chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT (batch number 77R93, expiry date 30th June 2018) and (batch number 34RE5, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On an unknown date, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site swelling and injection site erythema to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by Medical Assistant. The health care professional reported the patient had injection site reactions after receiving FLUARIX. The symptoms reported included pain, swelling, and redness the size of a half dollar. No patient information was available. This was 1 of 4 cases as reported by same reporter for same events.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: The age at the vaccination was not reported. The healthcare professional reported that no immunity established after receiving ENGERIX B, which led the patient to be a therapy non responder. No further details were provided by the healthcare professional and then disconnected the call.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT (batch number 77R93, expiry date 30th June 2018) and (batch number 34RE5, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On an unknown date, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, injection site swelling and injection site erythema to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by Medical Assistant. The health care professional reported the patient had injection site reactions after receiving FLUARIX. The symptoms reported included pain, swelling, and redness the size of a half dollar. No patient information was available. This was 1 of 4 cases as reported by same reporter for same events.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Body ache, swollen injection site and fever (on right arm).
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Pruritus generalised
Clinical narrative: I started itching at the injection site, my right deltoid. It had a big red whelp about the size of a fifty cent piece. The site was warm to the touch and raised. I started itching on my forehead and scalp then my arms and legs. Sxs lasted x 3-4 days. I continued taking CLARITIN until it stopped. At the time the reaction occurred I was working as an LPN in our Pediatric Convenient Care. NP gave me a dose of liquid steroid and CLARITIN. The meds really helped.
Age: 29.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Body temperature increased, Oropharyngeal pain, Polymerase chain reaction, Rash maculo-papular, Rash vesicular
Clinical narrative: 10/13/2017 - Developed maculopapular and vesicular lesions face/chest/back/arms. Low grade temp. Sore throat. 10/16/2017
Age: 29.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Varicella virus test
Clinical narrative: 10/13/2017 - Developed maculopapular and vesicular lesions face/chest/back/arms. Low grade temp. Sore throat. 10/16/2017
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Nausea, restlessness, headache, dizziness. I continue to experience tingling on left extremities, i.e. side of face, arm, hand, leg, and foot; nausea and headache when tingling intensifies; tingling increased during evening hours to point of soreness in leg by time I go to bed; subsides during the night; begins again as I start moving around in the morning and when sitting position. During the day the tingling sensation goes across my chin at various parts of the day.
Sex: F
Vaccine: FLU4
Symptoms: Restlessness
Clinical narrative: Nausea, restlessness, headache, dizziness. I continue to experience tingling on left extremities, i.e. side of face, arm, hand, leg, and foot; nausea and headache when tingling intensifies; tingling increased during evening hours to point of soreness in leg by time I go to bed; subsides during the night; begins again as I start moving around in the morning and when sitting position. During the day the tingling sensation goes across my chin at various parts of the day.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Feeling cold, Headache, Injection site pain
Clinical narrative: I received a pneumonia shot on Wednesday morning from pharmacy. On Wednesday evening, I started developing coldness and shakiness, starting to vomit, tired, weak, headache, sore, muscle pain underneath my right arm, where I received the shot.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Tremor, Vomiting
Clinical narrative: I received a pneumonia shot on Wednesday morning from pharmacy. On Wednesday evening, I started developing coldness and shakiness, starting to vomit, tired, weak, headache, sore, muscle pain underneath my right arm, where I received the shot.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Flu shot was given in the left arm after it was given he leaned over to the left and started shaking. Felt dizzy, was seeing black spots and felt weak.
