chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Computerised tomogram normal, Hypertension, Influenza, Insomnia
Clinical narrative: blood pressure was high; Kidney function was poor; intense back pain; Pain in back causing loss of sleep; getting the flu; Initial information received on 11-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 73 years old male patient who experienced getting the flu (influenza), his blood pressure was high (blood pressure increased), kidney function was poor (renal impairment) and intense back pain (back pain), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious getting the flu (influenza), blood pressure was high (blood pressure increased), intense back pain (back pain) and pain in back causing loss of sleep (insomnia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious kidney function was poor (renal impairment) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Other relevant tests were not reported.  Final diagnosis was intense back pain, kidney function was poor, blood pressure was high and getting the flu.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns an 73 years old male patient who presented with possible influenza, blood pressure increased, renal impairment and back pain after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Renal impairment
Clinical narrative: blood pressure was high; Kidney function was poor; intense back pain; Pain in back causing loss of sleep; getting the flu; Initial information received on 11-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 73 years old male patient who experienced getting the flu (influenza), his blood pressure was high (blood pressure increased), kidney function was poor (renal impairment) and intense back pain (back pain), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious getting the flu (influenza), blood pressure was high (blood pressure increased), intense back pain (back pain) and pain in back causing loss of sleep (insomnia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious kidney function was poor (renal impairment) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Other relevant tests were not reported.  Final diagnosis was intense back pain, kidney function was poor, blood pressure was high and getting the flu.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns an 73 years old male patient who presented with possible influenza, blood pressure increased, renal impairment and back pain after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2nd flu shot was given by mistake, a month after the first seasonal flu shot. No adverse signs or symptoms reported by patient or his mother.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt only 10 was given trumenba instead of menactra in error  pt had no reaction  ? do we need to call back and give menactra  anything we need to call the parent about regaring the trumenba
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Fatigue
Clinical narrative: Upper arm-Redness, swelling arm turned purple then darkened. Remained for 7 days. Discoloration lasted 1 month. October 26-Severe joint pain lasted 2 weeks October 27-Chills lasted 5 days  October 27- body temperatures 96-97 lasted 5 days October 26 weakness, fatigue-1 week November 1 sinus infection , laringitis 3 weeks
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Laryngitis, Peripheral swelling, Sinusitis, Skin discolouration
Clinical narrative: Upper arm-Redness, swelling arm turned purple then darkened. Remained for 7 days. Discoloration lasted 1 month. October 26-Severe joint pain lasted 2 weeks October 27-Chills lasted 5 days  October 27- body temperatures 96-97 lasted 5 days October 26 weakness, fatigue-1 week November 1 sinus infection , laringitis 3 weeks
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Pain
Clinical narrative: At 7 pm that night developed upper back pain that progressed into whole body aches by the middle of the night - lasted for 24 hours. Experienced chills that night as well.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Patient complained of blistering reaction to face, arms, chest, and torso the day after the vaccine and continued for 2 weeks afterwards. Patient did not go to doctor/hospital. Patient made the determination on her own the rash was a result of the HD vaccine as it was the only change in patient history. Daughter also noted this is the first time patient had HD, she's received the standard vaccine in the past with no issues.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called 2 days after injection complaining of pain in arm all the way down to her hand.  Said her hand was swollen and sore and she could not close it.  Pharmacist suggested Tylenol or nsaids.  12-9 patient called again same symptoms and said she had a doctors appointment on 12/12.  On 12-18 patient called said doctor told her to take Tylenol and that wasn't working, pharmacist suggested naproxen or ibuprofen.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: vomiting
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Walking aid user
Clinical narrative: patient had chills at night, but then after a day or so had severe knee pain, so severe that patient had to use a cane for a couple of days.  Patient is otherwise in good health and has no prior knee pain history, etc.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: localized reaction starting the following morning;   developed into cellulitis on left anterior thigh (11x11cm)
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: No reaction to Vaccine.   Needle was administered too high, essentially in the shoulder joint.  Continue to have pain in shoulder and upper arm.  Difficulty raising arm, opening doors, lifting weights, push-ups.
