chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a sales representative. This pharmacist reported same events for two patients. This is the first of 2 reports. An elderly female patient (over 65) received PREVNAR 13 (lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red arms for 3 days on an unspecified date. The patient used cold compresses, but did not require medical treatment. Outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018500271 same reporter/different patient/same drug/same event.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a sales representative. This pharmacist reported same events for two patients. This is the second of 2 reports. An elderly female patient received PREVNAR 13 (lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red arms for 3 days on an unspecified date. The patient used cold compresses, but did not require medical treatment. Outcome of the event was unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018500257 same reporter, same suspect drug, same event; different patients.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients. This is second of two reports. A patient of unspecified age and gender received PREVNAR 13, (Lot number: W51924, expiry date: Jul2020), via an unspecified route of administration on 04Oct2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. In 2018, the patient experienced cellulitis with outcome of unknown. Sender's Comments: The current information is very limited to allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, vaccination details and event description including onset date and location of the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2018499708 same product and event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling at the injection site on an unspecified date. It was reported that the patient was ok at the time of report. Outcome of the event was therefore recovered on an unknown date. No follow-up attempts are possible, information about batch number cannot be obtained
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. A male patient of an unspecified age received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that a patient after receiving his pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) injection there was severe swelling and redness at the injection site and the redness spread down the patients arm and the patient eventually was prescribed an antibiotic. The outcome for the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Fall, Hyperhidrosis, Incoherent, Loss of consciousness
Clinical narrative: Approx. 5 min after receiving HPV vaccine, pt was waiting in treatment room for 15-20 min per office police when mom came out of room stating pt had passed out and fell off exam table. RN went into room and pt was unconscious for approx. 5-10 sec. then sat up and was pale, diaphoretic, and talking incomprehensible words. MD and RN assisted pt back onto exam table, propped feet up, applied ice to scalp, VS stable. APRN treating pt came to bedside. Pt was monitored in the office for approx. one hr but then taken to ER due to pt still being pale, nauseous and making inappropriate comments not relative to the current conversation. The ER performed a head CT which was WNL and the patient was discharged home.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Pallor
Clinical narrative: Approx. 5 min after receiving HPV vaccine, pt was waiting in treatment room for 15-20 min per office police when mom came out of room stating pt had passed out and fell off exam table. RN went into room and pt was unconscious for approx. 5-10 sec. then sat up and was pale, diaphoretic, and talking incomprehensible words. MD and RN assisted pt back onto exam table, propped feet up, applied ice to scalp, VS stable. APRN treating pt came to bedside. Pt was monitored in the office for approx. one hr but then taken to ER due to pt still being pale, nauseous and making inappropriate comments not relative to the current conversation. The ER performed a head CT which was WNL and the patient was discharged home.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Ageusia, Blood heavy metal test, Dysgeusia, Fungal test negative, Headache
Clinical narrative: Swollen tongue - 6-12-2018. Loss of taste - 6-13-2018 to present. Metallic taste - 6-13-2018 to present. White skin patches (vitiligo) on hands 6-13-2018 to present. Headache 6-12-2018 to 6-15-2018. Fever (103 degree) 6-12 and 6-13-2018.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swollen tongue, Vitiligo
Clinical narrative: Swollen tongue - 6-12-2018. Loss of taste - 6-13-2018 to present. Metallic taste - 6-13-2018 to present. White skin patches (vitiligo) on hands 6-13-2018 to present. Headache 6-12-2018 to 6-15-2018. Fever (103 degree) 6-12 and 6-13-2018.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dyskinesia, Muscle twitching, Pyrexia
Clinical narrative: Patient developed high fever the night of the vaccination. Also per mom the patient had intermittent twitching and jerking for almost 6 min. in the night. Patient was seen in Hospital ER. Also has a neurology appt. pending.
