chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pain in extremity, Rash, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a 90 year old female patient. The patient's concurrent conditions include cardiac failure congestive, Parkinson's disease and drug hypersensitivity to DETROL LA, VESICARE and trospium chloride. The patient's historical conditions include atrial fibrillation and melanoma. The patient's  concomitant therapies included melatonin, metoprolol, famotidine, FLONASE, vitamin D, lisinopril (manufacturer unknown), pravastatin, spironolactone, aspirin(manufacturer unknown), carbidopa (+) levodopa (manufacturer unknown), MIRALAX, digoxin, vitamin B complex, dexamethasone, neomycin sulfate, MAXITROL, triamcinolone, cranberry with vitamin C and unspecified stool softener. On 17-APR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, on an unspecified arm, as prevention of pneumonia, lot number N030111 with expiration date on 21-APR-2019 (strength and dose were not reported). On 18-APR-2018, the patient began experiencing urticaria, rash, hotness (feeling hot), swelling (peripheral swelling), and pain (pain in extremity) in the arm that the PNEUMOVAX 23 was administered in. It was stated that on an unspecified date, the patient called her physician and she was placed under therapy treatment with BENADRYL, TYLENOL, and cool compress to the affected area. At the reporting time, it was unknown if the patient was recovered from the events pain in extremity, feeling hot, peripheral swelling, rash and urticaria. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the aforementioned events. This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about April 2016, the patient was inoculated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and blisters on the lower back and legs of her body. Thereafter, she was diagnosed with shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. The patient sustained severe and permanent injuries. The patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Persistent strain of herpes zoster was considered disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 18-APR-2018, the patient was inadvertently vaccinated with one expired dose of VARIVAX injection, (lot # M017290) (expiry date: 07-APR-2018) for prophylaxis (dose not reported) (expired vaccine used). No adverse effects reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-APR-2018, the patient was vaccinated with expired dose of VAQTA (lot # N002921, expiry date: 08-APR-2018) for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint involved.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date in October 2017, the patient who was beyond the age of 26, was vaccinated with GARDASIL 9 (lot # and expiration date were not reported) intramuscularly for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician from a  Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A patient of unspecified age ethnicity and gender received 2 doses of PREVNAR 13 via an unspecified route of administration at single dose on unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The reporter wanted to do allergen testing on as her patient had a rash after receiving two vaccines of the PCV-13.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Pulmonary pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. This 76-year-old  female consumer patient received the first dose of PREVNAR 13 for immunization at single dose on 03Apr2018 via unspecified route of administration in the left arm. Relevant medical history included Blood pressure and a mass in her upper half of her right lung since Oct2017 and ongoing, She states that when first diagnosed this mass measures 5.5 cm or mm. She states that it now measures 9.something. It has not been diagnosed as cancer because she has not had the biopsy. Concomitant medication included amlodipine for blood pressure since 05Apr2018 and ongoing at 500 mg, 1x/day.  The night after having the shot she woke up and had a lot of pain in her back and in the lower part of her lungs. It really hurt and she thought this was weird. The two events were recovered on the same date. The caller received her PREVNAR 13 vaccine in the doctor's office and doesn't have the lot number, NDC number, expiration date. The reporter also mentioned that she noticed she had more energy from 04Apr2018. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Condition aggravated, Cough, Depression, Haemoptysis
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for herself. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date in 2011, at single dose, for immunisation. Relevant medical history included bad allergies. Concomitant medications were not reported. About 4 weeks before she had to bring her great grandson to the hospital and she felt she caught something there. She had bad allergies, so she thought they were just acting up. But it got worse and she was coughing and felt itchy as well. She just did not feel well. So she went to the emergency room on 06Apr2018. Her oxygen level was down in the 70's, they gave her a breathing treatment, told her to take Levaquin and gave her Inhaler. They did an x-ray and she was diagnosed with pneumonia. On 17Apr2018 she was still coughing a lot and coughing up some blood. The patient was aggravating and depressing because she couldn't do what she wanted to do. No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Malaise, Oxygen saturation decreased, Pneumonia, Pruritus
