chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with live ZOSTAVAX within the last 6 months. No other co-suspects were reported. No concomitant medications were reported. On the day of administration, the patient experienced rash after receiving live ZOSTAVAX, The rash started to get better within 24 hours and developed right below the injection site and down to the patient's elbow. No treatment was given. No labs diagnostic studies were performed. The patient did not seek medical attention. The relatedness for rash is unknown for live ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age who in January 2012 was vaccinated with the first dose 0.5 ml of GARDASIL intramuscularly (lot number not provided). In November 2012, the patient received of second dose of GARDASIL (dose, route, lot number was not provided) and 06-FEB-2013, the patient received of third dose of GARDASIL (dose, route, lot number was not provided). No adverse event experienced. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 20-APR-2011, the patient was vaccinated with the first dose of GARDASIL (lot #, route and site of administration was not provided). On 07-FEB-2013 the patient was vaccinated with the second dose of GARDASIL (lot #, route and site of administration was not provided). No adverse symptoms was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On 08-FEB-2013, the patient was vaccinated with an expired dose of ZOSTAVAX lot # 671609/1165AA, exp. date 19-OCT-2012, 0.65 ml, subcutaneous. No adverse effect was reported. The outcome of the event was unknown. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a Certified Registered Nurse (CRN), concerns a female patient with 65 years old, with no known allergies and none adverse events following prior vaccination. The reporter stated that on 24-JAN-2013 at 16:25 hours, the patient was vaccinated with the first dose of ZOSTAVAX (Lot # H013943, expiration date not reported, in the right upper arm) resuspended in Diluant (Lot number H011543). No other cosuspect or concomitant medications were reported. On 24-JAN-2013 at 16:30 hours, the patient experienced a 10x12 cm red raised area. The reporter stated that on 28-JAN-2013 the patient was rechecked and it was observed that the size and red color of the raised area continued. No laboratory tests were performed. At the time of this report, the outcome of patient is not recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. The patient explained that she received GARDASIL (lot # was reported as 9883616, route and dose were unknown) during her second dose of the vaccine on an unknown date. She explained that her first dose was given some time in August or September 2012 and her last dose was scheduled for some time in March 2013. The outcome of event was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a school vaccine program coordinator refers to an 11 year old male patient. On 02-FEB-2013 the patient was vaccinated inadvertently with a dose of ZOSTAVAX (lot # dose and site of administration were not provided) instead of the second dose of VARIVAX (Merck). The patient did not report any adverse effect. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 63 year old male patient with asthma, penicillin allergy and aspirin allergy. On 16-JAN-2013 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot # H014196, expire date 19-MAR-2014) subcutaneously in the left arm. No suspect therapy reported. There was no concomitant medications. The patient developed wide spread erythema and swelling of the left arm, not just the injection site, and developed cellulitis two days later, on 18-JAN-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H014196, expire date 19-MAR-2014) subcutaneously in the left arm. No suspect therapy reported. There was no concomitant medications. The patient developed wide spread erythema and swelling of the left arm, not just the injection site, and developed cellulitis two days later, on 18-JAN-2013. The patient went to (emergency room)ER but was not admitted. Patient was treated with unspecified treatment. Patient was recovered on an unspecified date. The relatedness for the events to PNEUMOVAX23 was unknown. This is one of several reports received from same source. Additional information has been requested.
