chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Paralysis, Pyrexia
Clinical narrative: Fever, totally immobile at torso. Had to have rescue squad take to E.R. It was like being paralyzed from neck to waist.
Age: 1.7
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Hemiplegia, Intensive care, VIIth nerve paralysis
Clinical narrative: 9 days after getting her shot we were admitted and transferred to medical center in PICU for 2 nights 3 days. We see a neurologist every year for facial/body paralysis.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acupuncture, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm pain and shoulder pain. Physical therapy, acupuncture, pain medication, ice packs, heating pads, asper-cream. Multiple doctor visits and no diagnosis. Numerous calls to Dept. of Health and CDC with no prognosis.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Back pain, Chest pain, Middle insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Arm pain and shoulder pain. Physical therapy, acupuncture, pain medication, ice packs, heating pads, asper-cream. Multiple doctor visits and no diagnosis. Numerous calls to Dept. of Health and CDC with no prognosis.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Rotator cuff syndrome, Scan abnormal
Clinical narrative: Arm pain and shoulder pain. Physical therapy, acupuncture, pain medication, ice packs, heating pads, asper-cream. Multiple doctor visits and no diagnosis. Numerous calls to Dept. of Health and CDC with no prognosis.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium double contrast, Crying, Diarrhoea, Enema administration, Haematochezia
Clinical narrative: Crying, diarrhea increase sleeping, and vomiting. Bloody stool x one.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Somnolence, Ultrasound abdomen, Vomiting, X-ray
Clinical narrative: Crying, diarrhea increase sleeping, and vomiting. Bloody stool x one.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Paraesthesia oral, Pyrexia, Rash
Clinical narrative: Pt called on 9/25 to report that on the evening of 9/22, she was experiencing allergic reaction: rash on arm and torso, fever, tingling lips. Went to the local ER for treatment.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case of a cumulative total of 234 cases solicited from the database during the surveillance period from 01 January 2010 to 19 September 2014. These 234 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 19 September 2014 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 21 month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received four doses of DAPTACEL; dose one on 05 November 2012, dose two on 14 January 2013 and dose three on 14 March 2013 and dose four on 03 March 2014 (lot numbers, routes and sites of administration for all doses not reported). The subject developed cough, paroxysmal cough and cold-like symptoms on 24 June 2014, approximately 113 days after the last dose of DAPTACEL. The subject also experienced post-tussive vomiting on an unspecified date. Laboratory testing included a positive PCR on 07 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 July 2014 for an unspecified duration. The subject was not hospitalized. At the time of final contact on 08 July 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: This is one case of a cumulative total of 234 cases solicited from the database during the surveillance period from 01 January 2010 to 19 September 2014. These 234 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 19 September 2014 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 21 month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received four doses of DAPTACEL; dose one on 05 November 2012, dose two on 14 January 2013 and dose three on 14 March 2013 and dose four on 03 March 2014 (lot numbers, routes and sites of administration for all doses not reported). The subject developed cough, paroxysmal cough and cold-like symptoms on 24 June 2014, approximately 113 days after the last dose of DAPTACEL. The subject also experienced post-tussive vomiting on an unspecified date. Laboratory testing included a positive PCR on 07 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 July 2014 for an unspecified duration. The subject was not hospitalized. At the time of final contact on 08 July 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Hypoaesthesia, Injection site pain
Clinical narrative: Initial report received from a health care professional on 22 September 2014. A 78-years-old female patient had received a yearly intramuscular injection of FLUZONE HD (batch number U5003AA) in the left deltoid on 02 September 2014. She had previously received yearly flu shots. She had a history of long term health issues. She denied any specific illness at the time of vaccination. She was allergic to iodine, and she was taking PLAVIX as concomitant medication. On 03 September 2014, about 24 hours after she received the FLUZONE HD vaccination, she developed severe left shoulder pain, numbness in the right arm radiating to her jaw, generalized weakness and profuse sweating. She was evaluated by her cardiologist who had her admitted to the hospital based on her symptoms to rule out heart attack and stroke. She was hospitalized for 1 week. Date of admission and of discharge were unknown. Official diagnosis was unknown from reporter. The symptoms resolved on an unspecified date and patient had no lingering effects. Patient's outcome was recovered. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Discomfort, Insomnia
