight observation with no further events. Rash resolving at discharge.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of female patients of unknown age. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 09-JAN-2018, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N021721, expiration date 10-AUG-2019 for prophylaxis. Other suspect therapies included improperly stored doses of M-M-R II (strength, dose, frequency and route of administration were not provided), lot # N010496, expiration date 31-MAR-2019. Concomitant therapies included sterile diluent. The doses of VARIVAX and M-M-R II were exposed to a temperature excursion of multiple excursion, unable to organize data (according to the reporter), which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: HPV9, TTOX
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age, refers to herself. The patient had no medical history and no known drug reactions or allergies. On an unknown date, the patient performed a home pregnancy test (the result was not reported). The patient became pregnant with last menstrual period (LMP) on 06-NOV-2017. On 25-JAN-2018, while being in first trimester of pregnancy, the patient was vaccinated with GARDASIL 9 (dose, route, site, batch number, lot number and expiration date were not provided) for prevention of HPV. On the same date, she received a dose of unspecified tetanus vaccine (indication, dose, route, site, batch number, lot number and expiration date were not provided). The patient was not receiving any concomitant medications. At the time of this report, the outcome of pregnancy was pending. Estimated date of delivery was: 13-AUG-2018. No fetus demographics were provided. The patient reported that she had an upcoming appointment on 26-FEB-2018 for her first prenatal visit with a healthcare provider.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a 4 months patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # N013884, expiration date 05-DEC-2018, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was 9 °C to 25°C (11.3°C) for 1 hour 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Palpitations, Syncope
Clinical narrative: Generalized weakness, palpitations and syncope on 02/06/17. Presented to the ED with same. Admitted to rule out cardiac etiology and started on Clindamycin for cellulitis of left upper extremity.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, vomiting, diarrhea, slight headache and body ache.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, diarrhea, slight headache and body ache.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Vision blurred
Clinical narrative: This spontaneous report was received from an office manager, referring to a 44 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient went to the reporter's Facility to get a tuberculin purified protein derivative (PPD) test and instead of this she was injected with 0.1cc of GARDASIL 9 in the left forearm intradermally (lot number reported as 12093, no expiration date was provided). The patient was notified as soon as the error was found, on the same day. On 17-JAN-2018, the patient was called and stated she had been nauseated with blurred vision. She was advised to be checked out by a physician and said she would call back to schedule an appointment. The patient went to the reporter's Facility 2 weeks later for something unrelated. At the time of the report, the patient's outcome was reported as recovered. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the events of nausea and vision blurred.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ, TDAP
Symptoms: Dyspnoea, Glossodynia, Injection site rash, Odynophagia, Oropharyngeal pain
Clinical narrative: When the pt woke up Thursday morning (2/8/18), she noticed a rash on her face but considered it was possibly d/t her menstrual cycle. Friday 2/9/18 the rash on her face was worse and extended down to her neck and upper shoulders. She also C/O sore throat and the feeling like it was closing. Slight difficulty breathing while laying down so she sat up. Tongue also felt strange, slightly painful. Inside her mouth and tongue were really red. They did not call anyone for medical advice or seek medical attention from an MD or ER. Today, 2/12/18, they presented themselves to our office with complaint of possible reaction to vaccines, still C/O of face itching and throat hurts to swallow. Advising that she see a physician for evaluation to R/O another illness instead of reaction to vaccines or to get confirmation of a reaction to vaccines.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ, TDAP
Symptoms: Paraesthesia oral, Pruritus, Rash, Throat tightness, Tongue erythema