Age: 56.0
Sex: U
Vaccine: UNK
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Within 24 hours - face & tongue numb & arm numb. Felt like a stroke.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Full blood count normal, Laboratory test normal, Liver function test normal, Oral mucosal exfoliation, Rash
Clinical narrative: Patient reported rash developed within 1.5 hours of receiving Anthrax and Typhoid vaccines.  He presented to the emergency department 4 days after receiving the vaccines.  A rash was present on his trunk, arms, and legs.  There was also presence of a white linear ulceration on the left side of his tongue and he complained of tongue pain.  The patient was treated with Benadryl, Zantac, and Solu-Medrol while in the emergency department and admitted overnight.  He was discharged in stable condition the next day.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Tongue ulceration
Clinical narrative: Patient reported rash developed within 1.5 hours of receiving Anthrax and Typhoid vaccines.  He presented to the emergency department 4 days after receiving the vaccines.  A rash was present on his trunk, arms, and legs.  There was also presence of a white linear ulceration on the left side of his tongue and he complained of tongue pain.  The patient was treated with Benadryl, Zantac, and Solu-Medrol while in the emergency department and admitted overnight.  He was discharged in stable condition the next day.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Glossodynia, Rash, Tongue ulceration
Clinical narrative: Patient reported rash developed within 1.5 hours of receiving Anthrax and Typhoid vaccines.  He presented to the emergency department 4 days after receiving the vaccines.  A rash was present on his trunk, arms, and legs.  There was also presence of a white linear ulceration on the left side of his tongue and he complained of tongue pain.  The patient was treated with Benadryl, Zantac, and Solu-Medrol while in the emergency department and admitted overnight.  He was discharged in stable condition the next day.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Ophthalmological examination abnormal, Visual impairment
Clinical narrative: She received her 3rd GARDASIL on 1/24/13 & she started headaches that night, frontal area only and on Monday 1/28/13 she complained of blurry vision at school & saw her optometrist on 1/29/13 - New glasses prescribed & was told that she lost 10% vision due to GARDASIL.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Corrective lens user, Headache, Vision blurred, Visual acuity reduced
Clinical narrative: She received her 3rd GARDASIL on 1/24/13 & she started headaches that night, frontal area only and on Monday 1/28/13 she complained of blurry vision at school & saw her optometrist on 1/29/13 - New glasses prescribed & was told that she lost 10% vision due to GARDASIL.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Headache, Photophobia, Sudden visual loss
Clinical narrative: She received her 3rd GARDASIL on 1/24/13 & she started headaches that night, frontal area only and on Monday 1/28/13 she complained of blurry vision at school & saw her optometrist on 1/29/13 - New glasses prescribed & was told that she lost 10% vision due to GARDASIL.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Haemorrhage, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Started off with a low fever, runny nose, and irritability about one to two hours after receiving flu vaccine. I gave him Children's Motrin. He had diarrhea around 8:30 PM so I bathed him.  After his bath, I notice he had very large welts on his thighs and rear end, that later got so raw that they started to bleed. Both the welts/hives and the diarrhea continued for at least two weeks.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Started off with a low fever, runny nose, and irritability about one to two hours after receiving flu vaccine. I gave him Children's Motrin. He had diarrhea around 8:30 PM so I bathed him.  After his bath, I notice he had very large welts on his thighs and rear end, that later got so raw that they started to bleed. Both the welts/hives and the diarrhea continued for at least two weeks.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Exercise tolerance decreased, Insomnia, Joint swelling, Musculoskeletal discomfort
Clinical narrative: FEVER x 3 DAYS. INSOMNIA x 5 DAYS. REPORTED SIGNIFICANT PAIN AND INFLAMMATION IN THE JOINTS x 6 WEEKS.  SWELLING AND PAIN AFFECTED SHOULDERS, ELBOWS, WRISTS, FINGERS, HIPS, KNEES, ANKLES, NECK, ALONG THE SPINE, AND EVEN TOES.  PATIENT REPORTS WORST IN THE LT ARM, SHOULDER, TRICEPS, ELBOW, FOOT LT, AND BI-LATERALLY WITH HIS HANDS.  THE HANDS STILL PRESENTED WITH MILD EDEMA AND APPEARED SWOLLEN UPON INITIAL SIGHTING. THE PATIENT REPORTS THE PAIN AND SWELLING OF HIS JOINTS HAD PREVENTED HIM FROM EXCERCISING SINCE THE VACCINATIONS WERE RECIEVED.  ATTEMPTS TO EXCERCISE CAUSED HIM GREAT PHYSICAL DISCOMFORT AND PAIN IN THE JOINTS WHICH CAUSED CONTINUED PAIN AND INCREASED SWELLING INTO THE FOLLOWING DAY ACCORDING TO THE PATIENT.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: FEVER x 3 DAYS. INSOMNIA x 5 DAYS. REPORTED SIGNIFICANT PAIN AND INFLAMMATION IN THE JOINTS x 6 WEEKS.  SWELLING AND PAIN AFFECTED SHOULDERS, ELBOWS, WRISTS, FINGERS, HIPS, KNEES, ANKLES, NECK, ALONG THE SPINE, AND EVEN TOES.  PATIENT REPORTS WORST IN THE LT ARM, SHOULDER, TRICEPS, ELBOW, FOOT LT, AND BI-LATERALLY WITH HIS HANDS.  THE HANDS STILL PRESENTED WITH MILD EDEMA AND APPEARED SWOLLEN UPON INITIAL SIGHTING. THE PATIENT REPORTS THE PAIN AND SWELLING OF HIS JOINTS HAD PREVENTED HIM FROM EXCERCISING SINCE THE VACCINATIONS WERE RECIEVED.  ATTEMPTS TO EXCERCISE CAUSED HIM GREAT PHYSICAL DISCOMFORT AND PAIN IN THE JOINTS WHICH CAUSED CONTINUED PAIN AND INCREASED SWELLING INTO THE FOLLOWING DAY ACCORDING TO THE PATIENT.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Erythema, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Pt called the office 2/7/13 - reaction started Tues, 2/5/13. T - 100.0 area red, painful the redness size of pt's palm, welts 2" ling. Pain was pretty bad, pt took TYLENOL. Tingling, numbness, would come and go. 2/13/15 call to pt. arm still slightly sore but able to function better.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Pt called the office 2/7/13 - reaction started Tues, 2/5/13. T - 100.0 area red, painful the redness size of pt's palm, welts 2" ling. Pain was pretty bad, pt took TYLENOL. Tingling, numbness, would come and go. 2/13/15 call to pt. arm still slightly sore but able to function better.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Customer Safety Compromised: Pt was Pregnant.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Participant experienced redness and itching at the vaccination site (R deltoid)/ cold compress applied/ After 30 mins, participant reported less itching and less redness.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Headache for 2 days followed by numbness in finger on 3rd day, numbness in toes, foot and leg on 4th day, continued numbness in other fingers and toes thereafter.  Approximately 1 week after the vaccine, some feeling started to return to the initial numb sites.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia
