chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Angioedema, Urticaria
Clinical narrative: prolonged reaction of angioedema; prolonged reaction of hives; Initial information was received on 26-Oct-2020 regarding an unsolicited valid serious case from the physician via medical representative via an email .  This case involves an unknown demographic patient who had a prolonged reaction of hives (urticaria) and angioedema, while patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, family history and concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed prolonged reaction of angioedema (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed prolonged reaction of hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of both the events was unknown.  It was reported that, reactions were secondary to the vaccine based on the timing.   Information on the batch number was requested.; Sender's Comments: This poorly documented case concerns a patient who had urticaria and angioedema after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Also, the patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: patient had some facial drooping and some paralysis; Initial information regarding an unsolicited valid serious case was received from an other health professional via Global Medical Information (GMI) (Reference number- 00334033) and transmitted to Sanofi on 27-Oct-2020.  This case involves a seven-year-old male patient who experienced some facial drooping and some paralysis (facial paralysis), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccines at the same time.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073MA and expiration date: 30-Jun-2021, pre-filled syringes) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a serious facial drooping and some paralysis (facial paralysis), two hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Patient's father said that his face was not moving the way it was supposed to and so the patient was referred to the emergency room.. Father wanted to know if that was a known side effect.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.; Sender's Comments: This case concerns a seven years old female patient who experienced some facial drooping and some paralysis, two days after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Pt experienced soreness starting day after vaccine on 10/24/20 and called the pharmacy 11/5/2020 saying she is still experiencing soreness if she moves her arm a certain way or if she presses on the site of injection. Pt describes it as a muscle ache when she does these things. There is no redness or swelling and pt says shot was given in the left deltoid in an area approximately 3 finger widths below the shoulder.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception occurred on Nov. 1 . Evaluated at ER with ultrasound and given enema. Resolved easily . Child doing well.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site warmth, Pain, Puncture site induration, Swelling
Clinical narrative: 11/4/1547 Employee came to site After getting influenza vaccine in (L) arm @ about 1330 from Employee working off of flu cart. (L) Deltoid is warm to touch, has a hardened area at puncture site. Employee C/O soreness & achy which happened immediately happened after vaccination. The warmth & swelling started around 1530
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Balance disorder, Dizziness, Dysphemia, Fatigue, Headache
Clinical narrative: Within 24 hrs of vaccine, she was dizzy, tired, had poor balance, memory problems, stuttering, headaches, muscle weakness, tight feeling in arms, numbness around mouth & at left arm.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Limb discomfort, Lumbar puncture, Memory impairment
Clinical narrative: Within 24 hrs of vaccine, she was dizzy, tired, had poor balance, memory problems, stuttering, headaches, muscle weakness, tight feeling in arms, numbness around mouth & at left arm.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness
Clinical narrative: Within 24 hrs of vaccine, she was dizzy, tired, had poor balance, memory problems, stuttering, headaches, muscle weakness, tight feeling in arms, numbness around mouth & at left arm.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt received her vaccine 10/3 when leaving pt could not move her arm. Pain has only gotten worse. Pt has been to her physician, he said my have hit a tendon Pt went to the MD's office
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Aldolase normal, Anti-cyclic citrullinated peptide antibody negative, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Antinuclear antibody negative
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Antinuclear antibody positive, Asthenia, Blood calcium normal, Blood creatine phosphokinase normal, Blood fibrinogen normal
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood folate normal, Borrelia test, C-reactive protein increased, CSF glucose normal, CSF protein increased
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: CSF red blood cell count, CSF white blood cell count negative, Complement factor C3, Complement factor C4, Double stranded DNA antibody
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Fall, Gait disturbance, Gram stain, Guillain-Barre syndrome, Hepatitis viral test negative
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Histone antibody, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Pain
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Paraesthesia, Paraesthesia oral, Red blood cell sedimentation rate increased, Total complement activity decreased, Vitamin B12 normal
Clinical narrative: Pt presenting for several days of ascending weakness and paraesthesias without SOB or difficulty swallowing. Pt had been recovering well from surgery however starting last weekend started experiencing numbness and tingling of the distal b/l UE/LE. By 10/27 he was having difficulty ambulating due to weakness in the lower extremities and experienced a fall without injury. By 10/29 he was experiencing facial/tongue/lip parasthesias although not affecting his speech or ability to eat or drink. o Risk factors: recent surgery (L hip TR) on 10/8 and received flu shot during that admission   Workup: o LP - sent WBC, RBC, gram stain, glucose, protein, Lyme, and ME panel    History examination are compatible with AIDP, at this point more affecting sensory than overt motor pathways.  CSF analysis consistent.  Unclear if his complaints of pain today are related to the IVIG or another manifestation of his neuropathy. Different diagnosis might include Lyme disease, though that seems less likely, laboratory investigation pending. Recommendations as detailed below.  Continue with IVIG, add p.r.n. Muscle relaxant, consider gabapentin. Does not require MRI imaging in my opinion. No indication of any respiratory distress, RT to monitor NIF/vital capacity daily Plan: o Will follow up on pending results of LP  o If results are suggestive of GBS will start IVIG
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Cellulitis, Injection site haemorrhage, Injection site swelling, Malaise, Product administered at inappropriate site
Clinical narrative: Pt states that on her left arm where the pneumonia shot was given she had large swelling, felt sick, and had a fever. She also bled where the injection was given which she states she doesn't normally bleed from a shot. She went to Urgent care on Wednesday 11/4/20 where she was diagnosed with cellulitis on the left arm and was put on doxycycline. The PA told the patient that the injection was given too low. Pt states she did not have any issues with her right arm.