Age: 52.0
Sex: M
Vaccine: FLUC4
Symptoms: Cyanosis, Hypotension, Tremor, Vision blurred
Clinical narrative: 30 min. after flu shot, became hypotensive, B/P 80 systolic, lips cyanotic, uncontrollable shaking, blurred vision, resolved in about 1 hr.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt states arm still hurts and she cannot lay on that shoulder.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Stiff shoulder, painful, wakes me up at night. Aches down my arm since injection.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Vaccine received 10/4/17. PM of 10/4/17-Hive-like bumps, itching around the injection site, about 2 inches. 10/6/17 Bumps still there but itching is gone. 10/10/17 injection site reactions gone.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Flu shot 9/21/17 - had pain up (L) arm to shoulder area that night. Throbbing pain. Has taken TYLENOL for pain relief.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, MENB
Symptoms: Headache, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old male patient of an unspecified race and ethnicity received a single dose of TRUMENBA (lot S26986, expiry date Feb2019), via an unspecified route of administration, on 03Oct2017 for immunisation. The patient medical history included hip pain one month prior to vaccination, concomitant medications were not reported. The patient experienced post injection-headache, hip pain, numbness of lower extremity on an unspecified day in Oct2017. The patient went back to the physician's office on 06Oct2017, and he was referred to emergency room (ER). Outcome was unknown.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, MENB
Symptoms: Arthralgia, Headache, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old male patient of an unspecified race and ethnicity received a single dose of TRUMENBA (lot S26986, expiry date Feb2019), via an unspecified route of administration, on 03Oct2017 for immunisation. The patient medical history included hip pain one month prior to vaccination, concomitant medications were not reported. The patient experienced post injection-headache, hip pain, numbness of lower extremity on an unspecified day in Oct2017. The patient went back to the physician's office on 06Oct2017, and he was referred to emergency room (ER). Outcome was unknown.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Body temperature decreased, Headache, Hypoaesthesia, Nausea, Pallor
Clinical narrative: Father called and stated at end of 3 rd period (school)  patient starting getting headache/blurry vision. Blurry vision improved by 4th period. He had vaccine in 2nd period. Progressively, symptoms worsened through day- tingling to arms and legs, nausea, vomiting x1 at home; Got picked up at 240 from school ; Today feeling fine. Never had reaction in past. Took nap at home and felt better. Ate breakfast yesterday; 600 started to feel better; Slept fine;  Patient was asymptomatic in the FU apt on 10/13/2017.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Vomiting
Clinical narrative: Father called and stated at end of 3 rd period (school)  patient starting getting headache/blurry vision. Blurry vision improved by 4th period. He had vaccine in 2nd period. Progressively, symptoms worsened through day- tingling to arms and legs, nausea, vomiting x1 at home; Got picked up at 240 from school ; Today feeling fine. Never had reaction in past. Took nap at home and felt better. Ate breakfast yesterday; 600 started to feel better; Slept fine;  Patient was asymptomatic in the FU apt on 10/13/2017.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Headache, Nausea, Paraesthesia, Vision blurred, Vomiting
Clinical narrative: Father called and stated at end of 3 rd period (school)  patient starting getting headache/blurry vision. Blurry vision improved by 4th period. He had vaccine in 2nd period. Progressively, symptoms worsened through day- tingling to arms and legs, nausea, vomiting x1 at home; Got picked up at 240 from school ; Today feeling fine. Never had reaction in past. Took nap at home and felt better. Ate breakfast yesterday; 600 started to feel better; Slept fine;  Patient was asymptomatic in the FU apt on 10/13/2017.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Limb discomfort, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: On day 2 post vaccination patient describes increased pain in upper arm and shoulder which continued to increase over 1 week. Continues to have pain, heaviness in arm. Has tried cold and warm compresses with little improvement. States no visible signs of any abnormality but feels it is 'inside'.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Vaccination site pain
Clinical narrative: On day 2 post vaccination patient describes increased pain in upper arm and shoulder which continued to increase over 1 week. Continues to have pain, heaviness in arm. Has tried cold and warm compresses with little improvement. States no visible signs of any abnormality but feels it is 'inside'.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Limb discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: On day 2 post vaccination patient describes increased pain in upper arm and shoulder which continued to increase over 1 week. Continues to have pain, heaviness in arm. Has tried cold and warm compresses with little improvement. States no visible signs of any abnormality but feels it is 'inside'.
Age: 1.08
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Irritability, Loss of personal independence in daily activities
Clinical narrative: within 30 minutes, patient had violent diarrhea, and a 3" diameter swollen red spot at the injection site. She became very irritable and fussy. Diarrhea continued for 14 days with no successful treatment to stop the diarrhea. She was pulled from her ISR lessons (ISR Self-Rescue® Survival Swimming Lessons) due to the reaction of the vaccine.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Diarrhoea, Injection site dermatitis
Clinical narrative: Dermatitis on left arm 3 inch radius around injection site. Stomach pain and diarrhea 3 days after shot.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Chills, Decreased appetite, Nasal congestion, Nausea
Clinical narrative: 10/15: She woke up with nausea, decreased appetite; checked temp later in the day and it was 102.1 F. orally, also had chills, and she said her body was stinging/burning sensation on arms and legs. Nausea and fever of 101.1 on 10/16 and 10/17/17. She now has a stuff nose.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: 10/15: She woke up with nausea, decreased appetite; checked temp later in the day and it was 102.1 F. orally, also had chills, and she said her body was stinging/burning sensation on arms and legs. Nausea and fever of 101.1 on 10/16 and 10/17/17. She now has a stuff nose.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue, body aches.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Fall, Laceration, Nausea, Syncope
Clinical narrative: Nausea, diarrhea, syncope. Head laceration from syncope.