Clinical narrative: When the pt woke up Thursday morning (2/8/18), she noticed a rash on her face but considered it was possibly d/t her menstrual cycle. Friday 2/9/18 the rash on her face was worse and extended down to her neck and upper shoulders. She also C/O sore throat and the feeling like it was closing. Slight difficulty breathing while laying down so she sat up. Tongue also felt strange, slightly painful. Inside her mouth and tongue were really red. They did not call anyone for medical advice or seek medical attention from an MD or ER. Today, 2/12/18, they presented themselves to our office with complaint of possible reaction to vaccines, still C/O of face itching and throat hurts to swallow. Advising that she see a physician for evaluation to R/O another illness instead of reaction to vaccines or to get confirmation of a reaction to vaccines.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Flushing, Pruritus, Skin test positive, Throat irritation
Clinical narrative: Given history of anaphylaxis to flu vaccine in 2011, patient underwent skin testing to flu vaccine as recommended by the Practice Parameters, detailed below: 1. Skin prick test with 1:10 -no reaction at 15 minutes. 2. Skin prick test with full strength - no reaction at 15 minutes. 3. Intradermal with 1:100 dilution - Patient tested positive (12mm wheal/48mm flare) with associated flushing and pruritis of ears and face, throat clearing, and coughing. Epinephrine and Claritin were administered for anaphylaxis and symptoms resolved. She was monitored for 1 hour after and discharged from clinic in good health.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 23 month old patient, who is also the reporter's child. Information on patient medical history or concomitant medications was not reported. On 17-FEB-2009, at 18 months old, the patient received a first dose of VAQTA (route of administration, strength, lot number and expiration date were not reported) for prophylaxis. On 04-AUG-2009, 5 months later, the patient received a second dose of VAQTA (route of administration, strength, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JAN-2018, the patient was vaccinated with an expired dose of ZOSTAVAX injection (dose and route were unknown) (lot # M038351, expiration date 06-DEC-2017) for prophylaxis, which was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # L046300, expiration date 17-JUN-2018). The patient had denied any adverse effects.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a 13-month-old male patient. The patient's medical history was not reported. On 03-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. VARIVAX lot # N021315, expiration date 07-AUG-2019. Sender's Comments: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered pharmacist reporting on a 55 year old male patient. The patient had no concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medications. On 24-JAN-2018, the patient received an unspecified dose of PNEUMOVAX 23, intramuscularly, lot # N027624, expiration date 11-MAY-2019 for prophylaxis (strength and anatomical location were not reported). On 24-JAN-2018, two hours after the administration of PNEUMOVAX 23, he complained of swelling at injection site, vomiting and fever (onset date of the adverse event of fever was also reported as on 26-JAN-2018). There were no lab/diagnostics performed and the patient had not received treatment for the adverse events; however, the patient sought medical attention and the pharmacist recommended to the patient to take TYLENOL 325 mg, 2 tablets every 4 to 6 hours. The pharmacist also suggested contacting his doctor if the patient did not experience relief after a couple of days. At the reporting time, the patient's status was reported as not recovered. The reporter did not assess the causal relationship between site swelling, pyrexia and vomiting and therapy with PNEUMOVAX 23.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from Nurse refers to a patient of unknown demographics. The patient concurrent conditions, medical history and concomitant medications were not reported. On 22-AUG-2017, the patient was vaccinated with first dose of GARDASIL 9 when the patient was 11 year old. On 08-FEB-2018, the patient received second dose of GARDASIL 9 earlier than the 6 months minimal requirement for a two dose interval. No product quality compliant reported.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A 4-month-old female patient of an unspecified ethnicity received PREVNAR 13, via unspecified route of administration, on unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced severe redness and bumps. It was reported that patient received on a Monday and by Tuesday reaction has gotten worse. Outcome of the events was not recovered. No follow up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Continued pain on left arm / shoulder where injection was given. Pain with movement and at times decreased ROM due to pain. Usually relieved with OTC pain meds.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Syringe issue
