chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Chest pain, Dysphagia, Dyspnoea
Clinical narrative: Patient noticed a blister on her right arm after removing the Band-Aid, and also had some stiffness in her right arm and neck. She took some ADVIL and just figured blister was from adhesive Band-Aid and stiffness was normal reaction. Woke up Sunday and was having difficulty raising her right arm. She took more ADVIL. She reported to work Monday and was having difficulty sitting at her microscope due to right arm stiffness and weakness. Next day, she went to Urgent Care and while waiting to be seen, developed difficulty swallowing, shortness of breath and chest pain. Urgent Care Center referred her to Emergency Room. She was seen in the ER and was released later that day.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Injected limb mobility decreased, Injection site vesicles, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Patient noticed a blister on her right arm after removing the Band-Aid, and also had some stiffness in her right arm and neck. She took some ADVIL and just figured blister was from adhesive Band-Aid and stiffness was normal reaction. Woke up Sunday and was having difficulty raising her right arm. She took more ADVIL. She reported to work Monday and was having difficulty sitting at her microscope due to right arm stiffness and weakness. Next day, she went to Urgent Care and while waiting to be seen, developed difficulty swallowing, shortness of breath and chest pain. Urgent Care Center referred her to Emergency Room. She was seen in the ER and was released later that day.
Age: 85.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling, Sepsis
Clinical narrative: Redness, swelling of arm, sepsis.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Joint swelling
Clinical narrative: Resumption of joint swelling (dormant for two years) two hours following FLUCELVAX QUAD vaccination.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Erythema, Injection site erythema, Injection site nodule
Clinical narrative: PREVNAR 13 injection caused redness swelling, itching, very hard knots underneath the skin at the injection site, then extending to the side areas of the arm as well as underarm area. The arm feels very feverish, and the first night, I had chills and pain in the joints of the arm that was injected. I have pain in the hand and arms are aching as well. On the third day the arm swelling and reactions have not decreased. The pain in the arm has been consistent and has not improved.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: PREVNAR 13 injection caused redness swelling, itching, very hard knots underneath the skin at the injection site, then extending to the side areas of the arm as well as underarm area. The arm feels very feverish, and the first night, I had chills and pain in the joints of the arm that was injected. I have pain in the hand and arms are aching as well. On the third day the arm swelling and reactions have not decreased. The pain in the arm has been consistent and has not improved.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: PREVNAR 13 injection caused redness swelling, itching, very hard knots underneath the skin at the injection site, then extending to the side areas of the arm as well as underarm area. The arm feels very feverish, and the first night, I had chills and pain in the joints of the arm that was injected. I have pain in the hand and arms are aching as well. On the third day the arm swelling and reactions have not decreased. The pain in the arm has been consistent and has not improved.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient was given PREVNAR 23 vaccine on 10/17/18. Today - 10/18/18 patient reported to primary care office with very swollen right shoulder joint, unable to complete full ROM, low grade fever, swelling/redness at injection site on right deltoid.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Extensive swelling of vaccinated limb, Pruritus, Rash, Urticaria
Clinical narrative: She reported that after getting her flu shot and PNEUMOVAX 23 2 weeks ago she was out of commission for the weekend; her arm swelled up (had swelling from elbow to wrist) and she broke out in hives. Stated for the first day she felt like a zombie - also had some shortness of breath, but not a problem now. Has to take BENADRYL to control; her dermatologist has her take up to 100mg dose. The arm she received the flu shot continues to itch. Has used topical steroids without relief and also has a little rash on the eyelids.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 10-23-18 Patient and husband come to HD with c/o right shoulder pain. Reports that she has had pain for about 10 months, noticed it hurting a few days after receiving a Tdap vaccine. Patient reports having previously seen a chiropractor and another physician who directed her back to where she received the vaccine. Pt also reports that she has not had any medical evaluations, x-rays, scans or treatments for this issue. Inspection reveals no obvious deformity in right deltoid, scar noted near top of the right shoulder, patient states that was from a BCG vaccine received in another country when she was younger. Patient has limited range of motion with right arm abduction and extension. Advised patient to follow up with medical provider for further evaluation and treatment. Appointment made for 10-25-2018 at 1400 with PA-C at the Clinic.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: Redness, itching, localized inflammatory reaction.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: The patient states her arm was sore immediately after the shot and only continued to get worse and had a terrible night sleeping because of the pain. She is having trouble still raising her arm and has pain when she does. She no longer has pain when not lifting arm, pt called her doctor today who is giving her some gabapentin to see if it helps if a nerve has been affected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Temp 37.1C; pulse 72, wt. 34.6 kg; SpO2 96%; area of mild swelling and erythema on the left thigh around the site of vaccine approx 8 cm in circumference. Distal sensation/pulses intact. Range of motion intact hip and knee. Mother reported fever x 2 greater than 100.4 at home, giving Ibuprofen. Mother reported fever up to 105. No signs of anaphylaxis, diffuse, rash, itching, or respiratory distress. Afebrile in clinic.
