chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Troponin increased
Clinical narrative: Patient was woken from sleep with crushing, burning chest pain, rated a 7/10 on pain scale, blood pressure was 155/90. Wife brought him to local ER, initial troponin level 2.13, recheck 1.5 hours later, 3.11. Transferred to larger city hospital, underwent several tests finally concluding with a cardiac catheterization, Cardiologist team diagnosed patient with myopericarditis.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, swelling, itching of anterior left thigh extending between L hip and L patella.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted directly after a Gardasil injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Low grade fever to 101.5 started afternoon of 8DEC, followed by appearance of pink bumps AM of 9DEC.  Eval by pediatrician around 10:30 AM, rash consistent with mild varicella rash, pink maculopapular lesions, no vesicles.  T=101.1 in clinic.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Rash, Skin warm
Clinical narrative: Rash. skin warm, firm, erythematous diffuse about 8 X 11 cm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. A 78-year-old, female patient of an unknown race was received immunization of PREVNAR 13 vaccine 0.5 ml single intramuscularly in the left arm in 12Nov2016 for pneumonia. The lot number was reported as N97935, expiration date was Dec2017 and NDC number was 00005-1971-02. "Alternatively it was reported that the site of administration was right" (R). Her relevant medical history included high blood pressure (HBP) and allergic to guanabana on an unknown date. The concomitant medication and past drug history were unknown. On 12Nov2016, the patient developed inflammation on the injection site. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 05Dec2016, the clinical outcome of the event inflammation on the injection site was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date between 08-OCT-2016 and 11-OCT-2016, the patients were vaccinated with improperly stored unspecified dose of GARDASIL 9 injection (dosing details were not reported) (lot # M016193, expiry date: 24-APR-2018) for prophylaxis which was stored at temperature of 1 degree centigrade for 4 hours as worst. There were no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Follow up information has been received on 30-NOV-2016, it was reported that a call was placed to the medical assistant, but he/she was unable to provide any further information. Additional information has been requested. Sender's Comments: US-009507513-1610USA007903: US-009507513-1610USA007902: MERCK 1610USA005738: Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M025870, expiry date 24-MAY-2018, dose, strength, vaccination site, route unspecified) for prophylaxis. The vaccines were exposed to a temperature of 11 Fahrenheit (F) for 24 hours. Stability questions were asked about M-M-R II during the call, however no doses of improperly stored MMRII doses were administered to patients. Digital data logger was not involved. There were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Follow-up information was received on 30-NOV-2016 from a telephone call to the reporter. A message was left on voice mail for a return phone call for patient identifiers and dates of vaccinations. No other information was reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA007027: MERCK 1610USA005924: Mfr number.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a allied health official refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with VAQTA, M001815, 20-SEP-2017, L039659 15-MAR-2017, K018181 04-JUN-2017, M018644 20-SEP-2017 for prophylaxis. No adverse effects reported. Temperature 13.5 degree centigrade for 10 hours and 14.8 degree centigrade for 43.75 hours. Data logger was unsure. There was no previous temperature excursion. This is one of the three reports received from the same reporter. Follow-up information was received from a telephone call to the reporter.  A message was left on voice mail for a return phone call with patient identifiers and dates of vaccinations. No other information was reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1610USA007021: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9, lot # M013636, 15-FEB-2018, lot # M009378, 23-APR-2018, lot # M014927 expiration 18-FEB-2019 for prophylaxis. No adverse effects reported. Temperature excursion 10-AUG-2016 50.5 F for 1hour and 12mins, 18-AUG-2016 49.6F for 29mins, 29-AUG-2016 47.1 F for 21mins, 06-SEP-2016 48.2F for 12mins, 15-SEP-2016 47.4F for 25mins, 23-SEP-2016 34.1F for 1hour 13mins, 24-SEP-2016 34.7 F for 33mins, 25-SEP-2016 35F for 18mins, 26-SEP-2016 53.2 for 1hour 15mins. High temperatures 53.2 F 262 minutes, Low temperatures 34.1F 124 mins. Follow-up information has been received on 30-NOV-2016. All telephone attemps to obtain follow-up information have been unsuccessful. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: MERCK 1610USA008045: Mfr number.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 6 month old patient of unknown gender patient. The patient's pertinent medical history, drug reaction/allergies or concomitant medication information was not reported. In approximately July and September 2016 (reported as "at 2 months of age and 4 months of age") the patient was vaccinated with doses of PENTACEL. On 17-NOV-2016, the patient was vaccinated with PEDVAXHIB 0.5 ml, intramuscularly, lot # L042836, expiration date: 24-AUG-2018, with PENTACEL 0.5 ml, intramuscularly (lot # and expiration date were not reported) and with PREVNAR 13 0.5 ml, intramuscularly (lot # and expiration date were not reported), all therapies for prophylaxis. No adverse effects were reported. There was any adverse event reported.  Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy, Impulsive behaviour