Clinical narrative: Patient was here for a nurse visit for vaccinations today. He was accompanied by his father. The patient was very nervous and worked up about the injections. The Patient was to be given 2 vaccinations today. He was being given a HEP A vaccine and a HPV 9. I administered the Hep A first and it was a successful procedure. When I tried to administer the HPV9 injection, the needle was bad and I could not push the plunger up into the syringe to administer any medication into the patient. I removed the injection and covered the spot with a Band-Aid. I showed the patient and his father that I could not push the plunger so no medication was injected. I came out of the room and showed the syringe with the needle still on to MA. She could not push the plunger either. I went into the lab and got a new needle. I went back into the room and administered the HPV 9 vaccine successfully. No medication went into the patient during the first injection. When the patient came up to check out, he complained of feeling faint. I gave him orange juice and graham crackers. He was placed in a room and Dr. went in to evaluate him. The father felt that I had given him 2 doses of the HPV 9 vaccine because I had to inject him twice. I tried to reassure him that only one dose was given because I was unable to push any medication out of the syringe the first time.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt arm swollen at injection site 4"x4" red warm to touch. Pt told to take 25 mg BENADRYL every 8 hours. Warm compress to site. Told to go to ER if swelling increases as of 2/12/18. The swelling is almost gone still some redness.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling
Clinical narrative: Swelling on right thigh.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Eye irritation, Fatigue, Irritability, Lethargy
Clinical narrative: Patient had a fever of 103.5 for 3 days starting on 12/21/17. On 12/22/2017, he complained that his eyes burned. Closer inspection his eyes were irritated and red. He was lethargic, fatigued, irritable and had loss of appetite that did not return for 7 days after 12/21/2017. He had a mild rash on his torso. He had night terrors and sweats for 3 nights during the fever. He had a runny nose and sore throat that he complained about for 7 days after 12/21/2017.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Night sweats, Ocular hyperaemia, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Patient had a fever of 103.5 for 3 days starting on 12/21/17. On 12/22/2017, he complained that his eyes burned. Closer inspection his eyes were irritated and red. He was lethargic, fatigued, irritable and had loss of appetite that did not return for 7 days after 12/21/2017. He had a mild rash on his torso. He had night terrors and sweats for 3 nights during the fever. He had a runny nose and sore throat that he complained about for 7 days after 12/21/2017.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rhinorrhoea, Sleep terror
Clinical narrative: Patient had a fever of 103.5 for 3 days starting on 12/21/17. On 12/22/2017, he complained that his eyes burned. Closer inspection his eyes were irritated and red. He was lethargic, fatigued, irritable and had loss of appetite that did not return for 7 days after 12/21/2017. He had a mild rash on his torso. He had night terrors and sweats for 3 nights during the fever. He had a runny nose and sore throat that he complained about for 7 days after 12/21/2017.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, Redness and Bruising at injection site.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Myalgia, Rash maculo-papular, Skin burning sensation
Clinical narrative: Patient developed a maculopapular rash after 10-15 minutes of administration of vaccine at the clinic.  Patient returned to clinic 6 days later with complaints of myalgia, arthlagia, burning of the skin, chills. Patient took Benadryl OTC prn and Zyrtec.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Sensory loss
Clinical narrative: Noted with numbness on left arm within 24 hrs of receiving TRUMENBA vaccine on 2/3/2018. On 2/5/2018 he was seen by PA and he was able to move 30% but today 2/12/2018 he was unable to lift elbow or forearm, no sensation on left arm and forearm, very limited movement on left hand and no movement on arm and forearm.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Injection site hypoaesthesia, Monoplegia
Clinical narrative: Noted with numbness on left arm within 24 hrs of receiving TRUMENBA vaccine on 2/3/2018. On 2/5/2018 he was seen by PA and he was able to move 30% but today 2/12/2018 he was unable to lift elbow or forearm, no sensation on left arm and forearm, very limited movement on left hand and no movement on arm and forearm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Redness, warm, pain/tender to touch.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: The patient came to the pharmacy to complain from pain in the injection site from the last injection of the ENGERIX-B that was administered on 01/03/2018. The patient denied having any swelling or redness now but only the vague pain. I advised the patient and husband to consult a doctor and we will start our documentation of the event.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Nausea, Retching
Clinical narrative: Patient states she received a flu shot at our pharmacy on 02/11/18 and approximately 3&1/2-4hours later was short of breath, felt like she needed to throw up (gag reflex). Husband and her called an urgent care and they told them to take Benadryl and to go to the ER. She states her face was flushed and as time went on it became more and more difficult to breathe.
