chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Dizziness, Injection site movement impairment, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US042371, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622726) website on 29 Mar 2016. This report refers to a 51-year-old female patient. Past medical history included anxiety disorder, mild herniated disc lower back and kidney cysts. Current conditions included cavernous malformations of the brain, left carotid aneurysm, mitral valve prolapse mild, allergies to codeine and contrast dye to computer tomography (CT). Concomitant medications included LEXAPRO and clonazepam. The patient was vaccinated with FLUCELVAX (batch number: 62577 0614 01) intramuscularly in right arm along with ADACEL (batch number: 49281 0400 15) intramuscularly in left arm, both on 01 Nov 2015. On 02 Nov 2015, the patient experienced sore upper right arm (reported as more than previous shot) and sore right  shoulder which progressively got worse with range of motion limited, painful to move arm at different angles, especially upwards and lifting things that were not very heavy at different angles, at night arm throbbed and the shoulder pain was felt on the right side of neck, very faint and lightheaded. Laboratory data included right shoulder magnetic resonance imaging indication tendinosis and bursal surface fraying of the supraspinatus tendon. The outcome of the events was reported as condition unchanged. The seriousness of the events were reported as non serious. The causality of the events was not reported. Seriousness assessment of the events injected limb mobility decreased, pain in extremity, pain, dizziness, neck pain, musculoskeletal pain, syncope and tendon disorder were upgraded based on the information available in the source documents. Upon follow up from quality assurance department, it was confirmed that, the reported batch number (62577 0614 01) was not a valid batch number for FLUCELVAX. Hence, standard QA investigation could not be performed and no further action would be taken. Follow up report received from Quality assurance department on 11 Apr 2016: Updated QA comments.
Age: 51.0
Sex: F
Vaccine: FLUC3, TDAP, FLUC3, TDAP
Symptoms: Neck pain, Nuclear magnetic resonance imaging abnormal, Pain, Tendon disorder
Clinical narrative: Case number PHHY2016US042371, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622726) website on 29 Mar 2016. This report refers to a 51-year-old female patient. Past medical history included anxiety disorder, mild herniated disc lower back and kidney cysts. Current conditions included cavernous malformations of the brain, left carotid aneurysm, mitral valve prolapse mild, allergies to codeine and contrast dye to computer tomography (CT). Concomitant medications included LEXAPRO and clonazepam. The patient was vaccinated with FLUCELVAX (batch number: 62577 0614 01) intramuscularly in right arm along with ADACEL (batch number: 49281 0400 15) intramuscularly in left arm, both on 01 Nov 2015. On 02 Nov 2015, the patient experienced sore upper right arm (reported as more than previous shot) and sore right  shoulder which progressively got worse with range of motion limited, painful to move arm at different angles, especially upwards and lifting things that were not very heavy at different angles, at night arm throbbed and the shoulder pain was felt on the right side of neck, very faint and lightheaded. Laboratory data included right shoulder magnetic resonance imaging indication tendinosis and bursal surface fraying of the supraspinatus tendon. The outcome of the events was reported as condition unchanged. The seriousness of the events were reported as non serious. The causality of the events was not reported. Seriousness assessment of the events injected limb mobility decreased, pain in extremity, pain, dizziness, neck pain, musculoskeletal pain, syncope and tendon disorder were upgraded based on the information available in the source documents. Upon follow up from quality assurance department, it was confirmed that, the reported batch number (62577 0614 01) was not a valid batch number for FLUCELVAX. Hence, standard QA investigation could not be performed and no further action would be taken. Follow up report received from Quality assurance department on 11 Apr 2016: Updated QA comments.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test, Injection site bruising, Injection site pain, Mobility decreased, Muscle tightness
