chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Medication error, Product administered to patient of inappropriate age, Product dispensing error, Wrong product administered
Clinical narrative: ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead with no reported adverse event; The FLUZONE HD was administered accidently instead of FLUZONE QUADRIVALENT with no adverse event; 13 years old patient recived FLUZONE HD with no reported adverse event; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from a Physician via the Agency (under reference number - 00849976).  This case is linked to cases 2021SA376763(CLUSTER) and 2021SA378956(CLUSTER).  This case involves a 13-year-old female patient who was accidentally vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] due to ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead with no adverse event (product dispensing error) (wrong product administered) (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 28-Oct-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ773AC and expiry date was not reported) via intramuscular route in the left arm for prophylactic vaccination.  There were no laboratory data/results available.  It was case of an actual medication error due to drug dispensing error, wrong vaccine administered and inappropriate age at vaccine administration (latency was on same day)  At the time of report, no adverse events were reported.  Event outcome was unknown.  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.
Age: 1.25
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Medication error, No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: FLUZONE HD was administered to patient of less than 65 years age, no AE; FLUZONE HD was administered to patient instead of FLUZONE Quadrivalent, no AE; FLUZONE HD was administered to patient of less than 65 years age, no AE; Initial information received on 09-Nov-2021 regarding an unsolicited valid  non-serious case received from a physician via the Agency (under the reference number 00850043).  This case is linked to case 2021SA378207 and 2021SA378956 (cluster).  This case involves a 15 months old female patient who was below 65 years age and was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age) (wrong product administered) (overdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date (was unable to obtain), the patient received 0.7 ml first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once in total, lot number UJ773AC and expiry date: the caller did not have this information available) via intramuscular route in the left leg for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was also a case of overdose (same day latency).  It was reported "Physician called to report that she ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead. The FLUZONE HD was administered to three patients less than 65 years old before she realized it was FLUZONE HD. Adverse Events were reported for all THREE patients with as much information as the caller was able to provide. The caller was in a hurry to obtain/provide information and return back to her practice."  The physician was unaware of any treatment, emergency room (ER), or Doctor (DR) visit necessary post administration at the time of the call. At time of reporting, no adverse event 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 the 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.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of PENTACEL was inadvertently administered with no adverse event; Initial information regarding an unsolicited valid non serious case was received from other health care professional via Medical Information (MI) (Reference number- 00850122) and transmitted to Sanofi on 09-Nov-2021.  This case involves a 6-month-old male patient receiving expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was inadvertently administered (expired product administered).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Nov-2021, the patient received a 0.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Frequency: once, lot UJ390AA, expiry date: 15-Oct-2021, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD 0.25mL] via intramuscular route in the right thigh for prophylactic vaccination.  This case is medication error due to expired vaccine used (latency same day).  It was reported "medical assistant reporting that an expired dose of PENTACEL was inadvertently administered, on 04-Nov-2021 an expired dose of pentacel was given and the product expired on 15Oct2021."  At time of reporting, no adverse event was 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 the 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.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered every year; no adverse effect; Information has been received from a lawyer via referring to a currently 66-year-old female patient. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (strength, dose, route, lot # and expiration date not reported) for prophylaxis. It was reported that the patient received pneumococcal vaccine (manufacturer unknown) every year (inappropriate schedule of product administration). She did not experience any adverse reactions or side effects.   This is one report split from a case in litigation (regulatory authority# 2108USA004990).; Sender's Comments:  US-009507513-2108USA004990:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue, Social problem
Clinical narrative: Due to the pandemic / 2nd dose two years after the first dose; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was unknown. The reporter stated that, due to pandemic he/she had received the 2nd dose of Shingrix 2 years after the 1st dose. The reporter asked if he/she needed to get a 3rd dose within 6 months. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Vaccination site pain
Clinical narrative: HEADACHES IN THE BACK OF HEAD; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches in the back of head, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site, and the outcome of headaches in the back of head was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, FLUX, UNK
Symptoms: Diarrhoea, Nausea, Pain