Age: 29.0
Sex: M
Vaccine: FLUN4
Symptoms: Electromyogram, Hypoaesthesia, Loss of personal independence in daily activities, Muscle twitching, Pain
Clinical narrative: I have been having uncontrollable muscle twitching and believe my ulnar nerve has been effected from the flu shot. I wake up with numbness in my feet, hands, and pinky fingers that I have never experienced before. I went to a neurologist and my nerves and muscles are functioning promptly . They believe the flu shot I received could be the cause of my distress. I have had to miss work multiple days because the pain is so intense. I was a perfectly normal and healthy person until this flu shot. I haven't had a flu shot in years and never intend on getting one again.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left upper arm muscle soreness which has gradually improved overtime.  No loss of range of motion.  Patient is thin and frail.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Dyspnoea, Dysstasia, Flushing
Clinical narrative: after about 15 minutes (on my way out of office), Dark red flush Slight trouble breathing pain in central lower back intense enough not to be able to walk or stand for about 15 minutes(on my hands and knees on little white boxes outside office door ) (pain began tapering off enough to stand made my way to my car (15 feet away) sat leaning on door (open) for 15 more minutes until a nurse came out on her way home and asked if I was ok , took me back upstairs had doc check me out  , nauseous for hours, dizzy for hours, small amount of itching for several weeks with small amount of hives on mostly on back of hands in between fingers for about, Still now have mostly healed hives present on back of hands), (benadyrl helps with the itching)
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Gait inability, Nausea, Pruritus, Urticaria
Clinical narrative: after about 15 minutes (on my way out of office), Dark red flush Slight trouble breathing pain in central lower back intense enough not to be able to walk or stand for about 15 minutes(on my hands and knees on little white boxes outside office door ) (pain began tapering off enough to stand made my way to my car (15 feet away) sat leaning on door (open) for 15 more minutes until a nurse came out on her way home and asked if I was ok , took me back upstairs had doc check me out  , nauseous for hours, dizzy for hours, small amount of itching for several weeks with small amount of hives on mostly on back of hands in between fingers for about, Still now have mostly healed hives present on back of hands), (benadyrl helps with the itching)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Bright red, itchy, burny, raised rash showed up on the back of my leg a couple of days after the vaccine. A month later, the rash (hives?) is still there. Still very red- has not spread.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Client stated that:  Left shoulder pain started one day after flu vaccine.  Level of left arm pain increases along with burning, tingling  and numbness started at left arm radiate to fingers as days progress.   left hand has difficulty movements and can't move  backward. 12/4/2019  Was seen by MD.   Meds given.  X-Ray scheduled next week.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Client stated that:  Left shoulder pain started one day after flu vaccine.  Level of left arm pain increases along with burning, tingling  and numbness started at left arm radiate to fingers as days progress.   left hand has difficulty movements and can't move  backward. 12/4/2019  Was seen by MD.   Meds given.  X-Ray scheduled next week.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Strabismus
Clinical narrative: Patient was fine and chatting for the first 2 to 3 minutes after vaccine. I had her sit down in the waiting area - very close to my workstation. I counseled her to let me know if she was feeling dizzy or any different than baseline. I made eye contact and she gave me a thumbs up after about 5 minutes from administration of vaccine. At about the 7 minute mark, I noticed she placed her hand on her forehead, so I went closer to ask if she was alright. I said her name, she looked up at me,  then asked if she was feeling ok. She just had a plain, squinting look as if she was extremely confused and couldn't understand what I was saying. I immediately went out and sat next to her. She hunched over in her chair and was extremely confused. I immediately had my intern call 9-1-1. I asked her what her name was, and had to repeat the question three times before she answered. Asked her to smile for me - no noted facial droop, but again had to ask her twice before she understood. EMT came and brought her to the hospital, and she was admitted (they called that evening to verify her meds as she was being admitted.) I called the patient to follow up with her this morning, 12/18/19, and she said that she was in the hospital from 12/14/19, to 12/15/19, and was discharged home with PT and OT therapy assigned to her. She said that, "they think she may have had a stroke", but couldn't recall much of the details. She stated that she is feeling much better, but seemed a little unsure of what all had happened.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary mass, Axillary pain, Injection site pain
Clinical narrative: Lump under right arm that has grown within the hour! Soreness and pain at sight of injection and under right arm!
