chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 10/4/17: Right medial arm with warmth, erythema, tender. Erythematous patch measuring approximately 11cmx12cm. Clindamycin HCl 300 MG q8h for 10 days prescribed. 10/5/17: right medial arm with warmth, erythema and moderately tender patch. Right shoulder is tender and mildly warm but no longer erythematous. No moisture. Erythematous patch measuring about 18cm x 18cm. Discontinued course of Clindamycin. Continue with Naproxen 500mg q12h as needed.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Started with feeling chilled (though no fever initially). Very slight fever recorded at 11:00pm (99.6 F) and continued with fever all night until taking ADVIL at 5am. Muscle aches and nausea also present starting around 11pm. Symptoms resolved by noon next day. Another 36 hours of fatigue and now mostly back to normal.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with redness and some swelling to Rt arm at the site the Pneumo 23 was given. Some tenderness to palpation and slightly warm to touch. Redness measures 6 by 5 in size. Instructed by advice of Provider to apply warm compresses and Ibuprofen. Come back in to reevaluate site to see if redness has grown. Redness marked with black pen.
Age: 53.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to the pharmacy the next day with redness, swelling and warmth at the injection site of her left deltoid muscle.
Age: 64.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Dehydration, Diarrhoea, Nausea, Pain
Clinical narrative: 2 days later -arm soreness occurred. 5 days after injection: nausea, vomiting, diarrhea, and dehydration. Body aches and joints hurting 5 days later.
Age: 64.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain in extremity, Vomiting
Clinical narrative: 2 days later -arm soreness occurred. 5 days after injection: nausea, vomiting, diarrhea, and dehydration. Body aches and joints hurting 5 days later.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Rash
Clinical narrative: Patient called pharmacy on 10-5-17 and commented that she had been experiencing a rash on her neck and a "hot" or "flushed" feeling on her face beginning about midday on 10-4-17, about 24 hours after I had given her the FLUZONE HD immunization. When questioned, she could think of no other "new" things (soap, medication, cosmetics) that could have been responsible. She had no shortness of breath or rash on her trunk or the arm that was immunized. She had not taken any diphenhydramine, nor did she feel that she needed to. She just wanted to make us aware. I have immunized her here at this location for several years previously without any similar problems.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Induration
Clinical narrative: 11 x 6cm mild induration top margin about 2cm below site of injection.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Tenderness, soreness, and pain at the site of injection, feeling tired and pain when moving the arm. Patient has been using ice pack and ADVIL and still complain of the pain. Her doctor advised increasing ibuprofen to 400 mg every 8 hours and follow up after a couple of days.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Urticaria
Clinical narrative: Patient states she developed hives bilaterally on face Saturday morning after receiving both flu and pneumonia on Friday, 9/29/17. Patient states she has several allergies and is not positive that the reaction could be due to either vaccine. Patient will follow up with PCP as soon as possible.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pruritus, Insomnia, Pain, Pyrexia
Clinical narrative: The evening of the vaccination on 10/4/17, the patient states she had a lot of pain which kept her awake. The following morning, she experienced a high fever and headache at 5:00 AM and her arm became red with bumps and slight itching. When she presented at the pharmacy at 3:30 PM she had a 2.5" x 2.5" red splotchy patch where the vaccination was given and stated it was somewhat itchy. Patient was advised to take BENADRYL and contact her doctor. I marked the area with pen and told her if it got any bigger than the area, was hot to the touch or she saw any red lines, to call her doctor immediately or go to the ER.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash macular, Rash pruritic, Vaccination site reaction
Clinical narrative: The evening of the vaccination on 10/4/17, the patient states she had a lot of pain which kept her awake. The following morning, she experienced a high fever and headache at 5:00 AM and her arm became red with bumps and slight itching. When she presented at the pharmacy at 3:30 PM she had a 2.5" x 2.5" red splotchy patch where the vaccination was given and stated it was somewhat itchy. Patient was advised to take BENADRYL and contact her doctor. I marked the area with pen and told her if it got any bigger than the area, was hot to the touch or she saw any red lines, to call her doctor immediately or go to the ER.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives around face, back, arms- started in the car after getting shot. Of note, latex glove was used and h/o latex allergy but glove did not touch back or face.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Pt returned to vaccination station 2 minutes after receiving vaccine complaining of light-headedness and nausea. We had pt sit down and asked him the last time he ate, to which he replyed "yesterday".  I immediately applied an ice pack to back of patient's neck and had him eat candy bars and drink 7up.  He sat for 5 minutes and reported feeling "a lot better". He returned to work and reported no other residual effects.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported to pharmacy on October 3rd that since receiving the vaccination on September 20th 2017 her arm had been sore and any time she tried to lift the arm, she always experienced severe pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye pain, Headache, Lip blister, Ocular hyperaemia