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for herself. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date in 2011, at single dose, for immunisation. Relevant medical history included bad allergies. Concomitant medications were not reported. About 4 weeks before she had to bring her great grandson to the hospital and she felt she caught something there. She had bad allergies, so she thought they were just acting up. But it got worse and she was coughing and felt itchy as well. She just did not feel well. So she went to the emergency room on 06Apr2018. Her oxygen level was down in the 70's, they gave her a breathing treatment, told her to take Levaquin and gave her Inhaler. They did an x-ray and she was diagnosed with pneumonia. On 17Apr2018 she was still coughing a lot and coughing up some blood. The patient was aggravating and depressing because she couldn't do what she wanted to do. No follow-up attempts are possible, information about lot number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age and ethnicity received TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain injection site on an unspecified date. The outcome of the event was unknown. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018163454 same reporter/drug/event, different patient.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. This consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age and ethnicity received TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain injection site on an unspecified date. The outcome of the event was unknown. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018163421 same reporter/drug/event, different patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Injection site bruising, Mobility decreased, Nodule
Clinical narrative: Pt. stated that she began to run fever and experienced chills all day on Friday 04/20/2018. She wore 2 shirts all day and went to an outing later that night and wrapped herself up in a jacket then in addition to the 2 shirts. She also stated that Friday she could not lift her arm. She stated she never looked at the injection area on her arm until Saturday and when she did, she had a bruise at the injection site and had a large 3 inch knot on her arm around the injection site. She tried to come to our pharmacy to get consultation but we were closed. She then went to another pharmacy to purchase Benadryl and she consulted the pharmacist there. They informed her that what she experienced is normal for that vaccination. Today when she reported it to us, the swelling had gone down significantly. She did say that she felt slightly short winded today, but may not have anything to do with the injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt. stated that she began to run fever and experienced chills all day on Friday 04/20/2018. She wore 2 shirts all day and went to an outing later that night and wrapped herself up in a jacket then in addition to the 2 shirts. She also stated that Friday she could not lift her arm. She stated she never looked at the injection area on her arm until Saturday and when she did, she had a bruise at the injection site and had a large 3 inch knot on her arm around the injection site. She tried to come to our pharmacy to get consultation but we were closed. She then went to another pharmacy to purchase Benadryl and she consulted the pharmacist there. They informed her that what she experienced is normal for that vaccination. Today when she reported it to us, the swelling had gone down significantly. She did say that she felt slightly short winded today, but may not have anything to do with the injection.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Right arm became swollen from injection site down to wrist 1 day after injection was given in right arm.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blindness unilateral, Headache, Vaccination site pain
Clinical narrative: Soreness around vaccination site. Loss of vision in upper right eye. Mild headache. Loss of energy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Sunburn
Clinical narrative: Child was in the sun 2 days after the vaccine. She became sunburned on her cheeks and nose, which lead to blistering the next day. Prognosis is good. The child was not wearing sunscreen and has been in the sun before without getting sunburned. Parents read online that Hep A vaccine can cause hypersensitivity to sun.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: PATIENT STATED SHE IS GETTING BUMPS ALL OVER HER BODY.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness/STS/tenderness extending  from RT deltoid down to upper biceps and around slightly to triceps. TX - prednisone taper.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Peripheral swelling
Clinical narrative: Ptn reported to pharmacy on 4/21 complaining of cold chills and swollen arm. Patient seen at urgent care. Treatment and Outcome unknown.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash generalised, Urticaria
Clinical narrative: SEVERE TOTAL BODY RASH WITH HIVES TO ALL CONTACT SURFACESNG INTERCOSTAL NERVES AND SKIN CREASES  WITH SEVERE ITCHING AND STINGING PAIN.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Arthralgia, Burning sensation, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Pain and burning after vaccine. Constant pain after vaccine. Elbow pain and fingertips tingling.  Hand colder on left. Abduction limited by pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Peripheral coldness
Clinical narrative: Pain and burning after vaccine. Constant pain after vaccine. Elbow pain and fingertips tingling.  Hand colder on left. Abduction limited by pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Burning sensation, Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injected limb mobility decreased, Joint swelling
Clinical narrative: Pain and burning after vaccine. Constant pain after vaccine. Elbow pain and fingertips tingling.  Hand colder on left. Abduction limited by pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in extremity
Clinical narrative: Pain and burning after vaccine. Constant pain after vaccine. Elbow pain and fingertips tingling.  Hand colder on left. Abduction limited by pain.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea, Tinnitus
Clinical narrative: Nausea, headache, dizziness, tinnitus.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pain
Clinical narrative: Redness at injection site, localized pain.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis seen on 4/23/18 and prescribed a 10 day course of Cephalexin.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Decreased appetite, Fatigue, Hallucination, visual, Injection site discolouration
Clinical narrative: Patient received SHINGRIX at a retail pharmacy. Reports confusion, visual hallucinations, fevers, extreme fatigue, poor appetite, pain/redness/calor at the injection site (left deltoid).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient received SHINGRIX at a retail pharmacy. Reports confusion, visual hallucinations, fevers, extreme fatigue, poor appetite, pain/redness/calor at the injection site (left deltoid).
