chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Several weeks after the injection, I experienced a rash on many areas of my body. They started out as small bumps and later became welt looking and larger irregular patches on my back and side. They were very itchy.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient says his arm is still sore from shot and can pin point exactly where shot was given
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient reported that his arm could not be raised above his head for weeks after his vaccination. He stated the condition was improving but still present.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient described not being able to lift her arm above her shoulder since vaccination. She stated it has improved since vaccination date.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest tube insertion, Dyspnoea, Gastrostomy, Nausea
Clinical narrative: Patient reported on 11/18/2019 after he was released from nursing facility that he had an adverse reaction to the flu vaccine administered on 9/24/2019. The symptoms started approximately 5 hours after the vaccine was given. They included nausea, vomiting, loss of strength, and difficult breathing. Patient went to the hospital and was admitted on 9/26/2019 and stayed until 10/28/2019 when he was transferred to a nursing facility. He was released from nursing facility on 11/18/19 when he reported the adverse event to me. Patient could not tell me exactly the diagnosis or reason why he was in the hospital. He mentioned "chest tubes", "stents in esophagus?", "g-tube", "sepsis?",and "almost died".
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Near death experience, Vomiting
Clinical narrative: Patient reported on 11/18/2019 after he was released from nursing facility that he had an adverse reaction to the flu vaccine administered on 9/24/2019. The symptoms started approximately 5 hours after the vaccine was given. They included nausea, vomiting, loss of strength, and difficult breathing. Patient went to the hospital and was admitted on 9/26/2019 and stayed until 10/28/2019 when he was transferred to a nursing facility. He was released from nursing facility on 11/18/19 when he reported the adverse event to me. Patient could not tell me exactly the diagnosis or reason why he was in the hospital. He mentioned "chest tubes", "stents in esophagus?", "g-tube", "sepsis?",and "almost died".
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Nausea
Clinical narrative: Patient said she is still experiencing arm pain at injection site 1 week after vaccination. She also reports initially that the site was itchy and had a few red bumps that have now gone away.  She also reports feeling nauseous on and off since the vaccination and says that it is when she feels her arm hurting.  She did not report any respiratory issues other than her issues she has at baseline with her chronic lung condition.  She says that she will follow up with her primary care provider tomorrow morning about her concerns and call back with any new information.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Pain started day of immunization.  Redness and itching started the following day and has continued since. Redness and itching in arm of immunization below injection site.   Affected area about 5 inches long.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Extreme diarrhea  - began slowly at 6 pm and 6:30 then nonstop from 7 - 8 pm. Took an additional prednisone and 2 imodium tablets.  My internist assured me that despite my compromised immune system, these shots would pose no problem.  Do i take the second shot or not?
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: severe maiaise, shivering, body aches, headache.   Started a few hours after vaccination, much better after 36 hrs of time of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Fever (99.9-101.9), chills, body aches, joint and muscle pain, nausea and vomiting, headache, fatigue, pain and swelling at injection site.  Symptoms began approximately 6 hours post-injection and fully resolved 45 hours later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever (99.9-101.9), chills, body aches, joint and muscle pain, nausea and vomiting, headache, fatigue, pain and swelling at injection site.  Symptoms began approximately 6 hours post-injection and fully resolved 45 hours later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever (99.9-101.9), chills, body aches, joint and muscle pain, nausea and vomiting, headache, fatigue, pain and swelling at injection site.  Symptoms began approximately 6 hours post-injection and fully resolved 45 hours later.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Hot flush, Hyperaesthesia