Clinical narrative: Laying on L side to sleep, felt pain to armpit, feeling for lymph nodes, did not find any one particular but discomfort seems more on the 3rd day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Erythema, swelling at injection site greater than palm of pt's hand followed by headache and fever of 102 degrees Fahrenheit. No tx done at this time.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: More pain upon injection than usual.  Noticed the site of injection became red and hot to the touch withing an hour/hour and a half from injection and continued to increase in size throughout the day.  Placed a cold pack on it that night, 9/23/14, and again on 9/24/2014.  Reported to a nurse at LPH department where vaccine was administered, on 9/24/14 and then to the Immunization Charge Nurse at LPH Dept. on 9/25/2014.  When Immunization Charge nurse inspected site, noted by patient that size, pain and temperature had gone down significantly since previous day, 9/24/14, but were still more than just a local reaction.  Site appeared to Immunization Charge nurse to be lower than the deltoid muscle and apperared by observation to be closer or in the tricep muscle.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein increased, Hypertension, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Presented to the ER department at hospital around 2300 9/24/2014 with (per patient report) - The area around the injection site was baseball sized, red, flaming hot, and I had a 102 temperature and high blood pressure, which I'm assuming was due to the fever and stress.  And my ankles started swelling.  She could not lift her arm.  Ankles were also swollen.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Mobility decreased, Neutrophil count increased, Pyrexia, Stress
Clinical narrative: Presented to the ER department at hospital around 2300 9/24/2014 with (per patient report) - The area around the injection site was baseball sized, red, flaming hot, and I had a 102 temperature and high blood pressure, which I'm assuming was due to the fever and stress.  And my ankles started swelling.  She could not lift her arm.  Ankles were also swollen.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Presented to the ER department at hospital around 2300 9/24/2014 with (per patient report) - The area around the injection site was baseball sized, red, flaming hot, and I had a 102 temperature and high blood pressure, which I'm assuming was due to the fever and stress.  And my ankles started swelling.  She could not lift her arm.  Ankles were also swollen.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: PATIENT'S LEFT ARM BECAME VERY RED, SWOLLEN, AND TENDER.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Malaise, Pain, Pain in extremity
Clinical narrative: Patient reported arm redness, swelling, and soreness that lasted 4 days. She was most concerned with whole body aches and sickness that that kept her down for 2 full days and continued for 2 more days. No treatment mentioned.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Intensive care, Uvulitis
Clinical narrative: Went to hospital with severe uvulitis and is in ICU.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Pruritus generalised, Rash erythematous
Clinical narrative: Elevated temperature. Headache. General itching. Red rash on 09/16/2014.
Age: 52.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: SORE SHOULDER LIMITING USE OF MUSCLE LASTING GREATER THAN 1 WEEK.
Age: 52.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Blood test, Injection site pain, X-ray
Clinical narrative: SORE SHOULDER LIMITING USE OF MUSCLE LASTING GREATER THAN 1 WEEK.
Sex: F
Vaccine: TDAP
Symptoms: Blindness transient, Cerebrovascular accident, Computerised tomogram, Deafness, Drug administered at inappropriate site
Clinical narrative: This case was reported by a consumer and described the occurrence of systemic allergic reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 14 March 2014, the subject received an unspecified dose of BOOSTRIX (she was injected in the back of the arm and not in the muscle). On 14 March 2014, less than one day after vaccination with BOOSTRIX, the subject lost her eyesight for a minute and started to slur. Right after receiving the vaccine she had a systemic allergic reaction. She experienced tremendous hearing loss, had optical nerve damage and could barely see, and swelling. Her head was so swollen and her eyes were puffy. This case was assessed as medically serious by GSK. The subject went to the Emergency Room. They thought she had a stroke so she had an MRI and CT scan done (results not provided). The subject was treated with prednisolone. At the time of reporting, the events were improved. Agency has also gotten involved due to what happened. The subject said she is mostly fine now. The subject was not sure whether she was allergic to the vaccine or whether it was from a bad batch. She could not clarify this statement further other than she did not know and it could be either one. The patient did not wish to answer any questions from this report but agreed to receiving follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Dysarthria, Eyelid oedema, Hypersensitivity, Nuclear magnetic resonance imaging, Optic nerve injury
Clinical narrative: This case was reported by a consumer and described the occurrence of systemic allergic reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 14 March 2014, the subject received an unspecified dose of BOOSTRIX (she was injected in the back of the arm and not in the muscle). On 14 March 2014, less than one day after vaccination with BOOSTRIX, the subject lost her eyesight for a minute and started to slur. Right after receiving the vaccine she had a systemic allergic reaction. She experienced tremendous hearing loss, had optical nerve damage and could barely see, and swelling. Her head was so swollen and her eyes were puffy. This case was assessed as medically serious by GSK. The subject went to the Emergency Room. They thought she had a stroke so she had an MRI and CT scan done (results not provided). The subject was treated with prednisolone. At the time of reporting, the events were improved. Agency has also gotten involved due to what happened. The subject said she is mostly fine now. The subject was