Clinical narrative: Patient reported having a headache blister on upper lips and lower right  eyelid . Patient also reported having pain in the right eye redness.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Patient stated that her left arm hurts, still has a radiating pain to chest area, she had an ER visit to check the cause of the pain,  pt was administered the vaccine at her left deltoid muscle, according to Pharmacy knowledge pt took Advil / Tylenol and cold compressions.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass
Clinical narrative: Patient received vaccine in right deltoid. The following day noticed a lump underneath her arm with a red line from lump to lymph node in arm pit.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling on biceps down to elbow.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and swelling on biceps down to elbow.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Mild rash on arm and chest. Treatment includes self treatment with oral antihistamine. Course unknown.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient received the vaccine without incident. He came back after two hours complaining that he went and worked out and now had red dots on his legs and abdomen. He wouldn't show them to us. We assessed him for other symptoms which was all negative. We gave him 50mg of liquid diphenhydramine and told him to repeat the dose every 6 hours as needed for these symptoms.  We checked on him twice in the next 30 minutes. He was doing well. We explained that if they worsen or if he noticed facial/oral swelling and/or breathing issues to call 911 immediately. He understood.  My clinical services manager checked with him last night and this morning and he was doing well.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient called pharmacy on 10/5/17 at 8:15pm. Stated she had extreme soreness/stiffness in arm as well as warm to touch and a rash. Told patient we would call physician. Educated patient to take diphenhydramine/available NSAID and ice area of injection. Educated patient to call physician as well in the AM. If symptoms continued to worsen, educated to seek medical attention. Will call patient back in AM on 10/6/17
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: The patient claims that the next day after being given the vaccine, they started to get a red itchy rash all over their body. The worst was the upper torso and arms. They did not start any new medications or go outside or do anything that could really result in this reaction. They saw the doctor a week later and the doctor gave the patient a MEDROL dose pack and ATARAX to help with the rash and itching. This helped and the patient is doing better, but they still have some of the rash even 2 weeks later.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Joint injection, Musculoskeletal pain, Neck pain
Clinical narrative: Progressive worsening of pain to left arm, neck, shoulder and back after the flu shot was administered followed by numbness to left arm.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Progressive worsening of pain to left arm, neck, shoulder and back after the flu shot was administered followed by numbness to left arm.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient reported a 1/2 dollar size, approx. 1 inch diameter size red spot at the injection site. Told mom to monitor the red area and seek medical attention if the redness continues to spread. Reported to Pharmacist at 6:40pm on 10/5.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: RIGHT deltoid extremely swollen, hot, tender, red, itchy, hard.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site warmth
Clinical narrative: RIGHT deltoid extremely swollen, hot, tender, red, itchy, hard.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Hypersomnia, Nausea, Pain
Clinical narrative: Approximately 8 hours after getting the shot, I woke up in a complete sweat. I was trembling and my teeth were chattering. Eventually, I fell back to sleep. A couple of hours later, I woke up feeling nauseous. By morning, I was very, very achy and spent most of the day in bed, napping.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Approximately 8 hours after getting the shot, I woke up in a complete sweat. I was trembling and my teeth were chattering. Eventually, I fell back to sleep. A couple of hours later, I woke up feeling nauseous. By morning, I was very, very achy and spent most of the day in bed, napping.