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Anaphylactic reaction, Lip swelling, Urticaria
Clinical narrative: Anaphylaxis with hives and lip swelling. Required Benadryl and epipen admin.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Neck pain, Pain in extremity
Clinical narrative: Chills, arm and neck sore.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Musculoskeletal pain, Paraesthesia
Clinical narrative: 4/22/18- extreme sleepiness resulting in only being awake for 4.5 hrs, soreness in both shoulder and left knee joints, slight headache behind eyes, prickly sensations on abdomen. 4/23/18- Woke up with hives on abdomen. During course of working 4 hrs. hives spread to arms, neck, back,  prickly, itchy scalp--huge severe red welts on abdomen, scratchy throat. Went to walk-in clinic.  Dr gave me Steroid shot, and called in a non-drowsy anti-histamine to pharmacy (don't know name of drug--picking up shortly).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Throat irritation, Urticaria
Clinical narrative: 4/22/18- extreme sleepiness resulting in only being awake for 4.5 hrs, soreness in both shoulder and left knee joints, slight headache behind eyes, prickly sensations on abdomen. 4/23/18- Woke up with hives on abdomen. During course of working 4 hrs. hives spread to arms, neck, back,  prickly, itchy scalp--huge severe red welts on abdomen, scratchy throat. Went to walk-in clinic.  Dr gave me Steroid shot, and called in a non-drowsy anti-histamine to pharmacy (don't know name of drug--picking up shortly).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: AFTER ADMINISTERING PROQUAD VACCINE, THE SITE OF INJECTION INSTANTLY SWELLED INTO A BUBBLE FOLLOWED BY THE LEG TURNING RED AND HOT TO TOUCH.
Sex: U
Vaccine: MENB
Symptoms: Injection site rash, Rash generalised
Clinical narrative: The patient developed rash around the injection site, and scattered throughout the body.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Induration, Pain, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction consisting of pain, warmth, and induration developed 12 hours after administration.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Hypoaesthesia, Mobility decreased
Clinical narrative: Patient called 4/23/18 stating that she is having bad reaction to 1st dose of SHINGRIX. She said it started bothering her a few hours after the vaccine was given on 4/20/18. She put ice on it and took TYLENOL and that her arm was warm to the touch and area raised. Over the course of the weekend, the area has gotten larger (the size of baseball), she has fever, shivering, fatigue, dizziness. Today she is unable to move arm and has numbness below the elbow. I recommended that the patient go to ER/Urgent Care. Patient states that she will have daughter take her to Urgent Care/ER in the morning.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Patient called 4/23/18 stating that she is having bad reaction to 1st dose of SHINGRIX. She said it started bothering her a few hours after the vaccine was given on 4/20/18. She put ice on it and took TYLENOL and that her arm was warm to the touch and area raised. Over the course of the weekend, the area has gotten larger (the size of baseball), she has fever, shivering, fatigue, dizziness. Today she is unable to move arm and has numbness below the elbow. I recommended that the patient go to ER/Urgent Care. Patient states that she will have daughter take her to Urgent Care/ER in the morning.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Anaemia, Appendicectomy, Blood test, Colonoscopy, Crohn's disease
Clinical narrative: My son was diagnosed with Crohn's disease. During the first year he lost weight of a dancing failure to thrive however we did not correlate it originally to the vaccine or the disease. After the second dose he developed various dermatitis and G.I. issues consistent with Crohn's disease and an adverse reaction. After the third dose, his G.I. symptoms increased and he developed Rotavirus anemia and other symptoms consistent with Crohn's disease.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dermatitis, Endoscopy, Failure to thrive, Gastrointestinal disorder, Gluten sensitivity
Clinical narrative: My son was diagnosed with Crohn's disease. During the first year he lost weight of a dancing failure to thrive however we did not correlate it originally to the vaccine or the disease. After the second dose he developed various dermatitis and G.I. issues consistent with Crohn's disease and an adverse reaction. After the third dose, his G.I. symptoms increased and he developed Rotavirus anemia and other symptoms consistent with Crohn's disease.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Intestinal resection, Laboratory test, Lactose intolerance, Rotavirus infection, Small intestinal resection
