chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous as received from a nurse refers to a newborn female patient. The patient's mother was a 21 year old female with hypoglycemia, depression, dysplasia (unspecified), who smoke 5 cigarettes per day, allergic to CELEXA. The parent's concomitant medication included ZOLOFT and prenatal vitamins (unspecified). On 02-JAN-2014, the patient's mother received first dose of GARDASIL (dose and frequency not reported). On 13-MAR-2014, the patient's mother was vaccinated with her second dose of GARDASIL (lot# J006236, expiry 25-FEB-2016) in the right deltoid intramuscularly on an unknown date and time (however pm was reported). On 25-MAR-2014, the patient's mother reported to the practice that she was pregnant. The parent had positive pregnancy test on 25-MAR-2014. (See MARRS 1404USA003132). The patient's mother had her LMP (Last Menstrual period) on 18-FEB-2014. An EDD (Estimated Date of Delivery) was 24-NOV-2014. The patient was exposed to GARDASIL during the first trimester of pregnancy. At 39 weeks gestation, the parent delivered a female infant weighing 2777.68 gms via vaginal delivery. The pregnancy outcome was live birth. The patient's APGAR scores were 7 at one minute and 8 at five minutes. On 18-NOV-2014, the patient spent 4 days in Neonatal Intensive Care Unit (NICU) due to meconium aspiration. The outcome of Meconium Aspiration was reported as recovering (Spoke to the mother today and infant was doing very well). The outcome of fetal exposure during pregnancy, first trimester was reported as recovered on 18-NOV-2014. No causality between the above mentioned events and GARDASIL was provided. This is one of several reports received from the same reporter. Additional information is not expected, because all follow up information has been received.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Apgar score, Foetal exposure during pregnancy, Intensive care, Neonatal aspiration, Premature baby
Clinical narrative: This spontaneous as received from a nurse refers to a newborn female patient. The patient's mother was a 21 year old female with hypoglycemia, depression, dysplasia (unspecified), who smoke 5 cigarettes per day, allergic to CELEXA. The parent's concomitant medication included ZOLOFT and prenatal vitamins (unspecified). On 02-JAN-2014, the patient's mother received first dose of GARDASIL (dose and frequency not reported). On 13-MAR-2014, the patient's mother was vaccinated with her second dose of GARDASIL (lot# J006236, expiry 25-FEB-2016) in the right deltoid intramuscularly on an unknown date and time (however pm was reported). On 25-MAR-2014, the patient's mother reported to the practice that she was pregnant. The parent had positive pregnancy test on 25-MAR-2014. (See MARRS 1404USA003132). The patient's mother had her LMP (Last Menstrual period) on 18-FEB-2014. An EDD (Estimated Date of Delivery) was 24-NOV-2014. The patient was exposed to GARDASIL during the first trimester of pregnancy. At 39 weeks gestation, the parent delivered a female infant weighing 2777.68 gms via vaginal delivery. The pregnancy outcome was live birth. The patient's APGAR scores were 7 at one minute and 8 at five minutes. On 18-NOV-2014, the patient spent 4 days in Neonatal Intensive Care Unit (NICU) due to meconium aspiration. The outcome of Meconium Aspiration was reported as recovering (Spoke to the mother today and infant was doing very well). The outcome of fetal exposure during pregnancy, first trimester was reported as recovered on 18-NOV-2014. No causality between the above mentioned events and GARDASIL was provided. This is one of several reports received from the same reporter. Additional information is not expected, because all follow up information has been received.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Convulsion, Drug screen, Fatigue, Full blood count
Clinical narrative: Burning at site of injection, constant pain in arm, head pain, seizure grand mal tonic clonic as reported by EMT/paramedics and pharmacist and ER. Ongoing fevers and head pain. Taken by ambulance to ER.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine analysis
Clinical narrative: Burning at site of injection, constant pain in arm, head pain, seizure grand mal tonic clonic as reported by EMT/paramedics and pharmacist and ER. Ongoing fevers and head pain. Taken by ambulance to ER.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Grand mal convulsion, Headache, Injection site pain, Pain in extremity
Clinical narrative: Burning at site of injection, constant pain in arm, head pain, seizure grand mal tonic clonic as reported by EMT/paramedics and pharmacist and ER. Ongoing fevers and head pain. Taken by ambulance to ER.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Burning at site of injection, constant pain in arm, head pain, seizure grand mal tonic clonic as reported by EMT/paramedics and pharmacist and ER. Ongoing fevers and head pain. Taken by ambulance to ER.