Age: 23.0
Sex: F
Vaccine: FLU4, MNQ, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Left arm-24 hours after vaccine, patient noticed small area of redness and swelling. 48 hours after vaccine, patient noticed area getting larger, approximately 6" in diameter. Patient called office on 02/09/2018 to report redness and swelling. Had patient to come in to clinic. Patient saw NP on 02/09/2018. NP recommended cool compresses for swelling and ibuprofen for pain management.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Blood glucose normal, Heart rate decreased, Pallor, Presyncope
Clinical narrative: Patient received his flu shot and 15 min later he became pale and near syncopal. His hear rate dropped to 35/Min and blood pressure was 60/30. He was given juice after 45 minutes his color improved vitals came back to normal. After ambulating his symptoms returned pale weak he was sent to the ED via ambulance.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Injection site nodule, Injection site pain, Middle insomnia, Pain in extremity, Paraesthesia
Clinical narrative: Pain in the right upper arm that radiates down into her forearm, pain started after her tetanus shot on 1/10/18, reported to the primary provider on 02/01/18, initially her discomfort was at the site of the injection, however she states that as time has gone on the pain has actually gotten worse and it radiates down into her arm, the pain has been waking her up at night, she occasionally feels tingling discomfort down her arm, she states that she can "feel a knot" where she received the injection, there is no redness or warmth at the injection site. Provider recommended that she start an anti-inflammatory medication, ALEVE 1 tab oral twice daily, and initiated a referral to PT for evaluation and treatment, provider recommended that she apply heat to the right upper arm 3-4 times daily for 10-15 minutes and follow up on 02/08/18, the patient rescheduled this to 02/12/18.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 23-JAN-2018, the patient was vaccinated with an improperly stored VARIVAX with lot number N023959 and expiration date on 01-SEP-2019 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). It was reported that on an unspecified date, the vaccine was exposed to a temperature between -9 Centigrade degrees and 8 Centigrade degrees for 5 hours and 45 minutes. It was unknown if there was previous temperature excursion. No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Eyelid function disorder, Gait disturbance, Muscle twitching
Clinical narrative: This spontaneous report was received from the patient's mother via a company representative referring to her daughter, a 17 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date in June 2016, the patient was vaccinated with the third dose of GARDASIL 9 or GARDASIL (strength, route, anatomical location, lot # and expiration date were noted) for prophylaxis. The first dose and the second dose were administered on an unknown date in January 2016, and on an unknown date in March 2016, respectively. The reporter stated that on an unknown date in June 2016 (same date of the vaccination with the third dose), the patient experienced difficulty with walking, could not open her eyes and twitching like her body was convulsing. The patient's mother reported that she called an unknown name pediatrician, who advised her to go to emergency room. The mother reported that at the hospital's emergency room were unable to do anything for the patient and she was discharged her to home. A few days later everything was back to normal. The outcome of gait disturbance, eye disorder and muscle twitching was recovered on an unknown date in 2016, after received unspecified treatment. The reporter did not assess a causal relationship between the aforementioned events and GARDASIL 9 or GARDASIL. However, the reporter stated that pediatrician felt that this situation had nothing to do with the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Burning sensation, Gait disturbance, Headache
Clinical narrative: Information has been received from a 65 year old female patient referring to herself. The patient's medical history included a back surgery as well as shingles outbreak without the rash in November 2016 for which she was treated with VALTREX (unknown manufacturer). The patient's drug reactions included vomiting with DEMEROL, itching with ROBAXIN as well as itchy rash with cephalexin, AUGMENTIN, and antibiotics. Her historical drugs included an unspecified vaccination on approximately 04-DEC-2016 (reported as 6 weeks prior to receiving ZOSTAVAX). On 15-JAN-2017, the patient was vaccinated with ZOSTAVAX) (1 injection) in the left arm for prophylaxis (route of administration, lot number, and expiration date were not provided). On approximately 16-JAN-2017 (reported as within 24 hours from vaccination), the patient experienced horrible headache, horrid pain in her back and head as well as pain in her hip which was a ''burning, shooting pain that hurts with movement''. The patient also reported that the pain in her hip made it hard for her to take a step sometimes and that on an unspecified date in 2017 (after receiving ZOSTAVAX), she experienced minor sore throat from which she recovered on an unspecified date. On 24-JAN-2017, the