Clinical narrative: My son was diagnosed with Crohn's disease. During the first year he lost weight of a dancing failure to thrive however we did not correlate it originally to the vaccine or the disease. After the second dose he developed various dermatitis and G.I. issues consistent with Crohn's disease and an adverse reaction. After the third dose, his G.I. symptoms increased and he developed Rotavirus anemia and other symptoms consistent with Crohn's disease.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Stool analysis, Weight decreased
Clinical narrative: My son was diagnosed with Crohn's disease. During the first year he lost weight of a dancing failure to thrive however we did not correlate it originally to the vaccine or the disease. After the second dose he developed various dermatitis and G.I. issues consistent with Crohn's disease and an adverse reaction. After the third dose, his G.I. symptoms increased and he developed Rotavirus anemia and other symptoms consistent with Crohn's disease.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient became unconscious shortly after administration of HPV9 vaccine. Patient was sitting on exam table and was lowered down onto the table by the Medical Assistant.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Administration site erythema, Administration site induration, Administration site warmth, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction 10 hours after administration- erythema, warmth and induration surrounding the administration site.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Moderate swelling to left upper arm increased pain, states 10/10 pain. Increased warmth to area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: Reddened, swollen, painful left arm. Severe body and muscle aches, fever. Tiredness. "Feels like I got hit by a truck". Worsened as day 1 progressed with no change in body and muscle pain on day 2. Fever presented on day 2.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Reddened, swollen, painful left arm. Severe body and muscle aches, fever. Tiredness. "Feels like I got hit by a truck". Worsened as day 1 progressed with no change in body and muscle pain on day 2. Fever presented on day 2.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Nasopharyngitis, Oral herpes, Urticaria
Clinical narrative: GARDASIL vaccination administered to pt on 4/16/18. Pt states that the next day, 4/17/18, she developed a cold and took some SUDAFED. On 4/18/18, she developed hives on her lower legs and then on 4/20/18, she developed cold sores under her nose, above her lip. Pt did not report taking any medication for symptoms and she states that hives have resolved but cold sores are still present. Pt called clinic on 4/23/18 to report event. Pt advised to be seen by primary care provider and not have another GARDASIL vaccine unless advised by her primary physician.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Influenza like illness, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patients e-mail: This is just to let someone know about severe reaction to the pneumonia immunization on Fri. April 20. I couldn't raise my arm that I got the shot in for 48 hrs. and Flu like symptoms for a day. The shoulder pain and joint pain have almost subsided now but wanted to report symtoms.  Thank You
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cerebellar ataxia, Computerised tomogram head normal, Full blood count normal, Metabolic function test normal, Noninfective encephalitis
Clinical narrative: Vaccine given in office 4/19 am. One day after his 4 year vaccines, his parents noted him on the floor and was throwing up and noted not being able to sit up. He was then taken to ER where he was admitted for acute cerebellar ataxia and had a normal CT and MRI showing only mild post inflammatory changes. The next day, he was fine and has continued to improve.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Vomiting
Clinical narrative: Vaccine given in office 4/19 am. One day after his 4 year vaccines, his parents noted him on the floor and was throwing up and noted not being able to sit up. He was then taken to ER where he was admitted for acute cerebellar ataxia and had a normal CT and MRI showing only mild post inflammatory changes. The next day, he was fine and has continued to improve.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dyspnoea, Headache, Lip swelling, Swelling face