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash erythematous
Clinical narrative: There is persistent redness at center and scattered red dots in vicinity. The pharmacist advises me to use antibiotic ointment, but I'm worried about the redness. Not sore, not tender, but first time in decades of taking flu shot that I've had any reaction. I hope the ointment will help. My wife doesn't have this red infected look on her arm, but she does have itching periodically at the site. We wonder whether this batch of flu vaccine is different from past or has some defects.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Lip oedema, Myalgia, Nausea, Paraesthesia oral
Clinical narrative: Received the flu vaccine, a few hours later, lips became tingling with edema, nausea, muscle aches, fatigue. Treated with steroid injection and MEDROL DOSE PACK.
Age: 77.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 77-year-old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. There were no concomitant medications. On 06-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 injection, (lot # M041394 with expiration date on 23-MAY-2018; dose and route of administration were not provided) for prophylaxis (indication was reported as "vaccination"). On an unknown date in September 2017 (reported as "a couple days later"), the patient experienced swelling from his shoulder to elbow. No treatment was given for the event and no laboratory diagnostic studies were performed. Product quality complaint was not involved in this case. The outcome of the event was reported as recovered on an unknown date in September 2017 (reported as "a few days ago"). The reporter did not assess the relatedness between the event and PNEUMOVAX 23.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 7 years old male patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 26-SEP-2017, the patient accidentally vaccinated the ZOSTAVAX (0.65 ml, once, route, lot# and expiration date were unknown) for prophylaxis instead of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (Wrong drug administered). No adverse events were noted in the patient. It was unknown if there was relevant lab work.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender (reported as man). No information regarding medical history, concomitant therapies, current conditions and allergies was provided. On 19-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly in the left arm, lot # M035104 with expiration date 06-MAY-2018 (dose was not provided) for prophylaxis. Pharmacist reported, the patient was a thin man and after the injection of PNEUMOVAX 23, the reporter was not sure if she gave full dose. No adverse effects were reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, warm itchy patch on injection site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Malaise, Neck pain
Clinical narrative: Became ill 10 hours after vaccination with fever and chills, neck pain, weakness, lightheaded.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Became ill 10 hours after vaccination with fever and chills, neck pain, weakness, lightheaded.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Estimated due date was 4-21-18. On 9-8-17, I went in the office for my first prenatal check up and received the flu vaccine. Ultrasound showed that baby was measuring at 7 weeks 2 days. On 9-30-17, my body recognized that something was not right. After getting another ultrasound in the ER on 9-30-17, the baby was only measuring at 7 weeks 5 days (approximate date of death would be 9-12-17), when in fact it should have been measuring around 11 weeks.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Head discomfort, Headache, Pyrexia, Tremor
Clinical narrative: Started feeling chilled, then starting shaking uncontrollably. Fever of 102.6. Pressure headache. Lasted until midnight...morning temp. low grade 99.6. Feeling better today, but treating headache with ADVIL.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Crying, Pyrexia
Clinical narrative: FEVER , CRYING STARTING AT 102 AT  5 PM 10/14/17 PROGRESSING TO 105. TAKEN TO ER, FEVER CONTROLLED WITH ALTERNATING MOTRIN & TYLENOL.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Gait disturbance, Vomiting
Clinical narrative: The daughter reported that her mother had experienced vomiting, severe chills, weakness that she could barely walk, the night after the vaccination given. She suspected that it must be the flu vaccination given that day.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Pain
Clinical narrative: GOLF BALL SIZED LUMP UNDER SKIN AT INJECTION SITE COUPLED WITH 7/10 PAIN ALMOST IMMEDIATELY AFTERWARDS. PAIN CONTINUES TO 5/10 6 DAYS LATER. HAS TAKEN ALEVE DAILY SINCE THE INCIDENT.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram peripheral normal, Coagulation test normal, Full blood count normal, Renal function test normal, Skin discolouration
Clinical narrative: Employee states she developed left arm symptoms the day after receiving an influenza vaccine that was administered on 10/11/2017. She went to Urgent Care 10/12/2017 after noticing discoloration of her left hand and was told to report to ED. She has otherwise well without fever, chills, nausea and vomiting. Denies decreased range of motion or weakness in the extremity. She otherwise has no complaints.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound Doppler
Clinical narrative: Employee states she developed left arm symptoms the day after receiving an influenza vaccine that was administered on 10/11/2017. She went to Urgent Care 10/12/2017 after noticing discoloration of her left hand and was told to report to ED. She has otherwise well without fever, chills, nausea and vomiting. Denies decreased range of motion or weakness in the extremity. She otherwise has no complaints.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash that itches on chest, arms, stomach & legs.
