chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a currently 1-year-old patient of an unknown gender. There was no information about the patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot number: M009745, expiration date: 23-AUG-2017 (strength, dose, frequency, route, and anatomical location were not reported) for prophylaxis. The vaccine was exposed to a temperature that remained between -15 and - 10 Celsius degrees, for 60 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of three reports from the same source. There was no product quality complaint involved. Additional information has been requested.; Sender's Comments: US-009507513-1703USA002315: US-009507513-1702USA004244:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. From November 2016 to 23-FEB-2017, improperly stored doses of PROQUAD (dose, strength, frequency and route were unknown, lot # M037652 with expiration date 28-FEB-2018, lot# M038862 with expiration date 13-MAR-2018) were each administered to the unspecified patients for immunization. The PROQUAD was exposed -4.3 Celsius for a time frame of 1 hour 18 minutes. The previous temperature excursions of the PROQUAD with lot# M037652 are from -15 Celsius to -10 Celsius in 3 hours 59 minutes and from -10 Celsius to 8 Celsius in 1 hour 10 minutes. The previous temperature excursions of the PROQUAD with lot# M038862 are a range between -10 Celsius and -8 Celsius in 10 hours 40 minutes and a range between -15 Celsius and -10 Celsius  in 3 hour 59 minutes. A data logger was in use. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA011099.
Age: 7.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Migraine
Clinical narrative: Initial unsolicited report received from a patient's parent on 23-FEB-2017. This case involves a 7-year-old female patient who was subcutaneously vaccinated with a dose of MENOMUNE (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 19-SEP-2007. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none and Illness at the time of vaccination was reported as no. Any other vaccinations within four weeks of vaccinations and concomitant medications were also not reported. On 20-SEP-2007, one day following the vaccination the patient had experienced a severe headache which was diagnosed as migraine. The patient had a doctor visit (Neurologist) on an unknown date. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from physician on 23 Feb 2017. This case involves three patients (age and gender not reported) who were vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an unspecified date. The patient's medical history was not reported. Any other vaccinations within 4 weeks of vaccinations and illness at time of vaccination was reported as none. On an unspecified date, following the vaccination, the patient had experienced flu like symptoms. Patient required emergency room visit. Lab data was reported as none. The patient received corrective treatment with TAMIFLU. The patients was not recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: VARZOS
Symptoms: Beta haemolytic streptococcal infection, Vulvovaginal burning sensation, Vulvovaginal erythema
Clinical narrative: This spontaneous report was received from a female consumer of an unknown age referring to herself. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 30-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX) route reported as vaccine (dose, frequency, lot # and expiration date were not reported), for prophylaxis. On approximately 25-OCT-2016 (reported as "eight weeks later"), she got Group B Strep (Beta haemolytic streptococcal infection) and red burning down in private area (Burning sensation) (Localized erythema). The patient sought medical attention and she was prescribed with and unspecified antibiotic which has not worked. The outcome of the mentioned adverse events was unknown. The causality between the aforementioned adverse events and ZOSTAVAX were unknown. No product quality complaint was involved (PQC). Additional information is not expected, as there was no consent to contact.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via other company Pfizer and refers to an approximately 65 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, frequency, dose, route, batch/lot number and expiry date not reported) for prophylaxis. On an unknown date the patient experienced swollen arm  and injection site pain. The reporter considered peripheral the events to be related to PNEUMOVAX 23. The outcome of the events were unknown. This is one of 3 reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002598.
Sex: F
Vaccine: HPV9
Symptoms: Hypotension
Clinical narrative: This spontaneous report was received from a physician, via company representative, regarding a 20 year old white female patient. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, lot number and expiration date were not reported) for prophylaxis. In approximately January 2017 (reported as "after the shot, about 2 months ago"), the patient presented with persistent low blood pressure. At the time of reporting, she was on an unspecified medication to keep her blood pressure up. The outcome of the event was unknown at the reporting time. The reporter did not provide a causality assessment between hypotension and the suspect therapy. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Infantile spasms, Seizure
Clinical narrative: Infantile spasms (seizures).