Clinical narrative: Repeated involuntary movements of neck, takes tongue all the way out from his mouth. When asked he said he is not doing it, it just happens.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cough, Electromyogram normal, Muscular weakness, Nuclear magnetic resonance imaging normal
Clinical narrative: Weakness, profound, in 4 limbs with a "pulling sensation" down length of the limbs, fever, cough. Weakness in arms resolved nearly fully by noon, weakness in legs persisted at least 3 weeks.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sensory disturbance
Clinical narrative: Weakness, profound, in 4 limbs with a "pulling sensation" down length of the limbs, fever, cough. Weakness in arms resolved nearly fully by noon, weakness in legs persisted at least 3 weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram, Balance disorder, Deafness neurosensory, Dizziness, Nausea
Clinical narrative: Vertigo, dizziness, nausea, vomiting, sudden hearing loss, asymmetrical right sensorineural hearing loss, tinnitus, peripheral vertigo, benign paroxysmal positional vertigo.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain, Sudden hearing loss, Tinnitus, Vertigo, Vertigo positional
Clinical narrative: Vertigo, dizziness, nausea, vomiting, sudden hearing loss, asymmetrical right sensorineural hearing loss, tinnitus, peripheral vertigo, benign paroxysmal positional vertigo.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vertigo, dizziness, nausea, vomiting, sudden hearing loss, asymmetrical right sensorineural hearing loss, tinnitus, peripheral vertigo, benign paroxysmal positional vertigo.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site urticaria
Clinical narrative: Large hard welt on thigh 6 in x 3 in. Mom using warm soaks & compresses. Noticed welt on Sat, increased by Sunday & decreasing now. No other sxs.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No reaction - pt's wife concern heard of disease state Guillain-Barre Syndrome.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Systemic urticaria; swelling redness at site hives.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Immunization given late Thursday woke up in the night Fri night / Sat AM with itchy red, swollen face - responded to BENADRYL within 24 hours no sense of any swelling.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Intensive care, Mechanical ventilation, Peripheral coldness, Respiratory distress
Clinical narrative: On 2-2-2013 patient felt cold and blue and not responding. No fever. Was on ventilator for 1 day in Peds ICU for respiratory distress. Received albuterol and antibiotic.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Respiratory syncytial virus test positive, Unresponsive to stimuli
Clinical narrative: On 2-2-2013 patient felt cold and blue and not responding. No fever. Was on ventilator for 1 day in Peds ICU for respiratory distress. Received albuterol and antibiotic.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Musculoskeletal stiffness, Oedema peripheral, Rash, Upper respiratory tract infection
Clinical narrative: On 1/30/13 cl's mom called and reported that on 1/27/13 client developed hives on feet, knees, hands, a few on face, and her hands became "completely swollen" so that client couldn't bend her fingers, hands purple in color. Client treated at clinic with BENADRYL and CLARITIN. Mother was told rash related to client's URI which began 1/23/13.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: On 1/30/13 cl's mom called and reported that on 1/27/13 client developed hives on feet, knees, hands, a few on face, and her hands became "completely swollen" so that client couldn't bend her fingers, hands purple in color. Client treated at clinic with BENADRYL and CLARITIN. Mother was told rash related to client's URI which began 1/23/13.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Has erythema, induration, swelling of left upper thigh.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Deafness unilateral, Headache, Tinnitus
Clinical narrative: Initial report received on 04 February 2013 from a consumer who is also the patient. A 61-year-old female patient with no concurrent illnesses or reported medical history, had received an intramuscular left deltoid injection of FLUZONE (lot number UT440AA) on 12 October 2011. The evening of vaccination the patient experienced a bad headache, loud noises in her head like frying sounds and echos; she could not hear from her left ear; and she had trouble with finding words when she spoke. The patient required medical evaluation. At the time of this report, the symptoms were still ongoing and the patient was continuing with follow-up visits to her physician. Outcome is not recovered. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Syncope
Clinical narrative: Participant fainted after receiving vaccine/ participant stated has history of fainting when seeing needles/ per company policy 911 called/ EMS assessed participant, participant stated felt fine.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Epistaxis, Haemorrhage, Loss of consciousness, Syncope
Clinical narrative: Participant FAINTED AFTER FLU SHOT, experienced convulsions, bleeding from her head/nose area after receiving vaccinations/ epi was administered/ 911 called/ participant regained consciousness and was transported to hospital.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Participant fainted after receiving vaccine/ ice pack was applied to neck and forehead/ no epi administered/ 911 called by company security, participant declined transport to hospital, left the room in stable condition.