Clinical narrative: 1) 22 hours after injection, got flu-like symptoms (chills, hot flushes, muscle aches, general weakness and lack of appetite) for about 10 hours.  Injection site was also sore. 2) 40 hours after injection, started to get shingles symptoms in LEFT arm (injection was in right arm). Pain, mostly in biceps muscle, but also in crook of elbow where about 4 red spots appeared.  Pain moves around, but is not affected by massage.  Arm is very sensitive to cold -- I feel much better when it is covered by several layers or soaking in a hot bath. Symptoms have continued to time of writing (6 days after injection).  Should on left side near the neck has also become sore in the last day or two.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site rash, Myalgia
Clinical narrative: 1) 22 hours after injection, got flu-like symptoms (chills, hot flushes, muscle aches, general weakness and lack of appetite) for about 10 hours.  Injection site was also sore. 2) 40 hours after injection, started to get shingles symptoms in LEFT arm (injection was in right arm). Pain, mostly in biceps muscle, but also in crook of elbow where about 4 red spots appeared.  Pain moves around, but is not affected by massage.  Arm is very sensitive to cold -- I feel much better when it is covered by several layers or soaking in a hot bath. Symptoms have continued to time of writing (6 days after injection).  Should on left side near the neck has also become sore in the last day or two.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: 1) 22 hours after injection, got flu-like symptoms (chills, hot flushes, muscle aches, general weakness and lack of appetite) for about 10 hours.  Injection site was also sore. 2) 40 hours after injection, started to get shingles symptoms in LEFT arm (injection was in right arm). Pain, mostly in biceps muscle, but also in crook of elbow where about 4 red spots appeared.  Pain moves around, but is not affected by massage.  Arm is very sensitive to cold -- I feel much better when it is covered by several layers or soaking in a hot bath. Symptoms have continued to time of writing (6 days after injection).  Should on left side near the neck has also become sore in the last day or two.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling below the injection site
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: sore arm. Pain has spread to other parts of the arm. She has difficultly mobilizing it at times
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction, Pain, Product administered at inappropriate site
Clinical narrative: Shots administered in upper shoulder on bone. Cannot lift my arm without extreme pain.  It has been 4 days now. Had other reactions, but they subsided.  Went to walk in clinic today.  Doctor said this may last week or or months.        now.nowHaotherredactions
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Patient came down with a low grade fever and a very sore arm. She noticed a rash that began centralized at the injection site but then started moving down her arm to her elbow.
Age: 51.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Skin tightness
Clinical narrative: Patient presented to pharmacy on 11/24/19 with a chief complaint of her left arm being sore, tight, red, and swollen where she had received her influenza and pneumococcal vaccines. Patient received both vaccines on 11/21/19. On 11/22/19, she claims her left arm became sore. On 11/23/19, she claims that the soreness had increased, it became red, tight, and she couldn't lift her arm. On 11/24/19, the patient presented to the pharmacy with increased soreness, tightness, redness, and swelling. The patient has not taken anything to help with the adverse effects, but she is taking tylenol and an anti-inflammatory daily, neither of which have helped with the symptoms. I advised the patient that the symptoms were common after a vaccination, and that the symptoms should resolve within a couple of days. However, I advised her to seek medical attention if her symptoms got worse or if they did not get better after a day or two.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Exercise tolerance decreased, Fatigue, Myalgia, Peripheral swelling
Clinical narrative: Patient stated that she felt muscle aches and fatigue lasting a week on the side of the body that she received the flu shot on. She said that her leg swelled and she had shortness of breath "reduced lung capacity" so that she could not walk on her treadmill
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Gastrointestinal pain, Malaise, Nasal congestion
Clinical narrative: 11.22.19 PM, malaise. Gone by morning. 11.23.19 AM, runny nose, nasal congestion, sneezing. Decongestant OTC med, symptoms at 25% previous level in 24 hours. 11. 24. 19, 2 AM, GI signs, intestinal cramps with diarrhea.  Duration 4 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: 11.22.19 PM, malaise. Gone by morning. 11.23.19 AM, runny nose, nasal congestion, sneezing. Decongestant OTC med, symptoms at 25% previous level in 24 hours. 11. 24. 19, 2 AM, GI signs, intestinal cramps with diarrhea.  Duration 4 hours.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient had redness that went from an 1/2 inch below shoulder to about mid arm, on the outside of the arm.  Denied any pain, itching, fever, swelling