Age: 1.17
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Bacterial test, Body temperature increased, Decreased appetite, Diarrhoea, Irritability
Clinical narrative: Temp of 100.5 morning of 10/9/18, loose/diarrhea type stools started as well. For 3 days having multiple per day. Pt had decreased appetite. Pinpoint rash to trunk started on 10/12/18 and spread to whole body on 10/13/18. Pt began improving on 10/14/18 and continued to. Pt's appetite returned 10/15/18. Here today with parents with concerns of continued loose stools, irritability, and decreased appetite. Started with 100.5 temp on Tuesday after getting flu shot on Monday. Loose stools x 3 days. Multiple per day. Today stools are more formed, but still not eating well. He did eat watermelon for lunch. No blood to stool. No vomiting. He is much more irritable and fussy than normal. He is less energetic than normal. Pinpoint rash just noticed to trunk this afternoon. No cough or runny nose.
Age: 1.17
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash generalised, Stool analysis, Streptococcus test
Clinical narrative: Temp of 100.5 morning of 10/9/18, loose/diarrhea type stools started as well. For 3 days having multiple per day. Pt had decreased appetite. Pinpoint rash to trunk started on 10/12/18 and spread to whole body on 10/13/18. Pt began improving on 10/14/18 and continued to. Pt's appetite returned 10/15/18. Here today with parents with concerns of continued loose stools, irritability, and decreased appetite. Started with 100.5 temp on Tuesday after getting flu shot on Monday. Loose stools x 3 days. Multiple per day. Today stools are more formed, but still not eating well. He did eat watermelon for lunch. No blood to stool. No vomiting. He is much more irritable and fussy than normal. He is less energetic than normal. Pinpoint rash just noticed to trunk this afternoon. No cough or runny nose.
Age: 1.17
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash, Stool analysis normal
Clinical narrative: Temp of 100.5 morning of 10/9/18, loose/diarrhea type stools started as well. For 3 days having multiple per day. Pt had decreased appetite. Pinpoint rash to trunk started on 10/12/18 and spread to whole body on 10/13/18. Pt began improving on 10/14/18 and continued to. Pt's appetite returned 10/15/18. Here today with parents with concerns of continued loose stools, irritability, and decreased appetite. Started with 100.5 temp on Tuesday after getting flu shot on Monday. Loose stools x 3 days. Multiple per day. Today stools are more formed, but still not eating well. He did eat watermelon for lunch. No blood to stool. No vomiting. He is much more irritable and fussy than normal. He is less energetic than normal. Pinpoint rash just noticed to trunk this afternoon. No cough or runny nose.
Age: 1.17
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Streptococcus test negative
Clinical narrative: Temp of 100.5 morning of 10/9/18, loose/diarrhea type stools started as well. For 3 days having multiple per day. Pt had decreased appetite. Pinpoint rash to trunk started on 10/12/18 and spread to whole body on 10/13/18. Pt began improving on 10/14/18 and continued to. Pt's appetite returned 10/15/18. Here today with parents with concerns of continued loose stools, irritability, and decreased appetite. Started with 100.5 temp on Tuesday after getting flu shot on Monday. Loose stools x 3 days. Multiple per day. Today stools are more formed, but still not eating well. He did eat watermelon for lunch. No blood to stool. No vomiting. He is much more irritable and fussy than normal. He is less energetic than normal. Pinpoint rash just noticed to trunk this afternoon. No cough or runny nose.
Age: 21.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of arm.