Age: 41.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe pain in arm and unable to move arm at times.
Age: 41.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Severe pain in arm and unable to move arm at times.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Left upper arm (site of injection) became abnormally sore and achy from a high-dose senior flu vaccine injection. This site has become increasingly painful over the past 1-1/2 months since the injection and the arm is now experiencing severe stiffness, soreness, pain and limited range of motion.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left upper arm (site of injection) became abnormally sore and achy from a high-dose senior flu vaccine injection. This site has become increasingly painful over the past 1-1/2 months since the injection and the arm is now experiencing severe stiffness, soreness, pain and limited range of motion.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Dysstasia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Patient was unable to stand or walk under own strength.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Not feeling well in general. Redness at immunization site. Swelling from site to elbow on left arm. Symptoms noted on 12/15/2014.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Dizziness, Eye swelling, Lip pruritus, Lip swelling, Ocular hyperaemia
Clinical narrative: Twins arrived home told mother they felt dizzy, and took a nap. At 1 AM, mother checked on daughters and they had fever. Tylenol given. By 6 AM, both girls had facial swelling, reported itchy feeling in mouth/lips. One twin's R jaw was swollen and red. Other eyes were swollen nearly shut and red, facial swelling around cheeks and lips. Taken to Hospital and treated, one twin with IV steroids. Both girls were released by 8 PM on 12/06/2014.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Oral pruritus, Pyrexia, Swelling face
Clinical narrative: Twins arrived home told mother they felt dizzy, and took a nap. At 1 AM, mother checked on daughters and they had fever. Tylenol given. By 6 AM, both girls had facial swelling, reported itchy feeling in mouth/lips. One twin's R jaw was swollen and red. Other eyes were swollen nearly shut and red, facial swelling around cheeks and lips. Taken to Hospital and treated, one twin with IV steroids. Both girls were released by 8 PM on 12/06/2014.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Dizziness, Erythema, Eye swelling, Local swelling, Ocular hyperaemia
Clinical narrative: On 12/5/14, twins returned home saying they felt dizzy. They took a nap and mother found them with fever (tactile) at 1 AM. Tylenol given. By 6 AM, both girls had facial swelling and reported itchy feeling in lips/mouth. One twin had swelling and redness to R jaw. Other twin had swollen eyes (nearly shut), red eye lids and significant facial swelling around cheeks and lips. Mom took girls to hospital where they were treated, one twin with IV steroids. Both girls were discharged home by 8 PM on 12/6.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Oral pruritus, Pyrexia, Swelling face
Clinical narrative: On 12/5/14, twins returned home saying they felt dizzy. They took a nap and mother found them with fever (tactile) at 1 AM. Tylenol given. By 6 AM, both girls had facial swelling and reported itchy feeling in lips/mouth. One twin had swelling and redness to R jaw. Other twin had swollen eyes (nearly shut), red eye lids and significant facial swelling around cheeks and lips. Mom took girls to hospital where they were treated, one twin with IV steroids. Both girls were discharged home by 8 PM on 12/6.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Chills, fever, arm swelling, significant pain.
Age: 14.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Activities of daily living impaired
Clinical narrative: Symptoms muscular cramping of abdomen no nausea no vomiting. Appetite good. Went to school Wed, Thurs, Friday (12/10-12/13). Symptoms worse today. Child unable to attend school today. Cramping whole center of abdomen. Has not seen the doctor.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain in left arm - that continues to be very restrictive.
