chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Hypersensitivity, Irritability, Pyrexia, Urticaria, Vaccination complication
Clinical narrative: On 12/7/17 my husband picked up our son from the sitter and noticed a few hives on his hand. Once they got home he changed clothes and diaper, there he discovered hives all over his body and face. Our son was running a fever of 102. My husband called me at work and sent me photos. I called our sitter to see what our son ate that day thinking it was an allergic reaction to a food. The sitter confirmed our son had not eaten any of the food we sent nor any food at her home and had slept most of the day. She had not noticed any hives. My husband initially treated with 5ml BENADRYL thinking he must have touched something he was allergic to or he was developing a new allergy. The fever we treated with ibuprofen. The fever went down but the hives did not. When I arrived at home around 6:00 p.m. I gave another dose of BENADRYL 5ml. I considered giving him his EPIPEN thinking it was an allergic reaction to something but his breathing was fine and had no other side effects besides the fever. His hives did go away temporarily with the 2nd dose of BENADRYL. Our son was irritable and fussy and did not eat much for dinner. He did sleep but when he awoke the next morning on 12/8/17 the hives were everywhere again and his fever was 103. I treated with BENADRYL and Ibuprofen again. And continued to treat him all throughout the day with the hives and fever continuously returning every 3-4 hours. I started thinking back to did he have an illness or what happened recently? Then I remembered he had his vaccinations a week prior to start of all the reactions. The hives and high fever of 102-103 continued on 12/9/17 and 12/10/17 which we continuously used BENADRYL, ibuprofen and TYLENOL. The hives/high fever reactions lasted a total of 4 days upon inception. Out of all his allergic reactions this seemed nothing like anything we have experienced and we have never had a food allergic reaction last 4 days or be accompanied by high fever. We had an appointment with our new allergist on Tuesday, 12/12/17 and I shared with her our photos of hives and symptoms. She said it was definitely a severe adverse reaction from the MMR vaccination and I needed to report it to the CDC and our doctor, asap.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Started running a fever around 4 am of previous day of shots given. Fever started at 101 and rised to 102.5 before TYLENEL took contol and helped the fever break.
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: Patient received influenza and PNEUMOVAX 23 vaccines on 12/11/17 at 0935 in clinic (hospital-based clinic). Family notified medical team that patient developed high fevers, pain, and arm swelling on 12/12/17 at 1712. Patient was seen in ED (emergency department) for these symptoms on 12/12/17 at 2021; area of erythema on patient's arm was marked by ED staff and reaction was determined to be local and not systemic. Patient was seen again in ED on 12/14/17 at 0035 due to worsening reaction at the injection site (swelling extended past previous demarcation line). Arm swelling was concerning for cellulitis and patient was prescribed clindamycin TID x 10 days to treat cellulitis.
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site swelling, Local reaction, Pain, Peripheral swelling
Clinical narrative: Patient received influenza and PNEUMOVAX 23 vaccines on 12/11/17 at 0935 in clinic (hospital-based clinic). Family notified medical team that patient developed high fevers, pain, and arm swelling on 12/12/17 at 1712. Patient was seen in ED (emergency department) for these symptoms on 12/12/17 at 2021; area of erythema on patient's arm was marked by ED staff and reaction was determined to be local and not systemic. Patient was seen again in ED on 12/14/17 at 0035 due to worsening reaction at the injection site (swelling extended past previous demarcation line). Arm swelling was concerning for cellulitis and patient was prescribed clindamycin TID x 10 days to treat cellulitis.