Clinical narrative: body aches; nausea; diarrhea; Initial information received on 03-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via a specialty pharmacy.  This case involves "an approximately" a 58 year old female patient who experienced body aches, nausea and diarrhea while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via dupilumab single dose pre filled pen and COVID-19 VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In September 2021, the patient started taking DUPIXENT (DUPILUMAB) injection 300 mg QOW (every other week) subcutaneously (strength: 300 mg/ 2ml, batch number and expiration date: unknown) for Severe persistent asthma via dupilumab single dose pre filled pen. In October 2021, the patient started taking COVID-19 VACCINE (strength, formulation, dose, frequency, route, batch number and expiration date: unknown) for Prophylactic vaccination. In October 2021, the patient received a  dose of suspect INFLUENZA VACCINE (strength, formulation, dose, frequency, route, batch number and expiration date: unknown) for prophylactic vaccination.  In 2021 the patient developed a non-serious event "body aches" (pain) (unknown latency) following the first dose intake of DUPILUMAB and (unknown latency) following the first dose intake of COVID-19 VACCINE. In 2021 the patient developed a non-serious event "nausea" (unknown latency) following the first dose intake of DUPILUMAB and (unknown latency) following the first dose intake of COVID-19 VACCINE. In 2021 the patient developed a non-serious event "diarrhea" (diarrhoea) (unknown latency) following the first dose intake of DUPILUMAB and (unknown latency) following the first dose intake of COVID-19 VACCINE.  It was reported, "patient reports got covid booster and flu shot last week. Developed body aches, nausea, diarrhea. no fever she says, not sure is she should hold off on her dupixent dose. advised pt (patient) to speak with her physician to see if md (medical doctor) wane her to hold off until her symptoms improved . no additional information provided."  DUPILUMAB (DUPIXENT) was continued. Action taken with  INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the events (body aches, nausea, diarrhea).  At time of reporting, the outcome was Unknown for the event body aches, was Unknown for the event nausea and was Unknown for the event diarrhea.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood folate, Blood test normal, Blood thyroid stimulating hormone, Burning sensation
Clinical narrative: Tingling sensation, sharp pins and needles sensation to hands and feet. Burning sensation to feet. Symptoms began 9/16/2021. No treatment occurred. Symptoms still present two months later, but diminished.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Full blood count, Glycosylated haemoglobin, Metabolic function test, Paraesthesia
Clinical narrative: Tingling sensation, sharp pins and needles sensation to hands and feet. Burning sensation to feet. Symptoms began 9/16/2021. No treatment occurred. Symptoms still present two months later, but diminished.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid factor, Thyroxine, Vitamin B1, Vitamin B12
Clinical narrative: Tingling sensation, sharp pins and needles sensation to hands and feet. Burning sensation to feet. Symptoms began 9/16/2021. No treatment occurred. Symptoms still present two months later, but diminished.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Injection site reaction, Rash, Rash erythematous, Ulcer
Clinical narrative: Localized fine red rash on right arm at injection site, and rash continued to spread over entire body.   Rash became open sores - which were worse on arms, torso, groin area, legs - to include both feet.  Last area affected was ears and scalp.  Seen by local doctor, diagnosed initially with eczema - treated with protopics.  Rash continued to worsen with no relief from protopics.  Had several follow up visits with local dermatologist- to no avail. Patient was directed to a facility for further evaluation.  Was seen by a dermatologist- who referred patient to a rheumatologist due to concerns about new onset of possible auto immune issues secondary to COVID vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Muscle spasms, Pain
Clinical narrative: Low energy,   cramping, body ache, chills    I almost called 911 for emergency, (NB,  I have never called 911 in my life!)   I thought I was going to die!  If my symptoms got any worse I knew I would die
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Menstrual cycle change beginning 6 weeks after first dose and has continued every month to present. Beginning  6/3/21 length has been at least 7 days with very heavy flow (previously since I was 12 years old flow was light and maximum of 3-4 days). Cycle has always been 28 days since I was 12 years old, never have had irregularities in my cycle.  Beginning  October 2021 I had 2 cycles two weeks apart, this has never happened before. This again happened this month beginning 11/3 lasting one week until 11/10 then again  another cycle starting 11/15.  I have had no changes to my diet, exercise or medications. I began researching possible causes and saw various online articles about other women reporting changes to menstrual cycles after the Covid vaccine and possible research being done on this topic. I was very concerned because in 33 years I have never had any changes in my menstrual cycle and it has always been  regular, every 28 days and a short duration. Beginning 6 weeks after the Covid vaccine it has been longer, heavier and now occurring twice per month the last two months.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Induration, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Moderna COVID-19 vaccine EUA. Arm of injection sore and swollen. Lymph nodes under arm of injection site have swollen large and hard. It is extremely uncomfortable and painful. Fever of 102.4.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Moderna COVID-19 vaccine EUA. Arm of injection sore and swollen. Lymph nodes under arm of injection site have swollen large and hard. It is extremely uncomfortable and painful. Fever of 102.4.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site rash
Clinical narrative: 10cm localized rash at injection site; dizziness after injection occurred during 15 minute observation period. 50mg diphenhydramine IM administered. Dr, MD consulted. Patient improved over additional 30 minutes, vitals stable. Patient declined further intervention.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Ear pain, Epistaxis, Hypoaesthesia, Productive cough
Clinical narrative: Chest Pains 4-5 days after shot, intermittent   Ear Aches 5-6 days after shot Excessive phlegm in lungs 5-6 days after shot Random body extremities briefly going numb 5-6 days after shot, to include lower jaw and both arms  Blood in phlegm almost persistently 6-7 days after shot
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had expired on 10/21/2021. Contacted medical director, Dr. Educated patient vaccine had expired one day prior; however, not required to repeat dose.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns reported; GARDASIL 9 that was administered/Temperature: 72F; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # U008315, expiry date 15-AUG-2023, for prophylaxis (route and location of administration were not reported), which was stored in a temperature of 72 degrees Fahrenheit for 120 hours (product storage error). No previous excursion was reported. The nurse inquired about stability of administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No other issues or concerns were reported (no adverse event).