Clinical narrative: This spontaneous report was received from the patient's grandmother referring to her grandson a male patient of unknown age. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. In approximately 2010 (reported as "about six years ago"), the patient's mother received a dose of GARDASIL (route, dosage schedule, lot # and expiration date were not reported) for prophylaxis while pregnant. The reporter also stated that since an unknown date (reported as "now") the patient was "acting out" (impulsive behavior). The outcome of the patient's Impulsive behavior and was unknown at the reporting time. The reporter did not assess causality between the event and the use of GARDASIL. This is one of two reports received from the same reporter. The reporter considered the event to be a congenital anomaly. This case has been submitted with an incorrect E2B Linked report reported as 009507513-US-1611USA007732. Therefore, this version is also being created to report the correct E2B Linked report for this case which is US-009507513-1611USA007732. Upon internal clarification, this case has been downgraded from medically significant to non serious. Additional information is not expected as the reported refused contact for follow up. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between Gardasil and the reported serious event of impulsive behavior cannot be established. In addition, impulsive behavior is not uncommon in the general population. This report also contains the nonserious event of fetal exposure during pregnancy. Company Comment- No changes to the product safety information are warranted at this time.  Merck and Co., Inc., continues to monitor the safety profile of the product. Sender's Comments: US-009507513-1611USA007732: MERCK 1612USA000539: Mfr number.
Sex: F
Vaccine: MENB
Symptoms: Insomnia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received the first dose of 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, the patient experienced nausea for two days and couldn't sleep. The clinical outcome of the event, nausea for two days and couldn't sleep, was unknown.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Possible increase in reaction at local site of injection.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Muscle pain, electrical shock traveling from ear to injection site.
Age: 53.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site urticaria
Clinical narrative: PATIENT PRESENTED INFLAMED, REDNESS, AND MODERATE TO SEVERE URTICARIA AT THE SITE OF IMMUNIZATION. PATIENT WAS MANAGED WITH A COURSE OF DIPHENHYDRAMINE 50 MG.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: 5/7 left arm pain, decreased range of motion.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12/08/16 -patient reports left deltoid injection site became red; swollen; painful & hot to the touch. Went to ER. ER MD advised heat compresses & follow up with MD 12/09/16 patient came in for OV left deltoid injection site: 3cm x 3cm swollen, hot & painful to the touch. MD eval: Local swelling & tenderness; + joint & back pain.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Local swelling, Tenderness, X-ray limb
Clinical narrative: 12/08/16 -patient reports left deltoid injection site became red; swollen; painful & hot to the touch. Went to ER. ER MD advised heat compresses & follow up with MD 12/09/16 patient came in for OV left deltoid injection site: 3cm x 3cm swollen, hot & painful to the touch. MD eval: Local swelling & tenderness; + joint & back pain.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Aphasia, Asterixis, Autism, Crying, Decreased eye contact
Clinical narrative: Prior to this immunization patient was a normally functioning boy.  Patient fevered and became cranky the day of the immunization.  The next day he lost most of his speech, he could not make eye regular contact, he began stimming and flapping and jargoning.  He began spitting.  He demonstrated a lack of social skills and he cried on and off throughout his days with the smallest frustration.  He was unable to keep his body still, jumping around all day in order to register sensory input and he was unable to focus.  This lasted for six months until he was brought to an herbalist and patient underwent herbal chelation and treatment to boost his immune system.  Patient has been restored to normal functioning twice and twice he has regressed directly after immunizations, even when only being given one at a time.  This was documented by his ABA therapist, his speech therapist and his teachers.  For some unknown reason, patient's immune system cannot handle immunizations.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Disturbance in attention, Disturbance in social behaviour, Dyskinesia, Frustration tolerance decreased, Immune system disorder