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Pyrexia
Clinical narrative: Pt states that on her left arm where the pneumonia shot was given she had large swelling, felt sick, and had a fever. She also bled where the injection was given which she states she doesn't normally bleed from a shot. She went to Urgent care on Wednesday 11/4/20 where she was diagnosed with cellulitis on the left arm and was put on doxycycline. The PA told the patient that the injection was given too low. Pt states she did not have any issues with her right arm.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Joint range of motion decreased, Pain
Clinical narrative: Pt is roughly 7 weeks pregnant and has been experiencing 4 weeks of local pain (10/10) with decreased  ROM. I evaluated her virtually and there is no: swelling, bruising, or skin/ joint abnormality. Passive ROM was not evaluated given the exam was done virtually.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles developed along left flank, (hip, waist, back) and below belly button
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Significant flu-like symptoms including fever (100.4), full body aches, chills, nausea, and vomiting
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Significant flu-like symptoms including fever (100.4), full body aches, chills, nausea, and vomiting
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypokinesia, Limb discomfort, Myalgia
Clinical narrative: arm soreness, muscle soreness, inability to move left shoulder due to pain
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Injection site swelling
Clinical narrative: Erythema and swelling at R deltoid noted 11/4/2020 with spreading to the morning of 11/5/2020
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Disorientation, Dizziness, Dysstasia
Clinical narrative: Approximately 4 hours after receiving my second vaccine of Shingrix, I experienced extreme sweating, fever, dizziness, nausea, chills, loss of balance. I could not stand or walk. I was disoriented and fell. I could not stand and had to crawl to get back to bed. I could not eat for 48 hours. I drank only water and one Sprite.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Gait inability, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Approximately 4 hours after receiving my second vaccine of Shingrix, I experienced extreme sweating, fever, dizziness, nausea, chills, loss of balance. I could not stand or walk. I was disoriented and fell. I could not stand and had to crawl to get back to bed. I could not eat for 48 hours. I drank only water and one Sprite.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Vaccination error
Clinical narrative: Patient had MMRV vaccine and Varicella vaccine administered at the same time. They were administered in separate legs and in the sub q portion.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: bruised arm, painful, slightly red color
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported: "I have developed a pretty large area of redness, mild swelling and very warm area on my left arm below injection site. It is mildly itchy and sore."