Age: 51.0
Sex: M
Vaccine: HEPAB, MMR, TYP
Symptoms: Lymphadenopathy, Measles, Ocular hyperaemia, Rash, Rhinorrhoea
Clinical narrative: Starting 12/1/18, runny nose and cervical lymphadenopathy, 12/5 developed rash on torso, neck, and back and redness in eyes. Patient saw CNP at outside clinic, who asked patient to call us to report measles- like rxn. No labs ordered at this visit. 12/6 patient reports rash is improving but lymph nodes are same. Never took temp. 12/7 symptoms improving-slight rash only.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Pyrexia, Skin warm
Clinical narrative: Chills, fever, hot red arm, tiredness.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Deafness, Dizziness
Clinical narrative: Patient received the SHINGRIX vaccine on 5-1-18. Pt. then presented to Medical Center to be evaluated due to dizziness and elevated blood pressure. Pt's. dizziness continued along with hearing loss.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Records Showed patient was due for last HPV.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Assessed the patient to have it so I gave it.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Lip swelling, Malaise, Rash, Swelling face
Clinical narrative: Patient started feeling ill about an hour after the vaccination. She developed a rash on her chest and her face/lips began to swell. She said it was a similar reaction as to when she is exposed to shellfish. Patient was advised to take 50mg of BENADRYL which she responded well to - swelling started coming down and she was feeling better. I instructed her to take BENADRYL again tonight before bed and continue for a day or two until all symptoms fully subside.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Ice, TYLENOL, BENADRYL.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Pt had chills lasting 50 minutes the night of the vaccination and fever as high as 103 for 3 hours. Pt reports still feeling bad with no improvement seen until 12/9/18.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm was extremely swollen, red, and itchy beginning 2 days after vaccination and lasting a few days. She said it had resolved before calling us. She just wanted to report.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Dysstasia, Headache
Clinical narrative: Fever 101F, body pain intense including all joints and back, intense pain at injection site, red and hot at injection site, nausea, dry heaves, headache, muscle cramps, dizziness. All symptoms diminished after 36 hours, with  exception of malaise, redness and pain at injection site, headache. Treated with 400 mg of ibuprofen every 6 hours, with 650 mg of TYLENOL twice daily. I was very sick, unable to get up or stand for more than a minute. I needed care as I could not do for myself. I am much better on this 3rd day, but am still feeling very weak. I don't feel compelled to get my second shot. I feel that four years of protection is not worth what I am going through. If it carried protection for a decade or more, that would be a different story.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Loss of personal independence in daily activities, Malaise
Clinical narrative: Fever 101F, body pain intense including all joints and back, intense pain at injection site, red and hot at injection site, nausea, dry heaves, headache, muscle cramps, dizziness. All symptoms diminished after 36 hours, with  exception of malaise, redness and pain at injection site, headache. Treated with 400 mg of ibuprofen every 6 hours, with 650 mg of TYLENOL twice daily. I was very sick, unable to get up or stand for more than a minute. I needed care as I could not do for myself. I am much better on this 3rd day, but am still feeling very weak. I don't feel compelled to get my second shot. I feel that four years of protection is not worth what I am going through. If it carried protection for a decade or more, that would be a different story.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea, Pain, Pyrexia, Retching
Clinical narrative: Fever 101F, body pain intense including all joints and back, intense pain at injection site, red and hot at injection site, nausea, dry heaves, headache, muscle cramps, dizziness. All symptoms diminished after 36 hours, with  exception of malaise, redness and pain at injection site, headache. Treated with 400 mg of ibuprofen every 6 hours, with 650 mg of TYLENOL twice daily. I was very sick, unable to get up or stand for more than a minute. I needed care as I could not do for myself. I am much better on this 3rd day, but am still feeling very weak. I don't feel compelled to get my second shot. I feel that four years of protection is not worth what I am going through. If it carried protection for a decade or more, that would be a different story.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Loss of personal independence in daily activities
Clinical narrative: Patient started to get an annoying, moderate headache on the morning of Sat 12/8/2018 which has affected some day to day activities. The headache has continued at this time with no relief from ibuprofen 200mg 1-2 tablets as needed.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Dizziness, Erythema, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: Patient felt dizzy at time of injection. Patient was given cool compress for face and neck. Came in day after  injections with swollen and red left arm, red right arm. Patient stated he had been taking ibuprofen. Pharmacist recommended adding a cold compress to area.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Mobility decreased