Clinical narrative: Prior to this immunization patient was a normally functioning boy.  Patient fevered and became cranky the day of the immunization.  The next day he lost most of his speech, he could not make eye regular contact, he began stimming and flapping and jargoning.  He began spitting.  He demonstrated a lack of social skills and he cried on and off throughout his days with the smallest frustration.  He was unable to keep his body still, jumping around all day in order to register sensory input and he was unable to focus.  This lasted for six months until he was brought to an herbalist and patient underwent herbal chelation and treatment to boost his immune system.  Patient has been restored to normal functioning twice and twice he has regressed directly after immunizations, even when only being given one at a time.  This was documented by his ABA therapist, his speech therapist and his teachers.  For some unknown reason, patient's immune system cannot handle immunizations.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Irritability, Pyrexia
Clinical narrative: Prior to this immunization patient was a normally functioning boy.  Patient fevered and became cranky the day of the immunization.  The next day he lost most of his speech, he could not make eye regular contact, he began stimming and flapping and jargoning.  He began spitting.  He demonstrated a lack of social skills and he cried on and off throughout his days with the smallest frustration.  He was unable to keep his body still, jumping around all day in order to register sensory input and he was unable to focus.  This lasted for six months until he was brought to an herbalist and patient underwent herbal chelation and treatment to boost his immune system.  Patient has been restored to normal functioning twice and twice he has regressed directly after immunizations, even when only being given one at a time.  This was documented by his ABA therapist, his speech therapist and his teachers.  For some unknown reason, patient's immune system cannot handle immunizations.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt returned to clinic to complain of sore, red left arm that started night of vaccination.  Today progressed to left bicep area although injection in deltoid.  Left inside of bicep area to antecubital area with diffuse redness and warmth noted.  No other break in skin noted.  Slight swelling noted to lower end of bicep area, but full range of motion of left arm noted.  No redness, ecchymosis, or swelling noted to Left deltoid.  Patient states pain in left arm is minimal but still concerned about reaction.  Encouraged to try moist heat to arm and follow-up with primary care or urgent care today or tomorrow if no improvement or increase in pain, redness, swelling or develops any fever.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Pain in arm at injection site that increased over time. Patient reports pain radiates into neck and down to elbow. Patient reports difficulty raising arm above shoulder height.
Age: 4.0
Sex: M
Vaccine: FLU4, HEP, PNC13
Symptoms: Blepharospasm
Clinical narrative: Preschool Called stating that the child was having displaying "eye twitching".  He was NOT displaying any LOC or respiratory signs or symptoms at this time.  They were encouraged to seek medical advice by his medical provider. No one medical personnel from our District Health Department Nursing or our medical director ever saw this child while he was displaying this "event" Nor has any Medical provider ever reported anything to us regarding this event. Follow-up with school has been done. Child has not shown any further s/s.  School has stated parents have not mentioned anything about this any further. This nurse left a message for mother to call back with no returned phone call. RN
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Began to have body aches mid-morning that lasted all day.  Late morning had chills.  Had fever (101.5) and chills into the evening of 12/6/16 and lasted until morning of 12/7/16.  12/7/16 had a very swollen and painful lymph node / gland under left arm.  Had Tdap on my left are on 12/5/16.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood test, Electroencephalogram, Lumbar puncture, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Started having blank stares after 24 hours it became increasingly concerning so we went to ER they ran tests and showed she had constant seizure activity. Put on a pharmaceutical with no help. Continues to have constant seizures.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Staring
Clinical narrative: Started having blank stares after 24 hours it became increasingly concerning so we went to ER they ran tests and showed she had constant seizure activity. Put on a pharmaceutical with no help. Continues to have constant seizures.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Ear pain, Headache, Neck pain
Clinical narrative: Instant pain in neck and ear at time of injection. Has had mild headache since then. No treatment sought.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received on 14-NOV-2016 from pharmacist referring to a 23 year old patient (gender not reported.) The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-NOV-2016, the patient, age 23, was vaccinated with GARDASIL 9 lot # M032650 expiration 31-MAR-2019, dose 2, intramuscular for prophylaxis which was 1 month after first dose of GARDASIL 9 was administered. No further effects were reported. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity, Peripheral swelling, Ultrasound scan normal