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives, diphenhydramine, famotidine. Resolved after 10 days.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Peripheral swelling, Petechiae
Clinical narrative: Petechial rash  distal to injection site, swelling of arm
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria
Clinical narrative: Pt has been scratching injection site on both legs since injection date. pt now has raised, red dry patch on both legs by injection site. pt has been rx's meds also referred to specialist.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test, Central nervous system inflammation, Magnetic resonance imaging spinal abnormal, Movement disorder
Clinical narrative: Stopped moving lower extremities all at once.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Severe swelling at injection site approx 3in x 5in, followed within 8 hours by severe fatigue, fever (required medication), deep muscle aches, headache for both shots
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Severe swelling at injection site approx 3in x 5in, followed within 8 hours by severe fatigue, fever (required medication), deep muscle aches, headache for both shots
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: In August 2020 had a reaction presumed it may have been from the Bicillin Shot, Soldier stated he did not have allergy to this. Broke out in hives approx. 1-2 hrs. given Benadryl and sent to ER. 2nd dose of Varicella on Twin Shoot and this happen again approx. same time frame.  Sent to CTMC for evaluation then sent to  ER
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Dehydration, Lethargy
Clinical narrative: Lethargic ( laying still not moving or having any energy)  , temp of 105.5 ( with multiple doses of Tylenol and Motrin given )  , not eating or drinking - dehydration occurred, rash all over body .  Took to local Emergency Room , started an IV to get hydrated again and gave dose of Motrin.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Lethargic ( laying still not moving or having any energy)  , temp of 105.5 ( with multiple doses of Tylenol and Motrin given )  , not eating or drinking - dehydration occurred, rash all over body .  Took to local Emergency Room , started an IV to get hydrated again and gave dose of Motrin.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Peripheral swelling, Pyrexia
Clinical narrative: She developed a hard bump that feels like bone on the colar bone of her right arm 2 days after the shot. The same side as her shot. She also developed a low grade fever that has lasted longer than a month. No treatment that I'm aware of.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: raised red, intermittently itchy area about the diameter of a softball. moderately sore
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: Syncope with fall to ground. Patient was assisted to sitting and provided orange juice and additional sugar. No other management details available. Patient discharged to home and subsequent notes in EMR suggest full recovery.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cold sweat, Myalgia
Clinical narrative: Patient reported severe myalgias and weakness beginning at 11pm. These symptoms have persisted through present 11/5 11:30am. Patient also reported that early this morning at 1am he awoke in a cold sweat.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Cellulitis diagnosed by MD - patient had pain, swelling, itching at injection site. Patient was prescribed an antibiotic and steroid.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Blood test abnormal, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Morning of 10/17/20 patient experienced severe pain in right shoulder and could not bear to move her right arm. Condition became progressively worse in the ensuing days with severe joint pain in both shoulders, arms, fingers, hips and knees. By 10/26/20 patient could not move from her bed and was in agony 24/7. Dr. prescribed 4 MG tabs of Methylprednisolone which did not have any effect. Dr. met the patient on 10/28/20 and ordered a blood test. The results showed inflammation due to the flu vaccine. On 11/3/20 patient's condition became chronic and Dr. ordered her to go to E.R. She was admitted to Hospital and was diagnosed with polyarthralgia due to the flu vaccine. Dr prescribed Prednisone 60 MG tabs. To date they have had no effect
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Vaccination complication
Clinical narrative: Morning of 10/17/20 patient experienced severe pain in right shoulder and could not bear to move her right arm. Condition became progressively worse in the ensuing days with severe joint pain in both shoulders, arms, fingers, hips and knees. By 10/26/20 patient could not move from her bed and was in agony 24/7. Dr. prescribed 4 MG tabs of Methylprednisolone which did not have any effect. Dr. met the patient on 10/28/20 and ordered a blood test. The results showed inflammation due to the flu vaccine. On 11/3/20 patient's condition became chronic and Dr. ordered her to go to E.R. She was admitted to Hospital and was diagnosed with polyarthralgia due to the flu vaccine. Dr prescribed Prednisone 60 MG tabs. To date they have had no effect
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Lip swelling, Mouth ulceration, Myalgia
Clinical narrative: Days 1-4, starting around 8pm on the day of injection, had flu like symptoms: fatigue, total body and muscle aches.  *** Day 3, starting around noon, the inside of my mouth started to feel very sore, tender and sensitive to touch, heat, eating and oral hygiene. Became increasingly more painful overnight. Day 4, my mouth was filled with ulcers, which were incredibly painful. I had a virtual visit with my primary care physician, who confirmed this was an adverse side effect of the Shingrix vaccine. He put me on Valtrex tid x 10 days, plus ?magic mouthwash? PRN pain. He also advised me not to get the  second dose of the vaccine. Day 5, my lips were swollen and very red on the inside; mouth sores still very painful. Day 6, very slight improvement of the symptoms. Today,  Day 7, symptoms beginning to show signs of real improvement. Ulcers are fading, lips still sore, but not as red, and no longer swollen. I could not find any indication in the literature that this could be a side effect, but my physician told me what I suspected; this was an adverse reaction to Shingrix.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal erythema, Oral pain, Pain, Vaccination complication