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Patient reported swelling about the size of her palm ~3in in diameter in the first 4 hours after receiving vaccine.  Called the pharmacy and was instructed to use ice to reduce swelling and NSAIDs or APAP for discomfort.     Patient came to the pharmacy 24 hours later and the swelling had increased to ~6 in diameter below the injection site, was warm to the touch and tender.  Patient did not use ice and slept on the affected arm the evening before.  Patient referred to PCP or urgent care to assess reaction.   They drew around swelling and will watch and wait and follow up in 2 days as long as the swelling does not increase.  Patient was recommended to use Tylenol and ice in meantime.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Pain
Clinical narrative: Patient reported swelling about the size of her palm ~3in in diameter in the first 4 hours after receiving vaccine.  Called the pharmacy and was instructed to use ice to reduce swelling and NSAIDs or APAP for discomfort.     Patient came to the pharmacy 24 hours later and the swelling had increased to ~6 in diameter below the injection site, was warm to the touch and tender.  Patient did not use ice and slept on the affected arm the evening before.  Patient referred to PCP or urgent care to assess reaction.   They drew around swelling and will watch and wait and follow up in 2 days as long as the swelling does not increase.  Patient was recommended to use Tylenol and ice in meantime.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Angiogram normal, Blood test, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: 7:30 AM while taking a shower I had a circular burning sensational in my mid chest.  I thought it may be heartburn and went to work until 2 PM and than decided to get it checked at the emergency room before picking up my boys from school.  Blood pressure was normal approx 120/75 EKG was normal as well.  I was given a nitroglycerin tablet to see if the burning would lessen.  It did not so I was given a blood test and was told my Tryponin  count was a 6 and that I had a heart attack.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Myocardial infarction, Troponin increased
Clinical narrative: 7:30 AM while taking a shower I had a circular burning sensational in my mid chest.  I thought it may be heartburn and went to work until 2 PM and than decided to get it checked at the emergency room before picking up my boys from school.  Blood pressure was normal approx 120/75 EKG was normal as well.  I was given a nitroglycerin tablet to see if the burning would lessen.  It did not so I was given a blood test and was told my Tryponin  count was a 6 and that I had a heart attack.
Age: 18.0
Sex: F
Vaccine: FLUR4, HEPA, MNQ
Symptoms: Cold sweat, Nausea, Syncope
Clinical narrative: Patient fainted after getting the vaccines.  Patient was clammy and felt like she was going to vomit. Gave water, skittles and ice pack at the pharmacy. paramedics were called and she went to the ER
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site cellulitis, Injection site inflammation, Injection site pain
Clinical narrative: Patient received both vaccines in left arm, she states felt a pain while shot was given. One and a half hours later, she could not lift her arm and had inflammation and a lot of pain.  Also started feeling bad (shakes) and ended up going to the hospital where they diagnosed her with cellulitis at the injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Patient received both vaccines in left arm, she states felt a pain while shot was given. One and a half hours later, she could not lift her arm and had inflammation and a lot of pain.  Also started feeling bad (shakes) and ended up going to the hospital where they diagnosed her with cellulitis at the injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported redness and swelling at the injection site.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: SORE, HARD LUMP WITH SWELLING AND SLIGHT REDNESS DEVELOPED AT INJECTION SITE 7 DAYS AFTER RECEIVING INJECTION
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test, Computerised tomogram, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: I was diagnosed Guillain-Barre and admitted to Medical center on 03/Nov/2019. I presented weakness in arms and legs with no other health issues.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging, Muscular weakness, Nerve conduction studies
Clinical narrative: I was diagnosed Guillain-Barre and admitted to Medical center on 03/Nov/2019. I presented weakness in arms and legs with no other health issues.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Eye swelling, Myalgia, Neck pain