Sex: U
Vaccine: YF
Symptoms: Flavivirus test positive, Yellow fever
Clinical narrative: Initial report received from literature on 2 December 2014. This case is linked to case 2014SA169198 (same literature, same reporter, mother case). Before the development of a vaccine in 1937, Yellow Fever was one of the most feared and lethal diseases in human history. The live, attenuated Yellow Fever vaccine provides lifelong immunity and is safe for those with a developed immune system. Breastfeeding mothers, however, should not receive the vaccine as it may cause Yellow Fever in infants. Six cases of Yellow Fever transmitted via breastfeeding have been reported. These cases occurred when Yellow Fever vaccine was administered to breastfeeding mothers with infants from 10 to 15 days old. Serum and cerebrospinal fluid were positive for the Yellow Fever virus, and nucleotide sequences confirmed identical viral profiles between vaccine and cases. Such cases suggest acute central nervous system infection with Yellow Fever through breastfeeding. Further research is needed to evaluate more fully the risk of vertical transmission of such viruses via this route. Although vertical transmission of Dengue Fever and West Nile has been documented previously, little information exists regarding transmission of Yellow Fever via breast milk. A 6 patients (10 to 15 days old), whose medical history and concomitant medications were not reported, had received a dose of Yellow Fever Vaccine (batch number, route and anatomical site of administration were not reported) of unknown manufacturer via breastfeeding on an unspecified date. It was reported that, yellow fever was transmitted via breastfeeding. Serum and cerebrospinal fluid were positive for the Yellow Fever virus, and nucleotide sequences confirmed identical viral profiles between vaccine and cases. The patient's corrective treatment was not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Developed severe shoulder pain at site of injection (right arm) with severely limited range of motion, and intense pain on movement.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Abnormal faeces, Diarrhoea, Rash generalised, Rash macular, Skin burning sensation
Clinical narrative: When we got her up in the morning to change her diaper we noticed some red splotches on her chest & belly. The rash spread all over her body by 7/31/14, I contacted the doctor's office several times with the receptionist being very rude, they finally got back with me at close to tell me it was most likely a virus. I am a stay at home mom, my baby did/does not go out in public often how could it be a virus? I felt they weren't concerned with my childs reaction at all. The rash took a whole week to completely disappear. She also had horrible watery/foamy bowel movements that lasted for at LEAST a month .They were so bad it was burning her baby skin. I did not change anything in my diet or change any products used on her skin, she's breastfed & completely healthy so I know in my momma's instincts that it was all related to the shots.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eyelid ptosis, IIIrd nerve paralysis, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Strabismus
Clinical narrative: Strabismus of right eye that progressed over next several months to include ptosis of that eye with the resulting diagnosis of oculomotor nerve palsy, incomplete of the right eye.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Rash
Clinical narrative: Pt said experienced rash initially then had pain in joints of hands.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Fatigue, Lymph node pain, Lymph node palpable, Myalgia
Clinical narrative: Axillary pain, 2 day later pain in pectoral ms and biceps unilateral. Worsened through first weeks in Nov. Palpable tender nodes pectoral areas. No fever, some fatigue.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: The day after pt received the Prevnar vaccination he develop diffuse hives all over his body and lip swelling. Given tx: Benadryl 25 mg every 8 hours PREDNISONE taper starting at 30mg bid x 4 days.  12/10/14 added Zyrtec 10 mg twice daily for continued itching.  Hives   12/10/14 Appt with allergist: 2010 Pneumovax without problems. 12/4/14 Prevnar 13 with initially local swelling surrounding injection site. On the following day developed urticaria (generalized) and upper lip swelling. Hives described as red, raised, pruritic, migratory, however, ongoing flare. No other reactions such as tongue or throat swelling, shortness of breath, wheezing, abdominal cramping, vomiting, diarrhea, or light headeness. Hives/swelling noted on exam by Dr. Improved now with prednisone. In addition taking diphenhydramine (Benadryl) for pruritus, with only mild benefit.  12/12/2014  3:29 PM PST patient reports most of the hives have resolved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: 12-4-14 I received my flu shot from the ER charge nurse approx 830-845. About 1 hour later I began to feel dizzy and shaky. I noticed symptoms were increasing and I had chest tightness, heaviness, heart racing and pain. I went to the Emergency Room after my meeting at 1200 and my symptoms increased and I was admitted. Under observation from 12-4-14 to 12-6-14. I have continued to have high blood pressure and shakiness.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Metabolic function test, Nervousness, Pain, Palpitations