Age: 11.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site swelling, Pyrexia
Clinical narrative: Developed fever which peaked at 103 (ear thermometer) and swelling over the site of the injection (L deltoid). Mom estimates the redness and swelling peaked at about 72 hours after vaccination and reached about 5x15 cm.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Rash generalised
Clinical narrative: Pt given "vaccines" and ibuprofen on 11/20/12. Presented to ER w/ generalized rash over body.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Superficial cutaneous hives; resolved with Benadryl, no recurrences.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PPV, UNK
Symptoms: Injection site rash, Injection site urticaria, Pyrexia
Clinical narrative: Presented to ER w/ rash and hives to both thighs at injection sites. Fever on 12/08/12. Pt given Prelone 30mg and Benadryl 25mg PO.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Lymphadenitis, Myalgia, Pyrexia, Swelling
Clinical narrative: Fever, muscle aches, severe headache lasting for 24 hours.  On 2/13/2013 armpit of arm where vaccine was administered was swollen with inflamed lymph node.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Initial report was received on 04 February 2013 from a health care professional. A 53 year-old female patient with no reported past medical history had received on 24 January 2013 a right deltoid injection of FLUZONE intradermal (lot number not reported) and one week and one day following vaccination on 01 February 2013, developed swelling right side of neck. The patient was hospitalized for evaluation (dates not reported). Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Convulsion, Dyskinesia, Hand deformity, Musculoskeletal stiffness, Syncope
Clinical narrative: He came into mother's room, sat down on couch. He was flopping his arm, 1 minute his arm got stiff, then his hand became claw. Went to ER. Fainting seizure.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Convulsion, Hand deformity, Hypotonia, Musculoskeletal stiffness, Syncope
Clinical narrative: He came into mother's room, sat down on couch. He was flopping his arm, 1 minute his arm got stiff, then his hand became claw. Went to ER. Fainting seizure.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received ZOSTAVAX 9/26/12 developed zoster lesions L1 dermatome 10/2/12.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large localized injection site reaction, measuring 7.5 x 8.5 inches 24 hours post injection.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Decreased appetite, Headache, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Rec'd MMR vaccine 1/30/13. Hours later had headache, fever & decrease appetite. Took ADVIL that moment. Had to be in bed all next day & then began feeling better. A week later had stiff neck headache. 2/12/2013 noticed enlarged lymph nodes to neck & behind (R) ear.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Rec'd MMR vaccine 1/30/13. Hours later had headache, fever & decrease appetite. Took ADVIL that moment. Had to be in bed all next day & then began feeling better. A week later had stiff neck headache. 2/12/2013 noticed enlarged lymph nodes to neck & behind (R) ear.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a Medical Assistant via a Company Representative refers to a 20 year old male patient with type I Diabetes. On 17-AUG-2012, the patient was vaccinated intramuscularly (IM) with a dose of PNEUMOVAX23 (Lot #, and dose not reported). Concomitant medications were not reported. On 20-AUG-2012, while on PNEUMOVAX23, the patient had a seizure. The patient sought Medical Attention; he was admitted to an unspecified hospital (date unknown) for an unspecified length of time. Patients outcome was reported as recovered (stop date not reported). The relatedness between the event and PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Pain, X-ray
Clinical narrative: Flu shot given on 1/10/13 high on arm at shoulder. 1/10/13 Pain in arm from shoulder to elbow began - muscles in arm severe pain - worse at night when laying down - throbs. Unable to raise arm. Saw Dr. following week - thought nerve may have been hit. Reported to pharmacy - twice. Just had X-rays and will be going to specialist soon.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Condition aggravated, Cough, Dyspnoea, Influenza