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient received influenza and PNEUMOVAX 23 vaccines on 12/11/17 at 0935 in clinic (hospital-based clinic). Family notified medical team that patient developed high fevers, pain, and arm swelling on 12/12/17 at 1712. Patient was seen in ED (emergency department) for these symptoms on 12/12/17 at 2021; area of erythema on patient's arm was marked by ED staff and reaction was determined to be local and not systemic. Patient was seen again in ED on 12/14/17 at 0035 due to worsening reaction at the injection site (swelling extended past previous demarcation line). Arm swelling was concerning for cellulitis and patient was prescribed clindamycin TID x 10 days to treat cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Patient was given pneumonia shot and started wheezing 5 minutes afterwards. Patient had epipen on her due to other allergies, and i administered it and an ambulance was called as it was not getting any better.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Pt experienced redness, skin rash, itching and hives.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Myalgia, X-ray normal
Clinical narrative: Acute muscle pain between shoulder and elbow, especially in rotator cuff area from 12/08/2017 till today.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Called and stated injection site was "big as a dinner plate" and hot and painful. Recommended ice and to be seen by physician.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Patient had a large local reaction at injection site requiring prednisolone 15mg/5ml oral steroid and betamethasone 0.05% topical steroid to be prescribed. After steroids, symptoms resolved.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Head discomfort, Vertigo
Clinical narrative: 5 hours after receiving flu vaccine patient complained of pressure in head and vertigo.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient's arm turned red from elbow to shoulder and was hot to touch within hours of receiving immunization.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at site 1 week after receiving immunizations.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Dysphonia, Laboratory test, Pharyngeal oedema, Rash
Clinical narrative: Pt reported to the ER with c/o throat swelling, hoarseness, difficulty swallowing and rash RUA.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient was given vaccine on 12/12/17 and had no reaction or problems on date given. Patient noticed soreness to right upper arm deltoid area at site where vaccine given sore and warm to touch. Patient reports warmth to area lasted about 2 days and soreness to area about 5 days.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: ACTH stimulation test, Addison's disease, Blood electrolytes, Hyponatraemia, Vomiting
Clinical narrative: Child developed hyponatremia and vomiting one week post vaccination. Was admitted to hospital and diagnosed with Addison's disease.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Peripheral swelling, Soft tissue inflammation, Tenderness
Clinical narrative: Patient states approximately 5 hours after co-administration he began having chills, swelling in his upper extremity, and severe tenderness. After two days, the swelling had spread to his forearm and he went to see the doctor. The nurse practitioner who saw him stated he had soft tissue inflammation post vaccination administration.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product quality issue, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II rHA lot number N009799 and expiration date of 24-MAR-2019, subcutaneously for prophylaxis. The nurse reported that the patient only received a half of the recommended dose of M-M-R II vaccine due to half of the vaccine sprayed out of the syringe during administration. No adverse effects were reported. A Product quality complaint was filed for this defect.
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a 6 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 28-NOV-2017, the patient was vaccinated with GARDASIL 9 lot # M030380, expiration date 01-FEB-2019, for prophylaxis (strength, dose, route and frequency, were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 15-DEC-2017 regarding a case in litigation from a lawyer concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 28-SEP-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration are unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 22-JAN-2013, the patient was treated at a physician's office for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Polyneuropathy, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received on 15-DEC-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 30-DEC-2011, administered (by an unspecified person) at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 11-DEC-2016, the patient was treated at the hospital, for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 18-DEC-2016, the patient sought subsequent treatment at the hospital for worsening symptoms of shingles, which was diagnosed as polyneuropathy compounded upon Herpes zoster. On or about 19-DEC-2016, the male patient was treated by a family nurse practitioner at a medical facility for ongoing and worsening symptoms, diagnosed as zoster infections and post-herpetic neuralgia. The patient has been prescribed acyclovir and tramadol injections for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX. Upon