chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood test normal, Dizziness, Loss of consciousness
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. In June 2016, the outcome of the passed out and dizziness were recovered/resolved. It was unknown if the reporter considered the passed out and dizziness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116037 and US2016GSK116038, reported by the same reporter.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chest discomfort, Dyspnoea, Eyelid function disorder, Mobility decreased, Oropharyngeal pain
Clinical narrative: Patient called to report that he felt chest tightness difficulty breathing, he could not mover and could not close his eye. He did not seek medical attention. At the time of the call, he only had a sore throat and arm pain. Advised that he go see his doctor right away. He called the day after he had the symptoms (8/13/16).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient called to report that he felt chest tightness difficulty breathing, he could not mover and could not close his eye. He did not seek medical attention. At the time of the call, he only had a sore throat and arm pain. Advised that he go see his doctor right away. He called the day after he had the symptoms (8/13/16).
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Cold sweat, Dizziness
Clinical narrative: Normal day after vaccination. Awoke early am 7/30 feeling dizzy, faint. To kitchen and sat floor, clammy. Compresses and cool water helped. To bed 30 min, weak in am-better thru day 7/30.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Breast discharge, Breast injury, Injection site pain, Lymphadenopathy, Mastitis
Clinical narrative: Burning sensation at site of DTap and Hep A injections (right arm) 8/12/16, then burning sensation right breast 8/13/16. Mastitis diagnosed 8/15/16. No fever, axillary lymphadenopathy, nipple discharge, breast injury. No swelling, redness at any injection site. Clindamycin.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Rash, Skin warm
Clinical narrative: Vaccination rec'd 08/11/16. 24 hours post-vaccination, patient developed a red, swollen area below the vaccination site. 48 hours later - reddish purple swelling in upper arm, warm to the touch and painful. Patient described area as tight feeling. Patient saw her Dr on 8/15 - Pt says it was a "skin rash". Symptoms resolved as of 8/16.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis infective, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Sleep disorder
Clinical narrative: Got tdap vaccine 5/23/16. Arm was sore and continued to get worse until unable to raise overhead or sleep comfortably at night.  Returned 5/26/16 advised to use ice or heat and go to PCP if pain continued. PCP prescribed steroids. Has had MRI and Joint infection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Peripheral swelling, Rash generalised, Urticaria
Clinical narrative: Rash on body (hives), swelling of hands and feet.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope episode post MENACTRA.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Vaccines administered at approx 1100. Mom brought patient back to the clinic at approx 1445 noting that at 1300 - pt started with temp and shaking. TYLENOL given at home at 1430. Dr. saw the patient and documented this note: Patient return to clinic with fever up to 102.8 recorded here as well as shaking and shivering. He was monitored here for roughly about 2-2.5 hours and given TYLENOL and MOTRIN 600 milligrams. His fever remained high but that should bring stopped.  During this entire time neurologically he remained intact. There was no evidence of airway compromise such as wheezing, shortness of breath or tongue fullness. No swallowing issues. Ultimately was sent home with instructions to continue use of TYLENOL and ibuprofen to keep the fever down and to monitor and if worsening symptoms seek medical attention over the weekend. Parent was here who voiced understanding and agreement.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Bullous impetigo, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine administered in office. That evening, developed redness, swelling, and tenderness at injection site. Blistery rash developed shortly afterwards. Taken to ED on 08/14/2016. Prescribed antibiotics for cellulitis. Follow-up in office on 08/15/2016. Appeared to have a bullous impetigo.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash vesicular
Clinical narrative: Vaccine administered in office. That evening, developed redness, swelling, and tenderness at injection site. Blistery rash developed shortly afterwards. Taken to ED on 08/14/2016. Prescribed antibiotics for cellulitis. Follow-up in office on 08/15/2016. Appeared to have a bullous impetigo.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Injection site erythema, redness, pain, high grade fevers.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient was in the act of receiving seven vaccines when he fainted. He was supported to the floor where he quickly recovered. After the fact, he revealed that he had not eaten that day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Consciousness fluctuating, Feeling hot, Intensive care, Lethargy, Loss of consciousness