Clinical narrative: I had pain in all of my joints, muscle pain, neck pain, and my eyes swelled up.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and redness at site of injection.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within initial 6 hours, patient experienced slight swelling at the injection site which progressed over the next several hours and was red, tender and warm to the touch approx tennis-ball sized.  Patient called pharmacy following day and was instructed to use acetaminophen and ice on the affected site to reduce swelling.  Patient called pharmacy again on the second day to report improvement at site and reduced swelling, but still red and tender to the touch and now excess skin in the previously swollen site.  Spoke with patient on day 3 and she reports it is continuing to decrease in swelling and tenderness.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Within initial 6 hours, patient experienced slight swelling at the injection site which progressed over the next several hours and was red, tender and warm to the touch approx tennis-ball sized.  Patient called pharmacy following day and was instructed to use acetaminophen and ice on the affected site to reduce swelling.  Patient called pharmacy again on the second day to report improvement at site and reduced swelling, but still red and tender to the touch and now excess skin in the previously swollen site.  Spoke with patient on day 3 and she reports it is continuing to decrease in swelling and tenderness.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth in shoulder
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient stated she awoke in the middle of the night with itchy hands.  She described it as both palmar surfaces were very itchy and red.  She called me at approximately 11:30 am on 11/24/19.  No other areas were itchy and no obvious swelling.  She was advised to take diphenhydramine or loratadine and if worsened conditioned to see a medical doctor.  Follow up with her at 4:15pm she reported palms were better but she also noticed some itching of knees.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The patient has a lot of localized pain and swelling in the immunization area and it seems to be spreading. She has been taking OTC ibuprofen but it has not resolved the issue. The event has not seemed to diminish her range of motion but it is still very sore and swollen at the site of injection so she will see her PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: pt husband called about becoming nauseous after having been vaccinated...
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Influenza like illness
Clinical narrative: 11/18/19 flu like symptoms, by 10:15 pm  Angioedema of the lips lasting 24 hours
Age: 80.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Pt had an injection site reaction. Was red and warm on upper arm and a little hard where IMZ given. Pt applied Benadryl cream, cold compress, and was taking APAP OTC. Suggested seeing MD especially if rash worsened or if fever over 102 degrees F
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Loss of consciousness, Nausea, Neurological examination
Clinical narrative: fever, chills, light headed, slight nausea, Got out of bed at 2:30 AM to get a drink of water and passed out
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever, chills, light headed, slight nausea, Got out of bed at 2:30 AM to get a drink of water and passed out
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Urticaria
Clinical narrative: Breaking out in hives that lasted a few hours. 11:30-2:00 Screaming inconsolably at random times of the day for the next two days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, body ache, headache, sore arm that lasted 1.5 days
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Sensory loss, Vaccination complication
Clinical narrative: I got my flu shot Wednesday and Thursday evening I couldn?t feel my legs. I was diagnosed with gullian barre syndrome due to the vaccine
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: patient had redness and swelling from shoulder down to elbow. area was warm to the touch. advised patient to contact primary provider and see if they feel he should be seen.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pyrexia, Skin warm
Clinical narrative: Dypsnea; warming of body/fever
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Deafness, Hallucination
Clinical narrative: Agitation, Hallucinations & Hearing Loss.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Basophil count normal, Basophil percentage decreased, Eosinophil count normal, Eosinophil percentage, Erythema multiforme
Clinical narrative: 48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Glossodynia, Haematocrit normal, Haemoglobin normal, Laboratory test, Lymphocyte count normal
Clinical narrative: 48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume increased
Clinical narrative: 48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Papule
Clinical narrative: 48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Platelet count normal, Rash, Skin exfoliation, Tenderness, Tongue exfoliation
Clinical narrative: 48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: 48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
Age: 87.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash pruritic
Clinical narrative: After tolerating flu vaccine administration on 10/2/2019, pt developed mild pruritic rash, described as itchiness on back, stomach and chest where a small raised rash appeared. Pt reports symptoms onset one day after flu vaccine administration. SkinRash & Rash DIPHENHYDRAMINE 25 MG PRN, TRIAMCINOLONE small amount MG PRN