Clinical narrative: 12-4-14 I received my flu shot from the ER charge nurse approx 830-845. About 1 hour later I began to feel dizzy and shaky. I noticed symptoms were increasing and I had chest tightness, heaviness, heart racing and pain. I went to the Emergency Room after my meeting at 1200 and my symptoms increased and I was admitted. Under observation from 12-4-14 to 12-6-14. I have continued to have high blood pressure and shakiness.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Troponin
Clinical narrative: 12-4-14 I received my flu shot from the ER charge nurse approx 830-845. About 1 hour later I began to feel dizzy and shaky. I noticed symptoms were increasing and I had chest tightness, heaviness, heart racing and pain. I went to the Emergency Room after my meeting at 1200 and my symptoms increased and I was admitted. Under observation from 12-4-14 to 12-6-14. I have continued to have high blood pressure and shakiness.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Local swelling, Pain in extremity
Clinical narrative: Left arm became slightly sore evening after flu and pneumo vaccine. After a week arm pain became more severe and has continued to get worse. Patient now can't raise arm, arm has had swelling and heat. Saw MD on 11/12/14 regarding pain. Patient reported symptoms to MD (made appointment because arm pain was so severe) on Wednesday, 11/12/14. Patient notified pharmacy on 11/16/14 consulted patient to take ibuprofen 200mg - 2 tabs 3x daily for next 3 days and I will contact MD and vaccine manufacturers for addition treatment recommendations. Patient will follow up on Wednesday 11/19/14 if we do not contact before then with additional info. At MD visit, Dr. advised patient to apply heat. Symptoms have not gotten any better (still having severe pain and cannot raise arm). 11/20/14: Patient is on day 3 of MEDROL dose pack and has not had any improvement in her arm. Will continue dose pack. 12/10/14: Patient is still experiencing pain in her (L) arm that is preventing her from lifting, bearing weight and performing daily tasks; she cannot lay on her (L) side due to pain.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm, Weight bearing difficulty
Clinical narrative: Left arm became slightly sore evening after flu and pneumo vaccine. After a week arm pain became more severe and has continued to get worse. Patient now can't raise arm, arm has had swelling and heat. Saw MD on 11/12/14 regarding pain. Patient reported symptoms to MD (made appointment because arm pain was so severe) on Wednesday, 11/12/14. Patient notified pharmacy on 11/16/14 consulted patient to take ibuprofen 200mg - 2 tabs 3x daily for next 3 days and I will contact MD and vaccine manufacturers for addition treatment recommendations. Patient will follow up on Wednesday 11/19/14 if we do not contact before then with additional info. At MD visit, Dr. advised patient to apply heat. Symptoms have not gotten any better (still having severe pain and cannot raise arm). 11/20/14: Patient is on day 3 of MEDROL dose pack and has not had any improvement in her arm. Will continue dose pack. 12/10/14: Patient is still experiencing pain in her (L) arm that is preventing her from lifting, bearing weight and performing daily tasks; she cannot lay on her (L) side due to pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of ROTATEQ that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose and dose# not reported, route default as oral, indication default as prophylaxis) on unspecified date since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that he was aware that the administration of improperly-stored products to patients posed a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Swelling at injection site, bruising at and around site.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Convulsion, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: Received vaccine 11/13/14 (approximately 1240 PM). On 11/15/14 1 AM noted to have fever only. Previously well, no cough other URI symptoms. Mom concerned that (+) chills, "wobbly", took to ER. In waiting room had a generalized seizure and then "stiff". Duration 1 min. 10 mins before return to self. Urine/labs done; told "neg". No fever since return to home.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Received vaccine 11/13/14 (approximately 1240 PM). On 11/15/14 1 AM noted to have fever only. Previously well, no cough other URI symptoms. Mom concerned that (+) chills, "wobbly", took to ER. In waiting room had a generalized seizure and then "stiff". Duration 1 min. 10 mins before return to self. Urine/labs done; told "neg". No fever since return to home.