Age: 29.0
Sex: F
Vaccine: MEN
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm was swollen at the site of the injection and warm at the site. There was pain at the site on 10/15/2017. Patient will see a healthcare provider today (10/17/2017).
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Red circular area at insertion site. Warmth noted to site. Itching noted at site. Fever. Nurse on the skilled nursing unit advised her to go to the E.D. for evaluation. She was prescribed KEFLEX 500mg 1 capsule every 8hrs for 7 days and Dexamethasone 4mg twice daily for 3days. Diagnosis-Cellulitis.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Flushing, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: EMPLOYEE IMMEDIATELY TASTED METAL IN HER MOUTH AT TIME OF INJECTION, INJECTION SITE BECAME RED, SWOLLEN, WARM AND PAINFUL 7/10 IN MINUTES AFTER THE INJECTION. HAS HAD FLU SHOT BEFORE WITHOUT INCIDENT. SITE CONTINUES TO BE PAINFUL 5/10 TWO HOURS LATER, WITH THROBBING PAIN. LEFT CHEEK BECAME SWOLLEN AND FLUSHED AT JAW LEVEL.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Pain, Swelling face
Clinical narrative: EMPLOYEE IMMEDIATELY TASTED METAL IN HER MOUTH AT TIME OF INJECTION, INJECTION SITE BECAME RED, SWOLLEN, WARM AND PAINFUL 7/10 IN MINUTES AFTER THE INJECTION. HAS HAD FLU SHOT BEFORE WITHOUT INCIDENT. SITE CONTINUES TO BE PAINFUL 5/10 TWO HOURS LATER, WITH THROBBING PAIN. LEFT CHEEK BECAME SWOLLEN AND FLUSHED AT JAW LEVEL.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness on both sides of neck, severe pain with any movement of the head. pain radiates to top of head. After initial onset, pain be and s/s became worse with any movement of head causing severe pain. Any pressure on the head or neck created severe pain, also bending the head forward causes same s/s. After approximately 72 hours, s/s diminished somewhat although still present.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test, Oedema peripheral, Renal function test, Sepsis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pedal edema in a infant male patient who received ENGERIX B (batch number N002202 ?, expiry date unknown). On 6th September 2017, the patient received ENGERIX B. On an unknown date, less than a year after receiving ENGERIX B, the patient experienced pedal edema (serious criteria hospitalization) and sepsis (serious criteria GSK medically significant). The patient was treated with Ampicillin and Gentamicin. On an unknown date, the outcome of the pedal edema was recovered/resolved and the outcome of the sepsis was unknown. It was unknown if the reporter considered the pedal edema and sepsis to be related to ENGERIX B. Additional details were provided as follows: The patient was admitted to the hospital, kidney function tests were performed, the patient received a work up for sepsis. Expiration date was unknown. The reported lot number (N002202 ?) for ENGERIX B does not match any GSK lot number.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site mass, Injection site nodule, Limb discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received FLUARIX QUADRIVALENT (batch number BD742, expiry date 14th May 2018). On 27th September 2017, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), skin warm (serious criteria disability), injected limb mobility decreased (serious criteria disability), injection site mass (serious criteria disability) and arm discomfort (serious criteria disability). On an unknown date, the outcome of the extensive swelling of vaccinated limb, skin warm, injected limb mobility decreased, injection site mass and arm discomfort were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, skin warm, injected limb mobility decreased, injection site mass and arm discomfort to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in left deltoid. On 10th October 2017, an healthcare professional reported that the patient had experienced swelling of the left arm from the shoulder to the wrist, unable to lift her arm, warmth, arm feels full and had a knot at the injection site. The healthcare professional believed the reported symptoms were debilitating, since the patient was left handed.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received FLUARIX QUADRIVALENT (batch number BD742, expiry date 14th May 2018). On 27th September 2017, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), skin warm (serious criteria disability), injected limb mobility decreased (serious criteria disability), injection site mass (serious criteria disability) and arm discomfort (serious criteria disability). On an unknown date, the outcome of the extensive swelling of vaccinated limb, skin warm, injected limb mobility decreased, injection site mass and arm discomfort were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, skin warm, injected limb mobility decreased, injection site mass and arm discomfort to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in left deltoid. On 10th October 2017, an healthcare professional reported that the patient had experienced swelling of the left arm from the shoulder to the wrist, unable to lift her arm, warmth, arm feels full and had a knot at the injection site. The healthcare professional believed the reported symptoms were debilitating, since the patient was left handed.