patient sought medical attention and visited her physician who put her on a treatment therapy with 40 mg prednisone (manufacturer unknown) injection as well as unspecified oral prednisone. By the time of the report, the patient was recovering from the events of horrid pain in her back, head, and hip as well as difficulty in walking. The patient stated that she was still having the leg pain and the headache; however she stated that it was improving and getting better. The relatedness between the suspect therapy and the adverse events was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a 65 year old female patient referring to herself. The patient's medical history included a back surgery as well as shingles outbreak without the rash in November 2016 for which she was treated with VALTREX (unknown manufacturer). The patient's drug reactions included vomiting with DEMEROL, itching with ROBAXIN as well as itchy rash with cephalexin, AUGMENTIN, and antibiotics. Her historical drugs included an unspecified vaccination on approximately 04-DEC-2016 (reported as 6 weeks prior to receiving ZOSTAVAX). On 15-JAN-2017, the patient was vaccinated with ZOSTAVAX) (1 injection) in the left arm for prophylaxis (route of administration, lot number, and expiration date were not provided). On approximately 16-JAN-2017 (reported as within 24 hours from vaccination), the patient experienced horrible headache, horrid pain in her back and head as well as pain in her hip which was a ''burning, shooting pain that hurts with movement''. The patient also reported that the pain in her hip made it hard for her to take a step sometimes and that on an unspecified date in 2017 (after receiving ZOSTAVAX), she experienced minor sore throat from which she recovered on an unspecified date. On 24-JAN-2017, the patient sought medical attention and visited her physician who put her on a treatment therapy with 40 mg prednisone (manufacturer unknown) injection as well as unspecified oral prednisone. By the time of the report, the patient was recovering from the events of horrid pain in her back, head, and hip as well as difficulty in walking. The patient stated that she was still having the leg pain and the headache; however she stated that it was improving and getting better. The relatedness between the suspect therapy and the adverse events was not reported.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness postural, Headache, Injection site reaction, Lethargy, Oedema
Clinical narrative: Almost two weeks after receiving the vaccination, the employee reported a welt of about 2 by 2 inches at the injection site. She also reported feeling lethargic and having headaches as well as dizziness when standing abruptly. She ended up at her PCP at which time the swelling areas had grown to an area of 8 by 8 cm. She was given steroids and pain medication, and was instructed not to receive any additional doses at least until the edema had gone down.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Swelling, Urticaria
Clinical narrative: Almost two weeks after receiving the vaccination, the employee reported a welt of about 2 by 2 inches at the injection site. She also reported feeling lethargic and having headaches as well as dizziness when standing abruptly. She ended up at her PCP at which time the swelling areas had grown to an area of 8 by 8 cm. She was given steroids and pain medication, and was instructed not to receive any additional doses at least until the edema had gone down.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Tearfulness
Clinical narrative: Patient is complaining of severe pain in her arm. She can't raise her arm to get dressed or comb her hair. She said the pain started soon after her vaccine. She was in tears and says she has had to take time off from work due to the pain. She has tried anti-inflammatory and heat and cold and nothing helps.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient states she has had on and off left arm pain at the injection site for the past 4&1/2 months.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Delivery, Exposure during pregnancy, Injection site pain, Paraesthesia
Clinical narrative: Client states that she received TDAP and Influenza vaccine on 11/17/17 at clinic. Client reports that she started experiencing "tingling of left arm" and "pain on top of left shoulder" on 12/8/2017 the date she gave birth to her infant. At time of vaccine administration client was about 37 weeks pregnant.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, HIBV, PNC13
Symptoms: Emotional disorder, Erythema, Injection site reaction, Rash, Rash macular
Clinical narrative: After 15 minutes the client had a non raised blotchy red rash on his upper chest and legs at the injection sites and reddened cheeks. The client did not appear to be itching the rash. The clients mother states that he gets red when he gets upset. The mother states the client is 25lbs and has no allergies. Per standing orders .3ml of benadryl was administered IM. After 20 mins the client was starting to calm down and the rash appeared to be getting lighter.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Mouth swelling, Urticaria