Clinical narrative: WHEN CHILD WAS PUT INTO CAR SEAT AFTER INJECTIONS, SHE BEGAN FEELING HOT AND ITCHING, WAS TAKEN TO EMERGENCY ROOM WHERE MOM WORKS, CHILD PASSED OUT, LETHARGIC, VOMITING, IN AND OUT OF CONSCIOUSNESS, ADMITTED TO PEDIATRIC INTENSIVE CARE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Vomiting
Clinical narrative: WHEN CHILD WAS PUT INTO CAR SEAT AFTER INJECTIONS, SHE BEGAN FEELING HOT AND ITCHING, WAS TAKEN TO EMERGENCY ROOM WHERE MOM WORKS, CHILD PASSED OUT, LETHARGIC, VOMITING, IN AND OUT OF CONSCIOUSNESS, ADMITTED TO PEDIATRIC INTENSIVE CARE.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: One week after immunizations patient broke out in a rash from head down. Currently the rash has lasted 4 days. He also had a fever that started on 08/12/16 that lasted 3 days.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: My son came home in a panic. He was upset that his right shoulder was itching, red, and swollen. He said the skin in on his shoulder felt tight, hot, and sore. He described the itching as intense, the redness was pronounced, and his shoulder was noticeably puffy and larger than normal.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Injection site warmth, Panic reaction, Skin tightness
Clinical narrative: My son came home in a panic. He was upset that his right shoulder was itching, red, and swollen. He said the skin in on his shoulder felt tight, hot, and sore. He described the itching as intense, the redness was pronounced, and his shoulder was noticeably puffy and larger than normal.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING/REDNESS AT INJECTION SITE AND WARM TO THE TOUCH. REDNESS EXTENDS TO ELBOW.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: SWELLING/REDNESS AT INJECTION SITE AND WARM TO THE TOUCH. REDNESS EXTENDS TO ELBOW.
Age: 25.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: WITHIN 24 HOURS REDNESS/ITCHING/HARDNESS AT INJECTION SITE AS WELL AS BURNING HOT FEELING AT SITE IN LEFT ARM. HAS ICED IT AND TAKEN BENADRYL.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: (L) deltoid 5X6 cm soft tissue swelling. Mild tenderness. No erythema.
Age: 11.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Fall, Presyncope
Clinical narrative: Pt received-Hep A pediatric; IPV; Meningococcal 4; TDAP and Varicella-had vasovagal reaction fell out of chair to floor. Went to ER examined-sent home-no break in skin.
Age: 17.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles from Varicella Vaccine. Shingles over entire body.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Lymphadenopathy
Clinical narrative: Low-grade fevers for 2 days, arm pain at site of injection (right deltoid) for 4 days; seen in outpatient clinic on day 4 and assessed as right upper extremity cellulitis (tender area of erythema, induration 8 x 7.5 cm overlying right deltoid, no fluctuance or crepitus, but with moderate right-sided tender supraclavicular lymphadenopathy), treated with a 5-day course of AUGMENTIN and plans to f/u in 3 days for recheck; area demarcated in perm ink.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Tenderness
Clinical narrative: Low-grade fevers for 2 days, arm pain at site of injection (right deltoid) for 4 days; seen in outpatient clinic on day 4 and assessed as right upper extremity cellulitis (tender area of erythema, induration 8 x 7.5 cm overlying right deltoid, no fluctuance or crepitus, but with moderate right-sided tender supraclavicular lymphadenopathy), treated with a 5-day course of AUGMENTIN and plans to f/u in 3 days for recheck; area demarcated in perm ink.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, MENB, PPV
Symptoms: Nodule, Pain in extremity
Clinical narrative: Pain with knot in arm vaccine was given.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Nodule, Pain in extremity
Clinical narrative: Pain and knot in left arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Axillary mass, Injected limb mobility decreased, Pain in extremity
Clinical narrative: That morning left arm was very painful and a golf ball sized lump was noted in left axilla.  Patient couldn't put arm down by side because of pain.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site abscess, Pain in extremity, Skin warm
Clinical narrative: PATIENT RECEIVED IMMUNIZATION ON 8/19/2016. SHE STATED THAT HER ARM WAS SORE ON 8/20/2016, SHE NOTICED THAT IT WAS RED AND WARM TO THE TOUCH ON 8/21/2016 AND SHE CAME BACK INTO THE PHARMACY ON 8/22/2016 TO SEE IF SHE SHOULD SEEK TREATMENT. SHE DID GO TO A CLINIC WHERE SHE WAS TREATED FOR INJECTION SITE ABSCESS.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Head injury, Swelling face, Syncope
Clinical narrative: Patient stood up from mothers lap after vaccination and fainted. Hit head on corner of wall. Skin was intake but immediate swelling the size of a quarter on center upper forehead. Patient left immunization clinic in stable condition after nurse assessment and ice pack given.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: ALOT OF REDNESS AND LARGE AREA OF SWELLING.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Erythema, Nasal congestion, Throat tightness