not sure whether she was allergic to the vaccine or whether it was from a bad batch. She could not clarify this statement further other than she did not know and it could be either one. The patient did not wish to answer any questions from this report but agreed to receiving follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of systemic allergic reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 14 March 2014, the subject received an unspecified dose of BOOSTRIX (she was injected in the back of the arm and not in the muscle). On 14 March 2014, less than one day after vaccination with BOOSTRIX, the subject lost her eyesight for a minute and started to slur. Right after receiving the vaccine she had a systemic allergic reaction. She experienced tremendous hearing loss, had optical nerve damage and could barely see, and swelling. Her head was so swollen and her eyes were puffy. This case was assessed as medically serious by GSK. The subject went to the Emergency Room. They thought she had a stroke so she had an MRI and CT scan done (results not provided). The subject was treated with prednisolone. At the time of reporting, the events were improved. Agency has also gotten involved due to what happened. The subject said she is mostly fine now. The subject was not sure whether she was allergic to the vaccine or whether it was from a bad batch. She could not clarify this statement further other than she did not know and it could be either one. The patient did not wish to answer any questions from this report but agreed to receiving follow-up.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Burning sensation, Infection transmission via personal contact, Paraesthesia, Polymerase chain reaction, Scar
Clinical narrative: Multiple lesions to chin and neck area, Pos for vaccinia PCR. SPV contact transmission. CDC aware. Has scarring, and reports tingling/burning sensation in area.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion, Vaccinia test positive
Clinical narrative: Multiple lesions to chin and neck area, Pos for vaccinia PCR. SPV contact transmission. CDC aware. Has scarring, and reports tingling/burning sensation in area.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin warm, Tenderness, Urticaria
Clinical narrative: Red welt appoximately 2 inches wide. Warm to touch and painful to touch.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Fatigue, Malaise, Syncope
Clinical narrative: I felt extremely fatigued and light headed or faint.  It was enough that I called in sick to work the next day and went to bed 3 hours ahead of my normal bedtime.  The onset may have been earlier in the day, but I assumed it was fatigue or not having had my coffee yet. I had a similar fatigued, somewhat dizzy or light headed ailment a few months previous and both times have been about 1.5-2 weeks after the HPV vaccine was administered.   Given the time gap it may be conincidental, but it does seem similar.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness, Urticaria
Clinical narrative: Red welt appoximately 2 inches wide. Warm to touch and painful to touch.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Induration, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Swelling and induration with redness from shoulder to below elbow. Hot to touch. Pain and fever of 102 F.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and induration with redness from shoulder to below elbow. Hot to touch. Pain and fever of 102 F.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Swelling and induration with redness from shoulder to below elbow. Hot to touch. Pain and fever of 102 F.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Induration, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: After receiving PNEUMOVAX the patient's left arm became red, swollen, hot and with the touch , and hard by 9:30 p.m. on 9/23/14, at which time she also had a fever of 102 degrees F. As of 9/24/14 she saw the same symptoms in her right arm in a 2 inch by 2 inch section around the site of FLUZONE vaccination. (The original left arm symptoms were whole arm from shoulder to elbow). She received cephalexin 500 mg on 9/24/14 after receiving a diagnosis of cellulitis.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: After receiving PNEUMOVAX the patient's left arm became red, swollen, hot and with the touch , and hard by 9:30 p.m. on 9/23/14, at which time she also had a fever of 102 degrees F. As of 9/24/14 she saw the same symptoms in her right arm in a 2 inch by 2 inch section around the site of FLUZONE vaccination. (The original left arm symptoms were whole arm from shoulder to elbow). She received cephalexin 500 mg on 9/24/14 after receiving a diagnosis of cellulitis.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: After receiving PNEUMOVAX the patient's left arm became red, swollen, hot and with the touch , and hard by 9:30 p.m. on 9/23/14, at which time she also had a fever of 102 degrees F. As of 9/24/14 she saw the same symptoms in her right arm in a 2 inch by 2 inch section around the site of FLUZONE vaccination. (The original left arm symptoms were whole arm from shoulder to elbow). She received cephalexin 500 mg on 9/24/14 after receiving a diagnosis of cellulitis.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt developed a sore red rash around administration site that was warm to the touch.  Pt came back to pharmacy to show pharmist his arm on 9/24/2014.  Pt was advised to take Benadryl and monitor for any signs that it is getting worse such as fever, rash spreading, or difficulty breathing.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Patient called in morning of 9/24/14. Stated right arm was sore, a little swollen, warm to the touch and he was unable to use his right arm.  Advised him to use cold compress, take ibuprofen and Benadryl to help with reaction.  Patient stated that it seemed a little better in evening of 9/24/14.