Sex: M
Vaccine: VARZOS
Symptoms: Corneal opacity, Ophthalmic herpes simplex, Vision blurred
Clinical narrative: central corneal opacity of the right eye; herpes simplex virus stromal keratitis; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dosage, vaccination site and route of administration were not provided) as recommended for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered blurry vision in the right eye (OD) and was diagnosed with central corneal opacity of the right eye and herpes simplex virus stromal keratitis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.   Upon internal review, the events of central corneal opacity of the right eye and herpes simplex virus stromal keratitis were determined to be medically significant. The events of central corneal opacity of the right eye and herpes simplex virus stromal keratitis were considered to be disabling.
Age: 0.75
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional adverse events; was administered an MMR II at the age of 9 months old; This spontaneous report was received from a licensed practical nurse (also reported as medical assistant - conflicting information) and refers to a 9-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 16-SEP-2019, at the age of 9 months old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot# S006647, expiration date: 05-MAR-2021 (exact dose, frequency, site and route of administration were not reported) for prophylaxis due to travel. The vaccine was reconstituted with sterile diluent. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced side effects after receiving the dose of Shingrix. The reporter wanted to know how long do side effects last after second shingles shot.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Lethargy, Malaise
Clinical narrative: feel tired; Flu-like symptoms; inability to lift her arms or legs; overall malaise; Weak; Shaky; lethargic; Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, 1 days after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever. On 24th July 2019, the outcome of the tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever were recovered/resolved.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever to be related to Shingrix.  Additional case details were reported as follows: At night, the patient received Shingrix on an unknown arm and she started to feel tired.  The next day, she was in bed all day with flu-like symptoms, including the inability to lift her arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. She also felt like she had a fever but did not take her temperature.  The patient noticed she was feeling better but was not able to get out of bed until the afternoon.  All symptoms had resolved and she went in to work.  The reporter consented to follow up. This case has been linked with case US2019220473 (husband's case), reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pyrexia, Tremor
Clinical narrative: feel tired; Flu-like symptoms; inability to lift her arms or legs; overall malaise; Weak; Shaky; lethargic; Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, 1 days after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever. On 24th July 2019, the outcome of the tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever were recovered/resolved.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, mobility decreased, malaise, weakness, tremor, lethargy and fever to be related to Shingrix.  Additional case details were reported as follows: At night, the patient received Shingrix on an unknown arm and she started to feel tired.  The next day, she was in bed all day with flu-like symptoms, including the inability to lift her arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. She also felt like she had a fever but did not take her temperature.  The patient noticed she was feeling better but was not able to get out of bed until the afternoon.  All symptoms had resolved and she went in to work.  The reporter consented to follow up. This case has been linked with case US2019220473 (husband's case), reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: General muscle aches (flu like), shivering, headache.  All occurred about 12 hours after injection.  Lasted most of the night.  Better mid-morning after.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhoea
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse outcomes. Reporting IM injection.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: day of vaccination pt noted swelling/soreness of left arm. tremors, chills, dizziness, blurred vision. inability to raise left arm. pt called dr and was seen 12/16/19. dr reported no fever. pt given rx for prednisone that afternoon.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vision blurred
Clinical narrative: day of vaccination pt noted swelling/soreness of left arm. tremors, chills, dizziness, blurred vision. inability to raise left arm. pt called dr and was seen 12/16/19. dr reported no fever. pt given rx for prednisone that afternoon.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: 100.9 fever with muscle aches pains, at midnight, chills, tylenol and ibuprofen taken , symptoms subside 24 hrs later
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: diagnosed with the mumps on an unspecified date; This spontaneous report has been received from a physician, referring to an unspecified 8 or 9 years old child patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis (reported as prevention of measles, mumps and rubella).         On an unknown date, after having been immunized with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient was diagnosed with mumps. Whether treatment was given to the patient or not was unknown. The outcome of mumps was unknown. The causallity assessement was not provided.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects are being reported.; beyond the age of 45 years old and received GARDASIL 9; This spontaneous report has been received from a male patient beyond the age of 45 years old, referring to himself. Information about medical history, concurrent conditions and concomitant therapies were not provided.      On 19-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. No adverse effect was reported.