Age: 82.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, Prostatic specific antigen increased, Radiotherapy, Tooth infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tooth infection in a 82-year-old male patient who received TWINRIX. Co-suspect products included TWINRIX. Concurrent medical conditions included prostate cancer (diagnosed 5 years ago). Concomitant products included Atorvastatin, finasteride, Losartan, pantoprazole, Vitamin B12, Probiotics, vitamin d, COSOPT, Coq10, glimepiride, Lutein + Zeaxanthin and Potassium. On 5th May 2017, the patient received the 1st dose of TWINRIX (intramuscular). On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, less than a year after receiving TWINRIX and not applicable after receiving TWINRIX, the patient experienced tooth infection, prostate specific antigen increased and incomplete course of vaccination. The patient was treated with Amoxicillin. On an unknown date, the outcome of the tooth infection, prostate specific antigen increased and incomplete course of vaccination were unknown. It was unknown if the reporter considered the tooth infection to be related to TWINRIX. The reporter considered the prostate specific antigen increased to be unrelated to TWINRIX. Additional details were provided as follows: On 5th May 2017, the patient received the 1st dose of TWINRIX on an unknown arm for trip. The patient did not receive a second dose of TWINRIX, which led to incomplete course of vaccination. The patient wanted to know if it was okay to receive the second dose. The patient was observed without treatment for prostate cancer, which was diagnosed 5 years age until he started radiation therapy on 8th August 2017 because his prostate specific antigen (PSA) kept going up. The cancer did not seem aggressive.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that an employee of the hospital experienced the events. No product or patient information was available.
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site haemorrhage, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4XH59, expiry date 22nd June 2018). The patient's past medical history included bursitis. On 25th September 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th September 2017, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and injection site hemorrhage. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injection site hemorrhage was unknown. It was unknown if the reporter considered the pain in arm and injection site hemorrhage to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT injection in deltoid muscle. The patient said that she felt immediate pain in her arm that ran down the arm. The reporter stated that there was some blood back at the end of the injection but noted the patient jumped a little when the injection was given. The full dose was given, but afterwards the patient stated that it hurt and she could feel it all the way in her fingers. She was advised to apply compresses and take ibuprofen. The patient called back to the pharmacy and reported that she was feeling better about an hour after the injection. The patient had a history of bursitis and she was concerned that the pharmacist might have injected in the bursa, and was concerned the vaccine might not provide protection and should she get another one.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site mass, Swelling
Clinical narrative: Pt. noticed swelling and redness. It continued to get worse. She walked in to our office to show the Dr. on 10/04/2017. Dr. measured a 6 x 4 cm lump with erythema at the injection site.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: On 9/25/17, employee came to EH. RUA red, rash noted, C/O itching. No crusting, no drainage, couple of bumps noted. Denies any fever or other symptoms. On 9/26/17 employee returned to EH. Rash resolving - no longer red, slightly pink, denies itching, using hydrocortisone cream PRN. No new areas noted.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Vaccination complication, Vision blurred
Clinical narrative: Headache - dizziness - blurry vision/no treatment. I was checked out by the nurse at work - symptoms didn't change - went to outpatient clinic next, which stated it was a reaction to the flu shot.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Tenderness
Clinical narrative: Left arm red, hurts when you touch. 1:00pm 10/4/17. From flu vaccine administered by employer 10/4/17
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 55-year-old female patient who received FLULAVAL TETRA (batch number K5T45, expiry date 20th May 2018). Concomitant products included doxycycline, RESTASIS, vitamin D, ATIVAN and fish oil. On 21st September 2017, the patient received the 1st dose of FLULAVAL TETRA. On 22nd September 2017, 1 days after receiving FLULAVAL TETRA, the patient experienced sore throat. On 23rd September 2017, the patient experienced pain, runny nose, fatigue, cough and nasal congestion. The patient was treated with ALLEGRA. On an unknown date, the outcome of the sore throat, pain, fatigue, cough and nasal congestion were not recovered/not resolved and the outcome of the runny nose was unknown. The reporter considered the sore throat, pain, runny nose, fatigue, cough and nasal congestion to be possibly related to FLULAVAL TETRA. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on the left arm, on Thursday. On Friday, the patient began to experience events that worsened on Saturday and new events occurred on Sunday. Two days after receiving FLULAVAL QUADRIVALENT, the patient experienced aches, runny nose, fatigue, cough and nasal congestion. The patient contacted health department to inquire about relationship of events to Flu vaccine and was told not related. The patient called on reporting date seeking information about stated events and possible relationship to FLULAVAL. The patient was taking over the counter ALLEGRA for symptoms, but had not contacted her physician. The patient was encouraged to notify physician of current events. The patient noted this was a clinic being held by Health department in her town. The patient declined the healthcare professional information at this time. The patient would be seeing new healthcare professional on Wednesday. The patient was open to receive authorization form from the Safety.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 55-year-old female patient who received FLULAVAL TETRA (batch number K5T45, expiry date 20th May 2018). Concomitant products included doxycycline, RESTASIS, vitamin D, ATIVAN and fish oil. On 21st September 2017, the patient received the 1st dose of FLULAVAL TETRA. On 22nd September 2017, 1 days after receiving FLULAVAL TETRA, the patient experienced sore throat. On 23rd September 2017, the patient experienced pain, runny nose, fatigue, cough and nasal congestion. The patient was treated with ALLEGRA. On an unknown date, the outcome of the sore throat, pain, fatigue, cough and nasal congestion were not recovered/not resolved and the outcome of the runny nose was unknown. The reporter considered the sore throat, pain, runny nose, fatigue, cough and nasal congestion to be possibly related to FLULAVAL TETRA. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on the left arm, on Thursday. On Friday, the patient began to experience events that worsened on Saturday and new events occurred on Sunday. Two days after receiving FLULAVAL QUADRIVALENT, the patient experienced aches, runny nose, fatigue, cough and nasal congestion. The patient contacted health department to inquire about relationship of events to Flu vaccine and was told not related. The patient called on reporting date seeking information about stated events and possible relationship to FLULAVAL. The patient was taking over the counter ALLEGRA for symptoms, but had not contacted her physician. The patient was encouraged to notify physician of current events. The patient noted this was a clinic being held by Health department in her town. The patient declined the healthcare professional information at this time. The patient would be seeing new healthcare professional on Wednesday. The patient was open to receive authorization form from the Safety.
Sex: F
Vaccine: TDAP
Symptoms: Cough, Documented hypersensitivity to administered product, Fall, Peripheral swelling, Upper limb fracture
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received DTPa (batch number U57866AA ?, expiry date October 2019). The patient's past medical history included low blood pressure. Previously administered products included Influenza vaccine with an associated reaction of influenza (received in past and experienced flu (refer case US2017GSK149422)). Concurrent medical conditions included tetanus. On 8th September 2017, the patient received dTpa vaccine. On 8th September 2017, less than a day after receiving dTpa vaccine, the patient experienced cough and documented hypersensitivity to administered product. On 9th September 2017, the patient experienced swelling arm, fall and elbow fracture. In September 2017, the patient experienced vomiting. On an unknown date, the outcome of the cough and vomiting were recovering/resolving and the outcome of the swelling arm, fall and documented hypersensitivity to administered product were unknown and the outcome of the elbow fracture was not recovered/not resolved. The reporter considered the cough, swelling arm, fall, vomiting and elbow fracture to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient only weighed 108-110 lbs. The patient received Tdap vaccine on right deltoid and that evening she developed a terrible cough. One day after the vaccination, the patient was doing gardening when she suddenly fell and broke her elbow. The patient was allergic to tetanus and received Tdap vaccine, which led to documented hypersensitivity to administered product. She went to the emergency room, but was told her arm was too swollen for them to do anything, so she had to make an appointment with a surgeon for the next week. Less than a month after vaccination, the patient experienced vomiting. While waiting to see the surgeon she went to the hairdresser's to get her hair done. While there she started coughing so bad that she began throwing up. The cough seemed to be improving, but her husband was now developing a cough as well. She was scheduled to see the surgeon on the next day. As the patient had an allergy to tetanus, so when she was at the emergency room after she fell she was told she should not get the Tdap vaccine. She had not noticed a rash since receiving Tdap, but her past reactions had also included very low blood pressure, and she wondered if that could have been why she fell during normal gardening. The reporter thought these problems were related to her getting the Tdap vaccine.