Age: 44.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash, Reaction to food additive, Urticaria
Clinical narrative: Since vaccination, have developed hives/skin rash when consuming foods with MSG/glutamates. Was not allergic prior to vaccination, developed approx. 1-2 weeks following receipt of FLUMIST, progressively getting worse.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Hypopnoea, Pain
Clinical narrative: 11:30 PM 12/6/14 - woke up with dry, shallow cough. Sat in living room as breathing became short and shallow. Breathing became increasingly difficult. 12:30 AM 12/7/14 began shaking with chills and body pains. 2:00 AM 12/7/14 breathing began to ease. 3:00 AM 12/7/14 Returned to bed but still shaking from chills - finally fell asleep about 4:00AM. Slept rest of 12/7/14.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: 11:30 PM 12/6/14 - woke up with dry, shallow cough. Sat in living room as breathing became short and shallow. Breathing became increasingly difficult. 12:30 AM 12/7/14 began shaking with chills and body pains. 2:00 AM 12/7/14 breathing began to ease. 3:00 AM 12/7/14 Returned to bed but still shaking from chills - finally fell asleep about 4:00AM. Slept rest of 12/7/14.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden onset deafness in (R) ear on 12/3/14. Saw Dr. on 12/4/14: started prednisone on 12/4/14 and antiviral (acyclovir) on 12/4/14.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Had heart palpitations one hour after FLUZONE HD injection continued for about an hour after. Since this disappeared pt did not go to hospital. Went for check up with cardiologist one month later who advised pt to contact us for VAERS.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Local reaction, Pain, Pruritus
Clinical narrative: Localized vaccine injection reaction - onset in hours - pain, redness, itching. Given symptomatic treatment.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, X-ray
Clinical narrative: Intussusception. Hospitalized at hospital.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema
Clinical narrative: Erythema approximately 8 x 17 cm LUE - KEFLEX, Ibuprofen.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old patient of unknown gender. On 12-NOV-2014 the patient was vaccinated with ROTATEQ dose 1, oral (strength and lot # were not reported). No adverse effects had been observed or reported by the time of this report. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram, Headache
Clinical narrative: 45 minutes after receiving vaccine he started to have a headache which progressed to feeling like his head was going to "explode".  Went to ER, referred to a neurologist who prescribed medication which helped minimally.  Headache finally went away after 3 months.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Sensation of foreign body, Vision blurred
Clinical narrative: Perspiring, blurred vision, felt "something there when I swallowed" (pointed to salivary glands across neck).  This lasted ~45 minutes, then she had chills.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Limb discomfort, Pain in extremity
Clinical narrative: Severe pain and discomfort of upper arm the evening/night of vaccination.  This persisted for several days and extremely large hematoma developed on inner aspect of arm.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PT has red irritating patches along both arms and across his shoulders. Pt states they are itchy and Benadryl hasn't helped.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Injection site mass, Nausea, Pyrexia, Vomiting
Clinical narrative: A quarter-sized lump appeared in the area of vaccination on 10/10/2014 which spread to cover the entire upper arm within 3 days. High fever, nausea and vomiting, severe back pain followed. Fever, nausea and vomiting, and pain resolved in 48 hours. Lump in arm slowly resolved in 4 weeks. Took prednisone taper for 13 days.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Furuncle
Clinical narrative: Boil on arm followed by cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chest discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient felt wave come across her chest at time of vaccination.  Then acute pain in her Left shoulder starting 1-2 weeks after vaccination; difficult to put on clothing or put arm above head.  The pain has been ebbing and flowing since but has gradually subsided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash with redness and no blistering at location of vaccine administration site. Size is approximately 3.5 inches in diameter and round. The patient mentioned it wasn't very painful.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: I inadvertantly administered an extra dose of Tdap vaccine three days apart. Patient denies any adverse side effects.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Immunized arm became extremely sore.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Severe Redness, Severe Soreness, Swelling, Severe Itching and Severe Heat at the site of the injection.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Lip swelling, Memory impairment, Ocular hyperaemia
Clinical narrative: Chest pain, difficulty breathing, swollen lower lip, bloodshot eyes, rash on face, difficulty remembering/recalling personal information i.e. birthday and address.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Chest pain, difficulty breathing, swollen lower lip, bloodshot eyes, rash on face, difficulty remembering/recalling personal information i.e. birthday and address.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Patient has reported that she received a sore arm from the vaccination that was typical for a vaccination.  However, the soreness progressed over the last month.  She is currently experiencing discomfort and weakness in her left arm.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Activities of daily living impaired, Hypoaesthesia, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Patient has reported that she received a sore arm from the vaccination that was typical for a vaccination.  However, the soreness progressed over the last month.  She is currently experiencing discomfort and weakness in her left arm.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Expired product administered, No adverse event
Clinical narrative: Member was given a dose (0.5 mL) of expired Anthrax.  Expired by one month.  No adverse reaction was noted.