Clinical narrative: Parent called to report swelling around mouth and hives on body approximately 44 minutes after inoculation. Sent to ER now with parent taking child directly in.  Denied difficulty with swallowing or SOB.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: Pt had generalized rash on chest/abdomen morning of 2/8/18, Mom did not take patient to provider.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Pt has red area (circle in shape) not at the injection site but underneath the injection site. Pt says does not itch and not swollen or hard to touch. Pt says she has been on Benadryl so that may be why spot is not itching. Patient says only painful when lying on that arm.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Ammonia normal, Computerised tomogram head normal, Electroencephalogram, Generalised tonic-clonic seizure, Hepatic enzyme increased
Clinical narrative: On 01/29/18 patient came for well child exam. He had no fever or report of fever. He had conjunctivitis that day and was prescribed ophthalmic antibiotic drops. Closed Close to midnight the same day he had fever at home and had a tonic-clonic seizure. EMS called. Seizure lasted 20-25 minutes. Treated minutes, treated with medications, medications. Transported to ER. Head CT scan was normal. Patient was admitted for one day and discharged on only on DIASTAT in case of additional prolonged seizures. Initial temperature in the ER was 101.5. This was the highest temperature recorded.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Hepatitis viral test negative, Influenza virus test negative, Pyrexia, Toxicologic test abnormal, White blood cell count normal
Clinical narrative: On 01/29/18 patient came for well child exam. He had no fever or report of fever. He had conjunctivitis that day and was prescribed ophthalmic antibiotic drops. Closed Close to midnight the same day he had fever at home and had a tonic-clonic seizure. EMS called. Seizure lasted 20-25 minutes. Treated minutes, treated with medications, medications. Transported to ER. Head CT scan was normal. Patient was admitted for one day and discharged on only on DIASTAT in case of additional prolonged seizures. Initial temperature in the ER was 101.5. This was the highest temperature recorded.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant who reported that 2 unspecified patients (unknown ages and genders) were vaccinated, on an unknown date, with improperly stored VARIVAX, (lot # M048203, expiry date 07-DEC-2018) for prophylaxis. Information about patients' medical history, concurrent conditions and concomitant medications were not reported. The temperature excursion was reported as -12.8 degrees Celsius (°C) for 30 minutes. It was reported that the VARIVAX was administered after previous excursions as: -14.4°C for 8 hours, -10.6°C for 45 minutes, -13.3°C for 45 minutes, -12.8°C for 30 minutes. The case was reported (called) because of a data logger. No adverse symptoms reported.
Sex: U
Vaccine: HEP, PPV
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. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, frequency and route of administration was not provided) lot # N011491, expiration date 04-NOV2018, and lot # N022703 with expiration date 27-FEB-2019, for prophylaxis. Other suspect therapies included improperly stored doses of RECOMBIVAX HB, lot# M036153, expiration date 31-MAY-2018. The doses of PNEUMOVAX 23 and RECOMBIVAX HB were exposed to a temperature excursion below 32°Fahrenheit (°F) (28°F) during a time frame of 13 days, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a consumer and refers to her daughter, a 12 month old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JAN-2018, the patient was vaccinated with VARIVAX lot # N023957, expiration date 01-SEP-2019 (dose, route of administration and anatomical location were not reported) as a chicken pox vaccine (prophylaxis). On 07-FEB-2018, the patient developed chicken pox. It was reported that the patient did not receive any medical attention, no treatment was provided and that any Laboratory diagnostics or studies were performed. At the reporting time, the patient had not recovered from the event varicella post vaccine and the reporter did not assess the causal relationship between therapy with VARIVAX and the event.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Depressed level of consciousness, Dizziness, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Extreme high temperature-not taken-prob. 105 degrees (was at a local store) - profuse sweating, dizzy - ex. went extreme nausea-Almost passed out, employees almost carried me sit down-I thought I was having a heart attack-almost called ambulance. Came on slowly and then progressed rapidly. Vomiting in trash can. Very ill. I almost fell on floor. I should have called ambulance took 2 days to feel normal. This took place over course of approx 45 mins or 1 HR.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Extreme high temperature-not taken-prob. 105 degrees (was at a local store) - profuse sweating, dizzy - ex. went extreme nausea-Almost passed out, employees almost carried me sit down-I thought I was having a heart attack-almost called ambulance. Came on slowly and then progressed rapidly. Vomiting in trash can. Very ill. I almost fell on floor. I should have called ambulance took 2 days to feel normal. This took place over course of approx 45 mins or 1 HR.