Clinical narrative: Pain during injection. By evening pain increased, couldn't sleep. Next day couldn't lift my arm at all. Four days until I could get a jacket on without struggling. Day seven better but range of motion still not as it was before vaccine. Didn't have any problem with the first vaccine in the series.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt both shoulders red and swollen.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Palpitations
Clinical narrative: Patient stated that within 30 minutes of vaccination she started having heart palpitations, racing heart, dizziness, sweating, it lasted about 30 minutes but she felt tired that night. The next day she felt fine. She did not see her MD immediately or go to the ER, she sat in her car until she felt well enough to drive. She saw her MD the next day but all was fine at that point. Her primary doctor though that it may have been an adverse reaction.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Patient received the FLUBLOK vaccine into the left deltoid on 10/16/18. Approximately 2 hours later her shoulder was achy, which she expected after a vaccine. However, the achiness continues 8 weeks later and now she is experiencing decreased ROM and weakness to the left shoulder/arm.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia, Dyspnoea, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: I received the vaccine around 3:30 pm on 12/7. I had the usual arm soreness and arm swelling after the injection. Then around 11 pm on the night that I received the vaccine, I had trouble swallowing  with excessive salivation, difficulty breathing. I felt like the  difficulty breathing was a result of the excessive salivation and difficulty swallowing. I took two 25 mg BENADRYL along with 150 mg ranitidine. In addition, I had muscle aches in both legs which was not alarming.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Salivary hypersecretion
Clinical narrative: I received the vaccine around 3:30 pm on 12/7. I had the usual arm soreness and arm swelling after the injection. Then around 11 pm on the night that I received the vaccine, I had trouble swallowing  with excessive salivation, difficulty breathing. I felt like the  difficulty breathing was a result of the excessive salivation and difficulty swallowing. I took two 25 mg BENADRYL along with 150 mg ranitidine. In addition, I had muscle aches in both legs which was not alarming.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Influenza like illness
Clinical narrative: Patient reports having flu-like symptoms ever since he received the vaccination. The patient received a prescription for Ciprofloxacin after visiting his PCP.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chest X-ray, Chills, Decreased appetite, Differential white blood cell count, Full blood count
Clinical narrative: Patient reports having flu-like symptoms ever since he received the vaccination. The patient received a prescription for Ciprofloxacin after visiting his PCP.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Immunosuppressant drug therapy, Influenza like illness, Laboratory test, Muscular weakness, Prostatic specific antigen
Clinical narrative: Patient reports having flu-like symptoms ever since he received the vaccination. The patient received a prescription for Ciprofloxacin after visiting his PCP.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Tremor, Urine analysis, Weight decreased, White blood cell count increased
Clinical narrative: Patient reports having flu-like symptoms ever since he received the vaccination. The patient received a prescription for Ciprofloxacin after visiting his PCP.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Body temperature increased, Vaccination complication
Clinical narrative: Mother calls Health Department to inform us that the patient had a reaction to her 2nd Men B vaccination and had to be taken to the emergency room. Mother relates that she had a temp of 102, and that she felt like she was going to pass out. Mother states this occurred 30 minutes after leaving Health Department after vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 17-MAR-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient of an unknown age who received first dose of vaccine IMOVAX RABIES (Powder and solvent for suspension for injection) lot N1B05, expiry date: 26-Feb-2017 via unknown route in unknown administration site on an unknown date. Patient also received two doses from the series of three RABIES shots given by health care provider. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. He/she noticed that the first injection in the series of three was LOT NO: N1B05 (he/she not sure if that is a zero or the letter 'o') The expiration date on that was marked as 02/26/2017 - WELL OVER a year and a half EXPIRED. It was unknown if any adverse event was occurred. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient (age not reported) who did not return for her IMOVAX RABIES (Batch number, expiration date, dose, route and site of administration was not reported) on day 7. It was reported that, she was several days late. The patients medical history and concomitant medications were not reported. It was an actual/potential medication error due to inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: HEPA, RAB, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 52 years old male patient who was vaccinated with an expired dose of IMOVAX RABIES lot N1B05 and Exp. Date 26-FEB-2017 via unknown route in the right arm 05-Nov-2018. It was first dose at day 0. The patient's medical history not reported and concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunization. It was reported that, on 12 Nov 2018 and 03 Dec 2018 patient received second and third dose of rabies vaccine manufactured by GSK on day7 and day 28 respectively. It was an actual medication error case due to expired vaccine used.  