Age: 83.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Fall
Clinical narrative: & weakness causing falls
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Computerised tomogram abnormal, Headache, Lymphadenopathy, Myositis
Clinical narrative: Headache & Swelling of throat/parotitis
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Parotitis, Pharyngeal swelling, Scan with contrast abnormal
Clinical narrative: Headache & Swelling of throat/parotitis
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain
Clinical narrative: Dizziness, Headache & Pain to L shoulder and deltoid
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Areflexia, CSF test normal, Electromyogram abnormal, Guillain-Barre syndrome, Hypokalaemia
Clinical narrative: 10/21/2019- ED visit. Patient presented with bilateral lower extremity weakness with areflexia. Suspected Guillain Barre Syndrome. Had previously went to ED on 10/10/2019 with lower extremity swelling. Weakness progressively worsened at her ED admission of 10/21/2019. She complete 5 days of IVIG on 10/26/2019. Had hypokalemia on date of presentation.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immunoglobulin therapy, Magnetic resonance imaging spinal normal, Muscular weakness, Nerve conduction studies abnormal, Peripheral sensory neuropathy
Clinical narrative: 10/21/2019- ED visit. Patient presented with bilateral lower extremity weakness with areflexia. Suspected Guillain Barre Syndrome. Had previously went to ED on 10/10/2019 with lower extremity swelling. Weakness progressively worsened at her ED admission of 10/21/2019. She complete 5 days of IVIG on 10/26/2019. Had hypokalemia on date of presentation.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral swelling
Clinical narrative: 10/21/2019- ED visit. Patient presented with bilateral lower extremity weakness with areflexia. Suspected Guillain Barre Syndrome. Had previously went to ED on 10/10/2019 with lower extremity swelling. Weakness progressively worsened at her ED admission of 10/21/2019. She complete 5 days of IVIG on 10/26/2019. Had hypokalemia on date of presentation.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Areflexia, Borrelia test negative, CSF myelin basic protein normal, CSF oligoclonal band absent, CSF test normal
Clinical narrative: 10/21/2019- ED visit. Patient presented with bilateral lower extremity weakness with areflexia. Suspected Guillain Barre Syndrome. Had previously went to ED on 10/10/2019 with lower extremity swelling. Weakness progressively worsened at her ED admission of 10/21/2019. She complete 5 days of IVIG on 10/26/2019. Had hypokalemia on date of presentation.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cryptococcus test, Guillain-Barre syndrome, Hypokalaemia, Immunoglobulin therapy, Magnetic resonance imaging spinal normal
Clinical narrative: 10/21/2019- ED visit. Patient presented with bilateral lower extremity weakness with areflexia. Suspected Guillain Barre Syndrome. Had previously went to ED on 10/10/2019 with lower extremity swelling. Weakness progressively worsened at her ED admission of 10/21/2019. She complete 5 days of IVIG on 10/26/2019. Had hypokalemia on date of presentation.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Muscular weakness, Peripheral swelling, West Nile virus test negative
Clinical narrative: 10/21/2019- ED visit. Patient presented with bilateral lower extremity weakness with areflexia. Suspected Guillain Barre Syndrome. Had previously went to ED on 10/10/2019 with lower extremity swelling. Weakness progressively worsened at her ED admission of 10/21/2019. She complete 5 days of IVIG on 10/26/2019. Had hypokalemia on date of presentation.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood pressure decreased, Chills, Decreased appetite, Dizziness
Clinical narrative: Severe shaking chills,  then profound sweating, and when I was finally able to get out of bed -- temp of 101.5 Next day extremely weak, another round of chills and fever -- went to Urgent Tx -- neg flu test Lost 5 pounds in 2 days -- nausea -- lack of appetite Dangerous if I had been older or weaker as I got dizzy -- did not take other meds for BP next morning as BP was already low at 105 systolic. Arm was sore, minimally swollen and red
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperhidrosis, Influenza virus test negative, Nausea, Pain in extremity
Clinical narrative: Severe shaking chills,  then profound sweating, and when I was finally able to get out of bed -- temp of 101.5 Next day extremely weak, another round of chills and fever -- went to Urgent Tx -- neg flu test Lost 5 pounds in 2 days -- nausea -- lack of appetite Dangerous if I had been older or weaker as I got dizzy -- did not take other meds for BP next morning as BP was already low at 105 systolic. Arm was sore, minimally swollen and red
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tremor, Weight decreased