Age: 1.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Rash
Clinical narrative: experienced a rash; This spontaneous report was received from a medical assistant and refers to a currently 3-year-old female patient. The patient did not have any pertinent medical history or drug reaction and allergies. No information regarding the patient's concomitant medications was reported.   On 18-DEC-2017, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) lot # N014483, expiry date 10-MAY-2019, subcutaneously (dose and vaccination site were not specified) which was reconstituted with sterile diluent for prophylaxis.   On an unknown date, after receiving the vaccine on 18-DEC-2017, the patient experienced a rash. The patient sought medical attention in a physician's office. Lab diagnostics were not performed. The patient recovered from the event on an unknown date. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: pain at injection site 3-4 days after 1st dose; Patient did return for dose #2.; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows The age at vaccination not provided. The Shingrix vaccine administered about 2 months ago and experienced pain at injection site 3-4 days after 1st dose. The patient did return for dose 2 which led to incomplete course of vaccination. For tolerances of 2nd dose of Shingrix, refer case US2019AMR225546.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site after 2nd dose; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows The age at vaccination not provided. The Shingrix vaccine administered approximately 2 months ago and experienced pain at injection site 3-4 days after 2nd dose.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: joint pain; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, less than a day after receiving Shingrix, the patient experienced joint pain and injection site pain. On an unknown date, the outcome of the joint pain and injection site pain were recovering/resolving.   It was unknown if the reporter considered the joint pain and injection site pain to be related to Shingrix.  Additional details were received as follows: The patient experienced joint pain and pain at the injection site. The patient planned to continue follow-up with her physician on an unknown date. The patient consented to follow up. This case has been linked to US2019AMR223692, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac function test normal, Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Rash; Pain; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient reported that approximately 1 to 2 months after 2nd dose was received, the onset of pain occurred. The patient recently went to the hospital where they did a heart work up and had no significant findings. At the appointment with family physician, the patient had a rash, and the physician diagnosed the rash as shingles. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation for shingles was not provided. The emergency room visit required. The reporter consented to follow up.      Lab Comments: On an unknown date patient underwent heart work up and had no significant findings.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pain
Clinical narrative: Incomplete course of vaccination; chills; body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 19th March 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills and general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the chills and general body pain were resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills and general body pain to be related to Shingrix.  Additional details were received as follows: The patient stated that she received her first dose of Shingrix and that evening she experienced chills and had body aches for 36 hours.  Till the time of reporting patient has not receive the 2nd dose, which led to  incomplete course of vaccination. No additional details were available. The patient consented to follow up. This case has been linked to US2019AMR227598, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea
Clinical narrative: Teeth shaking chills, mild nausea and headache occurred at 2 AM. Significant weakness for 24 hours. I weigh 120 lbs. My friend who had to go to ER due to fainting, weighs less. A patient that I administered a Shingrix fainted the next day. All of us are small women. Is this vaccine something that should be dose aligned with weight?