medical review, the event of Sought subsequent treatment for worsening symptoms of shingles, which was diagnosed as polyneuropathy compounded upon Herpes zoster was considered to be a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This initial spontaneous report was received on 15-DEC-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 30-DEC-2011, administered (by an unspecified person) at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 11-DEC-2016, the patient was treated at the hospital, for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 18-DEC-2016, the patient sought subsequent treatment at the hospital for worsening symptoms of shingles, which was diagnosed as polyneuropathy compounded upon Herpes zoster. On or about 19-DEC-2016, the male patient was treated by a family nurse practitioner at a medical facility for ongoing and worsening symptoms, diagnosed as zoster infections and post-herpetic neuralgia. The patient has been prescribed acyclovir and tramadol injections for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. The outcome of the events was not resolved.  The lawyer felt the events were related to ZOSTAVAX. Upon medical review, the event of Sought subsequent treatment for worsening symptoms of shingles, which was diagnosed as polyneuropathy compounded upon Herpes zoster was considered to be a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 31-DEC-2012 the patient was vaccinated with ZOSTAVAX, 1DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 01-JUN-2013, the patient was treated at a clinic for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 28-AUG-2013, the patient was treated again at the clinic for ongoing and worsening symptoms which was diagnosed as zoster neuralgic. The patient has been prescribed VALTREX and analgesics for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial solicited report received on 12DEC2017 from an investigator in a trial. This is a 27 year old male who received immunization with ACAM2000 on 27SEP2017. The patient had no prior cardiac or other relevant medical history. No concomitant medications or vaccines were reported. On 08OCT2017 (12 days after smallpox vaccine) the patient had an abnormal electrocardiogram and troponin I (5.69ng/mL) and a normal echocardiogram. On 17OCT2017, he was diagnosed with myocarditis, unspecified. At the time of the report the outcome was unknown. No further information was provided.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Physician. A 65-years-old patient (Weight: 140 lb., Height: 59 in) of an unspecified ethnicity and gender received PREVNAR 13 (lot S43277, Exp date Sep2018), intramuscular in left arm on 03Nov2017 11:00 at 0.5 ml single dose for immunization at Physician office. Medical history included ongoing hypothyroidism. Concomitant medication included ongoing levothyroxine (unknown manufacturer) at 75 mcg daily for hypothyroid and FLUZONE on 27Oct2017 for immunization with no adverse effect. No additional vaccines were administered on same date of pneumococcal 13-val conj vac (dipht crm197 protein). On 03Nov2017 at 17:00, about 6hrs after injection, the patient experienced local injection reaction described as large area of intense skin reaction with erythema and local tenderness, very large and painful. The patient was evaluated at physician office and recovered on 06Dec2017.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a sales representative.  A female patient of an unspecified age and race/ethnicity received  the second dose of TRUMENBA, via an unspecified route of administration at single dose in Dec2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a red rash around the shot area in Dec2017 with outcome of unknown. The information on the lot number has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: The area from the injection site to her left hand became sore, tender and swollen. The severity of reaction weakened within 2 days after she took 1 tablet of diphenhydramine OTC. The patient was worried about asthma attacks, but her breathing was okay. Her symptoms lasted up to a week. The patient reported the adverse reactions to me on 12/18/2017.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Crying, Molluscum contagiosum, Pain, Rash
Clinical narrative: Patient started getting bumps on his back in November. Was unsure what they were but they slowly started to spread. On December 12, 2017 I took him to the doctor to find out what they were. Diagnosis molluscum warts. Doctor treated in office with Cantharidin. Patient had a reaction to the medicine about 2 hours later started screaming and crying that his skin hurt. He ended up having a reaction to the medicine and got these horrible painful blisters all over his body we had to go to the ER. Molluscum warts are also called the pox virus. Patient would have been better off getting chicken pox instead of these horrible warts. Online research a number of parents wrote that their children ended up getting these warts after the chicken pox vaccine. These warts could last up to a year! Still recovering from the blisters but warts still popping up here and there on his body.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Screaming