Clinical narrative: This case was reported by a consumer via literature and described the occurrence of influenza in an elderly male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included ingrown hair. Co-suspect medication included ADVAIR multi dose powder inhaler and Albuterol. Concurrent medications included antibiotics and Oxygen. On unknown dates, the patient started Fluticasone propionate+salmeterol xinafoate (unknown), unknown dosing. In November or December 2012 the subject received unspecified dose of Influenza vaccine unspecified (unknown). At an unknown time after starting Fluticasone propionate+salmeterol xinafoate and Albuterol, and approximately, three months after vaccination with Influenza vaccine unspecified, the subject experienced influenza, vaccination failure, weakness, hard to breath, heavy cough and blood oxygen really drops [low oxygen saturation aggravated]. The subject reported "I got a flu shot some months back, I think maybe November/December some time, but it only goes to show you that even the flu vaccination doesn't always work, because I'm battling it right now, very weak, hard to breathe, heavy coughing, but no fever. This last couple days it seems the more I lie down the more my blood oxygen goes down. When I have a bowel movement under normal circumstance my blood oxygen drops, but now it really drops so I have to be especially careful when I go. I glad that I'm in a nursing home right now, but they always can't do much for you. Fortunately I started antibiotic on Friday for a different related problem, an infected ingrown hair on my but...LOL. Hopefully it will help both ways, my doctor won't be back until Monday to do anything for me, like ROXYNAL for air starvation, I now have my oxygen at 5 units and it makes my canulas tubing at my nose soooo loud I can't stand it. This is the type flu that scares me, because it can easily take my life." This case was assessed as medically serious by GSK. At the time of reporting the influenza, weakness, hard to breath, heavy cough and low oxygen saturation aggravated were unresolved.
Sex: M
Vaccine: FLUX
Symptoms: Oxygen saturation decreased, Vaccination failure
Clinical narrative: This case was reported by a consumer via literature and described the occurrence of influenza in an elderly male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included ingrown hair. Co-suspect medication included ADVAIR multi dose powder inhaler and Albuterol. Concurrent medications included antibiotics and Oxygen. On unknown dates, the patient started Fluticasone propionate+salmeterol xinafoate (unknown), unknown dosing. In November or December 2012 the subject received unspecified dose of Influenza vaccine unspecified (unknown). At an unknown time after starting Fluticasone propionate+salmeterol xinafoate and Albuterol, and approximately, three months after vaccination with Influenza vaccine unspecified, the subject experienced influenza, vaccination failure, weakness, hard to breath, heavy cough and blood oxygen really drops [low oxygen saturation aggravated]. The subject reported "I got a flu shot some months back, I think maybe November/December some time, but it only goes to show you that even the flu vaccination doesn't always work, because I'm battling it right now, very weak, hard to breathe, heavy coughing, but no fever. This last couple days it seems the more I lie down the more my blood oxygen goes down. When I have a bowel movement under normal circumstance my blood oxygen drops, but now it really drops so I have to be especially careful when I go. I glad that I'm in a nursing home right now, but they always can't do much for you. Fortunately I started antibiotic on Friday for a different related problem, an infected ingrown hair on my but...LOL. Hopefully it will help both ways, my doctor won't be back until Monday to do anything for me, like ROXYNAL for air starvation, I now have my oxygen at 5 units and it makes my canulas tubing at my nose soooo loud I can't stand it. This is the type flu that scares me, because it can easily take my life." This case was assessed as medically serious by GSK. At the time of reporting the influenza, weakness, hard to breath, heavy cough and low oxygen saturation aggravated were unresolved.