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Eye irritation, Eye pain, Fatigue
Clinical narrative: Left arm very tender, red, and hot.  All over feeling of soreness and exhaustion, dizziness.  Eyes very irratated and tender.  Had to lay down and rest.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin warm, Tenderness
Clinical narrative: Left arm very tender, red, and hot.  All over feeling of soreness and exhaustion, dizziness.  Eyes very irratated and tender.  Had to lay down and rest.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Emotional distress, Euphoric mood, Irritability, Pyrexia
Clinical narrative: Became very fussy and inconsolable later in the day. Per parents, would cry uncontrollably and not be able to be soothed by usual methods. Sleeping patterns changed and was very drowsy the following day. Would fall asleep on one of the stairs in the house which is not her typical behavior. Also would repeat the same statements (ex: the beetle got the spider) over and over.  Did develop a fever 48 hours later which subsequently resolved. Over the weekend, was noted to have periods of alternating crying and laughing.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder, Somnolence, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Became very fussy and inconsolable later in the day. Per parents, would cry uncontrollably and not be able to be soothed by usual methods. Sleeping patterns changed and was very drowsy the following day. Would fall asleep on one of the stairs in the house which is not her typical behavior. Also would repeat the same statements (ex: the beetle got the spider) over and over.  Did develop a fever 48 hours later which subsequently resolved. Over the weekend, was noted to have periods of alternating crying and laughing.
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Lethargy
Clinical narrative: Local pain at injection site. Headache, nausea, full body aches (muscles and joints). Low grade fever. Lethargy. Infrequent chills. Diarrhea.
Age: 55.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Local pain at injection site. Headache, nausea, full body aches (muscles and joints). Low grade fever. Lethargy. Infrequent chills. Diarrhea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Localized redness/swelling reaction for 3 days and hasn't yet resolved. Fever that lasted around 1 day.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Eye movement disorder, Hypersensitivity, Hyporesponsive to stimuli, Lethargy, Mobility decreased
Clinical narrative: Was very lethargic, not moving, almost unresponsive. Violently vomitting with no response, eyes rolling back, slight fever Has since been diagnosed with allergies
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Viral test positive, Vomiting
Clinical narrative: Was very lethargic, not moving, almost unresponsive. Violently vomitting with no response, eyes rolling back, slight fever Has since been diagnosed with allergies
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Coccydynia, Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging normal
Clinical narrative: The patient experienced weakness, muscle pain and strong tailbone pain.  The tailbone pain started one month after injection with the Shingrix vaccine. From September the tailbone pain got worse and it is still strong.  An MRI showed no abnormalities. The pain interferes with her sleep and normal activities.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: The patient experienced weakness, muscle pain and strong tailbone pain.  The tailbone pain started one month after injection with the Shingrix vaccine. From September the tailbone pain got worse and it is still strong.  An MRI showed no abnormalities. The pain interferes with her sleep and normal activities.
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Balance disorder, Diarrhoea, Disorientation, Fatigue, Headache
Clinical narrative: Wednesday Dec. 11: late afternoon low grade fever with intense headache began; Dec. 12th awoke w malaise; began to dress for work; series of violent dry heaves; out of work all day; saw his intrenist  late afternoon for pre-arranged visit and 99.2 temp; Dec. 13th went to work for X-Mas Party; left at 2;30, 1 hour into party.  From  Dec.13th through Dec.16th  patient has been at home, in bed, with fever 100° to 101,8°; imbalance; occasional disorientation; malaise; mild diarrhea; significant fatigue, sleeping easily 16-18 hours.  On 12/17 patient worked half day with 99.6 temperature;  fell asleep for 5 1/2 hours; awoke in full sweat; temperature at 98.4 !