Age: 16.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Ataxia, Diplopia, Encephalitis brain stem, Headache, Lumbar puncture normal
Clinical narrative: Headache, diplopia, ataxia. Eventually diagnosed with Bickerstaff brainstem encephalitis.
Age: 16.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Headache, diplopia, ataxia. Eventually diagnosed with Bickerstaff brainstem encephalitis.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Chills 100.5 fever malaise headache and knee and elbow joint pain lasting approx 48 hours.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 12-6-14 All day tired and sleeping on the couch.  No appetite.  Not eating more than a half cup of soup. 12-6-14 Very bad rash all over both arms, rash also under breasts and on her back. Upper arm where injection was administered was swollen, red and very sore. 12-11-14 2:00 AM, Very dizzy, threw up, called 911 for ambulance. Had a silent heart attack according to doctor's report.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Myocardial infarction, Rash, Somnolence, Transient ischaemic attack, Vomiting
Clinical narrative: 12-6-14 All day tired and sleeping on the couch.  No appetite.  Not eating more than a half cup of soup. 12-6-14 Very bad rash all over both arms, rash also under breasts and on her back. Upper arm where injection was administered was swollen, red and very sore. 12-11-14 2:00 AM, Very dizzy, threw up, called 911 for ambulance. Had a silent heart attack according to doctor's report.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt called on 12/15/2014 asking how long does the pain last for Zostavax.  I responded a few days.  Pt said she received Zostavax shot on 11/3/2014 and she is still having pain on the arm she received the shot (not at the injection site).
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea, Rash
Clinical narrative: Headache, dizziness, nausea, rash on back of legs.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram normal, Headache, Loss of consciousness, Nuclear magnetic resonance imaging normal, Seizure like phenomena
Clinical narrative: Our daughter had received two HPV vaccinations. She started experiencing periods when she would lose consciousness for a few moments. A neurologist did and MRI and EEG and thought she may be having attention seizures. She also started getting headaches and having visual problems during the episodes. She did not have any of these symptoms before the vaccinations.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Our daughter had received two HPV vaccinations. She started experiencing periods when she would lose consciousness for a few moments. A neurologist did and MRI and EEG and thought she may be having attention seizures. She also started getting headaches and having visual problems during the episodes. She did not have any of these symptoms before the vaccinations.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Breast cancer female
Clinical narrative: This case was reported by a pharmacist and described the occurrence of breast cancer in a 55-year-old female patient who received ENGERIX B adult. Concomitant products included ENGERIX B adult, oxycodone, CYTOXAN, DECADRON, Vitamin D3, calcium and MIRALAX. On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced breast cancer (serious criteria GSK medically significant). The patient was treated with medication unknown (Unspecified Treatment). On an unknown date, the outcome of the breast cancer was unknown. The reporter considered the breast cancer to be unrelated to ENGERIX B adult. Additional details provided: Patient's concomitant products included also XANAX and fosprepitant. There was unknown if other vaccines were given on the same date. The patient's relevant medical history was unknown. On 24 November 2014, the patient received FLUARIX QUADRIVALENT. The patient was started on ENGERIX-B and received 2 doses. She was now due for her third dose but she was currently on breast cancer treatment. She was not on breast cancer treatment prior to starting the ENGERIX-B series. It is unknown whether she was diagnosed with breast cancer before or after starting the series of ENGERIX-B. The reporter stated that was "impossible" that her breast cancer was due to ENGERIX-B. The patient was currently on the 4th cycle of treatment for breast cancer. The Immunization was given in a different facility/clinic.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction - pt was administered Flu vaccine instead of pneumonia vaccine. Pt has now received 2 flu vaccines since September.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Lethargy, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: I received the vaccine on Tues. Nov 18, 2014. Later that evening I began to experience a sore throat. The next day I experienced a sore throat and nasal congestion of left nare. On Thurs I had intermittent nonproductive cough. Friday and Saturday green nasal discharge. Sunday lethargic, sore throat, nausea, nasal congestion.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: I received the vaccine on Tues. Nov 18, 2014. Later that evening I began to experience a sore throat. The next day I experienced a sore throat and nasal congestion of left nare. On Thurs I had intermittent nonproductive cough. Friday and Saturday green nasal discharge. Sunday lethargic, sore throat, nausea, nasal congestion.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site swelling