Clinical narrative: Soreness in shoulders and arms, muscle weakness, pain on top of left shoulder and constriction of muscles between neck and shoulder, inability to lift arms to level of cabinets or to open/close windows, reduced capacity to hold weight, aches/soreness in front shoulders.  Swelling of arm for 3.5 weeks  .4 weeks after vaccine, swelling began to go down, then bruise showed up at the sight of the injection. Now, 3 weeks later, still sore at injection site, shoulder muscles and arms still sore, but to a lesser extent. CIPRO was given at the time of the flu vaccine.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: Soreness in shoulders and arms, muscle weakness, pain on top of left shoulder and constriction of muscles between neck and shoulder, inability to lift arms to level of cabinets or to open/close windows, reduced capacity to hold weight, aches/soreness in front shoulders.  Swelling of arm for 3.5 weeks  .4 weeks after vaccine, swelling began to go down, then bruise showed up at the sight of the injection. Now, 3 weeks later, still sore at injection site, shoulder muscles and arms still sore, but to a lesser extent. CIPRO was given at the time of the flu vaccine.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site bruising, Injection site pain, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Soreness in shoulders and arms, muscle weakness, pain on top of left shoulder and constriction of muscles between neck and shoulder, inability to lift arms to level of cabinets or to open/close windows, reduced capacity to hold weight, aches/soreness in front shoulders.  Swelling of arm for 3.5 weeks  .4 weeks after vaccine, swelling began to go down, then bruise showed up at the sight of the injection. Now, 3 weeks later, still sore at injection site, shoulder muscles and arms still sore, but to a lesser extent. CIPRO was given at the time of the flu vaccine.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Weight bearing difficulty
Clinical narrative: Soreness in shoulders and arms, muscle weakness, pain on top of left shoulder and constriction of muscles between neck and shoulder, inability to lift arms to level of cabinets or to open/close windows, reduced capacity to hold weight, aches/soreness in front shoulders.  Swelling of arm for 3.5 weeks  .4 weeks after vaccine, swelling began to go down, then bruise showed up at the sight of the injection. Now, 3 weeks later, still sore at injection site, shoulder muscles and arms still sore, but to a lesser extent. CIPRO was given at the time of the flu vaccine.
Age: 0.33
Sex: F
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Throwing up.
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Glioblastoma
Clinical narrative: Initial unsolicited report received from a healthcare professional (physician assistant) on 01-Apr-2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone High-Dose (batch number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, after vaccination, the patient experienced acute disseminated encephalomyelitis (original diagnosis) and Glioblastoma (confirmed diagnosis). Laboratory investigations and corrective treatments were not reported. Outcome of the events were not reported. Upon internal review, the company decided to consider the event serious because of important medical events: acute disseminated encephalomyelitis and Glioblastoma. List of Documents held by sender: none. Sender's Comments: Glioblastoma and Acute Disseminated Encephalomyelitis are unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Initial symptom was weakness of left side of mouth. Diagnosed with Bell's Palsy. Left-sided facial weakness increased over two days. About 8 days after initial symptom, facial tone improved. Muscle strength gradually increased. Treated with prednisone 60 mg x 5 days, then 40 mg x 5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Raised rash at injection site, with itching. Site symptoms improved over time.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Patient reported receipt of annual flu vaccine 10/30/2015 with AFLURIA Lot# U56506, MFT CSL to his right deltoid during flu-fair. He advised leaving immediately after being vaccinated and began to cough. This lasted for a few moments and resolved once back in area about 1 mile away. Approximately <30 min later he felt a numbness/fullness to right nostril as if stuffy. Over next 2 hours this numbness worsened to right side of face along jaw and tongue (as if went to dentist). He denied any difficulty speaking, chewing, swallowing and no numbness to neck/eye/ear. He denied difficulty moving jaw/facial/neck muscles. This sensation and nasal fullness resolved by 9pm when he went to bed. He awoke the next morning with a dull 1/10 headache over frontal sinuses that persisted all day resolving later that evening. He again denied any fevers, chills, n/v, visual disturbances, tinnitus, weakness, rash, neck pain or any systemic like symptoms. HA was not like past migraine headaches - not as severe and different location. He advised he ate 2 homemade breakfast sandwiches with ginger tea which he had had before and since without reaction. He denied any new detergents, deodorants, food groups, trauma, odor exposure, or recent exercise prior to/after vaccination. He reported having mild pollen allergy but was never tested for.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Injection site erythema, Nausea, Peripheral swelling