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Hyperhidrosis, Hypersomnia, Loss of personal independence in daily activities, Malaise, Pyrexia
Clinical narrative: Wednesday Dec. 11: late afternoon low grade fever with intense headache began; Dec. 12th awoke w malaise; began to dress for work; series of violent dry heaves; out of work all day; saw his intrenist  late afternoon for pre-arranged visit and 99.2 temp; Dec. 13th went to work for X-Mas Party; left at 2;30, 1 hour into party.  From  Dec.13th through Dec.16th  patient has been at home, in bed, with fever 100° to 101,8°; imbalance; occasional disorientation; malaise; mild diarrhea; significant fatigue, sleeping easily 16-18 hours.  On 12/17 patient worked half day with 99.6 temperature;  fell asleep for 5 1/2 hours; awoke in full sweat; temperature at 98.4 !
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Retching
Clinical narrative: Wednesday Dec. 11: late afternoon low grade fever with intense headache began; Dec. 12th awoke w malaise; began to dress for work; series of violent dry heaves; out of work all day; saw his intrenist  late afternoon for pre-arranged visit and 99.2 temp; Dec. 13th went to work for X-Mas Party; left at 2;30, 1 hour into party.  From  Dec.13th through Dec.16th  patient has been at home, in bed, with fever 100° to 101,8°; imbalance; occasional disorientation; malaise; mild diarrhea; significant fatigue, sleeping easily 16-18 hours.  On 12/17 patient worked half day with 99.6 temperature;  fell asleep for 5 1/2 hours; awoke in full sweat; temperature at 98.4 !
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Mobility decreased, Myalgia, Nausea
Clinical narrative: PATIENT COMPLAINS OF HANDS FREEZING, TIRED/ FATIGUE (FELT LIKE SHE COULD NOT MOVE), MUSCLE ACHES IN LEFT ARM, SHOULD AND NECK, HEADACHE, NAUSEA
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: PATIENT COMPLAINS OF HANDS FREEZING, TIRED/ FATIGUE (FELT LIKE SHE COULD NOT MOVE), MUSCLE ACHES IN LEFT ARM, SHOULD AND NECK, HEADACHE, NAUSEA
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pallor, Pyrexia
Clinical narrative: Fever 102-103 for one day , headache, tiredness, pale face
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Immunization provider screened and vaccinated the patient (sitting down) for Flu and instructed the patient after vaccination to wait in front lobby for 15-20 mins in case of adverse reaction. the patient was waiting in the lobby and was ''on one knee/ sweating profusely stating he felt lightheaded". The patient was escorted to Dr's office down the hall for evaluation
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Disorganised speech, Pain, Pallor, Tremor
Clinical narrative: PT RECEIVED TDAP AND MENVEO IN THE RIGHT THIGH, COMPLAINED OF PAIN, HPV ADMINISTERED IN LEFT THIGH, COMPLAINED OF PAIN, SPREADING PAIN, PATIENT WAS NOTICED TO GET VERY PALE, SHE STARTED TO MIX UP HER WORDS, TOTAL BODY SHAKING STARTED, AS THE PATIENT WAS STARTING TO LEAN FORWARD I IMMEDIATELY EASED HER TO A LAYING POSITION ON THE EXAM TABLE. PATIENT RECOVERED FAIRLY QUICKLY AFTERWARDS, WONDERED WHY SHE WAS LAYING DOWN. SHE WAS STILL VERY PALE AND CONTINUED TO HAVE HER LAY ON THE TABLE. A COOL RAG WAS APPLIED TO HER FOREHEAD, GUARDIAN WAS INSTRUCTED TO REMAIN IN THE ROOM AS I WENT TO GET HER SOME WATER. PT DRANK THE WATER, STILL SHAKEY AND PALE AND FEELING CONFUSED, ORANGE JUICE WAS GIVEN WHICH SEEMED TO HELP MORE, PT CONTINUED TO IMPROVE. AFTER HAVING THE PATIENT SIT FOR MORE THAN 5 MIN, SHE WAS ABLE TO LEAVE THE OFFICE WITH HER GUARDIAN, AMBULATING ON HER OWN. NO FURTHER CONCERNS NOTICED.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram, Laboratory test, Magnetic resonance imaging, Seizure
Clinical narrative: MOTHER REPORTED THAT THE CHILD HAD SEIZURE AND SHE WAS TAKEN TO THE HOSPITAL
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Patient had syncopal episode immediately following administration: felt faint, BP dropped, clammy. Felt better within minutes and at 15-20 minutes following administration felt that she had returned to baseline (with BP return to normal). Left with spouse.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Lymphoedema, Skin warm, Urticaria
Clinical narrative: lymphodema? redness, whelpping, heat to touch, soreness along interior biceps area. several inches from injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Swelling