Clinical narrative: Chest tightness, throat closing up, nasal congestion, difficulty breathing, redness on face (especially nose & cheeks).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Diarrhoea, Lethargy, Meningitis meningococcal, Pallor
Clinical narrative: Patient developed fever, vomiting and diarrhea approximately 42 hours after receiving vaccines. Became pale w/cyanotic lips approximately 48 hours after vaccines. Evaluated at health center on 8/20/16, tachycardic, tachypneic, and lethargic so transferred to medical center then another hospital. Dx - Meningococcal meningitis, remains inpatient.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Tachycardia, Tachypnoea, Vomiting
Clinical narrative: Patient developed fever, vomiting and diarrhea approximately 42 hours after receiving vaccines. Became pale w/cyanotic lips approximately 48 hours after vaccines. Evaluated at health center on 8/20/16, tachycardic, tachypneic, and lethargic so transferred to medical center then another hospital. Dx - Meningococcal meningitis, remains inpatient.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 16-year-old male patient who received MENVEO. On 4th August 2016, the patient received MENVEO .5 ml. On 4th August 2016, less than a day after receiving MENVEO, the patient experienced vomiting (serious criteria other: As per reporter) and fever. On an unknown date, the outcome of the vomiting and fever were unknown. It was unknown if the reporter considered the vomiting and fever to be related to MENVEO. Additional details were provided as follows: The sales representative and nurse reported that the patient required emergency room visit with no admission for events. The limited patient details were available.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Cough, Malaise, Oropharyngeal pain, Pneumonia viral
Clinical narrative: 7/21/16-got PREVNAR 13 shot-7/22 bad sore throat, draining nose, cough-7/23 condition worsened-7/24 felt better-7/25 well, as if nothing happened. 8/8/16 virus, bad sore throat, draining nose, gut-wrenching cough, kept getting sicker. 8/15 to Urgent Care at my own Drs. office-chest x-rays diagnosis of pneumonia (viral) taking Levofloxacin, Prednisone, Albuterol Sulfate. 8/22 finally feeling better/to see my family Dr. on 24th to figure out what's next.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea
Clinical narrative: 7/21/16-got PREVNAR 13 shot-7/22 bad sore throat, draining nose, cough-7/23 condition worsened-7/24 felt better-7/25 well, as if nothing happened. 8/8/16 virus, bad sore throat, draining nose, gut-wrenching cough, kept getting sicker. 8/15 to Urgent Care at my own Drs. office-chest x-rays diagnosis of pneumonia (viral) taking Levofloxacin, Prednisone, Albuterol Sulfate. 8/22 finally feeling better/to see my family Dr. on 24th to figure out what's next.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Back pain, Blood test, Computerised tomogram, Computerised tomogram head, Electrocardiogram
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye movement disorder, Eye pain, Fatigue, Headache, Loss of consciousness
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Back pain, Cellulitis orbital, Computerised tomogram head abnormal, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye pain, Fatigue, Headache, Leukopenia, Loss of consciousness
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lumbar puncture normal, Musculoskeletal stiffness, Nausea, Pain, Platelet count decreased
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pyrexia, Thrombocytopenia, Viral infection, White blood cell count decreased
Clinical narrative: Fatigue, fever, achy, eyes sore, eye movement, backache, stiff neck, headache, nauseous, passed out. Symptoms occurred between 7/29/16 and 8/1/16.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Headache, Loss of consciousness
Clinical narrative: Patient received her 3 vaccines listed below. She was placed in waiting area for close monitoring. About 10 minutes later she started complaining of headache, dizziness, weakness and blurry vision. She was placed in a room on a supine position. She quickly started to breath faster, her O2 Sats dropped to low 90s, her skin was clammy and lose conscious for a few seconds (was not responding to questions). Given EPI Pen and jumped right up as in pain. O2 Sats improved and she was feeling better. About 5-7 minutes later, her O2 Sats started to drop again and she was breathing fast and feeling clammy again. A second dose of EPI Pen was given by doctor. She reported feeling better 2 minutes later. She was sent to ER for observation.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Oxygen saturation decreased, Respiratory rate increased, Vision blurred