Age: 67.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Redness, itchiness. Local reaction. Tx with BENADRYL and ice.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth on left arm where flu site was injected.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Really red swollen arm all the way down and red and warm to the touch.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Approx. 24 hours after receiving FLUZONE in (R) thigh - pt developed 2 inch red pruritic rash around injection site.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Developed redness and warmth at site day of vaccine. Sx progressed and now 4 1/2 inches x 5 inches area of erythema and warmth right upper arm. Instructed to use ice, elevate (R) arm. Also ZYRTEC 10 mg daily.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Eye swelling, Rash, Skin exfoliation, Swelling face
Clinical narrative: Breaking out with face rash, face is swollen, eyes are hurting and closing. Skin scaling, nostrils are crusted.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Received flu vaccination thru Employer Clinic. Injection given by MD but felt immediate pain. Indicates location of injection was too high near shoulder joint. Pain persistent range of motion limited and pain when sleeping on left arm. Noting tingling in left hand.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Received flu vaccination thru Employer Clinic. Injection given by MD but felt immediate pain. Indicates location of injection was too high near shoulder joint. Pain persistent range of motion limited and pain when sleeping on left arm. Noting tingling in left hand.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient called on 10/14/2018 and complained of sore and painful arm. She had not taken anything for the pain at the time of reporting the pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt's arm is constantly sore, has limited mobility pt went to his Dr office pt wanted pain medication but Dr gave him gabapentin he is also using over the counter muscle rubs.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, headache, muscle ache, tired.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Generalised tonic-clonic seizure, Immediate post-injection reaction
Clinical narrative: Tonic clonic seizure for 5 min immediately after vaccination (started within 1 minute).
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Urticaria, Vaccination complication
Clinical narrative: 4 days after my 6 year old daughter got her flu shot, she developed a large hive around the injection site. Saturday night she developed hives all over her back and torso. Sunday night again hives developed on her back, torso, legs, and face. We went to the ER, they started her on prednisone and sent us home. She had hives Monday all day but they were not as bad, then Tuesday morning she woke to hives all over her body, the worst it has been. Again we went to the ER and they didn't give us many answers except they believe it's something in the flu shot that she is reacting to, but she does not have an egg allergy. She has been getting BENADRYL around the clock and with the prednisone and her hives are getting worse and this all started when she got her flu shot. There has also been 2 other cases of this happening after getting the flu shot. I have lots of pictures I can email if needed.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: Member had a metallic taste in his mouth about 30 min after receiving influenza vaccine. He was kept for 15 observation. After the 15 min his metallic taste disappeared. Was kept for another 30 min observation. In that time he just complained about cottonmouth. Was able to drink water which helped. It resolved after 45 min and pt was discharged.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling abnormal, Immediate post-injection reaction, Injection site pain, Injection site reaction
Clinical narrative: Immediate "pop" feeling when needle inserted into Left Deltoid (I believe that it was injected too high). After 2 days of soreness, sharp constant pain in left shoulder. Decreased ROM and weakness.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased
Clinical narrative: Immediate "pop" feeling when needle inserted into Left Deltoid (I believe that it was injected too high). After 2 days of soreness, sharp constant pain in left shoulder. Decreased ROM and weakness.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Throat tightness
Clinical narrative: Acute mild throat tightness and lightheadedness that spontaneously resolved within 10 minutes. Given prescription for OTC Benadryl 25mg take one every 8 hours as needed.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Fever and chills on evening of vaccination. Visit to MD on 10/16. Left arm has 10cm area very painful, red and hot, with redness extending down arm. Not described as cellulitis. Patient reports itching over entire body, without hives. T37.4, HR 91, comfortable, not distress. BP 130/83. Prednisone 60mg daily x 5 days. Reports feeling better by October 18.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Fever and chills on evening of vaccination. Visit to MD on 10/16. Left arm has 10cm area very painful, red and hot, with redness extending down arm. Not described as cellulitis. Patient reports itching over entire body, without hives. T37.4, HR 91, comfortable, not distress. BP 130/83. Prednisone 60mg daily x 5 days. Reports feeling better by October 18.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Started with abdominal pain 2 hours after injection; increase muscle aches approximately 4 hrs later; 10hrs after injection shivering, chills and rigor started; increased body aches and headache; fever to 102 that evening with increased headache and body aches; 24 hrs after injection severe body aches and headache with fever to 100.5; dizziness; 29hrs post vaccine majority of symptoms had resolved; 48 hrs after injection all symptoms resolved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Started with abdominal pain 2 hours after injection; increase muscle aches approximately 4 hrs later; 10hrs after injection shivering, chills and rigor started; increased body aches and headache; fever to 102 that evening with increased headache and body aches; 24 hrs after injection severe body aches and headache with fever to 100.5; dizziness; 29hrs post vaccine majority of symptoms had resolved; 48 hrs after injection all symptoms resolved.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness and rash at injection site. No pain.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unspecified gender and age. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD lot # R002934, expiration date 29-JUL-2019, (dose, route, vaccination site and frequency were not reported), for prophylaxis which was reconstituted concomitantly with sterile diluent, lot# N014021, expiration date 04-AUG-2019. The suspect vaccine was exposed to a temperature of 6 Fahrenheit (°F) to 14 °F 39 hours 35 minutes and 15 °F to 46 °F 39 hours 57 minutes. There were no previous temperature excursions. A digital data logger was involved.  No adverse effects were reported in any patients. Furthermore, no product quality complaint (PQC) was involved.