Age: 10.0
Sex: M
Vaccine: HEPA, MMRV, TDAP
Symptoms: Blister, Erythema
Clinical narrative: Redness with bullseye mark and blisters.
Age: 5.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Crying, Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At the injection site, the entire thigh started to swell and heat up. It swelled up the point of pain and crying in my son. We took him to the walk in, where they said it could be an infection or an allergic reaction. They circled the swollen, red area, which was already the size of his entire thigh. We iced it and had him rest. The next day the swelling was bigger, he was limping, and pain was still there. The previous year for his flu shot, at the injection site of his arm, it did the same thing. At that time, however, we thought it was an infection since they too asked to do anitbiotics. After about 4 days it went away. However, when we did the flu shot this year and saw how it was the same reaction at a different injection site, I am leery of what is going on. It took about 5 days for the swelling, heat, and pain to clear up. We did also try antibiotics, but this time it didn't help it.
Age: 5.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site warmth
Clinical narrative: At the injection site, the entire thigh started to swell and heat up. It swelled up the point of pain and crying in my son. We took him to the walk in, where they said it could be an infection or an allergic reaction. They circled the swollen, red area, which was already the size of his entire thigh. We iced it and had him rest. The next day the swelling was bigger, he was limping, and pain was still there. The previous year for his flu shot, at the injection site of his arm, it did the same thing. At that time, however, we thought it was an infection since they too asked to do anitbiotics. After about 4 days it went away. However, when we did the flu shot this year and saw how it was the same reaction at a different injection site, I am leery of what is going on. It took about 5 days for the swelling, heat, and pain to clear up. We did also try antibiotics, but this time it didn't help it.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test positive, Dermatitis allergic
Clinical narrative: Pt had an allergic skin reaction to that required treatment from a physician. Physician had told pt that it was most likely due to the ZOSTAVAX vaccine or a component in the vaccine.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Abdominal pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: 3 days of fevers abdominal pain and nausea and diarrhea.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Epilepsy
Clinical narrative: Seen in Emergency Department on 3/3/17 for epilepticus due to refractory epilepsy.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client given vaccines of schedule.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Lip swelling, Swelling face
Clinical narrative: Began with swollen cheek, swelling spread to lips and other cheek, subsided after  3 days. This was PREVNAR-23; No previous reaction to PREVNAR-13 administered March 2016.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right thigh red, swollen et tender to touch. Treatment Keflex 400/5ml 5ml TID x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Localized redness, hard raised quarter size.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-FEB-2017, the patient was vaccinated with an expired dose of VAQTA injection, lot # L031196 with expiry date of 05-FEB-2017 (dose, route and site of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 23-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (route, lot # and expiration date were not reported). On 01-MAR-2017, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX subcutaneous for prophylaxis (lot # and expiration date were not reported). No side effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received on 02-MAR-2017 from a physician regarding a female patient of unknown age (reported as a child.) The patient's concurrent conditions, medical history and concomitant therapy were not reported. In the fall of 2015, the patient was vaccinated with PROQUAD (lot number and expiration not reported) subcutaneous for prophylaxis and was also vaccinated with a dose of FLUMIST (INTRANASAL (COLD) in the fall of 2015, with the doses of the vaccines given 2 weeks apart from one another. No adverse effects were reported. No additional information was available. Additional information is not expected because the reported did not give consent to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. The physician reported for her son. A 3 year-old male patient received four doses of PREVENAR 13 single dose, on an unknown date, for immunization. Relevant medical history included chronic sinusitis (he was constantly sick with chronic sinusitis before receiving pneumococcal 13-val conj vac (dipht crm197 protein)). Concomitant medications were unknown. It was reported that on 29Dec2016 his titer levels were checked and they showed no response despite receiving all four doses of (PREVENAR 13. After the titer level did not show response to PREVENAR 13, the physician tried PNEUMOVAX on 12Jan2017 but the results back were the same (on 22Feb2017). PNEUMOVAX was not considered successful either.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site nerve damage, Pain
Clinical narrative: PT'S FATHER CLAIMS THE FLU SHOT HIT A NERVE AND NOW HIS SON CANNOT LIFT HIS ARM WITHOUT PAIN.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Angioedema, Injection site pain
Clinical narrative: Leg pain at injection site on right thigh associated with leg angioedema.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fall, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: She was sitting quietly on couch. No pain. no fever. fell of cough. was unresponsive with brief tonic seizure. No history of seizures in past.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Eye swelling, Lip swelling, Pruritus, Rash generalised
Clinical narrative: Hives and rashes covering all surfaces of skin including palms and soles of feet. Intense Itching. Joint pain in hands and wrists swelling of skin around eyes and lower lip.  Topical benadryl and hydrocortisone not helpful. Urgent care administered steriod shot and RX for cream. Limited treatment because of breastfeeding newborn.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives and rashes covering all surfaces of skin including palms and soles of feet. Intense Itching. Joint pain in hands and wrists swelling of skin around eyes and lower lip.  Topical benadryl and hydrocortisone not helpful. Urgent care administered steriod shot and RX for cream. Limited treatment because of breastfeeding newborn.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: 2 year old was given a full dose of FLUZONE (0.5mL) rather than (0.25mL).