Clinical narrative: Patient started getting bumps on his back in November. Was unsure what they were but they slowly started to spread. On December 12, 2017 I took him to the doctor to find out what they were. Diagnosis molluscum warts. Doctor treated in office with Cantharidin. Patient had a reaction to the medicine about 2 hours later started screaming and crying that his skin hurt. He ended up having a reaction to the medicine and got these horrible painful blisters all over his body we had to go to the ER. Molluscum warts are also called the pox virus. Patient would have been better off getting chicken pox instead of these horrible warts. Online research a number of parents wrote that their children ended up getting these warts after the chicken pox vaccine. These warts could last up to a year! Still recovering from the blisters but warts still popping up here and there on his body.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Autoimmune disorder, Ear swelling, Hypersensitivity, Joint swelling, Pain
Clinical narrative: Patient started breaking out in hives on Tuesday Dec. 5th, 8 days after vaccination. I took her into the clinic that evening and the doctor thought she might be having an allergic reaction to her AUGMENTIN. He prescribed ZYRTEC every 12 hr. and it did not help at all. I had to keep taking her back to the clinic several times as her condition kept worsening. She was swollen all over her body, her joints, her face, her ear, hands and feet. She had a fever, severe hives, and was in immense pain and vomiting & nothing was helping. They finally gave her a shot of dexamethasone, which did help for 2 days. She started breaking out again on Friday evening, requiring one more steroid shot on Saturday. Our doctor referred us to an immunologist who said she was having an autoimmune response to her vaccines. Prescribes ZANTAC & ZYRTEC and said this could last up to 3 months.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Peripheral swelling, Pyrexia, Swelling, Swelling face, Urticaria
Clinical narrative: Patient started breaking out in hives on Tuesday Dec. 5th, 8 days after vaccination. I took her into the clinic that evening and the doctor thought she might be having an allergic reaction to her AUGMENTIN. He prescribed ZYRTEC every 12 hr. and it did not help at all. I had to keep taking her back to the clinic several times as her condition kept worsening. She was swollen all over her body, her joints, her face, her ear, hands and feet. She had a fever, severe hives, and was in immense pain and vomiting & nothing was helping. They finally gave her a shot of dexamethasone, which did help for 2 days. She started breaking out again on Friday evening, requiring one more steroid shot on Saturday. Our doctor referred us to an immunologist who said she was having an autoimmune response to her vaccines. Prescribes ZANTAC & ZYRTEC and said this could last up to 3 months.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Patient started breaking out in hives on Tuesday Dec. 5th, 8 days after vaccination. I took her into the clinic that evening and the doctor thought she might be having an allergic reaction to her AUGMENTIN. He prescribed ZYRTEC every 12 hr. and it did not help at all. I had to keep taking her back to the clinic several times as her condition kept worsening. She was swollen all over her body, her joints, her face, her ear, hands and feet. She had a fever, severe hives, and was in immense pain and vomiting & nothing was helping. They finally gave her a shot of dexamethasone, which did help for 2 days. She started breaking out again on Friday evening, requiring one more steroid shot on Saturday. Our doctor referred us to an immunologist who said she was having an autoimmune response to her vaccines. Prescribes ZANTAC & ZYRTEC and said this could last up to 3 months.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a Dtap vaccine instead of a Tdap vaccine. The Medical Assistant pulled and gave the wrong vaccine.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Rash pustular
Clinical narrative: Redness to left arm with pustules and rash. Treatment includes alternate hot and cold compresses to area with IBU 400mg Q6hr PRN(x48hr.).
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Soreness in area of shot, then down whole left arm. Within 12 hours I could not lift my arm or grasp anything without intense pain in my arm. The whole left side of my body ached. I applied heat and ice alternately to area of shot. (There was no redness or heat at site.)  Inability to lift my arm without intense pain lasted for three days, full range of motion did not return for 6 days.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Ultrasound scan normal
Clinical narrative: On Wednesday Dec 13th, 2017 patient received PREVNAR 13 at around 6pm. On Monday, patient came to the pharmacy and per pharmacist, her left arm showed red and bumpy, not around the injection site but below the injection about 2 inches wide and 3 to 4 inches long. On Tuesday morning, patient went to see her primary care doctor and was prescribed LEVAQUIN 500mg #10 - 1 tab qd.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Periarthritis
Clinical narrative: Her is hurting, she can hardly move her arm and her shoulder is frozen.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Chest discomfort, Discomfort, Eosinophil count increased, Full blood count normal