Clinical narrative: This 48 year old employee requests exemption to influenza vaccine. She advised she received 2 doses of influenza vaccine between 1993 and 1999 (records not available-"lost"). She recalls the first flu vaccine was given with an air gun to her left arm. She did not receive any other vaccines at that time. Later that day the vaccine site was sore and with orange size swelling and redness. The next morning she recalls having a fever with increased tenderness to vaccine site ("it stuck out about 1/2 inch or so"). She recalls seeing Occ Health provider and advised it was a response from the air gun. She stated she felt "bad" and it took about a week or so to recover. The next year she received another flu vaccine but with syringe. She again recalls the next morning having a fever but this time her entire left arm was swollen from shoulder to fingertips, skin appeared red (unsure if just at vac site or entire arm as it's been over 20 years), felt nauseated and vaccine site was sore and warm to touch. She recalls having difficulty bending fingers due to swelling. Is right handed. She reported back to Occ health and thinks they prescribed MOTRIN, but doesn't recall specifics. She did recall it again took a week for swelling, redness and pain to resolved. Fever resolved within 24-48 hours. Since then she has never had another flu shot. She sees a allergist since 1999 due to multiple severe drug allergies having been tested to flu vaccine in Oct 2013 (unknown vac tested to) and Oct 2015 (FLUARIX-preservative free quad vaccine by SP) each time having positive challenge results (test results requested - see attached note from Dr and pictures). She also reports severe reactions to various antibiotics to include sulfa, floxin, clindamycin, and CIPRO. Reactions to these antibiotics included rash, swelling, itching, fever which worsened with each new antibiotic received...all required hospitalization with last event with CIPRO resulting in blisters, peeling skin and itchy palms/soles. She denied any allergy to eggs, eats soft/hard cooked and had negative allergy testing in Oct 2015. She had similar reactions with PLAQUENIL and lemons. BENADRYL caused her to sleep for 3 days with one dose. She denied any latex allergy or issues with other vaccines.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: This 48 year old employee requests exemption to influenza vaccine. She advised she received 2 doses of influenza vaccine between 1993 and 1999 (records not available-"lost"). She recalls the first flu vaccine was given with an air gun to her left arm. She did not receive any other vaccines at that time. Later that day the vaccine site was sore and with orange size swelling and redness. The next morning she recalls having a fever with increased tenderness to vaccine site ("it stuck out about 1/2 inch or so"). She recalls seeing Occ Health provider and advised it was a response from the air gun. She stated she felt "bad" and it took about a week or so to recover. The next year she received another flu vaccine but with syringe. She again recalls the next morning having a fever but this time her entire left arm was swollen from shoulder to fingertips, skin appeared red (unsure if just at vac site or entire arm as it's been over 20 years), felt nauseated and vaccine site was sore and warm to touch. She recalls having difficulty bending fingers due to swelling. Is right handed. She reported back to Occ health and thinks they prescribed MOTRIN, but doesn't recall specifics. She did recall it again took a week for swelling, redness and pain to resolved. Fever resolved within 24-48 hours. Since then she has never had another flu shot. She sees a allergist since 1999 due to multiple severe drug allergies having been tested to flu vaccine in Oct 2013 (unknown vac tested to) and Oct 2015 (FLUARIX-preservative free quad vaccine by SP) each time having positive challenge results (test results requested - see attached note from Dr and pictures). She also reports severe reactions to various antibiotics to include sulfa, floxin, clindamycin, and CIPRO. Reactions to these antibiotics included rash, swelling, itching, fever which worsened with each new antibiotic received...all required hospitalization with last event with CIPRO resulting in blisters, peeling skin and itchy palms/soles. She denied any allergy to eggs, eats soft/hard cooked and had negative allergy testing in Oct 2015. She had similar reactions with PLAQUENIL and lemons. BENADRYL caused her to sleep for 3 days with one dose. She denied any latex allergy or issues with other vaccines.