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray limb
Clinical narrative: Pain at injection site, pain in shoulder, arm, pain radiates down arm.
Age: 58.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray limb normal
Clinical narrative: Pain at injection site, pain in shoulder, arm, pain radiates down arm.
Age: 72.0
Sex: M
Vaccine: HEPA, IPV, MMR, TD
Symptoms: Joint stiffness, Pain, Swelling
Clinical narrative: Pain, swelling, stiffness to bilateral wrists and knees. Worse in AM, improves throughout the day.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Breath holding, C-reactive protein normal, Cyanosis, Full blood count normal, Hypotonia
Clinical narrative: 3/4 towards afternoon mom was changing diaper and child's fists and jaw clenched, seemed to be holding breath. Had lips turn blue. Denies tonic-clonic movements, emesis or incontinence. Lasted about 2 min, then child started to breath normally, but body was limp and he was "out of it." Post ictal state lasted prob about 1.5-2hrs. Was taken by EMS to ER.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Influenza virus test negative, Metabolic function test normal, Muscle contractions involuntary, Postictal state, Respiratory syncytial virus test negative
Clinical narrative: 3/4 towards afternoon mom was changing diaper and child's fists and jaw clenched, seemed to be holding breath. Had lips turn blue. Denies tonic-clonic movements, emesis or incontinence. Lasted about 2 min, then child started to breath normally, but body was limp and he was "out of it." Post ictal state lasted prob about 1.5-2hrs. Was taken by EMS to ER.
Age: 0.92
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Rash, Roseola
Clinical narrative: Fever to 100% on day one, oscillating between 100% to 104 over next 4 days.  Experienced diarrhea on Day 1 and 2 and 4.  No prior history of fever or diarrea.  Rash on trunk on Day 6, diagnosed by doctor over phone as Rosolea. Someone do a google search and realize that Rosolea is highly correlated to MMRs.  Doesn't anyone care about the kids?  Or does Merk just need to make so much money they can continue to hire from the FDA/CDC and lobby the FDA/CDC at the same time?  Money matters the most to everyone right? ? I guess that's probably what does motivate 99% of the people out there. I just don't want my kid to be the 1% collateral damage!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red round rash, about 1.5" in diameter, directly below the injection site on arm. Rash is itchy, sensitive to touch, and has burning pain. On 3/9/17, a lighter rash extended around the original rash, growing to about 3" diameter. Doctor's office advised over phone that the vaccine had caused this rash, which is shingles, and to avoid infants and anyone with a weak immune system. They recommended benedryl for the itching but said not to take acyclovir and to let the rash run its course.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Asthenia, Burning sensation, Exercise tolerance decreased, Fatigue, Gait disturbance
Clinical narrative: Doctor advised to expect only usual shot soreness. Experienced immediate pain and burning sensation. Increasing soreness treated with TYLENOL and after Dr. returned call evening 3-3-17 began ibuprofen. Patient has been quite sore to the point of having difficulty walking. She has been using a heating pad for sore muscles at night. Has had headaches, nausea and fatigue. General feeling of malaise. Poor athletic performance beginning on Thursday 3-2-17. Patient indicated her leg (right, two shot) felt swollen, but she acknowledged that the pain could have made her feel that way without actual swelling. Injection points looked normal Thursday. Friday in PE (the second day after the injections) patient was expected to do 3 miles using two machines. Walking at 1/2 her usual pace on the treadmill resulted in a pulled/strained muscle. This was nearly 48 hours after the injections. Do keep in mind that this is a young, healthy athlete who swims competitively, runs cross country, and runs track. Tue March 7th, it was a struggle to do yoga in PE, due to lack of energy. Pain in leg gradually improved over the week. By Wed 3-8-17 energy levels were improved and soreness in leg was much improved. Returned to track practice and was able to run albeit with "warnings" from leg muscles not to push the stretching. Patient appears better, but will continue concerned observation.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Headache, Immediate post-injection reaction, Malaise, Myalgia, Nausea