Clinical narrative: Pt presented for a WWE on December 13th. She had no abnormal findings on exam and was administered the flu shot. The pt. started having right collarbone pain with a "bump" when she woke up on Friday (Dec 14). The discomfort seemed to improve with movement, but she noticed "a bump" that was malleable. It was normal in color, temperature. It did not have any open areas, drainage or signs of infection. The bump had mild tenderness to palpation. She placed a heating pad to the area. She denied fever or other complaints. She was woken up due to the pain on Saturday morning at 0200 which was so severe she that she presented to the EC. They did not perform imaging or labs. They gave her "a shot for the pain" (TORADOL?) in the left UE which improved her pain for the next several hours. They gave her an Rx for FLEXERIL and Ibuprofen 600mg. She presented to this office (her PCP) on the 18th at noon. The pain had intensified and was radiating up the right side of her neck. Her RUE "feels like someone is pushing down on my right arm." She described numbness, tingling from shoulder to fingers. Lifting her arm causes pain as well as light pressure to the clavicle/neck/shoulder. On exam, she had tender LAD to the right subclavicular and right cervical lymph nodes. She was TTP of the shoulder and right upper back. No skin abnormalities were appreciated. There was no edema, swelling, discoloration or other abnormalities at the site of the influenza injection. She had +TTP of right proximal extremity. Skin is intact, smooth. RUE well perfused. No edema. Pulses to bilat UE equal, regular and strong. Skin color and temp. is normal. No deformities. Grip strength 5/5 and equal bilaterally. Pain with active abduction of shoulder. She is c/o numbness and tingling in the entire RUE.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lymph node pain, Neck pain, Pain, Paraesthesia
Clinical narrative: Pt presented for a WWE on December 13th. She had no abnormal findings on exam and was administered the flu shot. The pt. started having right collarbone pain with a "bump" when she woke up on Friday (Dec 14). The discomfort seemed to improve with movement, but she noticed "a bump" that was malleable. It was normal in color, temperature. It did not have any open areas, drainage or signs of infection. The bump had mild tenderness to palpation. She placed a heating pad to the area. She denied fever or other complaints. She was woken up due to the pain on Saturday morning at 0200 which was so severe she that she presented to the EC. They did not perform imaging or labs. They gave her "a shot for the pain" (TORADOL?) in the left UE which improved her pain for the next several hours. They gave her an Rx for FLEXERIL and Ibuprofen 600mg. She presented to this office (her PCP) on the 18th at noon. The pain had intensified and was radiating up the right side of her neck. Her RUE "feels like someone is pushing down on my right arm." She described numbness, tingling from shoulder to fingers. Lifting her arm causes pain as well as light pressure to the clavicle/neck/shoulder. On exam, she had tender LAD to the right subclavicular and right cervical lymph nodes. She was TTP of the shoulder and right upper back. No skin abnormalities were appreciated. There was no edema, swelling, discoloration or other abnormalities at the site of the influenza injection. She had +TTP of right proximal extremity. Skin is intact, smooth. RUE well perfused. No edema. Pulses to bilat UE equal, regular and strong. Skin color and temp. is normal. No deformities. Grip strength 5/5 and equal bilaterally. Pain with active abduction of shoulder. She is c/o numbness and tingling in the entire RUE.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, Swelling, Tenderness
Clinical narrative: Pt presented for a WWE on December 13th. She had no abnormal findings on exam and was administered the flu shot. The pt. started having right collarbone pain with a "bump" when she woke up on Friday (Dec 14). The discomfort seemed to improve with movement, but she noticed "a bump" that was malleable. It was normal in color, temperature. It did not have any open areas, drainage or signs of infection. The bump had mild tenderness to palpation. She placed a heating pad to the area. She denied fever or other complaints. She was woken up due to the pain on Saturday morning at 0200 which was so severe she that she presented to the EC. They did not perform imaging or labs. They gave her "a shot for the pain" (TORADOL?) in the left UE which improved her pain for the next several hours. They gave her an Rx for FLEXERIL and Ibuprofen 600mg. She presented to this office (her PCP) on the 18th at noon. The pain had intensified and was radiating up the right side of her neck. Her RUE "feels like someone is pushing down on my right arm." She described numbness, tingling from shoulder to fingers. Lifting her arm causes pain as well as light pressure to the clavicle/neck/shoulder. On exam, she had tender LAD to the right subclavicular and right cervical lymph nodes. She was TTP of the shoulder and right upper back. No skin abnormalities were appreciated. There was no edema, swelling, discoloration or other abnormalities at the site of the influenza injection. She had +TTP of right proximal extremity. Skin is intact, smooth. RUE well perfused. No edema. Pulses to bilat UE equal, regular and strong. Skin color and temp. is normal. No deformities. Grip strength 5/5 and equal bilaterally. Pain with active abduction of shoulder. She is c/o numbness and tingling in the entire RUE.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: PAIN, NUMBNESS AND TINGLING IN LEFT ARM SINCE FLU SHOT GIVEN IN AUGUST.