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received DTPa (batch number U57866AA ?, expiry date October 2019). The patient's past medical history included low blood pressure. Previously administered products included Influenza vaccine with an associated reaction of influenza (received in past and experienced flu (refer case US2017GSK149422)). Concurrent medical conditions included tetanus. On 8th September 2017, the patient received dTpa vaccine. On 8th September 2017, less than a day after receiving dTpa vaccine, the patient experienced cough and documented hypersensitivity to administered product. On 9th September 2017, the patient experienced swelling arm, fall and elbow fracture. In September 2017, the patient experienced vomiting. On an unknown date, the outcome of the cough and vomiting were recovering/resolving and the outcome of the swelling arm, fall and documented hypersensitivity to administered product were unknown and the outcome of the elbow fracture was not recovered/not resolved. The reporter considered the cough, swelling arm, fall, vomiting and elbow fracture to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient only weighed 108-110 lbs. The patient received Tdap vaccine on right deltoid and that evening she developed a terrible cough. One day after the vaccination, the patient was doing gardening when she suddenly fell and broke her elbow. The patient was allergic to tetanus and received Tdap vaccine, which led to documented hypersensitivity to administered product. She went to the emergency room, but was told her arm was too swollen for them to do anything, so she had to make an appointment with a surgeon for the next week. Less than a month after vaccination, the patient experienced vomiting. While waiting to see the surgeon she went to the hairdresser's to get her hair done. While there she started coughing so bad that she began throwing up. The cough seemed to be improving, but her husband was now developing a cough as well. She was scheduled to see the surgeon on the next day. As the patient had an allergy to tetanus, so when she was at the emergency room after she fell she was told she should not get the Tdap vaccine. She had not noticed a rash since receiving Tdap, but her past reactions had also included very low blood pressure, and she wondered if that could have been why she fell during normal gardening. The reporter thought these problems were related to her getting the Tdap vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site nodule, Pallor, Vomiting
Clinical narrative: Patient described not feeling right. Looked pale and then vomited. (Mom returned to let us know patient is fine). After admin of vaccine RPh noticed immediate raised nodule at sight of injection. Told to wait in pharmacy for 15 minutes to make sure no reactions. After a few minutes patient complained of not feeling right and appeared pale, one minute later he vomited. RPh went to admin. EPI-PEN but Mom/and patient said he was feeling better and he did not want it. Tech called the EMS right away and they arrived shortly thereafter and agreed that patient was doing better. They took him to hospital for analysis.
Age: 57.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: Large red wheal, tender to touch, and hard in center 3" in diameter at injection site.