Clinical narrative: Patient came in today. Stated approximately 6-7-8pm on the evening of shot given face became swollen, had blisters from chest up, and headache, followed by difficulty breathing and lip swelling two days later up to this past weekend. States he did not call 911 or go to the ER until this past weekend. Dr. aware, and patient was seen today.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: My symptoms included: sore arm (mild to moderate to severe pain), redness and swelling where the shot was given, very tired and weak, muscle pain, headache, fever, nausea, shivering. It just flattened me! But the symptoms only lasted a little over a day. I got the vaccine on Friday April 13, 2018 and by Sunday April 15, I was feeling much better and by that Monday April 16, I was back to normal.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: My symptoms included: sore arm (mild to moderate to severe pain), redness and swelling where the shot was given, very tired and weak, muscle pain, headache, fever, nausea, shivering. It just flattened me! But the symptoms only lasted a little over a day. I got the vaccine on Friday April 13, 2018 and by Sunday April 15, I was feeling much better and by that Monday April 16, I was back to normal.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: My symptoms included: sore arm (mild to moderate to severe pain), redness and swelling where the shot was given, very tired and weak, muscle pain, headache, fever, nausea, shivering. It just flattened me! But the symptoms only lasted a little over a day. I got the vaccine on Friday April 13, 2018 and by Sunday April 15, I was feeling much better and by that Monday April 16, I was back to normal.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: My symptoms included: sore arm (mild to moderate to severe pain), redness and swelling where the shot was given, very tired and weak, muscle pain, headache, fever, nausea, shivering. It just flattened me! But the symptoms only lasted a little over a day. I got the vaccine on Friday April 13, 2018 and by Sunday April 15, I was feeling much better and by that Monday April 16, I was back to normal.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash on trunk area found the next day. The rash is getting better and patient wants to get 2nd shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Discomfort, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Neck and bilateral arm and shoulder achy and sore evening after injection Apr 18. "The more active I was the more serious the discomfort became over next 48h. At one point I felt weak and had to sit and couldn't do anything due to overwhelming achy feeling. The sx appeared evening after injection and were completely gone 3 days later".
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Neck and bilateral arm and shoulder achy and sore evening after injection Apr 18. "The more active I was the more serious the discomfort became over next 48h. At one point I felt weak and had to sit and couldn't do anything due to overwhelming achy feeling. The sx appeared evening after injection and were completely gone 3 days later".
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Pain, Rash erythematous, Rash generalised
Clinical narrative: Red rash and pain starting at the injection site and spreading throughout the whole body. It started about 6 hours after the injection and is still present. Dr prescribed Cephalexin 500mg qid x 7 days, fluconazole 150mg once and Ibuprofen.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Dysstasia, Feeling cold
Clinical narrative: Starting around 11 hours after shot, started to shiver (very cold), feel dizzy, and be restless. When woke up, could barely stand and was very dizzy; head was pounding; still shivering. Also had an upset stomach. Adverse events lasted about 36 hours. Only took TYLENOL for treatment.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Restlessness
Clinical narrative: Starting around 11 hours after shot, started to shiver (very cold), feel dizzy, and be restless. When woke up, could barely stand and was very dizzy; head was pounding; still shivering. Also had an upset stomach. Adverse events lasted about 36 hours. Only took TYLENOL for treatment.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Within 2 weeks of shot, my left arm became sore and my range of motion was diminished; it has continued to get worse. Chose influenza choice above, but do not know the type--it made me choose one.
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Second dose of rabies vaccine administered in gluteal muscle.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient called me last week after receiving the vaccine and then again today, 04/23/2018, to report that her arm was extremely sore, and the area around the injection site (about the "size of an apple") was red and warm to the touch.
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling hot, Neuropathy peripheral, Paraesthesia
Clinical narrative: Patient came to me on 04/17/18 to report the adverse effects he is experiencing which he states is from the flu shot given on 01/22/2018. He said within 7 days of getting the vaccine he started to experience neuropathy in his feet, his feet sometimes feel warm/hot and he experiences a "pins and needles" feeling in his feet.