Age: 66.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient. The patient's pertinent medical history included high cholesterol. The patient's drug reactions and allergies included allergy to clarithromycin. The patient's concomitant therapy included rosuvastatin calcium (CRESTOR). On 09-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left arm (lot # R012632, expiration date: 15-JAN-2020, dose was not provided) and FLUCELVAX in the left arm (lot # 252228, expiration date: 31-MAY-2019, dose and route of administration were not provided) for prophylaxis as the patient was over age of 65 and was due for second PREVNAR 13 on an unknown date in 2017 (reported as one year ago). On 10-OCT-2018, the patient experienced chills, fever and large red rash that was itchy and hot to touch on the injected arm and the patient was unable to move injected arm. The injection site reaction appeared to be stemming from where PNEUMOVAX 23 was injected. The patient received unspecified treatment for the events. The patient sought medical attention via coming to pharmacy. The outcome of the events was reported as not recovered. The relatedness between the events and suspect vaccines was not reported.
Age: 66.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site warmth, Pyrexia, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient. The patient's pertinent medical history included high cholesterol. The patient's drug reactions and allergies included allergy to clarithromycin. The patient's concomitant therapy included rosuvastatin calcium (CRESTOR). On 09-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left arm (lot # R012632, expiration date: 15-JAN-2020, dose was not provided) and FLUCELVAX in the left arm (lot # 252228, expiration date: 31-MAY-2019, dose and route of administration were not provided) for prophylaxis as the patient was over age of 65 and was due for second PREVNAR 13 on an unknown date in 2017 (reported as one year ago). On 10-OCT-2018, the patient experienced chills, fever and large red rash that was itchy and hot to touch on the injected arm and the patient was unable to move injected arm. The injection site reaction appeared to be stemming from where PNEUMOVAX 23 was injected. The patient received unspecified treatment for the events. The patient sought medical attention via coming to pharmacy. The outcome of the events was reported as not recovered. The relatedness between the events and suspect vaccines was not reported.
Sex: M
Vaccine: MMR
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a currently 5-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II 05. ml (route of administration, lot # and expiration date were not provided) as prevention of measles, mumps and rubella. On an unknown date, the patient experienced a localized injection site reaction, where his leg swelled up, became red, itchy and hot to touch, then turned black and blue. The patient received unspecified treatment for the events. The patient sought medical attention via seeing pediatrician. The outcome of the events was reported as recovered. The relatedness between the events and M-M-R II was not reported.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (age and gender not reported) who received a dose of vaccine PENTACEL on an unspecified date (lot number not reported via unknown route and site of administration). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that when the box was opened there was only one vial of the ACTHIB portion remaining, a patient somewhere may have received an incorrect dose. It was a case of actual medication error due to inappropriate reconstitution technique and incorrect dose. No information on adverse event reported. The patient outcome is reported as Not Applicable for from PENTACEL there was only one vial of the ACTHIB portion remaining. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Injection site rash, Urticaria
Clinical narrative: Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient (age and gender unknown) who experienced rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face, while received vaccine FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided. On 16-Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1809, expiry date 30-Jun-2019 via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. (urticaria) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. (rash) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. (vaccination site reaction) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Lab data was not provided. Final diagnosis was rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. During the evening on 17-Oct-2018, HCP instructed patient to take BENADRYL, ZYRTEC and ZANTAC. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for rash that started below the left arm injection site and then went down to her elbow and then developed into welts on the left side of her face. List of documents held by sender- none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right arm red and swollen. Per Dr. "Recommend supportive care with ibuprofen 400 mg Q6-8, PRN BENADRYL 25mg Q4-6h, and icing. To call for streaking redness, fevers, increased pain, failure to improve over next week."