Clinical narrative: This case was received from Pfizer, Inc (manufacturer report# 2016505408) on 14-NOV-2016. Information had been received from a nurse who was reporting on two patients who received the PREVNAR 13 shot and experienced severe arm pain. One of the patients was given prednisone and her arm pain had resolved (see MARRS# 1612USA004838). The other patient who received the PREVNAR 13 on 01-JUN-2016 has continued arm pain with limited mobility of that arm. The reporter clarified that the patients received PNEUMOVAX23. On 01-JUN-2016, a 68 year old female patient with arthritis and vitamin D deficiency received PNEUMOVAX23 (lot# L019836, expiration date 24-MAR-2017) 0.5 ml injected in right deltoid as preventative for pneumonia. On 27-APR-2016, patient had received Tdap vaccination in left deltoid. Concomitant medications included TOULEO 30 units at bedtime injected subcutaneously for diabetes (October 2015 - ongoing), metformin 1 gram twice daily for diabetes (start date unknown - ongoing) and losartan 50mg once daily for blood pressure high (start date unknown - ongoing). In August 2016, patient came to the doctor's office and reported that she has had arm pain since she received the PNEUMOVAX23 and it rated a 10/10 on the pain scale. The arm pain and limited mobility of the arm started right after receiving PNEUMOVAX23 on 01-JUN-2016. Patient also came back to the doctor's office in October 2016 and on 25-OCT-2016 to have a Duplex performed to check for blood clots because of the pain and swelling in her arm, but it came back normal. Onset of swelling arm was unknown. The outcome of severe arm pain, swelling arm and limited mobility of arm was reported as persisting. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VARIVAX (lot # M009766, expiration date 23-FEB-2018 and lot # M019641, expiration date 20-APR-2018) administered subcutaneously (dose and anatomical location of administration were not reported) for prophylaxis. No adverse effects were reported nor product quality complaint was involved. The vaccine had one temperature excursion of -13.3 Celsius (C) during 4 hours. With no previous temperature excursion and no data logger involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA008252.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not provided. On 02-DEC-2016, was vaccinated with ZOSTAVAX Lot # reported: M020921, expiration date 12-JUL-2016 (strength, dose and route were not reported) for prophylaxis. The reporter stated that approximately half of the vaccine leaked out of a faulty syringe onto the pharmacist arm (Case # 1612USA004857) and the patient's finger. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA004857.
Sex: M
Vaccine: HPV4
Symptoms: Autoimmune disorder, Headache, Malaise
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) via social media refers to a male patient of unknown age. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with GARDASIL, (dose, dose #, route, lot # and expiration date unknown) for prophylaxis. No concomitant medications were reported. The patient's mother reported that she thought this vaccine was great until she had her son vaccinated, knowing he could only be a carrier not get cervical cancer. On unknown dates, he stayed sick shortly after each round of vaccination and had bad headaches. Since an unknown date (reported as now), the patient had been experiencing autoimmune problems. The reporter also stated that, the vaccine only works for five years and it is not worth the fall out of the vaccine as it has too many side effects. The outcome of the events was unknown. The reporter did not provide causality assessment for the events. No product quality complaint was involved. Upon internal review, autoimmune problems was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information had been received from Pfizer, Inc (manufacturer report# 2016505408) on 14-NOV-2016 regarding a case for PNEUMOVAX23 (MARRS# 1611USA007354). Information had been received from a nurse who reported that a female patient (age unknown) received PREVNAR 13 shot and experienced severe arm pain (date not reported). On an unknown date, the patient was given prednisone and her arm pain had resolved. The reporter clarified that the patient received PNEUMOVAX23. This is one of two reports from the same reporter. No further information is anticipated.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist concerning him/herself, a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not provided. On 02-DEC-2016, the pharmacist was administering a dose of ZOSTAVAX Lot # reported: M020921, expiration date 12-JUL-2016 (strength, dose and route were not reported) to an unspecified patient (case # 1612USA001749). The reporter stated that approximately half of the vaccine leaked out of a faulty syringe onto the pharmacist arm. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001749:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Patient experienced bright red rashes (non-blistering) all across body 3-4 days after vaccine administered.  Patient has followed up with a physician within several days of their reaction, who is currently managing their condition.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site irritation, Injection site scab
Clinical narrative: Site red & irritated, became infected cleaned w/alcohol put neopsorin on it. never healed took 7 days antibiotic, still didn't heal for 4 weeks. at 5 weeks finally looks better small scab, scar, and hard bump where it is healed.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site scar, Injection site swelling
Clinical narrative: Site red & irritated, became infected cleaned w/alcohol put neopsorin on it. never healed took 7 days antibiotic, still didn't heal for 4 weeks. at 5 weeks finally looks better small scab, scar, and hard bump where it is healed.