Clinical narrative: Severe shaking chills,  then profound sweating, and when I was finally able to get out of bed -- temp of 101.5 Next day extremely weak, another round of chills and fever -- went to Urgent Tx -- neg flu test Lost 5 pounds in 2 days -- nausea -- lack of appetite Dangerous if I had been older or weaker as I got dizzy -- did not take other meds for BP next morning as BP was already low at 105 systolic. Arm was sore, minimally swollen and red
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: administered an initial dose of VARN AX on an unspecified date while pregnant; No adverse effects; This spontaneous report was received from a nurse referring to a 28 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On an unknown date, the patient was administered an initial dose of varicella virus vaccine live (oka/merck)(VARIVAX)(dose, route, lot # and expiration date were not reported) for prophylaxis while pregnant (Maternal exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effects.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 24-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) vial (lot # S009562 and expiry date 26-JUL-2020 both verified to be valid) (strength, exact dose, route of administration were not reported) for prophylaxis.  The suspect vaccine was stored in a temperature of 58.3 Fahrenheit (F) for 3 hours and 15 minutes and in a temperature of 52.1 for 1 hour and 21 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; a patient was administered the MMR II vaccine intramuscularly; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.         On 28-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (recombinant Human albumin (rHA)) (lot # R008687, expiration date 22-MAR-2020, dosage detail and strength were not provided) intramuscularly for prophylaxis (Inappropriate route of vaccination). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: dose of GARDASIL 9 was administered to a pregnant patient; indication: received in error; This spontaneous prospective pregnancy report was received from a nurse and refers to a 34-year-old female patient. The patient's current condition included diabetes. Concomitant therapies included insulin aspart (NOVOLOG) and insulin glargine (BASAGLAR). No information regarding the patient's pertinent medical history, drug reactions or allergies was provided.    On 29-OCT-2019, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621934, expiration date 29-JAN-2022, intramuscularly, during pregnancy.  The last menstrual period (LMP) was calculated as 13-APR-2019, and estimated date of delivery (EDD) was calculated as 18-JAN-2020. At the time of report the patient was 28 weeks and 3 days pregnant. The pregnancy outcome was outcome pending.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported; 6 month old received first dose of ROTATEQ yesterday; This spontaneous report has been received from a physician referring to a 6 months old patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.               On 29-OCT-2019 (reported as yesterday), the patient was vaccinated the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #: S004399, expiration date: 06-NOV-2020) orally for prophylaxis (product administered to patient of inappropriate age). No adverse effect reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1910USA017641:same reporter
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about pertinent medical history, drug reactions or allergies was not provided.           On 31-OCT-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017251, expiration date 01-DEC-2020, dosage detail, route and strength were not reported) for prophylaxis. The sterile diluent (lot # S015238, expiration date 08-MAR-2022) used to reconstitute the vaccine was properly stored. Administered doses of vaccine experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (also reported as 7.4 Fahrenheit degrees) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient was inadvertently administered ROT A TEQ and PEDV AXHIB, on 10/23/2019, that was improperly stored; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.     On 23-OCT-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R033251, expiration date 29-JUN-2020 (exact dose, frequency and route of administration were not reported) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027321, expiration date reported as 29-JUL-2021, but upon internal validation established as 09-JUL-2021 (exact dose, frequency and route of administration were not reported) for prophylaxis. The administered doses of vaccines experienced the temperature excursion of 30.07 degrees Fahrenheit for 35 minutes. The previous temperature excursion of 77 degrees Fahrenheit for 30 minutes was reported. The data logger was involved. No adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was administered an improperly stored dose of Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S015460, expiration date 20-MAY-2021 (exact dose, site and route of administration were not reported) that was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; inadvertently received first doses of VARIVAX and PROQUAD concomitantly/Nurse confirmed misuse was related to human error and not product confusion; inadvertently