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Muscle strain, Pain in extremity
Clinical narrative: I'm not sure of the exact vaccine; however, I've had radiating pain in my arm. It started in the back of my arm and is now in my elbow and forearm. It feels like a pulled muscle. I wanted to report this injury for informational purposes.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Soreness of upper arm started almost immediately--severe chills, body aches, slight temperature started around 5:00 pm--headache started in the middle of the night. It felt like I had the flu, minus any stomach issues. Additionally, I have tenderness (like nerve sensitivity) near the area that I had shingles 7 years ago--it feels like the beginning of shingles again. The feeling is at my inner left thigh. Hoping this "nerve sensitivity" goes away soon! I think I'm over the worse of the flu-like symptoms--will try to go into work later today.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: Soreness of upper arm started almost immediately--severe chills, body aches, slight temperature started around 5:00 pm--headache started in the middle of the night. It felt like I had the flu, minus any stomach issues. Additionally, I have tenderness (like nerve sensitivity) near the area that I had shingles 7 years ago--it feels like the beginning of shingles again. The feeling is at my inner left thigh. Hoping this "nerve sensitivity" goes away soon! I think I'm over the worse of the flu-like symptoms--will try to go into work later today.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Impaired work ability, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: On 9-26-18 when shot was administered I immediately commented that the injection was more painful than normal. By 3 PM my upper arm was hot, painful and very heavy feeling. I had to stop working, ice my arm and take pain meds. I could not move my left arm at first, I have tried to keep it loose, but I cannot lift my arm over my head to remove my shirt, nor can I rotate my shoulder or put pressure on my left arm in certain directions without having pain. This continued for a few days until I began to hear about SIRVA from others with frozen shoulders. I knew immediately that I have SIRVA. The symptoms have improved, but remain.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Limb discomfort, Pain, Shoulder injury related to vaccine administration
Clinical narrative: On 9-26-18 when shot was administered I immediately commented that the injection was more painful than normal. By 3 PM my upper arm was hot, painful and very heavy feeling. I had to stop working, ice my arm and take pain meds. I could not move my left arm at first, I have tried to keep it loose, but I cannot lift my arm over my head to remove my shirt, nor can I rotate my shoulder or put pressure on my left arm in certain directions without having pain. This continued for a few days until I began to hear about SIRVA from others with frozen shoulders. I knew immediately that I have SIRVA. The symptoms have improved, but remain.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Blindness, Neuralgia, Oral herpes, Pain in extremity
Clinical narrative: Tingling in legs and hands, pain in both wrists and hands, arm pain. New symptom cold sore and loss of vision.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling in legs and hands, pain in both wrists and hands, arm pain. New symptom cold sore and loss of vision.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Day of administration, she heard a pop and it was painful during the injection, since then her arm has been painful, limited with use. Left deltoid area with some anterior swelling and tenderness. Hurts to move the arm. No redness at the area.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Day of administration, she heard a pop and it was painful during the injection, since then her arm has been painful, limited with use. Left deltoid area with some anterior swelling and tenderness. Hurts to move the arm. No redness at the area.
Age: 48.0
Sex: F
Vaccine: FLU4, HEP, MMR, TDAP
Symptoms: Back pain, Condition aggravated, Grip strength decreased, Muscular weakness, Myalgia
Clinical narrative: A couple of days after taking first vaccine, felt achiness and myalgias that has lasted throughout, has felt weakness to arms (both) that seems to have increased over time since taking the vaccines 2 months ago (notably unable to open jars, doors feel heavy to open, etc); some relief with OTC analgesics but not as expected, even back pain that was present before taking vaccines has become more constant and using the analgesics have not relieved the pain.