Age: 57.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Sore arm & temperature of 99-100.
Age: 33.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Pain at injection site. Redness, swelling, and bruising at injection site. Nausea. A hard knot formed in the muscle under the injection site. It took approximately 7 weeks for the swelling, bruising, and muscle not to self-resolve.
Age: 33.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Nausea
Clinical narrative: Pain at injection site. Redness, swelling, and bruising at injection site. Nausea. A hard knot formed in the muscle under the injection site. It took approximately 7 weeks for the swelling, bruising, and muscle not to self-resolve.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pyrexia, Skin warm, Tenderness
Clinical narrative: Patient called me on 12/09 and she said after receiving her vaccine on 12/6 she started experiencing redness and hot in the arm ( the same night) she used cold compresses but didn't help, I advised her to take Benadryl 75 mg every 8 hours , she just took it once and she stopped , few hours after the first dose of Benadryl, she started having the same problem, today (12/9) she said the front of her arm started getting red, I asked her to come to pharmacy, I looked at it , the lower part of arm was completely red and painful to touch, the upper part of arm started getting red as well, she mentioned the first day she had fever as well, I asked her to continue taking benadryl and she can take advil and I asked her if it did not get better or got worst, she has to call her doctor office and pharmacy.
Age: 70.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Contraindication to vaccination, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported she presented to MC Immunizations clinic on 7 December to receive her seasonal influenza vaccine and was offered the Zoster vaccine given her age. She indicated she was not questioned regarding which medications she is taking, but stated she was shown a list of medications which would be a contraindication to receiving the vaccine (including Enbrel and Prednisone) after she received the vaccine. She complained of onset of a dull, bitemporal headache the morning of 8 December but denied photophobia, nausea/vomiting, neck stiffness, and fever/chills. She also complained of redness, swelling, and itching affecting the site where she received the Zoster vaccine (examination revealed a 50x60mm area of erythema, induration, and warmth at the vaccination site). She denied rash. She is currently taking Prednisone 1mg daily and Enbrel 50mg weekly.
Age: 70.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: Patient reported she presented to MC Immunizations clinic on 7 December to receive her seasonal influenza vaccine and was offered the Zoster vaccine given her age. She indicated she was not questioned regarding which medications she is taking, but stated she was shown a list of medications which would be a contraindication to receiving the vaccine (including Enbrel and Prednisone) after she received the vaccine. She complained of onset of a dull, bitemporal headache the morning of 8 December but denied photophobia, nausea/vomiting, neck stiffness, and fever/chills. She also complained of redness, swelling, and itching affecting the site where she received the Zoster vaccine (examination revealed a 50x60mm area of erythema, induration, and warmth at the vaccination site). She denied rash. She is currently taking Prednisone 1mg daily and Enbrel 50mg weekly.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient c/o redness at site of injection (Left deltoid) tenderness to touch and off and on fever. Required a doctors visit to assess the injection site. There was no need to go to the hospital. Patient recovered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, hot.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: Continuing pain reported 11/14/16.  Patient unable to raise arm.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pain in left arm and "blood red" armpit area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Noticed soreness, redness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hot flush, Pain in extremity, Pyrexia
Clinical narrative: Per mother fever + righ arm pain + hot flashes x1day.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Full blood count, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: Kawasaki disease was admitted to the hospital and given IVIG and REMICADE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Metabolic function test, Microscopy, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Kawasaki disease was admitted to the hospital and given IVIG and REMICADE.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Had flu shot on Monday left leg is red and swollen not feeling well. Tuesday woke up and leg was red, today school call and said it was hot; hurt to touch,
Age: 72.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abasia, Asthenia, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Patient's symptoms started 2 hours after administration of vaccine and included shortness of breath, headache, blurry vision, generalized numbness and weakness, couldn't walk. Went to hospital where no treatment was given. Symptoms fully resolved by midday.