Clinical narrative: Doctor advised to expect only usual shot soreness. Experienced immediate pain and burning sensation. Increasing soreness treated with TYLENOL and after Dr. returned call evening 3-3-17 began ibuprofen. Patient has been quite sore to the point of having difficulty walking. She has been using a heating pad for sore muscles at night. Has had headaches, nausea and fatigue. General feeling of malaise. Poor athletic performance beginning on Thursday 3-2-17. Patient indicated her leg (right, two shot) felt swollen, but she acknowledged that the pain could have made her feel that way without actual swelling. Injection points looked normal Thursday. Friday in PE (the second day after the injections) patient was expected to do 3 miles using two machines. Walking at 1/2 her usual pace on the treadmill resulted in a pulled/strained muscle. This was nearly 48 hours after the injections. Do keep in mind that this is a young, healthy athlete who swims competitively, runs cross country, and runs track. Tue March 7th, it was a struggle to do yoga in PE, due to lack of energy. Pain in leg gradually improved over the week. By Wed 3-8-17 energy levels were improved and soreness in leg was much improved. Returned to track practice and was able to run albeit with "warnings" from leg muscles not to push the stretching. Patient appears better, but will continue concerned observation.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain, Pain in extremity, Performance status decreased, Peripheral swelling
Clinical narrative: Doctor advised to expect only usual shot soreness. Experienced immediate pain and burning sensation. Increasing soreness treated with TYLENOL and after Dr. returned call evening 3-3-17 began ibuprofen. Patient has been quite sore to the point of having difficulty walking. She has been using a heating pad for sore muscles at night. Has had headaches, nausea and fatigue. General feeling of malaise. Poor athletic performance beginning on Thursday 3-2-17. Patient indicated her leg (right, two shot) felt swollen, but she acknowledged that the pain could have made her feel that way without actual swelling. Injection points looked normal Thursday. Friday in PE (the second day after the injections) patient was expected to do 3 miles using two machines. Walking at 1/2 her usual pace on the treadmill resulted in a pulled/strained muscle. This was nearly 48 hours after the injections. Do keep in mind that this is a young, healthy athlete who swims competitively, runs cross country, and runs track. Tue March 7th, it was a struggle to do yoga in PE, due to lack of energy. Pain in leg gradually improved over the week. By Wed 3-8-17 energy levels were improved and soreness in leg was much improved. Returned to track practice and was able to run albeit with "warnings" from leg muscles not to push the stretching. Patient appears better, but will continue concerned observation.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash generalised
Clinical narrative: Rash began on face and spread rapidly all over; patient's mother gave him generic Benadryl at 2:00 PM and brought him to doctor's office at 2:30 PM.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: Right Arm swollen from shoulder to elbow, red/hot/itchy, rash like developing. No Shortness of Breath. Patient taking BENADRYL and ice pack to right arm.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 53-year-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies were not reported. On 07-FEB-2017, the patient was vaccinated with a dose of PROQUAD lot number reported as M034691, expiration date: 24-JAN-2018 (strength, dose, frequency, route of administration, and anatomical location were not reported) for prophylaxis. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a physician assistant and a licensed practical nurse regarding a 2 month old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 02-MAR-2017 the patient was vaccinated with PNEUMOVAX23 lot # M022085, expiration 09-OCT-2017, 0.5 ml, intramuscular for prophylaxis instead of PREVNAR 13.  On 02-MAR-2017, during the same office visit, the patient received other unspecified routine vaccinations. The patient had not experienced any adverse effects. No further information was provided. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: EXTREME SWELLING IN UPPER ARM BICEP MUSCLE AREA. THROBBING PAIN AND ITCHINESS. APPLIED ICE PACK ALL NIGHT. PAIN SUBSIDED BUT SWELLING REMAINS 24 HOURS LATER.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid injection site swollen, red and painful and the above signs and symptoms extended to upper arm 2 inches above elbow.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever of 101, loss of appetite, fatigue, congestion.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection
Clinical narrative: Patient presented with erythema at injection site. Referred to local MD - site was enlarged and red with diffuse redness surrounding the center red spot. Looked more like a skin infection.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Pyrexia, Rash macular, Urticaria
Clinical narrative: Blotchy welts on right cheek, front and back of thighs, and fever.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to BEXSERO. Additional details were provided as follows: The age at the time of reporting was 19 years. The age at vaccination was not reported. The patient received BEXSERO in an unknown arm. Limited information was provided by the sales representative from the physician. This case has been linked with case US2017026063, US2017026065 and US2017026064 as reported by same reporter.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Mobility decreased, Pain
Clinical narrative: Painful, sore, bruise (feels like bruised), barely lift arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient given 2 month vaccines at 10:15 am. After vaccines given patient's both legs from thigh to ankle were red, swollen slightly and warm. As per MD cool towel applied which child didn't seem to like. After 20 minutes everything subsided. Vital signs T-99.0. HR - 140 O2 - 100%.
Sex: U
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in a adolescent patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad site reaction (unspecified). The reporter did not have the information about patient, vaccination, lot number and expiration date.
Age: 51.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain
Clinical narrative: Severe shoulder pain -starting 12/16/2016 after shot given in upper right arm.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Around 10/20 woke up an it was painful to raise arm; pain radiating from left shoulder. Took ADVIL/TYLENOL as needed since doesn't like to take medications. Had annual visit on 1/20/17 and doctor recommended 8 therapy sessions. Physical therapy helped a bit but pain still there. Will go to specialist to get more testing. Pain level at 7-8/10 when raise arm. Pain is mild, notice pain when wake up at night. Today shoulder pain still exist.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Around 10/20 woke up an it was painful to raise arm; pain radiating from left shoulder. Took ADVIL/TYLENOL as needed since doesn't like to take medications. Had annual visit on 1/20/17 and doctor recommended 8 therapy sessions. Physical therapy helped a bit but pain still there. Will go to specialist to get more testing. Pain level at 7-8/10 when raise arm. Pain is mild, notice pain when wake up at night. Today shoulder pain still exist.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Red, indurated area at the injection site ((L) Arm) was red, warm to touch, and itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Nausea, Somnolence, Vomiting, Wheezing
Clinical narrative: Approx. 3-5 min. after vac. c/o severe S/A positive N/V progressing to sleepiness, EPIPEN admin. 911 called, transp. to ERD, positive wheeze treated and released home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Angioedema, Hyperhidrosis, Hypoxia, Nausea
Clinical narrative: Approx. 3-5 min. after vac. c/o severe S/A positive N/V progressing to sleepiness, EPIPEN admin. 911 called, transp. to ERD, positive wheeze treated and released home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: Approx. 3-5 min. after vac. c/o severe S/A positive N/V progressing to sleepiness, EPIPEN admin. 911 called, transp. to ERD, positive wheeze treated and released home.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever 100.1, 6 cm swelling (R) lat arm. No cellulitis. Pruritus. Mild pain.