It was reported that first dose of IMOVAX was expired when patient received it. Patient reported that he received 3 dose pre exposure series of IMOVAX for anticipated travel on 07 Jan 2019. His documents from the HCP office show the Day 0 dose had expired on 26 Feb 2017. No symptoms reported. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with 2018SA335493 (same reporter). This case involves an 8 weeks old male patient who received an expired dose of PENTACEL.(Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on 03-Dec-2018.for both vaccines. On 03-Dec-2018, the patient received first 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C526AAA (expiry date: 29-Oct-2018) via intramuscular route in the left thigh. It was a case of actual medication error due to expired vaccine used. Patient did not experience any adverse event. 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. Documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient (age not reported) who received a dose of vaccine TENIVAC instead of ADACEL (lot number not reported) via unknown route in the deltoid on 03-Dec-2018 or 04-Dec-2018 (reporter was unsure). It was reported that the purpose of receiving ADACEL was to receive the pertussis component to protect newborn grandchild. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt states severe redness, swelling of arm and itching in the arm that the injection was given. Also increased blood pressure that led to a dr office visit.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced erythema, warmth, and swelling to area of injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Photopsia, Vitreous floaters
Clinical narrative: PATIENT DESCRIBED FLOATERS AND BRIGHT LIGHT FLASH IN EYES 10 OR SO DAYS AFTER VACCINE PATIENT HAS SEEN EYE DR AND SAYS FLOATERS MOSTLY RELATED TO AGE AND ACTIVITY LEVEL  ASKED PATIENT TO CONTACT PROVIDER AGAIN AND ASK ABOUT GIVING SECOND DOSE PATIENT'S FLOATERS LESS TODAY (12-10-18) AS IN SMALLER, PREVIOUSLY INTERFERED WITH DRIVING BECAUSE OF SIZE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Tiredness, aches, chills. Lasted for about 24 hours.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash, Urticaria
Clinical narrative: Patient experienced extreme arm swelling, hives/rash on the trunk of the body as well as his arm. Lasted for roughly 10 days after receiving the vaccine.
Age: 35.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
Clinical narrative: Right shoulder pain, inability to move right shoulder, "frozen shoulder".
Age: 1.25
Sex: F
Vaccine: MMR, PNC13
Symptoms: Eye movement disorder, Feeling hot, Foaming at mouth, Irritability, Musculoskeletal stiffness
Clinical narrative: On 12/19/2018 child was hot with fever and fussy and suddenly eyes rolled up and froth came from the mouth with stiff body. The whole episode lasted for a couple of seconds and then said "mama" and was responding well. Mom gave Ibuprofen 3mL and then she fell asleep.
Age: 1.25
Sex: F
Vaccine: MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: On 12/19/2018 child was hot with fever and fussy and suddenly eyes rolled up and froth came from the mouth with stiff body. The whole episode lasted for a couple of seconds and then said "mama" and was responding well. Mom gave Ibuprofen 3mL and then she fell asleep.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Concussion, Foreign body, Loss of consciousness, Road traffic accident, Skin abrasion
Clinical narrative: Clinic did not ask me to wait 15 to 20 minitues. Passed out 10 minutes after injection. Rolled car 3 times.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Clinic did not ask me to wait 15 to 20 minitues. Passed out 10 minutes after injection. Rolled car 3 times.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Extreme pain on the arm that is spreading to shoulder and neck. No signs of clots as he is on PLAVIX. No signs of blister or fever yet. Pt already took OTC pain medications and not really helping. Pt is going to try ice pack.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Patient received vaccination on 11/30/18 and developed shingles-like rash on 12/7/18. Patient went to MD office on 12/10/18 and MD diagnosed her with shingles and gave her an rx for an antiviral medication for treatment.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature decreased, Decreased appetite, Drooling, Emotional distress, Erythema
Clinical narrative: Mom reports that he began to feel bad 11/30 (Day 4 post vaccines). On 11/30 he developed welts on side of face and ear was red. Lasted a few hours and went away on its own. Temp 99 at this time. Gave TYLENOL because he was fussy. No other rash developed. Drooling a lot. Teething. Continued to be fussy/irritable. On 12/7 (Day 8 post vaccines) ear temp 91, repeat ear temp 94 Checked under arm X 3, was 93. Appetite decreased. Sleeping normally. Extremely irritable and inconsolable since waking from nap in afternoon.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Feeling abnormal, Irritability, Teething, Urticaria
Clinical narrative: Mom reports that he began to feel bad 11/30 (Day 4 post vaccines). On 11/30 he developed welts on side of face and ear was red. Lasted a few hours and went away on its own. Temp 99 at this time. Gave TYLENOL because he was fussy. No other rash developed. Drooling a lot. Teething. Continued to be fussy/irritable. On 12/7 (Day 8 post vaccines) ear temp 91, repeat ear temp 94 Checked under arm X 3, was 93. Appetite decreased. Sleeping normally. Extremely irritable and inconsolable since waking from nap in afternoon.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Since last night fever, aches and nausea.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Severe myalgia originating in right arm near injection site. Moderate headache and Fever of 103.0. Rigors (shivering) continuing for around 3 hours after onset of fever. Fever reduced to 99.3 approximately 12 hours after onset. Mild myalgia for a period of 24 hours after onset.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Vomiting