Age: 72.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vision blurred
Clinical narrative: Patient's symptoms started 2 hours after administration of vaccine and included shortness of breath, headache, blurry vision, generalized numbness and weakness, couldn't walk. Went to hospital where no treatment was given. Symptoms fully resolved by midday.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Patient called on 12-9-16 morning stating following symptoms. Chills, headache, fever, body ache, muscle ache.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given a Tdap injection when he should have received a DTaP no adverse reaction had.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot
Clinical narrative: Patient states 12hours after vaccination her hands started to get hot on both arms. Patient reported problem 12-9-16. At this time she states the problem has improved but her hands still feel hot on a daily basis.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: 2 inch red warm lump at imm. site. No streaking, no fever.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling with faint erythema size of baseball.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Left arm pain for 10 days and muscle spasms.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling
Clinical narrative: (L) upper arm swollen, erythematous w/streaking-> (L) chest.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling of thigh where immunization given. Slight red and tender.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given an adult dose of hep A vaccine when he was suppose to get the pediatric dose of Hep A vaccine.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Itchiness, redness, a little swelling; looked like hives - took BENADRYL -had vaccine last year w/no rxn.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash w/in 7-10 day of MMR.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Interchange of vaccine products, Nausea, Presyncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received BEXSERO (batch number 157601, expiry date 31st August 2017). Co-suspect products included TRUMENBA. On 22nd September 2016, the patient received BEXSERO .5 ml. In July 2016, the patient received TRUMENBA. On 22nd September 2016, an unknown time after receiving BEXSERO, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown. Additional details were provided as follows: The patient received a dose of BEXSERO after receiving TRUMENBA, which led to an interchange of vaccine products. No further information was reported regarding the event. Follow up information was received from nurse on 30th November 2016. The patient stated that he had a bowl of cereal at around 9:45 am and had not eaten anything since then, on the day of vaccination. The patient experienced vasovagal response with slight nausea and lightheadedness after approximately 5 minutes after receiving BEXSERO (11:15 am). The patient was given sugar and placed lying down with legs raised. 10 minute after the onset of events the patient reported feeling better. On 22nd September 2016, the patient's blood pressure was noted as 111/64 mm  Hg, pulse rate was 76, and oral temperature was 97.7 degree F. The nurse contacted GlaxoSmithKline Biologicals and spoke with the doctor of Pharmacy and was told that no tests have been evaluated to determine the interchangeability of BEXSERO and TRUMENBA. The VAERS details were updated.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of therapy non-responder in a patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter consider they therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, on unknown dates, an unspecified patient received 3 doses of ENGERIX B. On an unknown date, after receiving 3 doses of ENGERIX B, the patient had titer drawn, and the titers came back as not immune, which led to not responding to therapy. No further information was provided.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: On 12/7/16 patient given the solution portion of PENTACEL immunization. Did not mix solution with the powdered vial to give DTaP IPV and Hib mix.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Per 8/31/16 ER Attending note: Pt presented for L arm swelling/warmth/redness that began as a probable local reaction to pneumococcal vaccine now with evidence of superimposed infection. Patient discharged home with Doxycycline with instructions to follow-up in ER in 2 days for recheck. Left arm swelling/warmth/redness. Diphenhydramine 1 cap po q6hr prn, Doxycycline 1 pill po q12h x 7 days.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Skin hypopigmentation, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash urticaria-like in a 3-year-old male patient who received INFANRIX (batch number 5775L, expiry date 16th October 2017. On an unknown date, the patient received INFANRIX. On an unknown date, less than a year after receiving INFANRIX, the patient experienced rash urticaria-like and skin hypopigmentation. On an unknown date, the outcome of the rash urticaria-like was not recovered/not resolved and the outcome of the skin hypopigmentation was unknown. It was unknown if the reporter considered the rash urticaria-like and skin hypopigmentation to be related to INFANRIX. Additional details were provided as follows: This case was identified as duplicated of US2016178766. Case US2016178766 was deleted and all the future correspondence will be added in the present case