Clinical narrative: Swelling, mass at site of injection in muscle, unable to lift arm. Placed on steroids, physical therapy.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Swelling, mass at site of injection in muscle, unable to lift arm. Placed on steroids, physical therapy.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Local swelling, Nodule, Pain in extremity
Clinical narrative: Swelling, mass at site of injection in muscle, unable to lift arm. Placed on steroids, physical therapy.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: 1-2 hours after receiving flu shot my entire arm became very sore. I didn't know where to put my arm it hurt so bad. Pain subsided later that nite however my upper arm still hurts at times especially when I try to pull on a shirt etc or extend my arm any length.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant concerning unspecified patients (demographics not provided). The medical assistant reported that an unspecified number of unspecified patients received doses of Oral ROTATEQ on unspecified dates that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. This is one of three reports from the same reporter (see case #1411USA012708 and 1412USA007353). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported swelling, pain, and a band of redness around arm at injection site starting 24 hours after administration.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Local swelling, Lymphadenopathy, Malaise, Rash
Clinical narrative: Pt became ill with malaise 12/11 evening, noticed in 12/12 AM rash at axillary (L), swollen (L) axillary nodes. Area is swollen and erythematous. Came to office at 2:30 pm with same rash sx, feeling better over in regard to malaise. Treated with azithromycin 250 mg tab (2 tabs x 1 day, then 1 tab x 4 days). Told to call with worsening sx.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Flushing, Headache, Pain
Clinical narrative: Extreme fatigue, aching, chills, headache, cheeks flushed. No fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Paraesthesia oral, Throat irritation
Clinical narrative: Metallic taste in mouth and lips tingled for 2 days. Also, pruritus of back of throat.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oral discomfort, Swollen tongue, Throat irritation, Tongue disorder
Clinical narrative: Tongue thick/swollen day after with lips swollen and burning, "clearing throat a lot". Cardiac history.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Myositis, Nerve injury
Clinical narrative: Nerve damage and muscle inflammation.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Pruritus
Clinical narrative: Pt c/o headache and itching on trunk. Symptoms started 48 hrs. after vaccines.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) upper arm swelling with redness.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Lethargy, Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever, lethargy, emesis, muscle aches.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: The patient received flu vaccine and he received it also one month earlier.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Had vaccine 11/4/14. About 3-4 hrs afterward started having arm pain and has not resolved. Having trouble moving arm.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received flu seasonal (batch number 2A2KX, expiry date unknown). On an unknown date, the patient received flu seasonal .5 ml. The subject's estimated date of delivery was 7th March 2015. On an unknown date, an unknown time after receiving flu seasonal, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the reporter considered the vaccine exposure during pregnancy to be related to flu seasonal. The reporter considered the vaccine exposure during pregnancy to be not reported if related to flu seasonal. Additional information received on 23 September 2014: Her last menstrual period was on an unspecified date (but calculated on 31 May 2014) and estimated date of delivery was on 7 March 2015. The patient was exposed to the vaccine during unknown trimester.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Muscle spasms, Nausea, Underdose, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in a 30-year-old female patient who received HAVRIX 360 Junior. Co-suspect products included Thyroid Tablets for an unknown indication. On 3rd December 2014, the patient received the 1st dose of HAVRIX 360 Junior. On 2nd December 2014, the patient started Thyroid Tablets (oral) at an unknown dose and frequency. On 3rd December 2014, less than an hour after receiving HAVRIX 360 Junior, the patient experienced nausea (serious criteria disability), vomiting, cramp, abdominal pain and underdose. The patient was treated with invert sugar, EMETROL. On an unknown date, the outcome of the nausea, vomiting, cramp and abdominal pain were not recovered/not resolved and the outcome of the underdose was unknown. It was unknown if the reporter considered the nausea, vomiting, cramp and abdominal pain to be related to HAVRIX 360 Junior. Additional details provided: The pharmacist who reported the incident was also the patient. The events required medical attention at the doctor's office. The reporter was not aware of any adverse events following previous vaccinations.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 38-year-old female patient who received FLUARIX QUADRIVALENT (batch number 2L752, expiry date June 2015). On 16th October 2014 10:30, the patient received FLUARIX QUADRIVALENT (intramuscular). On an unknown date, the dose was an unknown dose. On 16th October 2014, 10 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash and hives were recovering/resolving. The reporter considered the rash and hives to be almost certainly related to FLUARIX QUADRIVALENT. Additional information: Caller reports that she received a FLUARIX QUADRIVALENT vaccine yesterday at her local pharmacy. Yesterday evening she started noticing a rash developing on her forearms. She woke up this morning and there were hives on both arms starting a little below her wrist to her elbow. The hives are red, elevated and flat, and they are worse on the arm where she received the injection. She spoke with her HCP and pharmacy, but has not had to go into the office. She took some BENADRYL this morning and the rash does seem to be doing better.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain, Rash