Age: 30.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Patient became dizzy and faint. She was moved to the floor, legs elevated. Given water and wet paper towels behind neck and on forehead. Recovered quickly (3-4 minutes) and was propped up with a pillow to rest and sip water. Rested around 25 minutes.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Reports to ED department on 4/19/18 itchy, swelling and redness on the outer aspects of left thigh (site of Varicella injection). Started on 4/18/18 not oozing, spreading symmetrically. No fever, no weakness, no fatigue.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia, Scar, Tremor
Clinical narrative: When our pharmacy called to remind the patient of her second dose, the patient reported having systemic side effects from her first vaccine. She experienced pain, swelling, shiver, fever, upset stomach and headache starting the night of her vaccination. A low-grade fever lasted for 3 days. She did not take any over the counter medications or seek medical advices.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: When our pharmacy called to remind the patient of her second dose, the patient reported having systemic side effects from her first vaccine. She experienced pain, swelling, shiver, fever, upset stomach and headache starting the night of her vaccination. A low-grade fever lasted for 3 days. She did not take any over the counter medications or seek medical advices.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: When our pharmacy called to remind the patient of her second dose, the patient reported having systemic side effects from her first vaccine. She experienced pain, swelling, shiver, fever, upset stomach and headache starting the night of her vaccination. A low-grade fever lasted for 3 days. She did not take any over the counter medications or seek medical advices.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 63-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 4th July 2020). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 2 days after receiving SHINGRIX, the patient experienced allergic reaction and influenza-like symptoms. On 22nd March 2018, the patient experienced general body pain, pain in arm, leg pain and erythema of extremities. On 26th March 2018, the outcome of the general body pain, pain in arm, leg pain, erythema of extremities and influenza-like symptoms were recovered/resolved. On an unknown date, the  outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction and influenza-like symptoms to be related to SHINGRIX. The reporter considered the general body pain, pain in arm, leg pain and erythema of extremities to be related to SHINGRIX. Additional information was reported as follows: The reporter had already reported all of the related details previously to Vaccine Adverse Event Reporting System (VAERS). The patient received SHINGRIX in the left deltoid. The reporter saw the patient's arm and describes the left arm redness as being erythema. There was not any exact injection site reaction. The erythema occurred from the start of the bend in the elbow up over most of her entire arm to just below the deltoid where the deltoid peaks, and the site of injection was might be an inch or two above that. The patient did not have any redness or reaction at the exact site where she had been injected. The reporter did not recall exact details for the left arm soreness, left leg soreness, and achy body describes as being flu-like symptoms. The prescribing physician had decided that the patient perhaps should not have a second dose as the doctor thought this might had been an allergic reaction. The symptoms had all resolved within 4 days of their starting. The patient had not changed detergents and nothing in her environment had changed, so the prescribing physician thought the symptoms were caused by the SHINGRIX. This case was transferred to medical information team to address the prescribing physician's inquiry of effectiveness of SHINGRIX if only 1 dose was given. The reporter granted permission to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 63-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 4th July 2020). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 2 days after receiving SHINGRIX, the patient experienced allergic reaction and influenza-like symptoms. On 22nd March 2018, the patient experienced general body pain, pain in arm, leg pain and erythema of extremities. On 26th March 2018, the outcome of the general body pain, pain in arm, leg pain, erythema of extremities and influenza-like symptoms were recovered/resolved. On an unknown date, the  outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction and influenza-like symptoms to be related to SHINGRIX. The reporter considered the general body pain, pain in arm, leg pain and erythema of extremities to be related to SHINGRIX. Additional information was reported as follows: The reporter had already reported all of the related details previously to Vaccine Adverse Event Reporting System (VAERS). The patient received SHINGRIX in the left deltoid. The reporter saw the patient's arm and describes the left arm redness as being erythema. There was not any exact injection site reaction. The erythema occurred from the start of the bend in the elbow up over most of her entire arm to just below the deltoid where the deltoid peaks, and the site of injection was might be an inch or two above that. The patient did not have any redness or reaction at the exact site where she had been injected. The reporter did not recall exact details for the left arm soreness, left leg soreness, and achy body describes as being flu-like symptoms. The prescribing physician had decided that the patient perhaps should not have a second dose as the doctor thought this might had been an allergic reaction. The symptoms had all resolved within 4 days of their starting. The patient had not changed detergents and nothing in her environment had changed, so the prescribing physician thought the symptoms were caused by the SHINGRIX. This case was transferred to medical information team to address the prescribing physician's inquiry of effectiveness of SHINGRIX if only 1 dose was given. The reporter granted permission to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hypersensitivity, Influenza like illness, Injection site erythema, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 63-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 4th July 2020). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 2 days after receiving SHINGRIX, the patient experienced allergic reaction and influenza-like symptoms. On 22nd March 2018, the patient experienced general body pain, pain in arm, leg pain and erythema of extremities. On 26th March 2018, the outcome of the general body pain, pain in arm, leg pain, erythema of extremities and influenza-like symptoms were recovered/resolved. On an unknown date, the  outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction and influenza-like symptoms to be related to SHINGRIX. The reporter considered the general body pain, pain in arm, leg pain and erythema of extremities to be related to SHINGRIX. Additional information was reported as follows: The reporter had already reported all of the related details previously to Vaccine Adverse Event Reporting System (VAERS). The patient received SHINGRIX in the left deltoid. The reporter saw the patient's arm and describes the left arm redness as being erythema. There was not any exact injection site reaction. The erythema occurred from the start of the bend in the elbow up over most of her entire arm to just below the deltoid where the deltoid peaks, and the site of injection was might be an inch or two above that. The patient did not have any redness or reaction at the exact site where she had been injected. The reporter did not recall exact details for the left arm soreness, left leg soreness, and achy body describes as being flu-like symptoms. The prescribing physician had decided that the patient perhaps should not have a second dose as the doctor thought this might had been an allergic reaction. The symptoms had all resolved within 4 days of their starting. The patient had not changed detergents and nothing in her environment had changed, so the prescribing physician thought the symptoms were caused by the SHINGRIX. This case was transferred to medical information team to address the prescribing physician's inquiry of effectiveness of SHINGRIX if only 1 dose was given. The reporter granted permission to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 63-year-old female patient who received SHINGRIX (batch number X3M27, expiry date 4th July 2020). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 2 days after receiving SHINGRIX, the patient experienced allergic reaction and influenza-like symptoms. On 22nd March 2018, the patient experienced general body pain, pain in arm, leg pain and erythema of extremities. On 26th March 2018, the outcome of the general body pain, pain in arm, leg pain, erythema of extremities and influenza-like symptoms were recovered/resolved. On an unknown date, the  outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction and influenza-like symptoms to be related to SHINGRIX. The reporter considered the general body pain, pain in arm, leg pain and erythema of extremities to be related to SHINGRIX. Additional information was reported as follows: The reporter had already reported all of the related details previously to Vaccine Adverse Event Reporting System (VAERS). The patient received SHINGRIX in the left deltoid. The reporter saw the patient's arm and describes the left arm redness as being erythema. There was not any exact injection site reaction. The erythema occurred from the start of the bend in the elbow up over most of her entire arm to just below the deltoid where the deltoid peaks, and the site of injection was might be an inch or two above that. The patient did not have any redness or reaction at the exact site where she had been injected. The reporter did not recall exact details for the left arm soreness, left leg soreness, and achy body describes as being flu-like symptoms. The prescribing physician had decided that the patient perhaps should not have a second dose as the doctor thought this might had been an allergic reaction. The symptoms had all resolved within 4 days of their starting. The patient had not changed detergents and nothing in her environment had changed, so the prescribing physician thought the symptoms were caused by the SHINGRIX. This case was transferred to medical information team to address the prescribing physician's inquiry of effectiveness of SHINGRIX if only 1 dose was given. The reporter granted permission to be contacted.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paresis
Clinical narrative: Physician told patient her vaccine most likely caused her to develop Bell's Palsy. Presented in office w/symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Physician told patient her vaccine most likely caused her to develop Bell's Palsy. Presented in office w/symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain lower, Chills, Headache, Herpes zoster, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received SHINGRIX. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved. The reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse. The reporter did not know the lot number. The injection site was the deltoid but it was unknown if it was the right or left deltoid. The patient's wife called the doctor because her husband had developed Shingles. The patient saw the doctor on 11th April 2018 and was prescribed Acyclovir. The nurse was transferred to MI for additional information.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received SHINGRIX. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved. The reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse. The reporter did not know the lot number. The injection site was the deltoid but it was unknown if it was the right or left deltoid. The patient's wife called the doctor because her husband had developed Shingles. The patient saw the doctor on 11th April 2018 and was prescribed Acyclovir. The nurse was transferred to MI for additional information.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received SHINGRIX. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was not recovered/not resolved. The reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse. The reporter did not know the lot number. The injection site was the deltoid but it was unknown if it was the right or left deltoid. The patient's wife called the doctor because her husband had developed Shingles. The patient saw the doctor on 11th April 2018 and was prescribed Acyclovir. The nurse was transferred to MI for additional information.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: He was normal. He went to sleep and never woke up. 11 days after his vaccines.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Patient had a fever approximately 100.5 fatigue flu like symptoms headache muscle pain nausea.