Sex: M
Vaccine: PPV
Symptoms: Asthma, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was also a pharmacist and refers to himself, via a company representative. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Since an unknown date, the patient was vaccinated multiple unspecified times every 5 years with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) due to a diagnosis of asthma. There were no adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Chemotherapy, Uveitis
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a currently 15-year-old female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9, injection, intramuscularly for prophylaxis (dose, lot# and expiration date were not provided). On an unknown date, the patient developed uveitis. The patient visited her doctor and she received a treatment with steroids and chemotherapy (brands and manufacturers were not provided), which was continued at the reporting time. The patient did not recover from the event at the reporting time. The causal relationship between the event and GARDASIL 9 was not provided. Upon internal review, the event of uveitis was considered to be medically significant.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Adenocarcinoma of the cervix, Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a physician via a medical affairs director and refers to a 31 years old female patient. The patient did not have any (at the age of 26 years old) pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and site of administration, lot # and expiration date were not reported) as a human papilloma virus (HPV) vaccination. On an unknown date, the patient visited the physician's office presenting with adenocarcinoma in situ, positive for P-16 from PAP smear for high risk HPV. The physician reported that the patient received an unspecified treatment on an unspecified date. The patient would have follow up PAP smears on unspecified dates. The outcome of the event was reported as recovering. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of adenocarcinoma in situ, positive for P-16 from PAP smear for high risk HPV was considered to be medically significant.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 week (also reported as 3 month) old male patient. The patient's concurrent condition included umbilical hernia without obstruction or gangrene. His relevant medical history and concomitant therapy was not reported. On 02-AUG-2017 at 08:45, RECOMBIVAX HB underwent an incorrect storage. On 03-AUG-2017 at 13:50, the patient was vaccinated with that incorrectly stored RECOMBIVAX HB (dose 2(second dose), lot# N006321 with expiry date 08-NOV-2019, dose and route unknown) in the left thigh for prophylaxis. Number of previous doses of RECOMBIVAX HB was reported as one. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005168:
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Vertigo
Clinical narrative: I have no idea what the make or lot number of the flu shot I got was. I checked the first option available. I experienced dizziness and vertigo 24-36 hours after receiving my annual flu shot.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient had a sore arm after she got her shot at a flu clinic at her job. Patient claimed she can't move or rotate her arm for almost 10 days which is quite unusual. Patient called her doctor and he is aware of her case.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Extreme fatigue, fever, chills, and body and head aches and pains. The symptoms slowly began within a few hours of receiving the shot and peaked over night with the extreme fever chills and body aches.  They are still persisting but they improved a bit from over night.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Paresthesia of L arm to L hand onset 1.5 hrs after receiving vaccine, lasted 2 days, no medication or treatment taken or received.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Injection site pain, Nausea, Pruritus
Clinical narrative: NAUSEA, VOMITING, RESPIRATORY SYMPTOMS- SHORTNESS OF BREATH, WHEEZING, HIVES, ITCHING, REDNESS, TENDERNESS AT SITE.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory symptom, Urticaria, Vomiting, Wheezing
Clinical narrative: NAUSEA, VOMITING, RESPIRATORY SYMPTOMS- SHORTNESS OF BREATH, WHEEZING, HIVES, ITCHING, REDNESS, TENDERNESS AT SITE.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Injection site swelling, Respiratory symptom, Rhinorrhoea
Clinical narrative: SWEELING AT SITE RESPIRATORY SYMPTOMS : DIFFICULTY BREATHING, SHORTNESS OF BREATH HEADACHE LOT OF MUCUS.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Injection site swelling, Respiratory symptom, Rhinorrhoea