Age: 48.0
Sex: F
Vaccine: FLU4, HEP, MMR, TDAP
Symptoms: Pain
Clinical narrative: A couple of days after taking first vaccine, felt achiness and myalgias that has lasted throughout, has felt weakness to arms (both) that seems to have increased over time since taking the vaccines 2 months ago (notably unable to open jars, doors feel heavy to open, etc); some relief with OTC analgesics but not as expected, even back pain that was present before taking vaccines has become more constant and using the analgesics have not relieved the pain.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Plantar fasciitis, Ultrasound scan
Clinical narrative: Plantar fasciitis.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder limiting mobility and strength with a significant impact on ability to sleep.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, X-ray limb normal
Clinical narrative: She developed left shoulder joint pain extending into her deltoid and acromioclavicular space after her flu injection administered at site which continued 3 weeks after the injection. She presented to the location for initial evaluation 10/05/2018. Rated left shoulder pain 7/10 stabbing and aching in nature. She states she had decreased ROM in the left shoulder joint. BP 119/77, pulse 61, temp oral 97.7. No visible edema, erythema, ecchymosis, streaking or wound. No neurovascular deficits. No epitrochlear nodes. Full ROM left shoulder joint. Hand grasps equal.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Warm to touch yesterday not so today. Red small circle around it. Lump underneath it. Vaccine given not in the deltoid given lower in the arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Seizure, Tremor
Clinical narrative: Was sleeping woke up with  suddenly with body violently shaking, fell right back to sleep and woke up again with violent shaking, back to sleep woke up normal time 7 AM. Just felt tired the next day.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection is red, swollen, tender, and hot to touch. Noticed symptoms the next morning after the injection.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Irritability, Wrong product administered
Clinical narrative: A nurse mistakenly drew up a ACTHIB when she intended to draw up a Hepatitis B, and administered it to the child. We checked with mother (and notified her of the error and apologized) and Mom reported that baby was extremely fussy after the vaccine, very difficult to settle, much more so than she recalled from her first son, but did not have a fever and is now doing well.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Chest pain, Pain in extremity
Clinical narrative: With in five minutes of administering vaccination  patient was experiencing severe stabbing pains throughout her entire core especially in her upper chest, arm, and back. Patient was not having trouble breathing and was able to talk. She wanted to go to the emergency room as a precaution so we did call an ambulance to transport her. At the time the ambulance arrived she was doing much better and walked into the ambulance.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: No issues until 10/23/18. Starting on 10/23 left arm/shoulder began hurting badly to the point of being unable to move arm without severe pain.
Sex: F
Vaccine: HPVX
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date approximately in 2013, reported as five years ago, the patient was vaccinated with an unspecified dose of an HPV vaccine, it was unknown if the vaccine was GARDASIL 9 or GARDASIL, as routine vaccination (dose, frequency, lot number and expiration date were not reported). It was reported that right after administration of the vaccine, the patient had a seizure that lasted a short amount of time and that the patient was still in the office visit by the time the seizure ended. At the time of the report, the patient was recovered from the event. Upon internal review, the event seizure was considered to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 19-OCT-2018 the patient was vaccinated with PROQUAD lot # R013125, 2 dosage form. On 19-OCT-2018, 1 day after onset of therapy the patient experienced accidental overdose and vaccination error. On an unknown date the patient experienced no adverse event. The outcome of accidental overdose, no adverse event and vaccination error is unknown.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Immediate post-injection reaction, Malaise, Urticaria, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 7-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number EN9S4, expiry date 30th June 2018) for prophylaxis. Previously administered products included FLUZONE (in 2012) and FLULAVAL (in 2015). On 25th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 25th September 2018, immediately after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced sickness. On an unknown date, the patient experienced hives (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), wheezing (serious criteria hospitalization) and vomiting. The patient was treated with epinephrine, diphenhydramine hydrochloride (Benadryl Intravenous) and methylprednisolone sodium succinate (Solumedrol (Methyl Prednisolone)). On an unknown date, the outcome of the hives, shortness of breath, wheezing, vomiting and sickness were recovering/resolving. It was unknown if the reporter considered the hives, shortness of breath, wheezing, vomiting and sickness to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The reporter stated that the patient had FLUZONE in 2012 and also had FLULAVAL in 2015 without any issues. After receiving FLUARIX QIV, the patient broke out in hives and got sick immediately. The patient also presented with vomiting, shortness of breath and wheezing. The patient was given epinephrine that seemed to work and was discharged from physician with oral medications. The patient ended up back in the hospital for 4 days due to the hives, shortness of breath and wheezing since none of the oral medications were working. The patient was given IV medications such as IV Benadryl and IV solumedrol which seemed to help. The patient was discharged from hospital after 4 days