Age: 62.0
Sex: U
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient called and informed me that he had a rash in his groin area and left inner thigh after he walked his dog.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Staphylococcal infection
Clinical narrative: Swelling, redness around site of ZOSTAVAX, back of (R) arm. Staph infx.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder joint.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 9/23/17 After receiving influenza vaccination, client states that arm (L) began to swell and he experienced significant pain - pt states arm was swollen for approx 3-4 days, after he applied ice and took an over the counter medicine for pain, swelling decreased.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain, Peripheral swelling, Skin warm
Clinical narrative: 24 hours after administration, swollen arm, red, tender warm to touch, pt. said painful, recommend BENADRYL and follow up w/primary care physician. Hives and swelling on right side of neck, didn't feel well.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness, Urticaria
Clinical narrative: 24 hours after administration, swollen arm, red, tender warm to touch, pt. said painful, recommend BENADRYL and follow up w/primary care physician. Hives and swelling on right side of neck, didn't feel well.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Swelling, Yellow skin
Clinical narrative: That night - flu like symptoms. Next morning - swelling, pain, yellow - all the way to armpit.
Age: 63.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Shingles inj given 10/3/17. Rx next AM red, swollen, tender, warm to touch, and itching.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient came in with redness on her arm just to the right of where flu shot was administered.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Employee states "I received flu vaccine Tues 10/3 (L) arm and I woke up this morning and my arm hurts and feels numb". Full ROM present. Radial and brachial pulse positive. No redness or swelling present.
Age: 27.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: R arm - red, non-raised rash approximately 20 mm wide x 40 mm length rash, itchy. Hydrocortisone cream applied.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Drug hypersensitivity
Clinical narrative: Cellulitis. Tx-Cephalexin 10ml BID x 10 days, ZYRTEC, BENADRYL.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Pt developed nausea, vomiting and diarrhea.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Pain
Clinical narrative: Patient presented with swelling, redness in the upper arm of injection site one day after administration with body ache and feeling unwell. Starting day 2, patient experienced swelling, redness below the elbow and tingling in her fingers. Symptoms resolved 5 days after administration.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Patient presented with swelling, redness in the upper arm of injection site one day after administration with body ache and feeling unwell. Starting day 2, patient experienced swelling, redness below the elbow and tingling in her fingers. Symptoms resolved 5 days after administration.
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Pain
Clinical narrative: Bruised arm, pain greater than 1 wk.
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red painful golf ball sized bump on right arm.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pruritus
Clinical narrative: Pt C/O of itching with mild headache.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: Pt called c/o of itching and swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Erythema, Injection site rash, Pruritus, Pyrexia, Rash
Clinical narrative: Vaccines given on 10-2-17 (L) deltoid: Hep A - (L) arm; MMRV - RN. (R) deltoid: KINRIX and FLUZONE - RN. Seen in office 10-4-17 with rash on (Rt) deltoid, (Lt) arm and (L) forehead - reddened, localized swelling and itching. Fever/vomiting in less than 24 hours. Unknown if vaccine related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Swelling, Vomiting
Clinical narrative: Vaccines given on 10-2-17 (L) deltoid: Hep A - (L) arm; MMRV - RN. (R) deltoid: KINRIX and FLUZONE - RN. Seen in office 10-4-17 with rash on (Rt) deltoid, (Lt) arm and (L) forehead - reddened, localized swelling and itching. Fever/vomiting in less than 24 hours. Unknown if vaccine related.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dyspnoea, Nail discolouration, Ocular hyperaemia
Clinical narrative: 10AM began with difficulty breathing then chills and achiness. Trouble deep breathing and coughing forcefully. Hands/fingers cold and white. Nail beds turned purple. Eyes red and bloodshot, vision cloudy.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pallor, Peripheral coldness, Vision blurred
Clinical narrative: 10AM began with difficulty breathing then chills and achiness. Trouble deep breathing and coughing forcefully. Hands/fingers cold and white. Nail beds turned purple. Eyes red and bloodshot, vision cloudy.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site and below on (L) arm.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Left arm swelling.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm swelling.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 104 and fussy.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy day after receiving FLUVIRIN and PNEUMOVAX 23. Her upper arm to elbow was red and slightly swollen. Warm to touch.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site erythema, Rhinorrhoea
Clinical narrative: The next night after getting the shot started to feel blah all the way into Sunday evening. Has had the sniffles and the injection site was red the day of on Thursday all the way to mid-day Saturday.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Bullous impetigo, Dermatitis bullous, Erythema, Polymerase chain reaction, Pruritus
Clinical narrative: Diffuse bulbous rash 3 days following vaccination pruritic, on face, trunk, and extremities. Bullous designating surrounding by circular erythema. H/O severe eczema. To ER as no urgent Derm apprs.  9/7 rash improving. Referred to Derm as urgent. ROI sent pending.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Diffuse bulbous rash 3 days following vaccination pruritic, on face, trunk, and extremities. Bullous designating surrounding by circular erythema. H/O severe eczema. To ER as no urgent Derm apprs.  9/7 rash improving. Referred to Derm as urgent. ROI sent pending.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red area at immunization site size of silver dollar. Area is raised, warm and itchy.