Clinical narrative: SWELLING ON SITE OF INJECTION, RESPIRATORY SYMPTOMS: HEADACHE LOTS OF MUCUS, DIFFICULTY BREATHING.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity, Paraesthesia oral
Clinical narrative: On the morning of 10/3/17, shortly after receiving her employee flu shot, the injection site became itchy, then very red and hot encompassing the whole deltoid area. Reported to manager. At 9:30 AM  Started having tingling of the lips. Benadryl 25 mg taken and sent to Urgent Care, received Rx for Benadryl 50 mg TID for first 3 doses, then 25 mg UAD PRN. On 10/4 the redness, hotness and itchiness was gone. Just the typical arm soreness from the injection. Didn?t need to take Benadryl prn on the 4th.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient had initial soreness from the vaccine lasting a few days.  One week after receiving the vaccine, soreness began again and has continued for 5 days. Soreness radiates down from the deltoid to the elbow and up from the deltoid to the shoulder/neck on right side.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, pain at the injection site. Per parents happened few hours after injection and thought it was normal. Swelling has increased and presented in office from shoulder down to elbow. Denied fever, shortness of breath.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Pyrexia, Tremor, X-ray
Clinical narrative: Tremeurs. High fever.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red welt, approximately 3/4 cm and itchy about 45minutes to 1 hr after receiving. Informed to take some oral BENADRYL and apply ice.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Rash generalised, Rash pruritic
Clinical narrative: Participant was given the flu-shot at approximately 1:30pm today, 10.9.17. She states she did not experience symptoms related to an allergic reaction until 4pm where she describes, ?I have a rash all over my body that?s itchy.? There were no associated signs and symptoms related to difficulty of breathing or cardiopulmonary distress. No neurological symptoms or change in sensorium as well. The participant also states that she forgot to tell the nurse that she was allergic to eggs. Advised Provider to give one dose of epinephrine, 0.5mL IM into the anterolateral aspect of the thigh. Advised Provider to call 911. After 5-10 minutes, the symptoms had subsided greatly. After 30 minutes, the participant felt much better and most of the rashes had subsided. Continues to have NO difficulty of breathing or signs and symptoms related to cardiopulmonary distress. Continues to have NO neurologic symptoms or change in sensorium. It was determined that a 2nd dose of epinephrine was NOT needed. The participant declined the 911 call as she said she will go to the ER after work. Participant was advised to go to the ER for follow-up as anaphylaxis may recur after several hours.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Neck pain, Tremor
Clinical narrative: Symptoms started with a headache at approximately 2:30PM. By 3PM, I had a severe neck ache, generalized aches in all joints, and shaking chills. I took Tylenol Extra Strength at 3:45 and had a temperature of 100.4. By 6:30, my temperature was 102.4. Symptoms continued as above, except for chills at that time. I called Dr on call and he felt I was having a severe reaction to the shot and thought I'd fell better within 24 hours. He suggested I alternate Tylenol with Ibuprofin. Temperature was normal this morning, however symptoms such as aching in joints and headache persist.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Skin discolouration, Syncope
Clinical narrative: Walking out of the office - she fainted, her arm and left leg were stiff, needed oxygen, and was very gray/white in color.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Red 2.54 cm raised welt and hot to touch; burned on receiving; itchy within 1 hr. Welt was gone 3 days later.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Shot administered 10/16/17 1835; Severe stomach pains 10/17/17 0015-0130; Fever 10/17/17 0015-0300; Rash/hives over entire body 10/17/17 0015-0130; 2-25mg Benadryl capsules administered 10/17/17 0043; Diarrhea 10/17/17 0015-0700; Vomiting 10/17/17 0015-0200.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Shot administered 10/16/17 1835; Severe stomach pains 10/17/17 0015-0130; Fever 10/17/17 0015-0300; Rash/hives over entire body 10/17/17 0015-0130; 2-25mg Benadryl capsules administered 10/17/17 0043; Diarrhea 10/17/17 0015-0700; Vomiting 10/17/17 0015-0200.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Throat tightness, Urticaria
Clinical narrative: Within a few minutes, itchy in face (cheeks, ears, neck, nose), followed by scalp, torso, thighs, calves and soles of feet, slight tight throat, scattered small number of hives (on nose, cheek, torso).