Sex: U
Vaccine: FLUX
Symptoms: Deafness bilateral, Foetal exposure during pregnancy, Jaundice
Clinical narrative: This retrospective pregnancy case was reported by a consumer (mother) and described the occurrence of deafness in a neonate subject of unspecified gender who was exposed to Influenza vaccine (manufacturer unspecified) transplacentally during the second trimester of pregnancy when the mother received the vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included: The mother had the Kell antibody in her blood (Kell antibody transfusion) and gestational diabetes; and the father had the Kell antigen in his blood. In October 2006, the 28 or 29 year-old mother received a dose of Influenza vaccine (unknown, unknown arm). The mother's last menstrual period was on June 2006 and the estimated delivery date was 13 March 2007. Around March 2007, approximately 5 months after vaccination with Influenza vaccine, the subject experienced bilateral deafness and jaundice. Around 13 March 2007, at unknown weeks gestation, but reported as full term, the neonate was delivered by an unknown method. The neonate's weight and APGAR scores were not provided. The mother's pregnancy was full term and the baby was hospitalized with jaundice for first 8 days due to the Kell antibody. The baby was bilaterally deaf due to a genetic reason. This was reported as medical history by the mother. The mother was aware of the Kell antibody issues, her gestational diabetes and genetic link prior to the influenza vaccination. The mother reported that for the bilateral deafness, there had been some testing which had a genetic link from a cousin. The maternal vaccine exposure occurred during the second trimester. At the time of reporting, the outcome of the events was unknown. At the time of reporting the outcome of the events were unspecified. The subject's mother was planning to get the flu vaccine during her current pregnancy at the time of the report (14 September 2013) and had experienced events for previous flu vaccinations. See case A0995817A for details on the mother.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Pt received yellow fever vaccine 2/4/13. Developed urticaria & redness (L) injection site 2/6/13 > conferred with MD. Instructed to observe x 1 wk. Sxs faded & reappeared after 1 wk. Pt applied cortisone cream (has used before without event). Injection site became bright red & swollen saw MD 2/11/13. Prescribed ZYRTEC sxs resolved after 24 hours. Today 2/13 injection site ecchymotic, sore, tender to touch.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pharyngeal oedema
Clinical narrative: Participant reported nausea and throat swelling after receiving vaccine/ no epi administered/ 911 called, participant was not transported to hospital/NURSE called pt a ride home.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediately after receiving injection experience intense pain at injection site, continuing.  Injection was given immediately below shoulder bone in area of Deltoid muscle.  Saw doctor twice and received steroid injections for the pain which continues but is getting better.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Participant bled after receiving flu shot, pain at injection shot and swelling, ice pack was given, participant was fine.
Age: 31.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Alopecia, Blood iron, Blood test, Blood zinc, Thyroxine
Clinical narrative: Hair became extremely thin. Hair falling out by the handfuls, 6 weeks later eyebrow hair is falling out, hair is fallling out won't stop falling.
Age: 31.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Tri-iodothyronine, Vitamin D
Clinical narrative: Hair became extremely thin. Hair falling out by the handfuls, 6 weeks later eyebrow hair is falling out, hair is fallling out won't stop falling.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient immediately felt ache in arm where shot was given. Participant indicated she'd recently had spinal surgery but Dr gave the OK to get flu shot.  She took Advil and 3 hours later reported pain was gone.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Heart injury
Clinical narrative: 911 called/Participant experienced tightness and pressure in her chest, not indicated if was related to vaccination/ EMS reported cardiac damage, participant was taken to nearby hospital.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Participant had 3 minute seizure after receiving flu shot/ 911 was called/ participant taken to hospital.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: Fever 101.3, stomach pain, headache.  Pediatrician contacted, cracker and Ibuprofen 200 mg given.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Participant felt dizziness, hot and sweaty after vaccinated/EPI administered/ 911 called, EMS arrived, participant transported to local ER for further evaluation.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: Participant experienced numbness to right side of face, headache and sore throat. After 1.5HRS, participant was feeling better.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Alopecia areata, Biopsy skin, Blood test
Clinical narrative: First noticed hair started to fall out, after morning shower. By the end of Jan, I am bald!!!!  Being treated for alopecia areata at this time.  I have never had a flu shot before this time.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Activities of daily living impaired, Anxiety, Crying, Depression, Suicidal ideation
Clinical narrative: I began experiencing extreme depression and anxiety followed by unexplained crying and suicidal thoughts that have continued currently. Unable to complete daily tasks due to severe depression. Very close to commiting suicide.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Participant moved while nurse was administering flu shot/ participant had lump in left arm where shot was given/ area was sore and swollen, nurse advised to apply heat.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, DTAP, FLUX
Symptoms: Grand mal convulsion
Clinical narrative: Pt brought in by dad-> the following morning seizing; pt with tonic clonic seizure - lasting 10 min, paramedics called, pt came out of seizure, but per mom seized again in ER - getting transferred to hospital.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, DTAP, FLUX
Symptoms: Convulsion, Dyspnoea, Gaze palsy, Tremor
Clinical narrative: Pt brought in by dad-> the following morning seizing; pt with tonic clonic seizure - lasting 10 min, paramedics called, pt came out of seizure, but per mom seized again in ER - getting transferred to hospital.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Macule, Rash erythematous, Rash pustular
Clinical narrative: Patient woke in AM of 12 Feb 13 finding "red spots" on chest and back.  As of 13 Feb 13, "red spots" have started to resolve.  Smallpox site itself is within normal limits.  Exam showed multiple (50-100) 2-3 mm in diameter, faint macules on chest and back.  Less than 10 showed tiny pustule without discharge.  Patient reports macules are resolving.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Participant felt numbness and tingling in left arm, both legs and right side by waist after receiving flu vaccination. Symptoms did not subside, 911 was called and participant was taken to the local hospital.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling around the site of injection with pain. Given Childrens Tylenol and Benadryl with little relief.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Participant experienced swelling after vaccination/no EPI administered. Participant took Benadryl, which did not help, so participant went to hospital.