Age: 5.0
Sex: F
Vaccine: HIBV, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Nervousness, Tremor
Clinical narrative: I administered 2 vaccines to patient. I could tell she was nervous and slightly shaking. I administered BOOSTRIX in the right arm and meningitis in left. The patient passed out and fell our of chair about 5 minutes after administered. I asked if she had eaten anything and she said yes. I think it was her nervousness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 3/8/17 - Pt walked in to clinic with LT arm swelling pain, redness of LT upper arm. Redness and swelling circumferential. Pt was evaluated by PCP treated with prednisone 40 mg daily x 5 days. Pt to follow up in 2 days. Aware prednisone may lower vaccine effectiveness. PCV-13 allergy added to pt's chart.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site urticaria
Clinical narrative: Hives on all of right leg where PREVNAR was given. ("Urticaria" entire right leg).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Burning sensation, Erythema, Peripheral swelling
Clinical narrative: (Rt) arm with red and raised with mild burning sensation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient given second dose of ZOSTAVAX. Initially vaccinated on 5/14/2012. Patient had requested PREVNAR at the time. No adverse reaction reported.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: 10/13/16 Flu shot left deltoid; customary discomfort. Pain did not subside; worsened to included shoulder, radiating down left arm under breast. Saw doctor; prescribed Ibuprofen. Referred to PT heat tx massage, exercises (11-23-16-). Orthopedist: Assessment-X-ray-MRI-consult recommended cortisone.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: 10/13/16 Flu shot left deltoid; customary discomfort. Pain did not subside; worsened to included shoulder, radiating down left arm under breast. Saw doctor; prescribed Ibuprofen. Referred to PT heat tx massage, exercises (11-23-16-). Orthopedist: Assessment-X-ray-MRI-consult recommended cortisone.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Haematocrit normal, Haemoglobin normal, Local swelling, Lymphocyte count increased, Lymphocyte percentage decreased
Clinical narrative: Patient developed fever night of vaccination. Next day again and mother noticed a bump in left side of neck. The next day bump kept growing and was painful. Mother took to Emergency Room.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Monocyte percentage increased, Neck pain, Neutrophil percentage, Platelet count normal, Pyrexia
Clinical narrative: Patient developed fever night of vaccination. Next day again and mother noticed a bump in left side of neck. The next day bump kept growing and was painful. Mother took to Emergency Room.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Ultrasound scan abnormal, White blood cell count increased
Clinical narrative: Patient developed fever night of vaccination. Next day again and mother noticed a bump in left side of neck. The next day bump kept growing and was painful. Mother took to Emergency Room.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site induration
Clinical narrative: Left thigh induration (2 cm) at site of PEDIARIX vaccine. RX: Warm compress, supportive care.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Onset of swelling Right SQ (upper extremity) 1630 - 1700. (+) TTP, (+) erythema, (+) itching. Took Ibuprofen 800 mg (also again 3/9th c 930 AM). Measured area of concern 3/8 2115 (8.5x5 cm) - circled. Today c 11:30 AM - 8x10 cm. (+) palpable firmness with area of erythema with warmth. No systemic Sxs - (rash, SOB, fever).
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Onset of swelling Right SQ (upper extremity) 1630 - 1700. (+) TTP, (+) erythema, (+) itching. Took Ibuprofen 800 mg (also again 3/9th c 930 AM). Measured area of concern 3/8 2115 (8.5x5 cm) - circled. Today c 11:30 AM - 8x10 cm. (+) palpable firmness with area of erythema with warmth. No systemic Sxs - (rash, SOB, fever).
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: Diffuse targetoid rash (erythema multiforme minor) with 102 degrees fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Right thigh swelling. Evaluated 2 days after vaccination. NVI, pulses WNL. Mild edema noted with erythema to injection site. Ace wrap applied. RX for BENADRYL and TYLENOL.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Few minutes after injection of vaccines mom notified RN that areas near injection sites were raised w/heat and red. Cool compress applied. MD was notified and examined pt. MD notified mom to call back if changed. BENADRYL if itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pyrexia, Rash erythematous, Rash morbilliform
Clinical narrative: Fever. Red morbilliform rash.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister
Clinical narrative: 2 wks. 6 days after MMR and Varicella vaccines, developed vesicles on multiple sites.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pyrexia
Clinical narrative: Fever 105.9 S/P vaccines as per mother of child. Temp 103.8 at ER visit.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dyskinesia, Eye movement disorder, Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure - fever 102 3/8/17, brief less than 20 sec jerking, eyes rolled back. Eval in ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous
Clinical narrative: Red Rash.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Patient received ZOSTAVAX shot  on 2/28/17. On 3/3/17 she reported that she had experienced redness, swelling and itching at injection site and towards elbow. She also developed a swollen lymph node.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left leg swelling and tenderness to touch 6 days after receiving 18 mo immunizations. Located where DTaP was given. Seen by PCM 3/8/17 to monitor for infection. MOTRIN as needed.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Ear pain, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Mom called patient had sl fever of 100 - not taken nausea ear pain lightheaded "flu like" symptoms mom also said she Googled side effects and just felt like it was the shot.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Sudden death, Viral upper respiratory tract infection
Clinical narrative: Immunizations administered on 5-11-16. Child found deceased on 5-12-16.