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood pressure increased, Erythema, Hyperhidrosis, Joint range of motion decreased, Local reaction
Clinical narrative: 29 yo male employee who received 3rd TWINRIX on Friday 3/11/2016. Sat evening 3/12/2016 he c/o bilateral ankle edema, redness and tenderness to touch (entire ankle L>R). Sunday there was no change or addition of any other symptom. No fever, rash, ha, increase in swelling or limitation in ROM. Monday 3/14/2016 he went to medical where nurse called Immunization Healthcare Branch to discuss possible vaccine reaction. Based on her statements then of sudden onset ankle swelling and sweating and elevated BP at 156/90 I advised these were not common side effect to TWINRIX and suggested he see MD there - they recommended he see his PCP or go to ER. He called his HCP and went. BP 156-90 Temp 98.3F HR 90 RR20. Pt's ankle appeared mildly edematous. Color was within normal limits. Pt. was sweating. Since he rode his bike to work this am I could not determine if this was medical or from exercise. Dr. suggested that the pt. be seen by his primary care MD or outpatient facility. I followed up with him 3/15/2016 to clarify symptom complaints: description of his ankles, and more details on the sweating. He states he is a big man (like Hoss Cartwright) and sweats a lot normally and suggested his bp up after riding his bike to work. His reports his BP was normal at medical facility. Today 3/16/2016 his redness and swelling are gone. He is on day 3 of 5 steroid dose (60 mg/day). Your reaction was discussed with Dr. of vaccine safety and allergist. While reported vaccine side effects do list swelling, redness, joint pain and sweating as reported post vaccine side effects to TWINRIX thereby suggesting a temporal association to the vaccine (timing of reaction <24 hours after vaccine administration); the localized reaction does not support an allergic reaction to the vaccine or it's ingredients (ankles only). Reactions typically include more than one site (unless a local injection site reaction). You said your vaccine site was okay.
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: 29 yo male employee who received 3rd TWINRIX on Friday 3/11/2016. Sat evening 3/12/2016 he c/o bilateral ankle edema, redness and tenderness to touch (entire ankle L>R). Sunday there was no change or addition of any other symptom. No fever, rash, ha, increase in swelling or limitation in ROM. Monday 3/14/2016 he went to medical where nurse called Immunization Healthcare Branch to discuss possible vaccine reaction. Based on her statements then of sudden onset ankle swelling and sweating and elevated BP at 156/90 I advised these were not common side effect to TWINRIX and suggested he see MD there - they recommended he see his PCP or go to ER. He called his HCP and went. BP 156-90 Temp 98.3F HR 90 RR20. Pt's ankle appeared mildly edematous. Color was within normal limits. Pt. was sweating. Since he rode his bike to work this am I could not determine if this was medical or from exercise. Dr. suggested that the pt. be seen by his primary care MD or outpatient facility. I followed up with him 3/15/2016 to clarify symptom complaints: description of his ankles, and more details on the sweating. He states he is a big man (like Hoss Cartwright) and sweats a lot normally and suggested his bp up after riding his bike to work. His reports his BP was normal at medical facility. Today 3/16/2016 his redness and swelling are gone. He is on day 3 of 5 steroid dose (60 mg/day). Your reaction was discussed with Dr. of vaccine safety and allergist. While reported vaccine side effects do list swelling, redness, joint pain and sweating as reported post vaccine side effects to TWINRIX thereby suggesting a temporal association to the vaccine (timing of reaction <24 hours after vaccine administration); the localized reaction does not support an allergic reaction to the vaccine or it's ingredients (ankles only). Reactions typically include more than one site (unless a local injection site reaction). You said your vaccine site was okay.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Fall, Fine motor skill dysfunction, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Child was extremely perturbed and spent the night in shallow, restless sleep. At the time a mild fever of about 100 degrees was detected. In the morning the area around the injection became visibly inflamed, extending up and down the front of the thigh, with the area immediately adjacent to the injection point becoming painful to the touch. The affected area was also extremely hard. Motor skills were affected and the child fell an unusual number of times that morning, at one point injuring themselves. After about 3 PM of the next day the symptoms abated.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Injury, Poor quality sleep, Pyrexia
Clinical narrative: Child was extremely perturbed and spent the night in shallow, restless sleep. At the time a mild fever of about 100 degrees was detected. In the morning the area around the injection became visibly inflamed, extending up and down the front of the thigh, with the area immediately adjacent to the injection point becoming painful to the touch. The affected area was also extremely hard. Motor skills were affected and the child fell an unusual number of times that morning, at one point injuring themselves. After about 3 PM of the next day the symptoms abated.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Pruritus, Swelling
Clinical narrative: Patient described arm as immediately very sore on day of vaccination, with notable adverse reactions several days (3 days) later of itching, redness, swelling and tenderness. Patient MD has advised diphenhydramine to treat reaction starting today.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Patient described arm as immediately very sore on day of vaccination, with notable adverse reactions several days (3 days) later of itching, redness, swelling and tenderness. Patient MD has advised diphenhydramine to treat reaction starting today.