Clinical narrative: Days 1-4, starting around 8pm on the day of injection, had flu like symptoms: fatigue, total body and muscle aches.  *** Day 3, starting around noon, the inside of my mouth started to feel very sore, tender and sensitive to touch, heat, eating and oral hygiene. Became increasingly more painful overnight. Day 4, my mouth was filled with ulcers, which were incredibly painful. I had a virtual visit with my primary care physician, who confirmed this was an adverse side effect of the Shingrix vaccine. He put me on Valtrex tid x 10 days, plus ?magic mouthwash? PRN pain. He also advised me not to get the  second dose of the vaccine. Day 5, my lips were swollen and very red on the inside; mouth sores still very painful. Day 6, very slight improvement of the symptoms. Today,  Day 7, symptoms beginning to show signs of real improvement. Ulcers are fading, lips still sore, but not as red, and no longer swollen. I could not find any indication in the literature that this could be a side effect, but my physician told me what I suspected; this was an adverse reaction to Shingrix.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT RECEIVED HD UNDER THE AGE OF 65
Age: 38.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia
Clinical narrative: Muscle pain, shivering, headache, stomach ache Treated with Ibuprofen
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Flushing, Headache, Ocular hyperaemia, Rash
Clinical narrative: Pt. had rash on arm 5.5 hours later, Temp of 99.9, Face flushed, Eyes, reddened, Headache,
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Computerised tomogram, Full blood count, Hypoaesthesia, Muscle twitching
Clinical narrative: Low back pain. Numbness tingling muscle twitching and  both legs.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Low back pain. Numbness tingling muscle twitching and  both legs.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye pruritus, Eye swelling, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling  and itching around site on L deltoid and both eyes.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Fatigue, Pyrexia
Clinical narrative: My husband and I received the flu vaccine on 10/22/2020.   Eight days later he became very tired and fatigued, and developed a dry cough. Two days later he developed a fever of 102.5,   treated with Tylenol.  The following day max temp. was 101.  Now, day5, he still has a dry cough, fever so far max of 100.2, and remains feeling weak and tired. Meanwhile I feel fine, with no symptoms or side effects.  His sense of taste and smell are normal.  No other possible side effects.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness
Clinical narrative: after giving pt. flu vaccine she started to fell clammy and faint.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient stated vaccine was placed to high and caused severe pain to arm. pain in which arm was not specified. Patient stated she had a high fever as well.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Crying, Injection site erythema, Injection site vesicles, Insomnia, Irritability
Clinical narrative: Chilkd developed erythematous base with vesicles around the vaccine site. 2 days later 11/2, developed macular rash to trunk. Child was fussy, crying, not sleeping well
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash macular
Clinical narrative: Chilkd developed erythematous base with vesicles around the vaccine site. 2 days later 11/2, developed macular rash to trunk. Child was fussy, crying, not sleeping well
Sex: F
Vaccine: PPV
Symptoms: Contusion, Pain in extremity
Clinical narrative: Same night arm painful could not move. Huge bruise 3-4 inches. in am not where injection was completed. pharmacist advised patient to contact HCP
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Muscle tightness, Nausea, Pyrexia
Clinical narrative: Redness, fever, tightness of muscle, headaches, nausea
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Pt received her 2nd Shingrix vaccine on 11/3/2020. At that time, pt reported having a rash on her neck and face following the first vaccine in August. Pt was asked to call back if she notices any unusual reactions.  Pt called the office on 11/5/2020 to report that a short while ago (~10:00am today) a rash began to appear on her face a neck. This rash is not as pronounced the rash following the first vaccine. Described as red and flat. The rash is greater on the left side than the right, and is on both sides of her neck and face near her temples. Pt denies any difficulty breathing or any swelling of her mouth, tongue, neck or cheeks.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: The patient was given the immunization on 10/24 in right arm. He states today that he is still having pain in arm at injection site area,. He states that when he was given the vaccination in his right arm that it was red and swollen for a few day and then turned into a bruise at injection site. Today upon presentation to pharmacy his arm appeared red at injection site but not bruised or swollen. He states that he is still experiencing pain at injection site when he lays on that arm or certain movements.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Employee believes that she received the HD dose of the flu vaccine because she said she saw a green label.  She was given a copy of the consent she signed with the vaccine sticker affixed documenting the dose she received before she left the clinic but was not convinced.    We did not have any HD doses in clinic for use that day.  The HD inventory that was received recently from Sanofi was intact in a separate refrigerator.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: pain, swelling and warmth at injection site starting 1 hour in, then fever, intense body and joint pain, nausea that lasted 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: pain, swelling and warmth at injection site starting 1 hour in, then fever, intense body and joint pain, nausea that lasted 24 hours.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Injection site pain, Lip swelling, Pruritus, Swelling face