Clinical narrative: PATIENT EXPERIENCED SWELLING, PAIN AND RASH THAT LASTED 5 TO 7 DAYS. ADVERSE REACTION CONTINUED TO GET WORSE AS DAYS PASTED.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pneumonia, Respiratory failure, Wheezing
Clinical narrative: Pneumonia; Acute hypercapnic; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On 10-FEB-2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). On an unknown date (reported as shortly after receiving the vaccine), the pt suffered dyspnea and wheezing. The pt was admitted to hospital and he was diagnosed with pneumonia and acute hypercapnic respiratory failure on an unknown date. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and severe and permanent personal injuries. The outcome of the events pneumonia and acute hypercapnic respiratory failure was considered as not recovered. The reporter considered pneumonia and acute hypercapnic respiratory failure to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the events of pneumonia and acute hypercapnic respiratory failure were determined to be medically significant and disabling
Sex: F
Vaccine: PNC13
Symptoms: Sleep apnoea syndrome
Clinical narrative: Experienced 36 sleep apnea episodes an hour; This is a spontaneous report based on the information received by Pfizer from Medical Information (Case ID: GI-2019-9828). The contactable consumer reported for herself. A 69-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 36 sleep apnea episodes an hour on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Muscle spasms, Peripheral swelling
Clinical narrative: arm swollen; injection site red; muscle spasms; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer reporting for herself. This female patient of unknown age received on 06Dec2019 a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. On Saturday, on 07Dec2019, her arm swollen, the injection site red and had muscle spasms that on 13Dec2019 they have become pretty severe. Outcome was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained
Age: 63.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Bone pain, Imaging procedure, Injection site pain, Musculoskeletal disorder, Pain
Clinical narrative: About 3 days later pain started on left arm at site of injection.  It felt like pain was in the bone at the site of injection; within 4 days pain gravitated to shoulder--that is where it has been since. Patient called the clinic when pain gravitated to shoulder. Patient has been to the facility several times since then for follow-up.  Patient has seen, PCP, rheumatologist and currently has appointment with orthopedist.   The pain level has not changed much since it gravitated to shoulder.  Patient has received cortisone shot, a dose of Celebrex, and 2 aspirin; it relieved pain a little bit temporarily. Patient has had shoulder imaging, x-rays, and sonogram.   Patient has not had other symptoms.  Patient has been very active all life, can carry weight when shoulder is down but it becomes unusable as soon as lift it slightly.   Patient has intense pain just when lifting it to grab steering wheel.
Age: 63.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Ultrasound scan, X-ray
Clinical narrative: About 3 days later pain started on left arm at site of injection.  It felt like pain was in the bone at the site of injection; within 4 days pain gravitated to shoulder--that is where it has been since. Patient called the clinic when pain gravitated to shoulder. Patient has been to the facility several times since then for follow-up.  Patient has seen, PCP, rheumatologist and currently has appointment with orthopedist.   The pain level has not changed much since it gravitated to shoulder.  Patient has received cortisone shot, a dose of Celebrex, and 2 aspirin; it relieved pain a little bit temporarily. Patient has had shoulder imaging, x-rays, and sonogram.   Patient has not had other symptoms.  Patient has been very active all life, can carry weight when shoulder is down but it becomes unusable as soon as lift it slightly.   Patient has intense pain just when lifting it to grab steering wheel.
Age: 0.25
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 3mos 28 day old male, no s/s following IZ