Age: 89.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, warm to touch Deltoid. Recommend Dr. visit for antibiotic.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever following Flu vaccine x 48 hours.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Patient had fever of 103.3 F. Mild headache and dizziness. Treatment: Administered 400 mg Ibuprofen PO. Outcome: Temp. 98.5 2 hours later.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Rash, Vaccination complication
Clinical narrative: Appox. 1:15 developed whelps and redness to bilat. arms from shoulder to elbow, with itching. Dad took child to a doctor and pharmacist who said it may be a reaction to the tetanus vaccine. Rask went away after one dose of BENADRYL.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient came in 2 days later with bruise and a patch of red rashes below the injection site. It's swollen too.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Extreme pain in (R) upper arm for 4 days - fever x 2 days.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Large local reaction left thigh - edema, warmth, tender to touch localized to entire quadricep. No systemic symptoms. TX: Cold compress/ibuprofen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nervousness, Rash
Clinical narrative: After several hours patient felt shaky and weak, had a rash on arm.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Client came to receive influenza vaccination at school based flu clinic. Client was inadvertently given high-dose flu vaccine for 65 and older and client was only 54 years of age. Client was notified about the inadvertent vaccine administration.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt. came in 9-30-17 with a rash under the injection site, size about 4 x 5 inches. Started 24 hrs after immunization, red and raised.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Local reaction, Oedema, Pain
Clinical narrative: Local reaction, soreness, redness. 9/27/17 spoke with doctor's office. Pt saw NP. Pt reported no fever, chills, drainage, etc. but did report pain, redness and edema.
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 34 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 20-SEP-2017, the patient was vaccinated with a dose of GARDASIL 9 injection, lot # N012093, expiration date 13-JAN-2020 (dose, route and site of administration were not reported) for prophylaxis. At the time of vaccine administration, she was 7 weeks pregnant. The last menstrual period (LMP) date was 02-AUG-2017 and estimated date of delivery (EDD) was 09-MAY-2018, both calculated based on gestational age at the time of vaccination. No lab diagnostic studies were performed. No adverse effects were reported. At the time of reporting, the pregnancy outcome was pending. No further information was provided.