Age: 0.36
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Immediate post-injection reaction, Skin discolouration, Skin lesion
Clinical narrative: Developed circular lesion on right cheek immediately after receiving Prevnar. Size larger than a quarter, initially red, then turned purple. Duration 1 week. No pain.  Resolved by itself.  Discussed with MD at 6 month visit.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Pain, Personality change, Tachycardia
Clinical narrative: SEVERE PAIN ALL OVER BODY, PERSONALITY CHANGES, INSOMNIA, AND TACHYCARDIA.  ALL SYMPTOMS REPORTED LASTED ~20 HOURS.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Chills, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Severe chills/shaking that resulted in fall. Unable to walk for 15 minutes.  Severe fever, diaphoresis.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Vaccination site induration, Vaccination site swelling
Clinical narrative: Patient developed a hard bump after vaccination.  About the size of a golf ball.  Patient did have a small dribble of blood after vaccination but nothing more than I have seen prior, but this is the first time that I noticed a large bump afterwards.  Checked with the patient an hour later and bump was still present.  Patient did not complain it hurt but I did mention to him that it will probably be black and blue and sore  eventually.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Injection site pain, Pain
Clinical narrative: Pt reported aching arm at sight of injection; body aches, chills and low grade temp; duration ~8 hours.
Age: 39.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Vaccination site rash
Clinical narrative: Rash surrounding the vaccine site only. Took Benadryl.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness, dyspnea.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Fever, stiff neck, pain in spine (felt like swelling), migraine, nausea, aches pain.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal pain, Swelling
Clinical narrative: Fever, stiff neck, pain in spine (felt like swelling), migraine, nausea, aches pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus
Clinical narrative: REDNESS AND ITCHING.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Convulsion, Dizziness, Hallucination, Headache
Clinical narrative: Patient had a seizure within 1 minute of receiving the Gardasil vaccine. She reported an immediate pounding headache, dizziness and hallucinations. Her blood pressure also dropped quite low. Took a half hour to be able to sit up.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction
Clinical narrative: Patient had a seizure within 1 minute of receiving the Gardasil vaccine. She reported an immediate pounding headache, dizziness and hallucinations. Her blood pressure also dropped quite low. Took a half hour to be able to sit up.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Headache, Lip injury, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Syncope episode causing fall with lip laceration/headache and vomiting.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Syncope episode causing fall with lip laceration/headache and vomiting.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Feeling hot, Flushing, Heart rate increased, Neurological symptom
Clinical narrative: RECEIVED FLU VACCINE THROUGH EMPLOYEE HEALTH FLU VACCINE CLINIC AT 10:10 AM, RETURNED TO CLASSROOM BEHIND CLINIC FOR CLASS AND STARTED FEELING LIPS TINGLE AND SKIN FLUSHED, HOT, SHAKING, HR INCREASED, DIFFICULTY SWALLOWING.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Tremor
Clinical narrative: RECEIVED FLU VACCINE THROUGH EMPLOYEE HEALTH FLU VACCINE CLINIC AT 10:10 AM, RETURNED TO CLASSROOM BEHIND CLINIC FOR CLASS AND STARTED FEELING LIPS TINGLE AND SKIN FLUSHED, HOT, SHAKING, HR INCREASED, DIFFICULTY SWALLOWING.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Reddened area of arm around injection site (4 x 4 inches in diameter), mildly tender to palpation, patient seen on 9/25/14, Benadryl spray applied, and asked to take Benadryl at home.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LOCATION OF INJECTION SWOLLEN TO SIZE OF "SMALL GRAPEFRUIT". SITE IS RED AND PAINFUL TO TOUCH.