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Dr. called us informing the pharmacy that the patient was experiencing pain that radiates from the injection site on the deltoid to the elbow upon pressure on the site. The patient told the doctor that she experienced the pain after she received the injection and went to the doctor today (12/19/17) when the pain got worse. The patient inquired with the doctor whether it was normal to have the pain last for that long to which the doctor stated that he told her "no." The doctor stated that the patient received the injection on the left arm but the documentation made by the pharmacist who gave the shot said right arm. I could not talk to the doctor for too long the first or second time due to him having other patients to see. Therefore, this is the extent to the information I could gather. I could not reach the patient in any of the three phone numbers we had available. Dr. asked the patient to come to the pharmacy. I tried reaching the doctor again for further information on the patient's medications and about the injection site but he was busy with patients so the pharmacy had to leave a message. The pharmacy could only infer the conditions of the patient based on the medications she receives regularly at the pharmacy.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Swelling face, Vision blurred
Clinical narrative: Patient reported blurred vision, lightheadedness & dizziness, initially occurring off & on for approx. 15 minutes starting a couple minutes after receiving vaccine so water was given. Reports ate & drank fluids prior to work today. Additionally headache & nausea began approx. 15 mins. after receiving vaccine. No fever (temp was 99.0 deg F prior to vaccine administration and although spiked transiently to 99.7 deg F, it went back to 99 deg by 11:39 12/9/17. BP initially 109/76 with pulse 67 at 09:50 am & 128/86 with pulse of 60 by 11:13 am. No hives or rash or swelling. Pt is stable at time of release although lingering constant headache is her main symptom. Also some nausea persists with occasional LH, dizziness & blurred vision. Advised to take TYLENOL PRN & seek medical care for any unresolving symptoms. Advised to go to ER if facial swelling, symptom worsening or dyspnea occur. Pt is improved & able to take fluids PO. Called pt later same day (at about 5:40 pm) & she reports only lingering symptom is slight headache, & that she has only taken TYLENOL once.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Itchy welts started by elbow and progressed up and around entire arm to shoulder over a 3 day period. It was not warm to the touch.
Age: 53.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT'S ARM SWELLED AND TURNED RED THE DAY AFTER THE IMMUNIZATIONS. PATIENT WAS SEEN BY PRIMARY CARE PHYSICIAN 4 DAYS AFTER IMMUNIZATION ADMINISTRATION. PATIENT GIVEN STEROID TO DECREASE SYMPTOMS.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Eczema, Eye swelling, Flushing, Immediate post-injection reaction
Clinical narrative: Immediate symptom- head swollen, eyes swollen, face extremely flush like a tomato. Doctor claimed serotonin reaction. Dr. Had patient stay in clinic for 30 minutes to ensure no anaphylaxis. Episode occurred again on Day 3 coupled with uncontrollable crying for 1 hour. Patient now has permanent ezcema on cheeks that is sore and painful.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pain, Swelling
Clinical narrative: Immediate symptom- head swollen, eyes swollen, face extremely flush like a tomato. Doctor claimed serotonin reaction. Dr. Had patient stay in clinic for 30 minutes to ensure no anaphylaxis. Episode occurred again on Day 3 coupled with uncontrollable crying for 1 hour. Patient now has permanent ezcema on cheeks that is sore and painful.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PATIENT'S ARM WAS SWOLLEN, HOT AND RED THE MORNING AFTER RECEIVING THE IMMUNIZATION. PATIENT ICED THE ARM AND USED OVER-THE-COUNTER ANALGESICS FOR RELIEF.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Hyperhidrosis, Rash
Clinical narrative: Rash, sweating, coughing, shortness of breath.
Age: 0.58
Sex: M
Vaccine: FLU4, RV5
Symptoms: Adenovirus infection, Blood uric acid increased, Brain death, Dyspnoea, Hypotonia
Clinical narrative: The morning of Sept. 20th pt was lethargic and burning up. I rushed him to the ER were he had a fever of 105.4. Once he was stable they transferred him by ambulance to Medical Center. There he was officially diagnosed with the rhinovirus and the adenovirus. I have discovered through his medical records, he possibly may have had RSV, which we were not made aware of. While in the hospital they did an ultrasound of his kidneys and checked his uric acid levels again, now they were at a 14.9. He was released on the 21st of September, and referred to a nephrologist. On the morning of the 27th, pt was in one of his spasms which were frequent with LNS, my husband was doing routine positioning taught by pt's physical therapist to us, to help him out of his fits. At this point, pt gasped and went limp. My husband ran into my room and we called 911. It took them 48 minutes to get pt heartbeat back, and by this point pt was brain dead. He was officially declared brain death at 1313 on September 29th. Almost instantly after arriving to the hospital, they started to accuse my husband of shaking our son. We know his is not true and believe this was cause from the brain injury due to lack of oxygen and vaccine injury.