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: reconstituted with expired powder portion; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA392A, expiry date 31st October 2021) and (batch number unknown, expiry date July 2022) for prophylaxis.   In November 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. In November 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo which was reconstituted with expired powder portion. Liquid portion had expiry date of July 2022. The pharmacist had limited information, patient demographics could not be collected. Date of vaccination was reported as a few days ago, exact date was not reported. The consent to follow up was denied.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Havrix pediatric dose to an adult patient; Havrix pediatric dose to an adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 34-year-old male patient who received HAV (Havrix pediatric) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 9th November 2021, the patient received the 1st dose of Havrix pediatric. On 9th November 2021, unknown after receiving Havrix pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional details were reported as follows: The health care professional reported that an adult patient received Havrix pediatric dose by error, which led to accidental underdose and adult use of a child product . The health care professional did not want an account in GlaxoSmithKline database. Consent to follow up was granted. The reporter confirmed that she was a health professional without specifying.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix, DOB: 25-FEB-2015; Received Boostrix instead of Flu Vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   On 9th November 2021, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that the 6-year-old patient received Boostrix vaccine in right deltoid instead of Flu vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This was 1 of 4 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231229:SAME REPORTER US-GLAXOSMITHKLINE-US2021231231:SAME REPORTER US-GLAXOSMITHKLINE-US2021231232:SAME REPORTER
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature fluctuation, COVID-19, Dyspnoea, Dyspnoea exertional, Hot flush
Clinical narrative: My arm got immediately sore followed by hot flashes and being unable to control my body temperature, I have near lost all of my lung capacity, I get winded if I walk up the stairs too fast, barely able to breathe, heart racing
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pain in extremity, Palpitations, SARS-CoV-2 test positive, Total lung capacity decreased
Clinical narrative: My arm got immediately sore followed by hot flashes and being unable to control my body temperature, I have near lost all of my lung capacity, I get winded if I walk up the stairs too fast, barely able to breathe, heart racing
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Joint range of motion decreased, Pain, Tenderness
Clinical narrative: Patient was administered the flu vaccine in the left arm. The next day experienced localized soreness, pain to palpation, limited range of motion, and strength limited by pain. Symptoms have been ongoing to date 11/17/2021
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Nausea
Clinical narrative: Immediate stiff neck, nausea. Lasted 2 days.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sudden onset of Tinnitus
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain
Clinical narrative: During observation period, patient reported onset of dull/gnawing chest pain; elevated BP, EMS activated. Assessment completed by EMS, patient declined transport; f/u call next day, patient reported "feeling great".