Clinical narrative: Patient received her 3 vaccines listed below. She was placed in waiting area for close monitoring. About 10 minutes later she started complaining of headache, dizziness, weakness and blurry vision. She was placed in a room on a supine position. She quickly started to breath faster, her O2 Sats dropped to low 90s, her skin was clammy and lose conscious for a few seconds (was not responding to questions). Given EPI Pen and jumped right up as in pain. O2 Sats improved and she was feeling better. About 5-7 minutes later, her O2 Sats started to drop again and she was breathing fast and feeling clammy again. A second dose of EPI Pen was given by doctor. She reported feeling better 2 minutes later. She was sent to ER for observation.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Patient noticed symptoms on 8/15/16. Patient has increasing red bumps that are itchy and painful. Patient was directed to use over-the-counter antihistamine, take 2 BENADRYLS at night, cooler baths/showers, no work until cleared at follow up office visit.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Pt experience syncopal episode (low BP, low HR, diaphoresis, warm sensation, light headedness, dizziness, and nausea after administration of MCV4 MENACTRA and Varicella. VS-212-92/56, 48. 218-100/56, 52. 223-110/60, 68. Ice applied to nape of neck, legs crossed, hand squeezed, remain in clinic 30min.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Pt experience syncopal episode (low BP, low HR, diaphoresis, warm sensation, light headedness, dizziness, and nausea after administration of MCV4 MENACTRA and Varicella. VS-212-92/56, 48. 218-100/56, 52. 223-110/60, 68. Ice applied to nape of neck, legs crossed, hand squeezed, remain in clinic 30min.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Autism spectrum disorder, Dyspnoea, Occupational therapy, Pyrexia, Speech disorder
Clinical narrative: Difficulty breathing, fever, hive like rashes. Currently being assessed for Autism spectrum, speech loss, occupational therapy, etc.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Difficulty breathing, fever, hive like rashes. Currently being assessed for Autism spectrum, speech loss, occupational therapy, etc.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth, low temp, pain. Area kept spreading over arm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, warm to touch. Ice and pain medication.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Mother of patient called on 8/16/2016 saying patient was at an outdoor event, standing in line waiting to purchase lemon aid, it was a hot afternoon. Patient fainted, she then attempted to get up and fainted again hitting her head on the lemon aid stand. Had no further problems after these two episodes of loss of consciousness.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Crying, Pyrexia
Clinical narrative: Mom reports at 2 mo. WCC, pt cried uncontrollably for 2+ hours after being given the DTaP. At his 4 mo. WCC she reported 4+ hours pt uncontrollable crying as well as low-grade fever, pulling legs into chest with the DTAP. We held off DTAP today and pt is tolerating all other shots normally. 8/22/16.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt was administered Gardasil 9 on 8-13-16. After about 60 seconds pt fainted. He did not require any medical treatment. He awoke with no memory of the previous events after about 60 seconds of being passed out.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash, red, no blisters. On and off started 2 days after vaccine. Will continue for 3 to 4 days than go away for about a day than return. Does not hurt. Itches but not bad. Worse on opposite arm from vaccine arm. Patient reported to me 8-19-16.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a multiple unknown patients. The patients pertinent medical history and concurrent conditions were not provided. On multiple unknown dates the patients were administered a dose of ZOSTAVAX (lot #, expiration date, dosage and therapy route were not provided), in the deltoid areas in the back of the arm (which was outside of the recommendations per the product information. Concomitant therapies were not provided. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA008349). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacy technician refers to a patient of unknown age. The patient pertinent medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L024999 and expiry date 06-OCT-2016). The vaccine was exposed to a temperature of 16F for 9 hours and 20F for 15 hours. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Herpes zoster, Hypoacusis, Rash, Visual impairment
Clinical narrative: Information has been received on 15-AUG-2016 from a 76 year old male consumer. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On 14-MAR-2016, the patient developed shingles. The patient had a rash on the right side of his face which affected his sight in the right eye and he lost 75% of his hearing in his right ear. The patient received unspecified treatment and an unspecified blood test was performed. The patient reported he recovered sometime within the last month. The patient reported that he saw a legal advertisement to obtain financial compensation for medical bills incurred for patients who developed shingles after receiving the vaccine. No further information was reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Body temperature increased, Herpes zoster, Hypoacusis, Ophthalmic herpes zoster