Age: 1.16
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Swelling, tenderness of right leg.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray, Cough, Full blood count, Laboratory test, Pneumonia
Clinical narrative: Cough, fever, congestion.  Diagnosed with pneumonia 01/24/2013 after being sick for nearly 10 days.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Cough, fever, congestion.  Diagnosed with pneumonia 01/24/2013 after being sick for nearly 10 days.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: HIVE LIKE RASH ON FACE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Shot hurt. Now have radiating pain down my arm. Cannot sleep on arm. Arm is weak.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Abdominal pain, Condition aggravated, Diet refusal, Faeces discoloured, Grunting
Clinical narrative: My daughter was extremely irritable after vaccines, developed a fever of 102.8 F which resolved the next day, appeared to have abdominal pain- lots of grunting, refusal to feed, and resumption of green mucousy stools which had previously subsided with neocate (note the green mucousy stools which were eventually blood streaked began soon after 6 week vaccines). One week later above symptoms continue and unclear if and when will resolve.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Haematochezia, Irritability, Mucous stools, Pyrexia
Clinical narrative: My daughter was extremely irritable after vaccines, developed a fever of 102.8 F which resolved the next day, appeared to have abdominal pain- lots of grunting, refusal to feed, and resumption of green mucousy stools which had previously subsided with neocate (note the green mucousy stools which were eventually blood streaked began soon after 6 week vaccines). One week later above symptoms continue and unclear if and when will resolve.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Soreness which is to be expected, but it's now 2/2013 and her arm is still sore can't do anything strenuous e.g. lift wts/exercise. Complains of off and on pain.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Paraesthesia
Clinical narrative: Onset of severe headache & stabbing pains on right side of head behind the ear, followed by paresthesia in same area, which moved to complete right side of head and ear.  Lasted for 8 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Headache, Hyperaesthesia, Hypoaesthesia, Pain
Clinical narrative: Onset of severe headache & stabbing pains on right side of head behind the ear, followed by paresthesia in same area, which moved to complete right side of head and ear.  Lasted for 8 hours.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 102 fever which spiked at 103.8 and resulted in a febrile seizure lasting 5+ minutes.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Oral herpes, Paraesthesia, Pruritus
Clinical narrative: 45 min after vaccination welt occurred, 2 days later pt saw her Dr who thought the pharmacist had only gone through a vein. It would turn black & blue, but her arm was hot & swollen. She came back on 2/13/13 with the swelling plus redness is better but now plus feels tight, pins & needles plus itchy plus pt had 2 cold sores since shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin tightness, Skin warm, Swelling, Urticaria
Clinical narrative: 45 min after vaccination welt occurred, 2 days later pt saw her Dr who thought the pharmacist had only gone through a vein. It would turn black & blue, but her arm was hot & swollen. She came back on 2/13/13 with the swelling plus redness is better but now plus feels tight, pins & needles plus itchy plus pt had 2 cold sores since shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site urticaria, Oedema peripheral, Oral herpes, Paraesthesia
Clinical narrative: 45 min after vaccination welt occurred, 2 days later pt saw her Dr who thought the pharmacist had only gone through a vein. It would turn black & blue, but her arm was hot & swollen. She came back on 2/13/13 with the swelling plus redness is better but now plus feels tight, pins & needles plus itchy plus pt had 2 cold sores since shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin tightness
Clinical narrative: 45 min after vaccination welt occurred, 2 days later pt saw her Dr who thought the pharmacist had only gone through a vein. It would turn black & blue, but her arm was hot & swollen. She came back on 2/13/13 with the swelling plus redness is better but now plus feels tight, pins & needles plus itchy plus pt had 2 cold sores since shot.