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Reported "tingling and numbness" in anterior neck, jaw, face and tongue during observation period. No rash, hives observed. 50 mg Diphenhydramine IM administered. Patient had similar event after first dose of Moderna Covid vaccine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Nervousness
Clinical narrative: Patient stated he was "nervous" before injection. Five minutes post injection, patient became diaphoretic and nauseated. Vital signs assessed; patient provided water and a banana, tolerated without incident. Patient left after 10 minutes. EMS not activated, no medications provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: SEVERE NOSE BLEED LASTING 10 MINUTES APPROXIMATELY 1 HOUR AFTER SECOND DOSE OF MODERNA VACCINE. I DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NOT A RECURRENCE OF BLEEDING AFTER IT STOPPED.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Patient received Moderna on 9/17/21, called facility on 9/27/21 to report redness at injection site. Patient encouraged to contact PCP or care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever, muscle soreness, joint pain, swollen lymph node(s) in left armpit
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, Kidney pain, Fever, Nightmares, Body aches, pain at injection site Headache, dizziness, disorientation
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pain, Pyrexia, Renal pain
Clinical narrative: Swollen lymph nodes, Kidney pain, Fever, Nightmares, Body aches, pain at injection site Headache, dizziness, disorientation
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: While administering vaccine, drops of vaccine noted on arm; hub of needle not tightened on syringe.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: I have had consistent low back pain starting about 3 days after the shot.  My joints also started aching around the same time.  I am still having these symptoms almost 4 weeks after the first dose.  I have made my doctor aware of these symptoms and she informed me that this is normal and would resolve.  So far, that has proven not to be the case.  Mr. doctor recommended I take over the counter pain relievers for this pain.  This has provided only temporary relief.  I am still having the symptoms to this day.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: It was discovered that the MA was improperly giving the rotavirus monovalent vaccine and only giving the diluent of rotavirus vaccine instead of mixing the diluent with the vial of the rotavirus vaccine and administering that. The clinic was able to track back which patients this affected. Patients on this date may have gotten the diluent only or the proper vaccine based on counts of abnormal diluent and reconstitute vaccine vials. The mother of patient was notified 10/29/21. Provider discussed with patient family the need to vaccinate between Nov 29th and Dec 6th in case this will be the first dose as well as in case this was the second dose. Provider documentation also notes the patient will then get another dose at either the 4 month or 6 month visit. Scheduled for Dec 3rd.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal erythema, Pharyngeal erythema, Throat irritation
Clinical narrative: During observation period, patient complained of itchy throat, initial observation showed normal vitals; however, after 2-3 minutes soft palate and posterior esophagus had turned red. Epipen administered, EMS activated. 50 mg diphenhydramine IM administered. Patient had hx of anaphylaxis with own Epipen. EMS transported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypoaesthesia, Tremor, Visual impairment
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient was lightheaded, dizzy and had chills and was feeling like fainting so we called 911 and paramedics monitored her for 15 minutes they asked her if she wants to go to the hospital she refused because she started feeling better and they made her sign a conset that she can go home.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, diaphoresis post injection during observation period. Patient placed in prone position, legs elevated. Vitals assessed. After 15 minutes, patient assisted to sitting position. Declined further intervention.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Pain, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: AER# from Pfizer / BioNtech Covid Vaccine follow up Questionnaire from Pfizer
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Arthralgia, Blood test normal, Confusional state, Fatigue
Clinical narrative: Arm swelling from shoulder to elbow, extreme pain and sensitivity, headaches, nausea, vomiting, rash on torso,   long term effects- confusion, brain fog, severe fatigue, ongoing rash/breakouts under arms,  joint pain, weight gain, hair thinning, heart palpitations,  This is effecting my life
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: Arm swelling from shoulder to elbow, extreme pain and sensitivity, headaches, nausea, vomiting, rash on torso,   long term effects- confusion, brain fog, severe fatigue, ongoing rash/breakouts under arms,  joint pain, weight gain, hair thinning, heart palpitations,  This is effecting my life
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Peripheral swelling, Rash, Sensitive skin, Vomiting
Clinical narrative: Arm swelling from shoulder to elbow, extreme pain and sensitivity, headaches, nausea, vomiting, rash on torso,   long term effects- confusion, brain fog, severe fatigue, ongoing rash/breakouts under arms,  joint pain, weight gain, hair thinning, heart palpitations,  This is effecting my life
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight increased
Clinical narrative: Arm swelling from shoulder to elbow, extreme pain and sensitivity, headaches, nausea, vomiting, rash on torso,   long term effects- confusion, brain fog, severe fatigue, ongoing rash/breakouts under arms,  joint pain, weight gain, hair thinning, heart palpitations,  This is effecting my life
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: PT WAS CRYING AND UPSET PRIOR TO VACCINE AND RESISTING
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: It was discovered that the MA was improperly giving the rotavirus monovalent vaccine and only giving the diluent of rotavirus vaccine instead of mixing the diluent with the vial of the rotavirus vaccine and administering that. The clinic was able to track back which patients this affected. Patients on this date may have gotten the diluent only or the proper vaccine based on counts of abnormal diluent and reconstitute vaccine vials. The mother of patient was notified 10/29/21. Provider discussed with patient family the patient should be vaccinated at 6 months visit.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Red rash all over patient's face as well. Ran 102 degree fever. Patients arm swelled up with a knot that was painful, warm and then later itched and her skin peeled around injection site. Lasted several days. Area still visible 28 days later