Clinical narrative: Information has been received on 15-AUG-2016 from a 76 year old male consumer. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On 14-MAR-2016, the patient developed shingles. The patient had a rash on the right side of his face which affected his sight in the right eye and he lost 75% of his hearing in his right ear. The patient received unspecified treatment and an unspecified blood test was performed. The patient reported he recovered sometime within the last month. The patient reported that he saw a legal advertisement to obtain financial compensation for medical bills incurred for patients who developed shingles after receiving the vaccine. No further information was reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Visual impairment
Clinical narrative: Information has been received on 15-AUG-2016 from a 76 year old male consumer. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On 14-MAR-2016, the patient developed shingles. The patient had a rash on the right side of his face which affected his sight in the right eye and he lost 75% of his hearing in his right ear. The patient received unspecified treatment and an unspecified blood test was performed. The patient reported he recovered sometime within the last month. The patient reported that he saw a legal advertisement to obtain financial compensation for medical bills incurred for patients who developed shingles after receiving the vaccine. No further information was reported. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 11-JUL-2016 from a medical assistant who reported that an improperly stored dose of VARIVAX (dose/frequency not reported) (lot # L019124, expiration date 27-MAY-2017) was administered to a patient (age and gender not reported) subcutaneously on an unspecified date. No adverse experience reported. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 19-AUG-2016, the patient inadvertently was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II lot # K010319 with expiration date of 22-JUL-2016 (dose, route and anatomical location were not reported). No concomitant medications, adverse effects or product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist (who learned of the event from another unspecified pharmacist), refers to two unspecified patients of unknown age and gender. The concurrent conditions, medical history and drug reactions/allergies of the patients were not reported. On an unknown date, the patients was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose and route of administration were unknown. The lot number was M0159326 with expiration date of 28-JUN-2017. There were no concomitant therapies reported. The reporter stated that, ion an unknown date, the patients experienced injection site adverse effects, severe pain, localized swelling and tenderness. The pharmacist was requesting a lot check to be done. No product quality complaint was involved. The outcome of injection site pain and injection site swelling was unknown. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a pharmacist referring to a 3 days old male patient. There was no information about the patient's concurrent condition and concomitant medication. On an unknown date (reported as "when he was two days old"), the patient was vaccinated with a dose of RECOMBIVAX HB when he was three days old. Lot # L039660 with expiration date 20-FEB-2018 was provided but the pharmacist could not state whether this lot was administered as the first or second dose. No adverse effects were reported. Additional information is not expected as no contact consent was given.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from Pfizer, Inc. [2016385284] on 17-AUG-2016 via a consumer. A patient's mother reported her daughter was vaccinated with GARDASIL and experienced alopecia (MARRS # 0901USA02690). The patient's mother reported that according to the internet, 2000 girls had the same problem (alopecia). This is one of several reports from the same source. Additional information is not expected. Information was received via a business partner.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a clinical medical assistant referring to three unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Starting approximately on 01-AUG-2016, the patients were vaccinated with prefilled syringes with PNEUMOVAX 23 (lot # M018766 with expiration date 15-OCT-2017, intramuscular or subcutaneous, once; dose was not reported). On an unknown date in August 2016, each patient experienced redness, warmth and swelling at the injection site. The patient sought medical attention. The physician ordered unspecified antibiotics for all three patients on unspecified dates. The primary reporter stated that the physician would like this lot of PNEUMOVAX 23 to be checked. The outcome of the events was reported as recovering. Causality was not reported. Additional information had been requested.