Age: 10.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, Swelling, Pain to injection site.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient was vaccinated in the morning. Came in the afternoon with her left arm swell but without pain. She complain of itching on her left arm. Was advised to use BENADRYL for the itching and cold compress for the swelling.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Extreme pain in left arm where injected - after 2 weeks still pain - stiffness up in my neck.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Left arm/starting at shoulder/pain on use/raising arm or picking up/low heavy materials.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dehydration, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: After patient had flu shot Oct 29th 2017 within 2 weeks she became weak and short of breath and dizzy. Took her to Dr she said she probably had spot on her lung took her to Emergency-nothing on lungs said she was dehydrated. Sent her home. Next day she had diarrhea-I called Dr. she said it was flu. She would be fine in a couple of days.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: After patient had flu shot Oct 29th 2017 within 2 weeks she became weak and short of breath and dizzy. Took her to Dr she said she probably had spot on her lung took her to Emergency-nothing on lungs said she was dehydrated. Sent her home. Next day she had diarrhea-I called Dr. she said it was flu. She would be fine in a couple of days.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Right arm/pain descending down to fingers (digit 4 and 5).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: On 2/12/18, Patient reported still having pain and soreness at the injection site. Patient described pain as numbness and tingling at the injection site and hurts when lifting the arm and while moving and sleeping at the injection site arm. Suggested patient to consult with the doctor.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient received shot at 4:15pm on 02/11/2018. She reported pain, redness, swelling of 5-6 inches in length and itch on arm of injection at 8pm on the same day 02/11/2018. She went into an urgent care the next morning on 02/12/2018. She was prescribed PERCOCET 5/325, prednisone 5mg, cephalexin 250mg, and ALLEGRA 180mg.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: Patient received shot at 4:15pm on 02/11/2018. She reported pain, redness, swelling of 5-6 inches in length and itch on arm of injection at 8pm on the same day 02/11/2018. She went into an urgent care the next morning on 02/12/2018. She was prescribed PERCOCET 5/325, prednisone 5mg, cephalexin 250mg, and ALLEGRA 180mg.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Superficial pink raised itchy rash over entire lateral surface of right arm, where injection was given.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, MMRV, PNC13
Symptoms: Injection site swelling
Clinical narrative: Received 12M shots Hib, PCV13, MMRV, influenza on (L) VL. MMRV was given to swollen leg.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient taken to ED on 02/10/18. Vaccine given 02/09/18. From ED note: Rt. arm is red, warm and markedly swollen. Pt. given acetaminophen and diphenhydramine.
Age: 18.0
Sex: F
Vaccine: HIBV, HIBV, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Due to Human error - HIB was accidently given to pt. instead of MENACTRA that was ordered.
Age: 18.0
Sex: F
Vaccine: HIBV, HIBV, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Due to Human error - HIB was accidently given to pt. instead of MENACTRA that was ordered.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Unevaluable event
Clinical narrative: (R) VL influenza (FLUZONE), (L) VL SQ MMR/V (PROQUAD), (R) VL DtaP/IPV (KINRIX).