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site urticaria
Clinical narrative: Localized hives at site of injection, treated with OTC BENADRYL, hives resolved overnight, residual numbness in L arm.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and route of administration were not reported) lot # N012134, expiry date 17-APR-2019 (also reported as 11-APR-2019). There was no side effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 Celsius degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history, concomitant medications and drug allergies were not specified. On an unknown date, the patient was vaccinated with a properly stored PNEUMOVAX 23 lot # N013521, expiration date 23-JAN-2019, one dose (reported as one shot) for prophylaxis. On an unknown date, after administration of PNEUMOVAX 23, the patient was unable to move her arm for three days. The patient had discomfort, pain, swelling and hot sensation around injection site. Due to the events, she received unspecified treatment. The patient did not seek medical attention. The outcome of the events was reported as recovered/resolved. The relatedness between PNEUMOVAX 23 and the events was not specified. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA007749: US-009507513-1710USA007750:
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Central nervous system viral infection, Decreased immune responsiveness, Herpes zoster, Hip fracture
Clinical narrative: Information had been received on 13-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX in or about 11-APR-2007 at a family medical clinic, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During September of 2012, patient woke up to blistering vesicles throughout his body. He was experiencing extreme pain, and because of the pain, collapsed and broke his hip. Patient was ambulated to a medical center, where he was treated for the broken hip and the painful vesicular outbreak and rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient was transferred to another medical center for continued treatment of his severe symptoms, where he had to undergo a spinal tap, because the ER doctors believed the shingles had spread to his brain, causing him to collapse. Patient has been prescribed antivirals and pain medications for management of his persistent and painful symptoms. Patient experiences chronic neuralgia and permanent nerve pain secondary to his shingles infections (onset not reported). As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, collapsed and broke his hip and herpes zoster which spread to brain were determined to be medically significant events. Chronic neuralgia and permanent nerve pain secondary to his shingles infections was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Lumbar puncture, Neuralgia, Pain, Rash, Rash vesicular
Clinical narrative: Information had been received on 13-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX in or about 11-APR-2007 at a family medical clinic, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During September of 2012, patient woke up to blistering vesicles throughout his body. He was experiencing extreme pain, and because of the pain, collapsed and broke his hip. Patient was ambulated to a medical center, where he was treated for the broken hip and the painful vesicular outbreak and rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient was transferred to another medical center for continued treatment of his severe symptoms, where he had to undergo a spinal tap, because the ER doctors believed the shingles had spread to his brain, causing him to collapse. Patient has been prescribed antivirals and pain medications for management of his persistent and painful symptoms. Patient experiences chronic neuralgia and permanent nerve pain secondary to his shingles infections (onset not reported). As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, collapsed and broke his hip and herpes zoster which spread to brain were determined to be medically significant events. Chronic neuralgia and permanent nerve pain secondary to his shingles infections was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Information had been received on 13-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX in or about 11-APR-2007 at a family medical clinic, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During September of 2012, patient woke up to blistering vesicles throughout his body. He was experiencing extreme pain, and because of the pain, collapsed and broke his hip. Patient was ambulated to a medical center, where he was treated for the broken hip and the painful vesicular outbreak and rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Patient was transferred to another medical center for continued treatment of his severe symptoms, where he had to undergo a spinal tap, because the ER doctors believed the shingles had spread to his brain, causing him to collapse. Patient has been prescribed antivirals and pain medications for management of his persistent and painful symptoms. Patient experiences chronic neuralgia and permanent nerve pain secondary to his shingles infections (onset not reported). As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, collapsed and broke his hip and herpes zoster which spread to brain were determined to be medically significant events. Chronic neuralgia and permanent nerve pain secondary to his shingles infections was considered to be disabling. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot# N023328, expiration date 22-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced two temperature excursions. Firstly, the vaccine was exposed to temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 120 hours (5 days) and secondly to temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 48 hours (2 days). Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Malaise
Clinical narrative: Initial unsolicited report received from a physician on 04-Oct-2017. This case involves a 69-year-old male patient who was vaccinated with a single dose of FLUZONE QUADRIVALENT (batch number: UI850AA, expiry date: 30-Jun-2018) in left deltoid via intramuscular route on 02-Oct-2017 in afternoon. The patient's medical history and concomitant medications were not reported. On an unknown date, few hours following the vaccination, the patient developed uncontrollable rigors, temp 100 F, and malaise around midnight. The patient's laboratory data was not reported. Corrective treatment includes Tylenol. On 03-Oct-2017, the patient was recovered from events. List of documents held by sender: none.