Sex: F
Vaccine: RUB
Symptoms: Arthritis
Clinical narrative: Information has been received from SPMSD (manufacturer control# was not reported) on 04-AUG-2016. Information has been received from a female physician of unknown age referring to herself in a video. She was spoke that "vaccine tested" and was told that it was necessary that she received the (wistar ra 27-3) MERUVAX II before she could practice medicine. On an unknown date the patient was vaccinated with (wistar ra 27-3) MERUVAX II (lot#, strength, dosage, frequency and route unspecified) and a few weeks following the vaccine administration the physician reported that she developed arthritis. The outcome of the event was unknown. The causality was not reported. This is one of two reports received from same TV program. Additional information is not expected since no contact information is provided.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact
Clinical narrative: Information has been received from a male pharmacist of unknown age referring to himself. The patient's medical history, concurrent condition and concomitant medication were not reported. On 04-AUG-2016, the pharmacist inadvertently squirted ZOSTAVAX (which was in the syringe, strength, lot#, expiration date and route were not reported) on his skin and into his eye, while he was preparing a dose of ZOSTAVAX. It was reported that he immediately washed his skin and flushed his eye with water. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients. The patients' Concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored (0.2C for 251 hours, 55 minutes and the data logger was involved) doses of VARIVAX (dose, frequency and route were unknown, lot # L023587, expiration date 26-JUN-2017, another  lot # L024250, expiration date 30-JUN-2017). The VARIVAX didn't have previous excursions and currently backed in range. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Erythema, Influenza like illness, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, Adhesive capsulitis diagnosis, steroid injection and Phys. therapy. On May 6 I received an injection of PREVNAR 13 in my PCP office during my annual physical. The next day I woke with a sore Left shoulder and flu like symptoms, which I was told could be a side effect. The flu symptoms w/fever 101 lasted 1 day, then subsided. The sore left arm remained and became red and itchy and had a baseball size lump, but resolved in a few days. The injection area remained tender. In the next week 5-10-16, I reached up for a seatbelt and felt a quick sharp pain. When it did not resolve and my range of motion decreased, I saw doctor thinking it was a strain. I saw him 5 times over the next 2 wks with no improvement. He treated me with stim therapy, manipulation and exercise and diagnosed left lateral deltoid strain the pain worsened and R.O.M diminished on 6/29/2016. I saw ortho surgeon who diagnosed adhesive capsulitis and injected area w/steroid and prescribed P.T. I have completed to date 14 P.T. sessions and am regaining R.O.M. Pain levels fluctuate. Limited Daily Activities due to R.O.M and Pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Periarthritis, Pruritus, Pyrexia, X-ray
Clinical narrative: Shoulder pain, Adhesive capsulitis diagnosis, steroid injection and Phys. therapy. On May 6 I received an injection of PREVNAR 13 in my PCP office during my annual physical. The next day I woke with a sore Left shoulder and flu like symptoms, which I was told could be a side effect. The flu symptoms w/fever 101 lasted 1 day, then subsided. The sore left arm remained and became red and itchy and had a baseball size lump, but resolved in a few days. The injection area remained tender. In the next week 5-10-16, I reached up for a seatbelt and felt a quick sharp pain. When it did not resolve and my range of motion decreased, I saw doctor thinking it was a strain. I saw him 5 times over the next 2 wks with no improvement. He treated me with stim therapy, manipulation and exercise and diagnosed left lateral deltoid strain the pain worsened and R.O.M diminished on 6/29/2016. I saw ortho surgeon who diagnosed adhesive capsulitis and injected area w/steroid and prescribed P.T. I have completed to date 14 P.T. sessions and am regaining R.O.M. Pain levels fluctuate. Limited Daily Activities due to R.O.M and Pain.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Paraesthesia
Clinical narrative: Based on additional information received on 10-AUG-2016, this case became medically confirmed. Initial unsolicited report received from the literature on 19 March 2002. From information received via telephone at Aventis Pasteur, Inc. on 18/Mar/2002 from the patient: The patient, a 47-year-old female, was vaccinated with IMOVAX Rabies post exposure series 4-years ago for a rabid dog bite. The patient now has nerve damage and spasms. The patient has been diagnosed with GBS by neurologist. From follow-up e-mail correspondence received at Aventis Pasteur Inc. on 8/May/2002 from Aventis Pasteur SA it was made aware that correction needed to be made to the latest received date. The initial information was received on 18/Mar/2002, not 19/Mar/2002 as previously reported. Follow-up information received from the literature on 10-AUG-2016. This case was linked to 2006-03101, 2016SA148890, 2016SA148885, 2016SA148766, 2016SA148892, 2007-00117, 2016SA148897 and 2016SA148776. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, IMOVAX Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. The patient did not had a history of gastrointestinal or upper respiratory infections before being vaccinated. Other medical history and concomitant medications were not reported. On an unspecified date following the vaccination patient had Guillain-Barre Syndrome and muscle spasm. Laboratory details were not reported. Corrective treatment was not reported. This case was considered as serious by the reporter due to medical event: Guillain-Barre Syndrome. Outcome of the event was not reported. Document held by sender: none. Sender's Comments: Amount of data is not sufficient to assess this non medically confirmed case.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Guillain-Barre syndrome, Muscle spasms, Nerve injury