Age: 0.58
Sex: M
Vaccine: FLU4, RV5
Symptoms: Lethargy, Muscle spasms, Pyrexia, Resuscitation, Rhinovirus infection
Clinical narrative: The morning of Sept. 20th pt was lethargic and burning up. I rushed him to the ER were he had a fever of 105.4. Once he was stable they transferred him by ambulance to Medical Center. There he was officially diagnosed with the rhinovirus and the adenovirus. I have discovered through his medical records, he possibly may have had RSV, which we were not made aware of. While in the hospital they did an ultrasound of his kidneys and checked his uric acid levels again, now they were at a 14.9. He was released on the 21st of September, and referred to a nephrologist. On the morning of the 27th, pt was in one of his spasms which were frequent with LNS, my husband was doing routine positioning taught by pt's physical therapist to us, to help him out of his fits. At this point, pt gasped and went limp. My husband ran into my room and we called 911. It took them 48 minutes to get pt heartbeat back, and by this point pt was brain dead. He was officially declared brain death at 1313 on September 29th. Almost instantly after arriving to the hospital, they started to accuse my husband of shaking our son. We know his is not true and believe this was cause from the brain injury due to lack of oxygen and vaccine injury.
Age: 0.58
Sex: M
Vaccine: FLU4, RV5
Symptoms: Skin warm, Ultrasound kidney
Clinical narrative: The morning of Sept. 20th pt was lethargic and burning up. I rushed him to the ER were he had a fever of 105.4. Once he was stable they transferred him by ambulance to Medical Center. There he was officially diagnosed with the rhinovirus and the adenovirus. I have discovered through his medical records, he possibly may have had RSV, which we were not made aware of. While in the hospital they did an ultrasound of his kidneys and checked his uric acid levels again, now they were at a 14.9. He was released on the 21st of September, and referred to a nephrologist. On the morning of the 27th, pt was in one of his spasms which were frequent with LNS, my husband was doing routine positioning taught by pt's physical therapist to us, to help him out of his fits. At this point, pt gasped and went limp. My husband ran into my room and we called 911. It took them 48 minutes to get pt heartbeat back, and by this point pt was brain dead. He was officially declared brain death at 1313 on September 29th. Almost instantly after arriving to the hospital, they started to accuse my husband of shaking our son. We know his is not true and believe this was cause from the brain injury due to lack of oxygen and vaccine injury.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Pt received the flu vaccine on 12/15/17. On 12/17/17 pt began having left sided pain and then left sided numbness. Pt went to her local ER where she was treated and released.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, C-reactive protein increased, Coronavirus test positive, Injection site erythema, Injection site induration
Clinical narrative: Pt. developed intense pain, swelling, redness and induration in the Rt. upper arm involving an area of 6 inches x 6 inches over next 4 days.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, White blood cell count increased
Clinical narrative: Pt. developed intense pain, swelling, redness and induration in the Rt. upper arm involving an area of 6 inches x 6 inches over next 4 days.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Achy all over, pain distal to the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local reaction, Peripheral swelling
Clinical narrative: Patient called to inform staff she had localized reaction and had to be seen on 11/15/2017 due to arm swelling and redness radiating down arm. States MD reports of adverse event with cellulitis and treated with KEFLEX.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Presyncope
Clinical narrative: Redness, itching, swelling, tenderness (L) upper arm. Near syncopal episode 4 days post vaccine.