Age: 1.71
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever of 104.7.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site. Bump the size of a quarter and 1/2 high.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Malaise, Pain, Pyrexia
Clinical narrative: Patient reported malaise, aches, low grade fever, and shingles.
Age: 1.63
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Large adult fist sized lump at injection site. Parent noted redness, swelling and warmth at right thigh.  Pt did NOT c/o pain.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Drug hypersensitivity, Rash
Clinical narrative: Severe rash all over arms.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itch, 7 hours after administration.
Age: 52.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness and pain to the left deltoid.
Age: 52.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient given TDAP 9-23-14 on 9-25-14 patient presents with localized redness and pain to (L) deltoid. Treated by Dr.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: Severe Chills. Temperature of 101. Severe body aches. Severe headache.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Aphasia, Decreased eye contact, Social avoidant behaviour
Clinical narrative: child completely withdrew from family members, mom, dad, sister. No eye contact for verbal sounds made again.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Foetal exposure during pregnancy, Group B streptococcus neonatal sepsis
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 25 days old male patient. The patient's mother became pregnant with Last Menstrual Period of 23-NOV-2013 and Estimated Date of Delivery of 30-AUG-2014. Mother had bacterial infection due to streptococcus, group B (GBS) carrier, anemia and no known drug allergies. Medical history included a previous pregnancy (macrosomic infant). The patient's mother was a smoker and occasional drinker. On 07-JUL-2014, the patient's mother was inadvertently vaccinated with GARDASIL lot # J009788, expiration date 17-MAR-2016, 0.5 ml, intramuscular. Concomitant therapies included PRENATAL DHA one every day, oral since 13-MAR-2014 for pregnancy and iron (unspecified) 325 mg, oral, one every day since 26-AUG-2014 for anemia. On 26-AUG-2014, a male patient was born normal with no congenital anomalies through a Cesarean section, breech. APGAR score 8 and 9 in minute 1 and 5 respectively. On an unknown date in 2014, the patient experienced GBS. The outcome of GBS was not reported. Upon internal review Group B streptococcus neonatal sepsis was considered as an other important medical event. The mother experienced other events which was captured into case MARRS #1407USA003972. Additional information has been requested.
Age: 0.07
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Foetal exposure during pregnancy, Group B streptococcus neonatal sepsis
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 25 days old male patient. The patient's mother became pregnant with Last Menstrual Period of 23-NOV-2013 and Estimated Date of Delivery of 30-AUG-2014. Mother had bacterial infection due to streptococcus, group B (GBS) carrier, anemia and no known drug allergies. Medical history included a previous pregnancy (macrosomic infant). The patient's mother was a smoker and occasional drinker. On 07-JUL-2014, the patient's mother was inadvertently vaccinated with GARDASIL lot # J009788, expiration date 17-MAR-2016, 0.5 ml, intramuscular. Concomitant therapies included Prenatal DHA one every day, oral since 13-MAR-2014 for pregnancy and iron (unspecified) 325 mg, oral, one every day since 26-AUG-2014 for anemia. A male patient was born normal with no congenital anomalies through a cesarean section, breech, APGAR score 8 and 9 in minute 1 and 5 respectively. On an unknown date in 2014, the patient experienced GBS. The outcome of GBS was not reported. Upon internal review Group B streptococcus neonatal sepsis was considered as an other important medical event. The mother experienced other events which was captured into case MARRS #1407USA003972. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Pt had reaction to vaccine developed cellulitis had to have steroid and BENADRYL in the after hrs clinic and a KEFLEX abx.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, chills.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received MMR on 9-10-14. 1 wk later she noticed red halo around site. She used OTC BENADRYL EOD x 1 wk and noticed color and itch improved. Still sore when pressed. Objective: minimal light erythema, warm to touch, looks like 3 puncture wounds ? insect bites all on pt's (R) arm.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient experienced visual disturbances, and turned pale, was dizzy and sweating profusely. This lasted about 5-7 mins or maybe less. Called 911 cause it seemed like the patient had momentarily passed out.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Patient experienced visual disturbances, and turned pale, was dizzy and sweating profusely. This lasted about 5-7 mins or maybe less. Called 911 cause it seemed like the patient had momentarily passed out.