Age: 99.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Peripheral swelling, Rash, Urticaria
Clinical narrative: The vaccine was given Feb 6, 2017. 3 days later, I broke out with hives-thighs, chest, back, intense scratching and itching/swollen armpit.
Age: 99.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: The vaccine was given Feb 6, 2017. 3 days later, I broke out with hives-thighs, chest, back, intense scratching and itching/swollen armpit.
Age: 45.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye pain, Injection site pain, Nausea, Tachycardia
Clinical narrative: Information has been received from a pharmacist referring to a 45 year old female patient. Concomitant therapies included LO LOESTRIN FE, NATURE THROID, fluticasone and spironolactone. The patient had no pertinent medical history and no drug allergies. On 14-JAN-2017, the patient who was indicated for an adult dose of RECOMBIVAX HB was accidentally vaccinated with a dialysis dose of RECOMBIVAX HB dose: 1 ml, route: intramuscular, lot#M033613, expiration date: 18-NOV-2018) for prophylaxis (incorrect dose administered). On 15-JAN-2017, the patient developed nausea, burning at the RECOMBIVAX HB injection site, and both eyeballs hurting. On 23-FEB-2017, the patient went into the pharmacy and reported the events to the pharmacist to seek medical attention. No treatment was given for the events. The outcome of events was reported as recovered on an unknown date in 2017. The causality assessment was not provided. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye pain, Injection site pain, Nausea
Clinical narrative: Information has been received from a pharmacist referring to a 45 year old female patient. Concomitant therapies included LO LOESTRIN FE, NATURE THROID, fluticasone and spironolactone. The patient had no pertinent medical history and no drug allergies. On 14-JAN-2017, the patient who was indicated for an adult dose of RECOMBIVAX HB was accidentally vaccinated with a dialysis dose of RECOMBIVAX HB dose: 1 ml, route: intramuscular, lot#M033613, expiration date: 18-NOV-2018) for prophylaxis (incorrect dose administered). On 15-JAN-2017, the patient developed nausea, burning at the RECOMBIVAX HB injection site, and both eyeballs hurting. On 23-FEB-2017, the patient went into the pharmacy and reported the events to the pharmacist to seek medical attention. No treatment was given for the events. The outcome of events was reported as recovered on an unknown date in 2017. The causality assessment was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Blister, Erythema, Incisional drainage, Induration, Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old female patient with obesity and esotropia of left eye. The patient was born prematurely (in 36 week of pregnancy) and spent a couple of weeks in neonatal intensive care unit (NICU). The patient had no concomitant medications, drug reactions, or allergies. On 27-FEB-2017, the patient was vaccinated with a dose of PROQUAD injection (RHA; lot # M037011, expiration date: 21-FEB-2018; dose and route of administration were not reported) and a dose of KINRIX (dose, route of administration, lot# and expiration date were not provided). On 28-FEB-2017, the patient developed redness and swelling at the injection site on her leg (unspecified). On 28-FEB-2017, the patient was taken to the hospital due to those events, but the reporter stated that nothing was done there. On 01-MAR-2017, the patient's symptoms got worse. On the same day, the patient was admitted to the hospital due to abscess on her leg (onset date was estimated to an unspecified date in approximately 2017). On an unspecified date approximately in March 2017, the patient had an unspecified x-ray performed, which revealed possible muscle involvement (onset date was estimated to an unspecified date in approximately 2017). Additionally, unspecified laboratory tests were performed (date and results were not provided). On an unspecified date in March 2017, the patient had a surgery to drain the abscess. The patient was treated with unspecified antibiotics. The nurse stated, the patient's wound would be left open and a "wound back" would be placed. The patient was going to be discharged on an unspecified date with home healthcare. At the time of the report, the patient was recovering from all adverse events. The relatedness between all adverse events and PROQUAD and KINRIX was not provided. The events were considered as significantly disabling by the reporting nurse. Upon internal review, the adverse events of abscess on the patient's leg and muscle abscess were considered to be medically significant. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Surgery, X-ray limb abnormal