Clinical narrative: PATIENT FELT "BAD", FATIGUED, FEVERISH (BUT DIDNT TAKE TEMP), AND VOMITED ONE TIME THE DAY AFTER THE VACCINATION (SATURDAY 12-8-18). STARTED FEELING BETTER ON SUNDAY (12-9-18) WAS ABLE TO KEEP FOOD DOWN ON 12-9-18. TOOK A BENADRYL TODAY 12-10-18 AND HAS FELT BETTER. HER ARM IS STILL INFLAMED AND WILL GO TO DR IF IT DOESNT GET BETTER.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus, Scab
Clinical narrative: Patient presented at pharmacy today 12-10-18 at 230pm, reporting that she had reaction to immunizations received one month prior on 11-12-18. Lower section of Right arm was red and showed signs of being scratched with small scab like areas (looked like patient scratching self). It didn't appear inflamed (swollen or hot to touch), it was just red on the arm. Patient stated that itching started about one week after receiving immunizations, she didn't report pain, only itching. She only reported to us today.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Concussion, Head injury, Syncope
Clinical narrative: A FEW MINUTES AFTER VACCINE, PATIENT STOOD UP AND FAINTED HITTING HIS HEAD ON FLOOR ON THE WAY DOWN.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient received the shot on 10/27/18 from the charge nurse. Two weeks after the shot she noticed she was still having pain at the injection site. Pain started to get better and waited to see if it would resolve on its own. Pain began to increase again and she was not able to lift her left arm above her chest, no range of motion, unable to put on or take off shirt without extreme amount of pain. On 11/28/18 she contact health coordinator to discuss her symptoms. She was going to look into this and get back to her.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Pyrexia, Rash generalised
Clinical narrative: The patient reported severe right arm pain, subjective fevers/chills, and rash all over her body. She reported the pain in her right arm was so severe she could not move her arm. These symptoms began around 5:00 PM the day she received the vaccine, and resolved within 24 hours.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site scab
Clinical narrative: Patient came into Pharmacy on 12-10-2018 and while here mentioned that she may have had a reaction to the high dose flu vaccine received on 11-20-2018 and just thought she would mention to us. She states that the day after the injection she had a hard lump at injection site and was red and sore. She states that the redness and lump resolved after about a week and was replaced with a sore that has not healed as of the reporting of this event today. She pulled up sleeve showing a scabbed over spot on her left upper arm and says that she is sure that this was the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Patient reported tachycardia the evening following vaccine administration in 12/07/2018 which resolved without treatment by the following day. The patient then reported the adverse event to pharmacy on 12/10/2018 and denies and further recurrence of the adverse event.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Severe headache, chills, fever, nausea, throwing up for about 8 hours. Drank to rehydrate - was able to resume regular activities by the next day. Started food slowly- took a BENADRYL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe headache, chills, fever, nausea, throwing up for about 8 hours. Drank to rehydrate - was able to resume regular activities by the next day. Started food slowly- took a BENADRYL.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Full blood count normal, Metabolic function test normal, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Deep arm pain that radiates through shoulder. Tenderness to palpation. No erythema or swelling.  Pt complaining of worsening pain on day 13 after event.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Deep arm pain that radiates through shoulder. Tenderness to palpation. No erythema or swelling.  Pt complaining of worsening pain on day 13 after event.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Dry mouth, Headache, Rash
Clinical narrative: Rash getting worse and bigger 7 day after, headache, dry mouth.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has arm soreness that is still continuing at present and is using a heating pad at times for relief.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Aneurysm ruptured, Craniotomy, Dermatitis allergic, Headache, Herpes zoster
Clinical narrative: Headache for six weeks after first administration. On 5/2/18 patient suffered a ruptured aneurysm (pca). In June 2018/July2018, patient developed a rash on right side of neck/ear lobe area, which was thought to be an allergic dermatitis. 12/10/18, the same rash/same location developed. This time diagnosed as Shingles.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Therapeutic embolisation
Clinical narrative: Headache for six weeks after first administration. On 5/2/18 patient suffered a ruptured aneurysm (pca). In June 2018/July2018, patient developed a rash on right side of neck/ear lobe area, which was thought to be an allergic dermatitis. 12/10/18, the same rash/same location developed. This time diagnosed as Shingles.