Sex: U
Vaccine: FLUX
Symptoms: Back pain
Clinical narrative: Back pain.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Arm cert sore, red, swollen. Hot to the touch - only in pneumonia arm flu shot arm is fine.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Insomnia, Neck pain, Pain in extremity
Clinical narrative: Soreness in arm where vaccine given. Severe up all night, then fever/chills for 24 hrs after injection. Joint pain shoulders, back, neck. Skin hurt below her waist. Severe pain in arm, up into neck and down her arm. Still sore 8 days later and itchy.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Pain of skin, Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: Soreness in arm where vaccine given. Severe up all night, then fever/chills for 24 hrs after injection. Joint pain shoulders, back, neck. Skin hurt below her waist. Severe pain in arm, up into neck and down her arm. Still sore 8 days later and itchy.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Red circle on arm. Tender and warm to the touch.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea
Clinical narrative: Pt described feeling nausea and chills - instructed to lie down and relax , (also to take a pain reliever if needed).
Age: 1.66
Sex: M
Vaccine: HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema, pain (L) thigh of side of HIB and PCV 13 shots.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Erythema, Local swelling, Mobility decreased
Clinical narrative: Pt. experienced redness near injection site. Swelling of (L) arm and unable to move arm or raise it (can't get dressed).
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Worse pain w/use 9-10/10 2-3/10.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Vaccination site swelling
Clinical narrative: Left arm swelling after vaccines were given. Patient taken to ER two days after vaccines were given due to reaction site itching and painful. Pt given BENADRYL, swelling and all other sx resolved. Pt followed up with doctor on 8/26/14.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local reaction to immunization - area outlines with marker - (L) deltoid with 7 x 8 cm pink, slightly warm, non-tender, area of mild induration.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash appeared 24 hrs after FLUMIST - antiviral meds done thinking varicella at first (immunized).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Rash, Sluggishness, Tremor, Vertigo
Clinical narrative: Rash area, chest, abdomen, hot happened 2 days later - muscle pain, vertigo, shaking, slow - motion.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Pt arm swollen and red below injection site at deltoid and above elbow. Entire upper arm affected and erythematous to touch. Pt had fever of 101 degrees F evening after receiving immunization.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect dose administered, Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 4 year old male patient. No information about medical history, drug reactions and allergies was specified. The field representative reported that on 28-AUG-2014 the patient went for a routine check up, received one shot of (Oka-Merck) PROQUAD (lot#, dose not reported), injection in each arm, subcutaneously for routine vaccination. Concomitant therapies included QVAR. On 29-AUG-2014 the right arm was sore. The next day it continued to swell from "his shoulder to his elbow". It looked like he had a purple sleeve and arm was also hot (also reported as 28-AUG-2014). The field representative called the doctor and the doctor said it was "normal". The doctor did not say that she needed to report the AE. There was no product quality complaint. The outcome was reported as recovered on 31-AUG-2014. The causality of the events was not specified. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, route, lot/batch number, expiration date were not reported) at the patient's pharmacy. On an unknown date, few hours after receiving ZOSTAVAX, the patient was getting a pain on her side. The patient wanted to know if this was a side effect. After heard the possible side effects she said it could have been gas. The outcome of a pain on her left side was unknown. The relatedness between the event and the ZOSTAVAX was not reported. Additional information is not expected due to the lack of contact details.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No concurrent condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with GARDASIL lot # J009243, 0.5 ml, intramusular. No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) GARDASIL that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. No adverse effects reported. The outcome of GARDASIL stored at 47f for 120 hours was unknown. No PQC involved. This is one of the several reports. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 81 year old female patient. The patient's medical history and current conditions are not reported. On 15-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the right arm (lot # J009837 and expiry date 10-AUG-2014). Concomitant therapies included INFLUENZA VIRUS VACCINE (Unspecified) in the left arm. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. Product quality complaint was not reported. The outcome of expired vaccine administered is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 22-SEP-2014, the patient was vaccinated with MMR II lot # H017027, 0.5 ml, subcutaneous. No concomitant medication was reported. The nurse is reporting the patient was inadvertently administered MMR II lot # H017027 on 22-SEP-2014 that had expired on 14-SEP-2014. No adverse effects reported. No further information provided. The outcome of administered MMR II that had expired was unknown. No PQC was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route- intramuscularly, dose strength was not reported). No concomitant medication was reported. On an unknown date the patient experienced very swollen injection site which was painful and red. The outcome of very swollen injection site which was painful and red was reported as not resolved. Causality was unknown. Patient sought medical attention was reported as yes, contacted pharmacy. Treatment provided for adverse event and laboratory diagnostics studies performed was reported as none. No PQC was involved. No further information reported. No further information provided. This is one of the several reports. Additional information is not expected.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving FLUZONE QUADRIVALENT.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pallor, Tremor, Vomiting
Clinical narrative: 30 min. after injection pt. became pale and nauseated. She then vomitted, became dizzy and shakey. She was given ZOFRAN for nausea and symptoms subsided with rest.