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a physician regarding a male patient of an unknown age. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient's fever maxed 101 about 24 hours after receiving the product. On an unknown date, the patient experienced large welts across his left arm. The outcome of the events were not reported. Causality assessment was not reported.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Chest discomfort, Varicella post vaccine
Clinical narrative: Developed symptoms of chicken pox and was treated with acyclovir. Vaccine rec'd 10/10/17. 10/17, quarter sized lump at injection site. 10/18 lump larger, now 4 inches by 4 inches in diameter. 10/19, lump still 44, fluid filled rash to arms, trunk, and face, lungs tight, wheezing, extreme fatigue, headache, fever 100.8, itching all over. Acyclovir started on 10/20/18, which was prescribed by MD.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Fatigue, Headache, Injection site mass, Lung disorder, Pruritus generalised
Clinical narrative: Developed symptoms of chicken pox and was treated with acyclovir. Vaccine rec'd 10/10/17. 10/17, quarter sized lump at injection site. 10/18 lump larger, now 4 inches by 4 inches in diameter. 10/19, lump still 44, fluid filled rash to arms, trunk, and face, lungs tight, wheezing, extreme fatigue, headache, fever 100.8, itching all over. Acyclovir started on 10/20/18, which was prescribed by MD.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular, Wheezing
Clinical narrative: Developed symptoms of chicken pox and was treated with acyclovir. Vaccine rec'd 10/10/17. 10/17, quarter sized lump at injection site. 10/18 lump larger, now 4 inches by 4 inches in diameter. 10/19, lump still 44, fluid filled rash to arms, trunk, and face, lungs tight, wheezing, extreme fatigue, headache, fever 100.8, itching all over. Acyclovir started on 10/20/18, which was prescribed by MD.
Age: 0.75
Sex: F
Vaccine: FLUX, PNC13, FLU4, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Initial unsolicited report received from a non-health care professional (office staff) on 29-Nov-2017. This case involves a 10-month-old female patient who was vaccinated with 0.25 ml second dose of FLUZONE QIV intramuscularly (frequency: once, dosage form: prefilled syringe, batch number: UT5897NA, expiration date and site of administration were not reported) and also with third dose of PCV13 (manufacturer: Other) (Batch number, expiration date, dose, route and site of administration were not reported) on 27-Nov-2017. Patient had no known allergies. Patient's other medical history was not reported. Concomitant medications were not reported. On 29-Nov-2017, two days following the vaccination, the patient had developed a generalized, flat, red, macular, rash and a fever. The patient was previously vaccinated with first dose of FLUZONE QIV (Batch number, expiration date, dose, route and site of administration were not reported) on 25-Oct-2017. Laboratory investigations and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 0.75
Sex: F
Vaccine: FLUX, PNC13, FLU4, PPV
Symptoms: Pyrexia, Rash generalised, Rash macular
Clinical narrative: Initial unsolicited report received from a non-health care professional (office staff) on 29-Nov-2017. This case involves a 10-month-old female patient who was vaccinated with 0.25 ml second dose of FLUZONE QIV intramuscularly (frequency: once, dosage form: prefilled syringe, batch number: UT5897NA, expiration date and site of administration were not reported) and also with third dose of PCV13 (manufacturer: Other) (Batch number, expiration date, dose, route and site of administration were not reported) on 27-Nov-2017. Patient had no known allergies. Patient's other medical history was not reported. Concomitant medications were not reported. On 29-Nov-2017, two days following the vaccination, the patient had developed a generalized, flat, red, macular, rash and a fever. The patient was previously vaccinated with first dose of FLUZONE QIV (Batch number, expiration date, dose, route and site of administration were not reported) on 25-Oct-2017. Laboratory investigations and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypotension, Influenza, Influenza A virus test positive
Clinical narrative: Initial unsolicited report received from a consumer on 11-Dec-2017. This case involves a 84-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE HIGH-DOSE (Batch number; expiry date, dose in series and site of administration were not reported) intramuscularly on 08-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced viral infection, dehydration and atrial fibrillation (afib) for which patient has been hospitalized for one week. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient recovered from all the events. List of documents held by sender: none. Sender's Comments: Patient developed afib, viral infection and dehydration after vaccination. Exact time to onset is not known. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Age: 85.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Dehydration, Viral infection
Clinical narrative: Initial unsolicited report received from a consumer on 11-Dec-2017. This case involves a 84-year-old female patient who was vaccinated with 0.5 ml single dose of FLUZONE HIGH-DOSE (Batch number; expiry date, dose in series and site of administration were not reported) intramuscularly on 08-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced viral infection, dehydration and atrial fibrillation (afib) for which patient has been hospitalized for one week. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient recovered from all the events. List of documents held by sender: none. Sender's Comments: Patient developed afib, viral infection and dehydration after vaccination. Exact time to onset is not known. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.