Clinical narrative: This case was reported by a other health professional and described the occurrence of rash in a patient who received FLUARIX (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, immediately after receiving FLUARIX, the patient experienced rash, injection site pain and discomfort. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the injection site pain and discomfort were unknown. The reporter considered the rash, injection site pain and discomfort to be probably related to FLUARIX. Additional information: The physician assistant reported that there had been several patients (about 6) that have reported inflammatory reactions with more than normal (unusual) pain and discomfort after receiving the FLUARIX TIV vaccine. In 2 of the 6 patients they developed a rash which was indurated hard and painful. One of the 2 patients that developed the rash it was in size about 10-15cm. All of these patients are reporting these adverse events immediately upon receiving the vaccine and reported that it gradually worsened over time. About 5 patients came back in the office to be evaluated. The PA believes these reactions have resolved but is not sure.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report as received from a nurse practitioner as part of a marketing research program, refers to a male patient of unknown age. Patient's concurrent conditions and relevant medical history was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose and route unspecified) for prevention of shingles. Concomitant medications were unknown. On an unknown date the patient and his wife came in together and stated that they both received ZOSTAVAX, however the patient still got shingles event after vaccination and both verbalized understanding. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Had ZOSTAVAX vaccine on 12/01/2014. Patient states that she has had no problems until this morning (12/03/2014) states that her left arm was itching a little, when she scratched her arm is when she noticed that area was warm and swollen, but was not tender. Patient does state that she has felt nauseated since receiving the vaccine but enough to produce vomiting. Denies loss of appetite. Advised patient to apply cool compress to area and MOTRIN as directed per directions on bottle and if itching increases to take BENADRYL per bottle directions.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report was receivd from a 53 year old female patient, regarding herself. Patient's pertinent medical history was reported as none. Patient was reported as allergic to MAXIDE, WELLBUTRIN and penicillin. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX .65 ml, subcutaneous (lot #, expiry date unspecified). Concomitant medications included other unspecified medications (unspecified names, dose/frequencies and manufacturers). On 02-DEC-2014, patient experienced an itchy and red inflamed rash, at the injection site, after receiving ZOSTAVAX. No treatment was given for the adverse event. Outcome of the events were reprted as not recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Pt came in on 12/5 w/ swelling, rash, and redness. It was hot to the touch. Pt instructed to use ice pack to relieve. Called each subsequent day and improved each day until resolution on 12/9/14.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant concerning unspecified patients (demographics not provided). The medical assistant reported that an unspecified number of unspecified patients received doses of RECOMBIVAX HB on unspecified dates that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. This is one three reports from the same reporter (see #1411USA012708 and 1412USA007342). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant concerning unspecified patients (demographics not provided).  The medical assistant reported that an unspecified number of unspecified patients received doses of VAQTA on unspecified dates that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. This is one of three reports from the same reporter (see case # 1412USA007342 and 1412USA007353). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Nausea, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a 60 year old female patient with seasonal allergies reporting on herself. Patient declined to provide any medical history. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX in the left arm for shingles vaccination (route, lot number and expiration date were not reported). Concomitant therapies included paroxetine and levothyroxine sodium (manufacturer unknown). On 10-OCT-2014, the patient had some kind of rash in the injection site. On 13-NOV-2014, the patient began having nausea, itching and pain. The outcome of pain, nausea and itching was unknown. The patient also reported that the rash feeling had been continuous. Patient did not received any treatment for the adverse events. Patient sought unspecified medical attention. Additional information is not expected, because the patient did not want us to contact the physician.