Age: 55.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Urticaria
Clinical narrative: Some swelling raised whelps and itching at site of injection.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Diplegia, Influenza, Pneumonia, Pyrexia
Clinical narrative: 01/06/14 Paralysis of legs for three. 6 days after vaccine. Fever. Pneumonia. Flu occurred in 2/24/14. Flu occurred in 2/24/14. (3/14) March of same eye.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Eyelid oedema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Approx 3/24 patient began noticing red, itchy spots on face and cheeks and (R) eyelid was "puffy. Patient is following up with PCP.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Generalised tonic-clonic seizure, Headache
Clinical narrative: Patient developed tonic-clonic seizures which were quite severe.  Also chronic daily headaches.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Body temperature, Erythema, Fatigue, Headache
Clinical narrative: I received a ZOSTAVAX shot on 4-5-2016. My arm became sore, red, aggravated, then blistered on the second day. The pain has increased. The itching has increased. I am extremely tired. I have a temperature and had a bad headache especially the following day and is slowly lessening. I work in a hospital. They sent me home because I developed the rash with blisters. I transport immuno-compromised individuals.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: I received a ZOSTAVAX shot on 4-5-2016. My arm became sore, red, aggravated, then blistered on the second day. The pain has increased. The itching has increased. I am extremely tired. I have a temperature and had a bad headache especially the following day and is slowly lessening. I work in a hospital. They sent me home because I developed the rash with blisters. I transport immuno-compromised individuals.
Age: 2.0
Sex: F
Vaccine: JEV1, MMR, TYP
Symptoms: Rash
Clinical narrative: Gluteal rash, right side, appeared 10 minutes after vaccine administration. Patient showed no sighs of NVD, difficulty breathing, swelling, or wheezing. No treatment needed, per provider. Patient told to follow up if symptoms worsen.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Flatulence, Irritability, Muscle spasms, Poor feeding infant
Clinical narrative: Fussiness and cramping after feeding until passed loose stools.Fussiness awakens child.  Gassy after feeding.  Feeding poorly. Poor feeding and weight loss. No mucous or blood in stool.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Sleep disorder, Weight decreased
Clinical narrative: Fussiness and cramping after feeding until passed loose stools.Fussiness awakens child.  Gassy after feeding.  Feeding poorly. Poor feeding and weight loss. No mucous or blood in stool.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Patient is experiencing a rash, skin redness and warm to the touch.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Provided Hepatitis B Vaccine which was too early. Did not see birth dose. Should have been 6 months rather than 2 months.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash, itching, swelling. Patient went to ER. Dr prescribed antibiotic and steroid.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Local swelling
Clinical narrative: Red raised area extending from shoulder to just above elbow. Cephalexin 500 mg TID.
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: Initial unsolicited report received from a healthcare professional (trained Medic) via social media on 12 October 2015. "That report is from social media and contact information in based upon the location of our trading partner". This case involves a female patient (age at onset not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DPT) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient experienced bad leg muscle spasms and her legs were locked with severe pain. Laboratory investigations and corrective treatments were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 13.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Chills, Dehydration, Hypotension, Tinnitus, Vomiting
Clinical narrative: Chills, vomiting, ringing in ears - IV fluids in ER.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Diarrhea. Blood and mucous in stools.