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 7-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number EN9S4, expiry date 30th June 2018) for prophylaxis. Previously administered products included FLUZONE (in 2012) and FLULAVAL (in 2015). On 25th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 25th September 2018, immediately after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced sickness. On an unknown date, the patient experienced hives (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), wheezing (serious criteria hospitalization) and vomiting. The patient was treated with epinephrine, diphenhydramine hydrochloride (Benadryl Intravenous) and methylprednisolone sodium succinate (Solumedrol (Methyl Prednisolone)). On an unknown date, the outcome of the hives, shortness of breath, wheezing, vomiting and sickness were recovering/resolving. It was unknown if the reporter considered the hives, shortness of breath, wheezing, vomiting and sickness to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The reporter stated that the patient had FLUZONE in 2012 and also had FLULAVAL in 2015 without any issues. After receiving FLUARIX QIV, the patient broke out in hives and got sick immediately. The patient also presented with vomiting, shortness of breath and wheezing. The patient was given epinephrine that seemed to work and was discharged from physician with oral medications. The patient ended up back in the hospital for 4 days due to the hives, shortness of breath and wheezing since none of the oral medications were working. The patient was given IV medications such as IV Benadryl and IV solumedrol which seemed to help. The patient was discharged from hospital after 4 days
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a female patient who received FLUARIX QUADRIVALENT (batch number 2MA5F, expiry date 30th June 2019) for prophylaxis. On 11th October 2018, the patient received FLUARIX QUADRIVALENT (intramuscular). On 11th October 2018, several minutes after receiving FLUARIX QUADRIVALENT, the patient experienced tingling. On an unknown date, the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the tingling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient received FLUARIX in left deltoid. The health care professional (HCP) reported that minutes after administering FLUARIX to the patient, patient had tingling in her ring and pinky fingers and on the left side of her face. Adverse events were still occurring when HCP called in. The HCP did not want to disclose the patient demographics.
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of frozen shoulder in a female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced frozen shoulder. On an unknown date, the outcome of the frozen shoulder was unknown. It was unknown if the reporter considered the frozen shoulder to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated she had frozen shoulder after receipt of an influenza vaccine in the past. The HCP (Healthcare professional) stated patient was unsure of which flu vaccine was given. The HCP did not have any other details.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The limited information was provided. The caller reported that he was at a myeloma support group meeting and another patient's husband (patient) reported that he had the SHINGRIX and experienced a sore arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced rash and joint pain. On an unknown date, the outcome of the rash and joint pain were recovering/resolving. It was unknown if the reporter considered the rash and joint pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a rash down her arm and really sore joints. The healthcare professional did not know the onset but patient informed her of this on Saturday 13th October 2018.  It was getting better. The healthcare professional stated that would informed the patient to call the agency as well to report this.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (reoccurring). On 3rd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient developed another case of shingles. The patient was currently taking acyclovir for most recent outbreak of Shingles. No further details were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Ligament pain, Mobility decreased, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received Shingrix for prophylaxis. On 24th April 2018, the patient received the 1st dose of Shingrix. In April 2018, less than a day after receiving Shingrix, the patient experienced bedridden, mobility decreased, muscle pain, joint pain and ligament pain. On 24th April 2018, the patient experienced general body pain. On an unknown date, the outcome of the general body pain, bedridden and mobility decreased were recovered/resolved and the outcome of the muscle pain, joint pain and ligament pain were unknown. It was unknown if the reporter considered the general body pain, bedridden, mobility decreased, muscle pain, joint pain and ligament pain to be related to Shingrix. Additional details were provided as follows: The caller reported that less than a day after receiving Shingrix, the patient experienced whole body hurt, except her face. By midnight of the day of the vaccination, the patient could not lift her arm. The patient's every muscle, joint and ligament in her body ached and she could not get out of bed for 3 days. By the 4th day, the patient felt better and was up and about.