which stands as a case of record for this patient. The healthcare professional stated that the mother called the doctor and said that the patient developed 6-8 hive like spots on both arms following vaccination with INFANRIX. The patient also developed spots of loss of pigment on both arms. The healthcare professional while examination of the patient noticed bilateral hypo-pigmented spots on arms, and was not sure if relate to vaccination. The reporter did not know if the hive like spots turned into the hypo pigmented spots. The reporter was unsure of how long after vaccination the hives developed or resolved. The date of vaccination was not sure to be 27th October 2016 or 31st August 2016, clarification requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received KINRIX (batch number MH9T7, expiry date 29th September 2017). On 25th April 2016, the patient received KINRIX. In May 2016, less than a month after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash to be related to KINRIX. Additional details were provided as follows: This case was not associated with product complaint. The healthcare professional reported that the patient experienced monthly a 2 to 2.5 inches raised red rash with swelling, itchy at the injection site which lasted for 3 to 4 days after receiving KINRIX. The rash occurs every month. On 23rd November 2016, the patient was last seen at the practice office and rash was present at that time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received KINRIX (batch number MH9T7, expiry date 29th September 2017). On 25th April 2016, the patient received KINRIX. In May 2016, less than a month after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash to be related to KINRIX. Additional details were provided as follows: This case was not associated with product complaint. The healthcare professional reported that the patient experienced monthly a 2 to 2.5 inches raised red rash with swelling, itchy at the injection site which lasted for 3 to 4 days after receiving KINRIX. The rash occurs every month. On 23rd November 2016, the patient was last seen at the practice office and rash was present at that time.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Discomfort, Erythema, Skin warm, Swelling
Clinical narrative: Patient reported on 11/23 swelling, discomfort, area encircled with marker approximately 2in in diameter, red, raised and warm to touch, without fever or drainage. On 11/25/16 patient called and now 5-6 inches in diameter. Diagnosed with cellulitis upper arm and prescribed Cephalexin 500 mg 1 capsule four times daily for 5 days.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt. work up approximately 12 hrs after an ADACEL shot with dizziness and vomiting that has last most of the day. Advised to stay hydrated, see Dr. if worse. (Pt had hit his head on a rusty nail at work earlier in the day, so came for ADACEL).
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Redness, heat at injection site. Initially after general malaise- No SOB, (+) f/cH.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 4 cm swelling and redness to (L) arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site mass, Swelling
Clinical narrative: Patient has large red and raised area on right underarm. States painful and warm - with hardness lump at injection site. Erythema: 5-6in wide x 12 in long on 12/9/16.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Local swelling at the injection sight. She was instructed to take BENADRYL and put ice on the site. She said that helped to get the swelling down. It looks better but not totally gone. If not gone by Monday she will go to the doctor. She thinks it's going away.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) shoulder developed 3 inch x 2 inch large area of redness to induration. All resolved spontaneously in 4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: 12/9/16 1:00p injection site presented with no visible issues below site rt. upper arm, above elbow is warm to the touch. Site is approximately 6 in (l), 3 in (w). No fever. Pt. complains she "can't put weight on it". Notified MD 1:16 pm 12/9/16.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Influenza like illness, Injection site swelling
Clinical narrative: The patient's left arm turned red and swelled; the swelling was from the elbow to the shoulder. The redness and swelling remained for about one week. The patient also reported feeling "achy like the flu" for about one week. No medications were taken to relieve these symptoms and no treatment was sought.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, hot rash, muscle pain, headache, tired, from 2" above injection site to mid upper arm.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Redness, swelling, hot rash, muscle pain, headache, tired, from 2" above injection site to mid upper arm.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot rash, muscle pain, headache, tired, from 2" above injection site to mid upper arm.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Redness, swelling, hot rash, muscle pain, headache, tired, from two inches above injection site to elbow.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Redness, swelling, hot rash, muscle pain, headache, tired, from two inches above injection site to elbow.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot rash, muscle pain, headache, tired, from two inches above injection site to elbow.