Age: 36.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: 1 x 2 inch erythematous, warm patch over deltoid, similar appearing patch over left upper chest. Both non-tender and no fluctuance/induration or drainage.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly M-M-R II lot # L026551 (expiry 16-JUL-2017) and L002859 (expiry date 05-FEB-2017) (dose and route not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Cellulitis, Erythema, Malaise, Pain in extremity, Skin induration
Clinical narrative: Treatment antibiotic in the hospital and at for 7-10 days. My arm was very red and very hard. My had gotten very large and very painful my body was very sick.
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: X-ray
Clinical narrative: Treatment antibiotic in the hospital and at for 7-10 days. My arm was very red and very hard. My had gotten very large and very painful my body was very sick.
Age: 71.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Malaise, Pain, Peripheral swelling
Clinical narrative: Treatment antibiotic in the hospital and at for 7-10 days. My arm was very red and very hard. My had gotten very large and very painful my body was very sick.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly (Merck) VARIVAX lot # L040419 (expiry 14-OCT-2017) and L040421 (expiry date 15-OCT-2017) (dose and route not reported). The temperature excursion time frame was reported as "-4.7 C for 682 hours, -5.3 C for 130.45 hours (-14.9 C to -10 C for 121.95 hours, -9.9 C to 5.3 C for 8.5 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Rash, Streptococcus test negative, Urticaria
Clinical narrative: Information has been received from a consumer refers to his daughter, a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with her first dose of PROQUAD (Merck) (lot#, expiration date, strength, dose were unknown and on 05-APR-2016 received her second dose of PROQUAD (Merck)) (lot#, expiration date, strength, dose were unknown) both intramuscularly. The patient's concomitant medication was not reported. On 05-APR-2016 (reported as "a couple hours") after receiving the second dose of PROQUAD (Merck), the patient developed a fever and "a couple hours after that she broke out in hives and a rash". The reporter stated that "the rash got worse yesterday to the point where three quarters of her body was covered. The rash was on her neck, face and most of her back, belly and legs". The reporter stated he gave the patient BENADRYL as treatment (unspecified date). The reporter stated on 07-APR-2016, he took his daughter to the emergency room due to her reaction. The patient was given DECADRON while at the emergency room and had a "strep test" performed which came back as "negative". The patient daughter was not admitted to the hospital and went home later in the day. The outcome of pyrexia and rash generalised was reported as not recovered/not resolved. The causality between the events and PROQUAD (Merck) was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: 11 yo female with post vaccine- syncopal episode. Lasted 5-10 sec. No ill effect. Hx at similar syncope episode per father in past with administration of ear piercing. Neurosurgeon.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 07-APR-2016 the patient was vaccinated with an expired dose of MMR II (lot # K003822, expired date: 14-MAR-2016). No symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Irritability
Clinical narrative: This spontaneous report as received from a consumer reporting on a friends child, a 23 week old male patient. Information regarding the patient's medical history and concurrent conditions was not provided. On an unknown date in January 2016, after fifteen weeks of age, the patient was vaccinated with his first dose of ROTATEQ, oral. She stated that the child was "irritable" after he was vaccinated . No laboratory tests were reported. No product quality assessment (PQC) was involved. The outcome of the event irritability was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diarrhoea, Diet refusal, Flatulence, Hypophagia, Irritability
Clinical narrative: Within 12 hrs of vaccine, watery stools in 36 hrs, refusal of food (22 ounce formula per day to 6 ounces per day x 4 days). More fussy, gassy. Resolved after approx. 6 days.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This case was reported by a other health professional via sale rep and described the occurrence of fainting in a 16-year-old male patient who received BEXSERO (batch number 149001, expiry date 1st September 2016). Concomitant products included MENACTRA, On 4th April 2016, the patient received BEXSERO .5 ml. On 4th April 2016, immediately after receiving BEXSERO, the patient experienced fainting. On 4th April 2016, the outcome of the fainting was recovered/resolved. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details provided as follows. The healthcare professional reported that, the patient fainted instantly after receiving a dose of BEXSERO vaccine in the left arm once the needle was pulled out. The patient also received the MENACTRA vaccine right before the BEXSERO administration in the right arm. The patient recovered after a few moments.