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 34 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 20-SEP-2017, the patient was vaccinated with a dose of GARDASIL 9 injection, lot # N012093, expiration date 13-JAN-2020 (dose, route and site of administration were not reported) for prophylaxis. At the time of vaccine administration, she was 7 weeks pregnant. The last menstrual period (LMP) date was 02-AUG-2017 and estimated date of delivery (EDD) was 09-MAY-2018, both calculated based on gestational age at the time of vaccination. No lab diagnostic studies were performed. No adverse effects were reported. At the time of reporting, the pregnancy outcome was pending. No further information was provided.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reported to the pharmacy on Oct, 4, 2017, complaining of redness and soreness in right bicep. Pharmacist suggested patient use topical hydrocortisone and/or take NSAID orally for pain and inflammation. If pain worsens, patient should report to the doctor.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported to the pharmacy on Oct, 4, 2017, complaining of redness and soreness in right bicep. Pharmacist suggested patient use topical hydrocortisone and/or take NSAID orally for pain and inflammation. If pain worsens, patient should report to the doctor.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Limb mass, Pruritus
Clinical narrative: Pt phoned on 10/2/2017 to state she had a hard lump and a 2 x 3 inch itchy red spot on her arm. She hadn't noticed it until this day and that is why she called.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warm to the touch, swelling.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: On 9/27/2017, we administered both PNEUMOVAX 23 and FLUZONE HD to the patient's left arm. She left the pharmacy feeling fine. On 9/29/2017, she came by the pharmacy, and complained of swollen and painful site of injection, and she could hardly raise her arm. We gave her 2 tabs of 25mg BENADRYL. On 10/1/2017, we called and found out her symptoms had gotten worse. Her armpit area had become tender, and she also felt her entire left arm down to her left thumb was tender. We urged her to seek medical care. A few days later, she came by the pharmacy, and reported that her symptoms had improved.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Night of the vaccine he had a red rash over his scalp. this resolved in 1-2 days but then developed a fine reticulonodular rash over full back as well as sides and lower abd.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: LEFT ARM RED AND WARM TO TOUCH @ SITE OF IMMUNIZATIONS. AFEBRILE.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling abnormal, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a consumer, who was the patient's mother and refers to a 3-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with VAQTA dose 1, lot # 1068AA, expiration date: 09-MAY-2014 for prophylaxis (strength and route of administration were not provided). On an unknown date (reported as immediately after receiving VAQTA, the patient had a "dazed look" and did not respond to her name or act normal. On an unknown date (reported as: "after 30 minutes"), the patient recovered from the events. The causal relationship between the events and VAQTA was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 02-OCT-2017, the patient was vaccinated with an improperly stored dose of M-M-R II 1 dose, lot number lot M044351 and expiration date 04-NOV-2018 (Albumin status rHa) (strength and frequency were not reported) for prophylaxis which was reconstituted with a sterile diluent (manufacturer unknown) that was not undergo a temperature excursion. No adverse effects reported. The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit, time frame of 12 hours and no previous temperature excursion. Digital Data logger was involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1710USA001694: US-009507513-1710USA001901.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a medical assistant and referred to a 68-year-old female patient. The patient had no medical history. The patient's concurrent conditions included allergy to AUGMENTIN, erythromycin, LEVAQUIN, TEQUIN and latex. On 29-SEP-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 intramuscularly, (dose and frequency were not reported) lot # N013521 and expiration date: 23-JAN-2019. On 30-SEP-2017, the patient experienced swelling and redness of whole upper arm down to elbow after getting vaccinated. The patient went to physician's office on 02-OCT-2017 and the symptoms were beginning resolved. The outcome of the events was also reported as recovered. No causality assessment was provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA002412.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacy intern, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N014942 and expiration date 02-FEB-2018 (dose, frequency and route of administration were not provided) for prophylaxis, which was reconstituted with a sterile diluent (manufacturer unknown) that not had a temperature excursion prior to administration. The vaccine was stored at a temperature of -10.6 grade Celsius, time frame of 10 hours and no previous temperature excursion. Digital Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report refers to a male patient of an unknown age who reported on himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On an unknown date in August 2017 (reported as a month and a half ago), the patient experienced shingles. The outcome of herpes zoster was unknown. The causality assessment was not provided.
Age: 46.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: I have had severe body aches that lasted for 2 days and milder body aches that still continue. My arm that I had the shots in has been in a lot of pain and I can hardly use it to get dressed or do anything. I have had the flu shot for 18 years in a row so not sure why my arm is so bad other than if the pneumonia shot caused it.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is red and swollen and warm to the touch. The patient has contacted the physician and will be seen on Monday, if the reaction does not get any better, physician also suggested to ice and massage the area where the vaccines are given. Patient was also directed to monitor the injection area for any changes.