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old female patient with obesity and esotropia of left eye. The patient was born prematurely (in 36 week of pregnancy) and spent a couple of weeks in neonatal intensive care unit (NICU). The patient had no concomitant medications, drug reactions, or allergies. On 27-FEB-2017, the patient was vaccinated with a dose of PROQUAD injection (RHA; lot # M037011, expiration date: 21-FEB-2018; dose and route of administration were not reported) and a dose of KINRIX (dose, route of administration, lot# and expiration date were not provided). On 28-FEB-2017, the patient developed redness and swelling at the injection site on her leg (unspecified). On 28-FEB-2017, the patient was taken to the hospital due to those events, but the reporter stated that nothing was done there. On 01-MAR-2017, the patient's symptoms got worse. On the same day, the patient was admitted to the hospital due to abscess on her leg (onset date was estimated to an unspecified date in approximately 2017). On an unspecified date approximately in March 2017, the patient had an unspecified x-ray performed, which revealed possible muscle involvement (onset date was estimated to an unspecified date in approximately 2017). Additionally, unspecified laboratory tests were performed (date and results were not provided). On an unspecified date in March 2017, the patient had a surgery to drain the abscess. The patient was treated with unspecified antibiotics. The nurse stated, the patient's wound would be left open and a "wound back" would be placed. The patient was going to be discharged on an unspecified date with home healthcare. At the time of the report, the patient was recovering from all adverse events. The relatedness between all adverse events and PROQUAD and KINRIX was not provided. The events were considered as significantly disabling by the reporting nurse. Upon internal review, the adverse events of abscess on the patient's leg and muscle abscess were considered to be medically significant. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abscess drainage, Abscess limb, Injection site erythema, Injection site swelling, Laboratory test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old female patient with obesity and esotropia of left eye. The patient was born prematurely (in 36 week of pregnancy) and spent a couple of weeks in neonatal intensive care unit (NICU). The patient had no concomitant medications, drug reactions, or allergies. On 27-FEB-2017, the patient was vaccinated with a dose of PROQUAD injection (RHA; lot # M037011, expiration date: 21-FEB-2018; dose and route of administration were not reported) and a dose of KINRIX (dose, route of administration, lot# and expiration date were not provided). On 28-FEB-2017, the patient developed redness and swelling at the injection site on her leg (unspecified). On 28-FEB-2017, the patient was taken to the hospital due to those events, but the reporter stated that nothing was done there. On 01-MAR-2017, the patient's symptoms got worse. On the same day, the patient was admitted to the hospital due to abscess on her leg (onset date was estimated to an unspecified date in approximately 2017). On an unspecified date approximately in March 2017, the patient had an unspecified x-ray performed, which revealed possible muscle involvement (onset date was estimated to an unspecified date in approximately 2017). Additionally, unspecified laboratory tests were performed (date and results were not provided). On an unspecified date in March 2017, the patient had a surgery to drain the abscess. The patient was treated with unspecified antibiotics. The nurse stated, the patient's wound would be left open and a "wound back" would be placed. The patient was going to be discharged on an unspecified date with home healthcare. At the time of the report, the patient was recovering from all adverse events. The relatedness between all adverse events and PROQUAD and KINRIX was not provided. The events were considered as significantly disabling by the reporting nurse. Upon internal review, the adverse events of abscess on the patient's leg and muscle abscess were considered to be medically significant. Additional information has been requested.