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 07-APR-2016, the patient was vaccinated with a dose of GARDASIL lot number J008423, expiration date 21-JAN-2016 (route was not provided). Concomitant therapy information was not provided. On 07-APR-2016, an expired product was administered as the patient was inadvertently administered an expired dose of GARDASIL. No adverse event was reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot # L035276 (expiry 09-JUN-2017) ( dose not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly PROQUAD lot # L047305 (expiry 23-MAY-2017) and L046507 (expiry date 17-MAY-2017) (dose and route not reported). The temperature excursion time frame was reported as "-4.7 C for 682 hours, -5.3 C for 130.45, -14.9 C to -10C for 121.95 hours, -9.9 C to 5.3C for 8.5 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Bacterial infection
Clinical narrative: None stated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # L033343 (expiry 13-SEP-2017) (dose and route not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly VAQTA, lot # L041676 (expiry 15-MAR-2017) and L035105 (expiry date 14-MAY-2017) (dose and route not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3 days after vaccine given mother noticed swelling on left upper thigh 2 cm redness, 2 point blisters. No tenderness. no inguinal lap.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Asthenopia, Confusional state, Fatigue, Joint stiffness, Somnolence
Clinical narrative: Unable to wake up, was confused of surroundings.  Took two or three minutes to get "my wits" about me.  Fatigued and eyes feel heavy.  Joint stiffness mostly in knees.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Directly following vaccine adminstration patient experienced minor bleeding, instant swelling, and formation of a small knot at adminisrtation site.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site exfoliation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed swelling, redness, warmth, pain and intense itchiness at injection site.  Mostly subsided by time patient reported event, with residual redness, pain, skin peeling on day event was reported.
Age: 25.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe left deltoid pain, could not move arm for about a week. Did not seek treatment at time, was on school trip. To be evaluated by medical provider on 4/13/16.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Localized induration and erythema requiring Benadryl for itching.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness/erythema and warmth of right thigh where immunization was given, progressive affected area for about 1-2 days. Not indurated and not tender on physician exam.
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Left thigh cellulitis at site of PEDIARIX immunization. Rx: BACTRIM x 7 days.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Chest X-ray normal, Chest discomfort, Dyspnoea, Nausea
Clinical narrative: Patient awoke day after immunizations feeling weak, nauseated, chest pressure/heaviness, SOB and low-grade fever. Patient seen in clinic, was stable with normal exam and recommended to rest at home.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient awoke day after immunizations feeling weak, nauseated, chest pressure/heaviness, SOB and low-grade fever. Patient seen in clinic, was stable with normal exam and recommended to rest at home.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Muscle spasms
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant medication was unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (19400 PFU, 0.65 ml, he got the shot once; lot#, strength and route unspecified). On an unknown date, 2 days after vaccination, the patient went back to the pharmacy and his arm looked extremely red. Then, the patient came back to see the pharmacist again "a week later" complaining of muscle spasms in and around the injection area. Representative mentioned that the Pharmacist advised the patient to go see his primary care physician but it was unknown if the patient actually did contact or see their doctor at the time of the report. The outcome of the events was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Immediate post-injection reaction, Local reaction, Malaise, Peripheral swelling
Clinical narrative: Immediate localized reaction, 2 days later went to emergency room with swelling in arm and general malaise, diagnosed with cellulitis and put on antibiotic for 10 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician regarding a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiry not reported). On an unknown date the patient experienced induration, erythema, itching, warmth and "two small clear blisters" at the injection site following administration of ZOSTAVAX. The physician stated he felt that the blisters were "not vesicles" and he did not feel the blisters were indicative of a varicella or varicella-like rash. The outcome of the events were unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to two patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that on unknown dates, the