Clinical narrative: pain at the injection site; angioedema; hives all over the body; face swelling; lips swelling; generalized itching; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), hives, facial swelling, lip swelling and generalized pruritus. On an unknown date, the patient experienced injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the angioedema, hives, facial swelling, lip swelling, generalized pruritus and injection site pain were recovered/resolved.   It was unknown if the reporter considered the angioedema, hives, facial swelling, lip swelling, generalized pruritus and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was also a physician and reported the events for himself. The age at vaccination was not reported, however it could be 77 years. The patient received 2nd dose in September 2020 on a Thursday and experienced angioedema, hives all over the body, face swelling, lips swelling and generalized itching and these all were resolved by the following week on Friday. Less than 2 months after vaccination, the patient experienced pain at the injection site that was resolved at the time of reporting. The patient was seen at the clinic for these events. The patient did not have vaccines lot number or expiration date information. The patient did not give consent to follow up with health care professional.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: pain at the injection site; angioedema; hives all over the body; face swelling; lips swelling; generalized itching; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), hives, facial swelling, lip swelling and generalized pruritus. On an unknown date, the patient experienced injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the angioedema, hives, facial swelling, lip swelling, generalized pruritus and injection site pain were recovered/resolved.   It was unknown if the reporter considered the angioedema, hives, facial swelling, lip swelling, generalized pruritus and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was also a physician and reported the events for himself. The age at vaccination was not reported, however it could be 77 years. The patient received 2nd dose in September 2020 on a Thursday and experienced angioedema, hives all over the body, face swelling, lips swelling and generalized itching and these all were resolved by the following week on Friday. Less than 2 months after vaccination, the patient experienced pain at the injection site that was resolved at the time of reporting. The patient was seen at the clinic for these events. The patient did not have vaccines lot number or expiration date information. The patient did not give consent to follow up with health care professional.
Age: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to 17 years old patient, No AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case was linked to the case 2020SA279466 (same reporter).  This case involves a 17-years-old patient (gender unknown) who received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2047, expiry date-30-Jun-2021) via an unknown route in left upper arm for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatments, vaccinations and family history were not provided.  This was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported that, no other medications or vaccinations were administered at that visit.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia legionella
Clinical narrative: Legionnaire's disease; Initial information received on 28-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media (global digital media).  This case involves a patient (unknown demographics) who experienced Legionnaire's disease (pneumonia legionella), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Legionnaire's disease (pneumonia legionella) unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pneumonia legionella.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from pneumonia legionella after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination, lab tests ruling out predisposing etiologies were not reported. Based upon the reported information and considering the infectious nature of the event, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Vaccine positive rechallenge
Clinical narrative: The patient received 0.25ml fluzone quadrivalent; swelling that could blister over the size of her palm at the deltoid injection site; swelling that could blister over the size of her palm at the deltoid injection site; Initial information was received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) who had a swelling that could blister over the size of her palm at the deltoid injection site (swelling and vaccination site reaction) after she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The past vaccination included 0.25 mL dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in the deltoid not specified (NOS) for prophylactic vaccination (assumedly 10 years ago) and the patient had swelling that could blister over the size of her palm at the deltoid injection site (swelling) after vaccination.  Medical treatments, concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.25 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry date not reported) via an unknown route in the deltoid not specified (NOS) for prophylactic vaccination.  On 01-Oct-2020, the patient developed a non-serious swelling that could blister over the size of her palm at the deltoid injection site (swelling and vaccination site reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  She has not had a flu shot in 10 years because she had the same reaction with her last Fluzone Quadrivalent in past and was remembering it now.   It was a case of vaccine underdose as the patient received 0.25 mL dose of Fluzone Quadrivalent (latency same day).  The patient questioned if Fluzone Quadrivalent-No Preservative, Fluzone Quadrivalent-Trivalent, and Flublok contains Formaldehyde and asked which flu vaccine was indicated for patient's over 65 years of age.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment for swelling and vaccination site reaction.  At the time of report, the outcome of swelling and vaccination site reaction was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 5.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5-year-old patient received a dose of Flublok with no adverse event; Initial information regarding this unsolicited valid non-serious case from a pharmacist.  This case involved a 5-year-old patient received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ497AA, Expiration date- 03-May-2021) via unknown route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 11-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccine included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  It was a case of actual medication error due to Inappropriate age at vaccine administration.(Latency: Same day).  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Adverse reaction
Clinical narrative: Patient in the past has had reactions to flu vaccines; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographics patient who had reactions to flu vaccines (adverse reaction), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE injection lot number not reported for prophylactic vaccination.  On an unknown date, (unknown latency) the patient experienced reactions (adverse reaction) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests included no lab data.  Final diagnosis was adverse reaction.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event.  There will be no information available on the batch number for this case.