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Bacterial test negative, Erythema, Inflammation, Needle issue, Nodule
Clinical narrative: Inflammatory nodule that is red and tender to the touch. Had it cultured at the lab on 10/26/2018 and came back on 10/30/2018 as no bacteria growth.
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Syringe issue, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch. Had it cultured at the lab on 10/26/2018 and came back on 10/30/2018 as no bacteria growth.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 53.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 41.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 61.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Nausea, Pain
Clinical narrative: Wed 12/5/2018 8pm Sore arm on movement; Thurs 12/6/2018 at 5:30am Chills, 7:15am Nausea, 10am Fatigue and aches, 11:15am Fever 99.4, Left arm still sore, 3:00pm Took TYLENOL 325mg,  4:30pm Fever and aches gone still tired; Friday 12/7/2018 Left arm still sore, other adverse reactions gone, 4:30pm Took shower and noticed redness on left arm about 2 inches below shot site and warm to the touch; Sat 12/8/2018 Reactions gone.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Wed 12/5/2018 8pm Sore arm on movement; Thurs 12/6/2018 at 5:30am Chills, 7:15am Nausea, 10am Fatigue and aches, 11:15am Fever 99.4, Left arm still sore, 3:00pm Took TYLENOL 325mg,  4:30pm Fever and aches gone still tired; Friday 12/7/2018 Left arm still sore, other adverse reactions gone, 4:30pm Took shower and noticed redness on left arm about 2 inches below shot site and warm to the touch; Sat 12/8/2018 Reactions gone.
Age: 28.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Bacterial test negative, Erythema, Inflammation, Mass excision, Nodule
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Acne, Erythema, Pain, Swelling
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Peripheral swelling
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Acne, Culture negative, Erythema, Fungal test
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Incisional drainage, Mycobacterium test negative, Pain, Pain in extremity, Swelling
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Slight headache, chills, slight soreness over entire body. Not enough to interrupt daily activities but noticeable.
Age: 34.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 54.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Inflammation, Nodule, Skin reaction, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 56.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 36.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 36.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Culture, Fungal test, Incisional drainage, Injection site discharge, Injection site erythema
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 36.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Injection site pustule, Mycobacterium test, Ultrasound scan, Wound treatment
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 66.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 33.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 58.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 45.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 42.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Candida test, Culture, Fungal test, Gram stain, Incisional drainage
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mycobacterium test
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Abscess, Culture, Debridement, Fungal test, Injection site erythema
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site pain, Mycobacterium test, Wound treatment
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site eczema, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: Within 24 hours developed eczema on thighs and lower legs. Became ill and congested with a low grade fever. Symptoms lasted for about a week. Eczema is still on going.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Local reaction
Clinical narrative: Localized reaction with some cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: (L) arm swelled 2nd day after vaccine. Seen by Dr 11/29/18 red, swollen and slightly warm to touch measuring 17 x 10 cm firm raised area at injection site 3.5 x 3.5 cm.
Age: 90.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: (L) arm swelled 2nd day after vaccine. 3rd day seen by Dr, slightly warm to the touch, redness 17 x 10 cm where vaccine was placed firm raised area 3.5 x 3.5 cm.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Blister, Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Cellulitis, upper arm (acute). LUE pain/swelling/redness - blistering. Abx AUGMENTIN 500/125 BID x 10 days. Naproxen 500 BID PRN. SILVADENE BID topical/NEOSPORIN topical BID.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, PNC13, RV1
Symptoms: Heart sounds abnormal, Hypersomnia, Lethargy, Pallor
Clinical narrative: Mother reports that patient slept longer than ml on 11/26-11/27/18 but main concern is that patient became lethargic at 10/10:30 am on 11/27/18 w/facial pallor and "faint heart sounds" - pt. had to be slapped and splashed w/water and disrobed to awaken and even then only slowly woke up. Parents did not check temperature at that time so unknown if fine. Mom called office once pt. was alert and wanted to speak w/a phone nurse who was not available at the time so advised to bring pt to office. Pt was stable then (approximately 12/1 pm) so mom decided to not come to office.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: The patient received the vaccination and immediately her arm started to swell in the injection area. I asked the patient if they felt alright and not dizzy or anything. The patient stated that they felt fine and that this has happened before several years ago. I offered BENADRYL and asked for the patient to stay for at least 15 minutes for observation. The patient did not have a severe enough reaction for EPI-PEN. The swelling dissipated after about 12 minutes. The patient left and said they still felt fine and I promised a follow up call.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Large red swollen area.