received first doses of VARIVAX and PROQUAD concomitantly/Nurse confirmed misuse was related to human error and not product confusion; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patients concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 28-OCT-2019, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # S019463 and expiry date 24-JUN-2021 verified to be valid) (strength, exact dose, route of administration were not reported) for prophylaxis concomitantly with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # S019463 and expiry date 24-JUN-2021 verified to be valid) (strength, exact dose, route of administration were not reported) for prophylaxis. Both vaccines were reconstituted with sterile diluent. No adverse effects were reported.; Sender's Comments:  US-009507513-1911USA000667:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one patient was administered improperly stored PROQUAD; This spontaneous report was received from an administrator, concerning to a 4-year-old patient of an unknown gender. Information about the patient's concurrent conditions, pertinent medical history and previous drug reactions or allergies was not provided. The concomitant medications included sterile diluent.  On 04-OCT-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) therapy type recombinant human albumin, lot number S003861, expiration date 08-AUG-2020 (dose number, route of administration and anatomical location of vaccination were not provided), for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  On an unknown date, the vaccine was exposed to a temperate excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees for 420 hours and from 15 Fahrenheit degrees to 46 Fahrenheit degrees, where the highest temperature was 34 Fahrenheit degrees, for 106 hours. The previous temperature excursion reported was from 6 Fahrenheit degrees to 14 Fahrenheit degrees for 200 hours and from 15 Fahrenheit degrees to 46 Fahrenheit degrees, where the highest temperature was 34.268 F, for 18 hours. The call was placed because of a Digital Data logger report.  No adverse effects were reported.; Sender's Comments:  US-009507513-1911USA000877:
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix
Clinical narrative: The patient became HPV positive; This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. Information about patient's pertinent concurrent conditions, medical history, concomitant therapies previous drug reactions and allergies were unknown by the reporter.  In 2009 (reported as approximately 10 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, intramuscularly as a human papilloma virus (HPV) protection (strength, dose, vaccination scheme frequency, lot number and expiration date were not reported).  On an unspecified date, the patient became HPV positive (papilloma viral infection) ,a papanicolaou test (PAP SMEAR) was performed, however  the result was not reported. No treatment was given to the patient, and it was unknown by the reporter if the patient sought medical attention.   At time of this report, the outcome of papilloma viral infection was reported as not recovered.  The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the aforementioned event was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 04-NOV-2019 or on 05-NOV-2019, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S000352 with expiration 17-OCT-2021 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of lowest temperature below 36°F/2 degrees Celsius (1.3C) for 2 hours and 18 minutes with no previous temperature excursion.  There was no adverse effect reported. This call was because of a data logger.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1911USA001917: US-009507513-1911USA002263: US-009507513-1911USA004087: US-009507513-1911USA001946: US-009507513-1911USA002198: US-009507513-1911USA002043: US-009507513-1911USA001926: US-009507513-1911USA002053: US-009507513-1911USA002033:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: on an unspecified date a 6 month old patient was administered the first dose of ROTATEQ; No adverse effects reported; This spontaneous report was received from a physician referring to a 6-month-old patient. The patient's pertinent medical history, concurrent condition, previous drug allergies or reactions, and concurrent condition were not reported.  On an unknown date , the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, as prophylaxis (dose, concentration, lot number and expiration date were not reported) (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the administration of one dose of an improperly stored vaccine VAQTA; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 06-NOV-2019, the patient received one dose of improperly stored vaccine, Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml (strength and route were not reported, lot # S009943, expiration date: 26-JUL-2020) for prophylaxis (product storage error). The vaccine was exposed to 58.5 degrees Fahrenheit for 10 minutes. No previous temperature excursion was reported. The data logger was involved. No adverse effects were reported.