Clinical narrative: Based on additional information received on 10-AUG-2016, this case became medically confirmed. Initial unsolicited report received from the literature on 19 March 2002. From information received via telephone at Aventis Pasteur, Inc. on 18/Mar/2002 from the patient: The patient, a 47-year-old female, was vaccinated with IMOVAX Rabies post exposure series 4-years ago for a rabid dog bite. The patient now has nerve damage and spasms. The patient has been diagnosed with GBS by neurologist. From follow-up e-mail correspondence received at Aventis Pasteur Inc. on 8/May/2002 from Aventis Pasteur SA it was made aware that correction needed to be made to the latest received date. The initial information was received on 18/Mar/2002, not 19/Mar/2002 as previously reported. Follow-up information received from the literature on 10-AUG-2016. This case was linked to 2006-03101, 2016SA148890, 2016SA148885, 2016SA148766, 2016SA148892, 2007-00117, 2016SA148897 and 2016SA148776. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, IMOVAX Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. The patient did not had a history of gastrointestinal or upper respiratory infections before being vaccinated. Other medical history and concomitant medications were not reported. On an unspecified date following the vaccination patient had Guillain-Barre Syndrome and muscle spasm. Laboratory details were not reported. Corrective treatment was not reported. This case was considered as serious by the reporter due to medical event: Guillain-Barre Syndrome. Outcome of the event was not reported. Document held by sender: none. Sender's Comments: Amount of data is not sufficient to assess this non medically confirmed case.
Sex: F
Vaccine: RAB
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Initial unsolicited report received from the literature on 10 August 2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148787, 2016SA148792, 2016SA148885, 2016SA148890 and 2016SA148892 (same literature). The following is verbatim from the article: Abstract: Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8 percent) were serious. Among all reports, the three most common AEs included pyrexia (18.2 percent), headache (17.9 percent), and nausea (16.5 percent). Among serious reports, four deaths appeared to be unrelated to vaccination. This case involves a female patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, route and site of administration: not reported) on an unspecified date while she was pregnant. The patients last menstrual period date and pregnancy trimester was not reported. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, post vaccination during her pregnancy, the patient had spontaneous abortion. Upon internal review, the company decided to consider the event as serious because of important medical event: Spontaneous abortion. Documents held by sender: none. Sender's Comments: This case was extracted from a literature article involving a patient who had spontaneous abortion following vaccination with RABIES (HDC) VACCINE. As per the available information it is unclear whether the vaccine administered was a pre-exposure or a post exposure dose. RABIES (HDC) VACCINE however is not recommended during pregnancy for pre-exposure. Details such as patient's relevant medical history, prior vaccination history and tolerance, etc. are needed to further assess the role of vaccine. Based on available information, no conclusion can be drawn.
Age: 0.17
Sex: F
Vaccine: VARCEL, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Pt started vomiting 5 hours after vaccines. Vomited 20 times in 2 hours T100.1 (R). Fussy, no other symptoms. Hydrated on exam, TYLENOL 60mg PR At 7pm, PEDIALYTE and formula.
Age: 0.17
Sex: F
Vaccine: VARCEL, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Vomiting
Clinical narrative: Pt started vomiting 5 hours after vaccines. Vomited 20 times in 2 hours T100.1 (R). Fussy, no other symptoms. Hydrated on exam, TYLENOL 60mg PR At 7pm, PEDIALYTE and formula.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Pruritus, Urticaria
Clinical narrative: Took shingles shot 8-4-16 about 2:00 pm. On Wed 8-10-16 woke u with hives at wrist and hips. Also diarrhea. Called pharmacy. They said to get to my doctor. Saw her at 10:00. Gave me prednisone 20mg, 5 days. It was a reaction to the shingles shot.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Took shingles shot 8-4-16 about 2:00 pm. On Wed 8-10-16 woke u with hives at wrist and hips. Also diarrhea. Called pharmacy. They said to get to my doctor. Saw her at 10:00. Gave me prednisone 20mg, 5 days. It was a reaction to the shingles shot.