Age: 57.0
Sex: F
Vaccine: RAB, TDAP, TYP, YF
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Called on 2/13/13 with report of blotches that started on left breast a few days later; now also has blotchy areas (largest 1 cm, smallest 3-4 mm) on abdomen, back, right arm, left arm, (R) side of back. Not itchy; no trouble breathing, no fevers, no pain. One near right deltoid that lasted 1 week.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a 59 years old female occupational safety nurse refers to herself. She was allergic to the following medications: penicillin, erythromycin, parathyroid hormone, tapezole and cardizem. The patient's medical history included chicken pox when she was a child. Both of her children had chicken pox. Her husband received ZOSTAVAX on the same day (01-FEB-2013) without incident. The patient was vaccinated with the first dose of ZOSTAVAX (lot# reported as H019042; expired date: 17-JAN-2014) intramuscularly in the left deltoid on 01-FEB-2013 07:00. No other co-suspects were reported. Concomitant medications included LIPITOR, aspirin (81 mg), SYNTHROID, COLACE and multivitamin (unspecified). She was fine during the day (01-FEB-2013), but late that night she had a feeling of being uncomfortable and itchy around the injection site. She did not get up to inspect the area of the injection. When she awoke on Saturday AM (02-FEB-2013) the site was "very red, itchy and hot to the touch". She did not measure, but stated that it was much larger than it was today (04-FEB-2013). Some improvement on 03--FEB-2013 but on 04-FEB-2013 AM it was still very itchy so she applied a steroid cream which helped with the itching. On 04-FEB-2013, she was well appearing and afebrile. The area of redness and warmth is a soft (no induration), erythematous patch that irregular surrounded the injection site and was approximately 2 inches by 3 inches in diameter. It was warm to the touch. There was no induration and no axillary nodes were felt. Samples obtained: blood and mouth swab. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of PNEUMOVAX23 and had an adverse reaction. It was unknown if the patient sought medical attention. The outcome of adverse reaction and relationship was unknown. Additional information is not expected.
Age: 1.53
Sex: F
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Rash, Rhinorrhoea, Sleep disorder, Sneezing
Clinical narrative: "Rash on both legs. Pt was given pomegranate juice for the first time. Possible reaction." This cute 18-month-old female comes in with her mom and dad because of rash noted this morning on her thighs. Three days ago she had the second flu shot of her life in the thigh. Then, over the weekend she was given pomegranate juice and carrot juice for the first time in her life. Last night she woke up a lot, which is unusual for her. She had a runny nose and sneezing, but no cough or fever. No breathing problems. No family history of allergies.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt. was diagnosed w/ shingles 3 days after receiving ZOSTAVAX.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Extreme pain in R arm. My right arm is still very painful. It cycles in and out of pain. It feels like nerves shooting pain into the muscles. It goes down my arm into my hand, down myside body, up into the shoulder into my neck. It is interfering with rest. I don't know what to do. Will side subside? It is almost 3 weeks of this pain now. I don't know if I even should do the 2nd hep b shot. I think this may be from a reaction to that injection, because it sure is not from the interferon. I know that now, because my leg is perfect.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: Pt contacted us on 2/5/13 stating after receiving flu vaccination on 12/12/12 she began to lose her hair just as she did during her cancer treatment. Primary MD was contacted -> did not see a link, offered referral to dermatologist, pt said - not needed.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Nausea, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: 11-29-12 at 1530 called HD and reported that she was feeling dizzy, nausea, tingly in right arm and just felt "weird". Was advised to go to ER but waited until AM on 11-30-12 and went to ER and was told to go to regular doctor on Monday. Went to regular MD on Monday 12-3-12 symptoms were not better. 12-4-12 Went to Neurologist, 12-16-12 - ER.
Age: 11.0
Sex: U
Vaccine: FLUN3, VARCEL
Symptoms: Condition aggravated, Oral herpes, Psoriasis, Pyrexia, Rash
Clinical narrative: After receiving vaccines pt developed low grade fever & fever blister under bottom lip. 1 week later rash appeared. Rash from head to feet typical papules non blistered itchy. Left arm at vaccine administration site psoriasis patch appeared > 1 wk later. Psoriasis to head & face prior methotrexate > 1 year ago. Last psoriasis outbreak > 1 year prior.
Age: 11.0
Sex: U
Vaccine: FLUN3, VARCEL
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: After receiving vaccines pt developed low grade fever & fever blister under bottom lip. 1 week later rash appeared. Rash from head to feet typical papules non blistered itchy. Left arm at vaccine administration site psoriasis patch appeared > 1 wk later. Psoriasis to head & face prior methotrexate > 1 year ago. Last psoriasis outbreak > 1 year prior.