patients were vaccinated with the improperly stored doses of PEDVAXHIB (lot # K011077 with expiration date 30-MAR-2017 and lot # reported as L042257 with expiration date 17-AUG-2018; dose, frequency and route of administration were not reported). The vaccine was stored in 32.9 F for 96 hours. No previous temperature was reported. No adverse effects were reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old female patient. There was no concurrent conditions, medical history, and concomitant medications. Patient had allergy to latex. Approximately in 2006 (reported as 10 years ago) the patient received a full series of an unspecified Hepatitis B vaccine (manufacturer unknown) (dosing details, route of administration, lot# and expiry were not reported). The patient tested negative for Hepatitis B titers after she had an occupational exposure to saliva in 2015. The patient consulted the physician because of the workman's compensation claim, and the physician discovered the negative Hepatitis B titers during routine tests regarding that claim. The physician also tested the patient for Hepatitis B surface antigen, and the patient did not test positive for Hepatitis B surface antigen. The physician was not able to provide the name of the Hepatitis B vaccine that the patient received "10 years ago", or the dates that the patient received the doses because the patient received the series under the care of another provider. The physician does not have access to the patient's records from the previous provider at the time of this report. Since testing negative for Hepatitis B titer, the patient received a dose of RECOMBIVAX HB (lot # L010595, expiry: 12-NOV-2016) and (lot# L029631, expiry: 14-MAR-2017) on 30-SEP-2015 and 13-NOV-2015 respectively. The patient was otherwise healthy. The outcome of the event was unknown. The reporter did not provided the causality between the event and the suspect therapy. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Pt's arm became inflamed (red), swollen at site of injection.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Local reaction, Pruritus, Skin warm, Swelling
Clinical narrative: Localized reaction: bruising, swelling, itching, hot to touch. Recommended ice packs, pain reliever of choice (APAP/IBU), hydrocortisone crm.
Age: 15.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Headache, Injection site pain, Pain, Urinary tract infection, Vomiting
Clinical narrative: Generalised pain, particularly increase pain at injectable site, vomiting, headache.
Age: 15.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: White blood cells urine positive
Clinical narrative: Generalised pain, particularly increase pain at injectable site, vomiting, headache.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Patient complained of feeling hot with nausea and dizziness. Assisted to supine position. No LOC. No fall. Alert, oriented throughout event. Observed in immunization area approximately one hour. Tolerated oral liquids and peanut butter crackers. With persisting c/o dizziness assisted to nurse clinic for continued observation. Stable throughout event but because of c/o being light headed and some dizziness observed longer. Sibling arrived to drive her home. Vital signs stable during time in clinic. Observed in clinic (total time) for 2 hours total after her immunization.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Injection site reactions---Within 30 minutes itching all around injection.  Within 2 hours red area.  Within 5-6 hours, very itchy, very red, very swollen, hardened area; arm painful; affected area is 5" x 3 1/2".  On 4/8/16 symptoms still there but less intense; affected area enlarged to 5" x 4 1/2".  On 4/9/16 still swollen and red and painful; affected area now all the way down to my elbow; upper area discolored like a bruise.  On 4/10/16 symptoms lessened greatly.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site reactions---Within 30 minutes itching all around injection.  Within 2 hours red area.  Within 5-6 hours, very itchy, very red, very swollen, hardened area; arm painful; affected area is 5" x 3 1/2".  On 4/8/16 symptoms still there but less intense; affected area enlarged to 5" x 4 1/2".  On 4/9/16 still swollen and red and painful; affected area now all the way down to my elbow; upper area discolored like a bruise.  On 4/10/16 symptoms lessened greatly.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Feeling hot, Headache, Malaise
Clinical narrative: Patient reported that a couple of hours after Prevnar administration, her arm became swollen and red.  She did get an headache, nausea, chills and was sick in bed for 2 days and felt like her body was on fire.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Patient reported that a couple of hours after Prevnar administration, her arm became swollen and red.  She did get an headache, nausea, chills and was sick in bed for 2 days and felt like her body was on fire.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP, VARCEL, DTAP, HEP, HEPA, HPVX, MEN, VARCEL
Symptoms: Seizure
Clinical narrative: 2 seizures each lasting about 10 seconds, 20 seconds apart.