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced swelling and redness to site immediately after vaccine administered. Ice pack applied to site. No S/S of anaphylaxis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture urine negative, Influenza virus test negative, Lumbar puncture, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Approx 12 hours after 2 month vaccines had temp of 102.5. At ER, fever work up done including WBC 22k, spinal tap. ROCEPHIN given. All cultures negative.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: White blood cell count increased
Clinical narrative: Approx 12 hours after 2 month vaccines had temp of 102.5. At ER, fever work up done including WBC 22k, spinal tap. ROCEPHIN given. All cultures negative.
Age: 0.5
Sex: F
Vaccine: HEP, HPV9, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: HVP was mistakenly given by staff instead of PENTACEL; Mother notified about 1 hour later when mistake was discovered; no known adverse patient reactions at that time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Loss of consciousness, Palpitations, Pruritus, Syncope
Clinical narrative: Approximately 20 hours after vaccination pt stated that she fainted. When she regained consciousness she said her head felt "itchy", she had palpitations and felt "weird". She said she took one of her anti-anxiety tablets (alprazolam) and began to feel better. She had someone come to stay with her to observe her but that she was feeling better. She was advised to see medical treatment if symptoms returned.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Patient started to be itchy and started to get a rash and welts, as patient described. Patient took BENADRYL and it helped, but as soon as the effect of the BENADRYL wears off, she would get rash and welts again. Patient stated her whole body was itchy.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Crying, Fall, Feeling abnormal, Gait inability, Joint swelling
Clinical narrative: First weeks he was fuzzy dude to pain on his legs, by the forth week he was crying of pain at night not just during the day. I would help him by week 5 take a bath because his legs where giving up on him i thought he might of hurt him self but saw no bruces on his leg and knees. Three days before he was in hospital he cry so much he was fuzzy he would not eat drink as much he began to puke his food and milk his eye where dark i though he might of got sick but show no flu or sniffles. He would fall and not walk by the time i took him in he leg was big  and knee was big.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: First weeks he was fuzzy dude to pain on his legs, by the forth week he was crying of pain at night not just during the day. I would help him by week 5 take a bath because his legs where giving up on him i thought he might of hurt him self but saw no bruces on his leg and knees. Three days before he was in hospital he cry so much he was fuzzy he would not eat drink as much he began to puke his food and milk his eye where dark i though he might of got sick but show no flu or sniffles. He would fall and not walk by the time i took him in he leg was big  and knee was big.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Patient came in to the pharmacy to describe some of the side effects he experienced after receiving the SHINGRIX shot. He stated that approximately 24 hours after the shot, he was extremely fatigued but has improved since. He had also developed a rash which he noticed after he removed his band-aid 24 hours after the shot was initially administered. The rash appeared as of his visit on 2/12/18 at approximately 3:00 pm to be light-medium pink in color and approximately 3 to 4 inches in diameter.  He stated that it was slightly warm and slightly painful. He stated that he does not have a fever and is otherwise fine. Patient was recommended to continue observing the rash to see if it spreads or gets more warm or painful or intolerable, and if so he was instructed to inform his primary care physician.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Fatigue and itchy, red rash directly below  injection site, appeared 3 days after injection. Rash area is approximately 2.5 inches by 5 inches. Notified pharmacy and Dr. Advised to take Benadryl.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Fatigue and itchy, red rash directly below  injection site, appeared 3 days after injection. Rash area is approximately 2.5 inches by 5 inches. Notified pharmacy and Dr. Advised to take Benadryl.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Reddened area on left arm.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Redness that spread down arm from injection site starting 2/2. Still present on 2/11. Patient went to doctor and states she was told her lymph nodes were enlarged as well.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site discomfort, Pain, Pain in extremity
Clinical narrative: When vaccine given pt experienced "pressure" as it was going in. Ached all night (pain scale of 6-7 per pt). Arm sore the next day. Gone by day 2 post shot.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pallor, Panic attack, Paraesthesia, Skin warm
Clinical narrative: Patient complained of tingly/ numbness on arm a few minutes after shot. Arm felt warm, could feel, and could squeeze me back with force. Patient became increasingly pale, so had her lie down and rest a bit. After not being better after 10 minutes father asked me to call 911. Father drove patient to hospital after the paramedics checked her out. She had a panic attack as we suspected