Age: 89.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 89 year old female patient. The patient's medical history and current conditions are not reported. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the right arm (lot # J009827 and expiry date 10-AUG-2014). Concomitant therapies included INFLUENZA VIRUS VACCINE (Unspecified) in the left arm. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. Product quality complaint was not reported. The outcome of expired vaccine administered is unknown. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 79 year old male patient. The patient's medical history and current conditions are not reported. On 15-09-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the right arm (lot # J009827 and expiry date 10-AUG-2014). Concomitant therapies included INFLUENZA VIRUS VACCINE (Unspecified) in the left arm. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. Product quality complaint was not reported. The outcome of the expired vaccine administered is unknown.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route- subcutaneous, dose strength was not reported). No concomitant medication was reported. On an unknown date the patient experienced very swollen injection site which was painful and red. The outcome of very swollen injection site which was painful and red was reported as not resolved. Causality was unknown. Patient sought medical attention was reported as yes, contacted pharmacy. Treatment provided for adverse event and laboratory diagnostics studies performed was reported as none. No PQC was involved. No further information reported. No further information provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot#, expiration date, dose, frequency and route were unknown) which were exposed to an unknown number of excursions were supported, but the healthcare worker reported that the variations in temperature have occurred a predictable intervals, which resemble a defrost cycle. These variations in temperature had been occurring "for months." No adverse experiences had been reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 13 year old female patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route, frequency, lot# and expiration date were unknown). The patient did not receive the second dose of GARDASIL until a year later. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (intramuscular, dose unknown) which expired on 21-FEB-2014. Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients unknown age. It was reported that RECOMBIVAX B (dose and lot# not reported) experienced excursion of 1.7C for 3 hours, as well as a prior excursion of 0 C for 8 hours. Excursion supported. Both products have been administered post excursion. No adverse effects reported. This is one of the reports from the same reporter (lined with MARRS# 1409USA012752). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patients of unknown age. It was reported that PNEUMOVAX 23 (dose and lot# not reported) experienced an excursion of 1.7C for 3 hours, as well as a prior excursion of 0 C for 8 hours. Excursion supported. Both products have been administered post excursion. No adverse effects reported. This is one of the reports from the same reporter (lined with MARRS# 1409USA010969). Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: IPV
Symptoms: Rash generalised
Clinical narrative: Developed generalized rash after 2nd and 3rd IPV vaccination.
Age: 31.0
Sex: M
Vaccine: TYP, YF
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular dermatoses overlying poster elbows, anterior knees. Occurred 24 hours after yellow fever and typhoid vacc.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Mother noted rash on back of left arm - site when MMRV was given. Rash noted the morning of 7-24-14. Vesicular rash.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of PNEUMOVAX 23 (Lot# and expired date unspecified) and other vaccines (captured in MARRS# 1409USA008659, 1409USA008509, 1409USA006676, 1409USA008510, 1409USA008511, 1409USA008514) were administrated to unspecified patients (dose, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/temperature excursions on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.43
Sex: F
Vaccine: RV1
Symptoms: Culture stool negative, Diarrhoea, Escherichia test negative, Haematochezia, Rotavirus test positive
Clinical narrative: Dr. received a call from her parents on 9/20/14, stating she had a bloody stool and diarrhea. She received ROTAVIRUS vaccine 5 days prior. She was sent to ER; her ultrasound was neg, rota Ag was neg, shign toxin neg, stool cx neg. She was went home. Now passing normal stools w/o blood.
Age: 0.43
Sex: F
Vaccine: RV1
Symptoms: Ultrasound scan normal
Clinical narrative: Dr. received a call from her parents on 9/20/14, stating she had a bloody stool and diarrhea. She received ROTAVIRUS vaccine 5 days prior. She was sent to ER; her ultrasound was neg, rota Ag was neg, shign toxin neg, stool cx neg. She was went home. Now passing normal stools w/o blood.