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Nodule, Pain
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Red rash all over patient's face as well. Ran 102 degree fever. Patients arm swelled up with a knot that was painful, warm and then later itched and her skin peeled around injection site. Lasted several days. Area still visible 28 days later
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash erythematous, Skin exfoliation
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Red rash all over patient's face as well. Ran 102 degree fever. Patients arm swelled up with a knot that was painful, warm and then later itched and her skin peeled around injection site. Lasted several days. Area still visible 28 days later
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Angiogram, Blood test
Clinical narrative: nonSTEMI (heart attack) required angiogram, in hospital for 3 days
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Influenza like illness, Loss of personal independence in daily activities, Pollakiuria, Sleep disorder
Clinical narrative: Accompanying flu-like symptoms was testicular pain that was on and off for 2 days, as it subsided a constant need to urinate that has disrupted life, work, and sleep.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Urine analysis
Clinical narrative: Accompanying flu-like symptoms was testicular pain that was on and off for 2 days, as it subsided a constant need to urinate that has disrupted life, work, and sleep.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: hands are tingling and numb
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt was given 1 shot of epipen 0.3 mg , called 911 , pt symptoms improved right after the epipen shot , his mom drove him to emergency room to monitor and follow up , the kid was ok before leaving the pharmacy
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt was given 1 shot of epipen 0.3 mg , called 911 , pt symptoms improved right after the epipen shot , his mom drove him to emergency room to monitor and follow up , the kid was ok before leaving the pharmacy
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Meniscus injury, X-ray
Clinical narrative: left knee pain with non traumatic meniscal tear
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain, Restless legs syndrome
Clinical narrative: Severe Restless Legs for 2 days. Severe Leg Joint Paint for 2 weeks. Walking very difficult and painful for 2 weeks. Unable to run again for 2 months.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Systemic: Tinnitus-Mild, Additional Details: Patient briefly passed out 6-7 minutes after receiving vaccine. She appeared to have a 20 to 30 second seizure(later confirmed from emt that it is possible for that to happen with syncope. Patient was walked out of pharmacy by EMTs and taken to hospital for evaluation. There are no further up details at this point. I will follow up with parents and pateint tomorrow as this vaccine was given late at night.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tinnitus, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Systemic: Tinnitus-Mild, Additional Details: Patient briefly passed out 6-7 minutes after receiving vaccine. She appeared to have a 20 to 30 second seizure(later confirmed from emt that it is possible for that to happen with syncope. Patient was walked out of pharmacy by EMTs and taken to hospital for evaluation. There are no further up details at this point. I will follow up with parents and pateint tomorrow as this vaccine was given late at night.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received Booster Dose of Moderna after receiving J&J as first dose. Patient fainted in waiting area while seated approximately 10 minutes after the injection. Patient revived on her own and was helped to a sitting postion on the floor. She did not complain of any pain or injury and fully recovered and was escorted home by her husband.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Intermittent itchy rash that migrates throughout the body including his bl wrists/ue, LE and face since receiving his 2nd moderna vaccine 5/2021. Rash appeared within minutes of getting vaccinated. Symptoms completely abate w/10 mg of cetirizine daily.  Still continues to get hives on a daily basis since receiving his 2nd Moderna vaccine and continues to take Cetirizine 10 mg daily.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Oropharyngeal pain
Clinical narrative: - Sore throat  - Allergic reaction, initial encounter
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pharyngitis
Clinical narrative: J02.9 - Pharyngitis, unspecified etiology R10.84 - Generalized abdominal pain
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Viral upper respiratory tract infection
Clinical narrative: - Viral URI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events monitored for up to 1 hour after inoculation
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Middle ear inflammation, Tinnitus
Clinical narrative: Inflammation of middle ear, pulsatile tinnitus since first shot worsened after second shot.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Dizziness, Seizure, Speech disorder
Clinical narrative: Patient went into a seizure about 5-10 minutes after administration of vaccine, She stated she was dizzy and then her chest hurt and went into a stare , she was non verbal but did follow with the eyes,  The whole time this happened was about 20 minutes, Ems was called to make sure patient was ok, she was out of the seizure and talking within 20 minutes They checked all vitals  and was transported to the hospital to make sure every thing was ok.  Outcome is not known at this time
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Staring
Clinical narrative: Patient went into a seizure about 5-10 minutes after administration of vaccine, She stated she was dizzy and then her chest hurt and went into a stare , she was non verbal but did follow with the eyes,  The whole time this happened was about 20 minutes, Ems was called to make sure patient was ok, she was out of the seizure and talking within 20 minutes They checked all vitals  and was transported to the hospital to make sure every thing was ok.  Outcome is not known at this time
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Viral infection
Clinical narrative: B34.9 - Viral illness Z20.822 - Encounter for laboratory testing for COVID-19 virus
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated. Vaccine breakthrough with inpatient ICU admit
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: R07.0 - Throat pain
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, SARS-CoV-2 test negative
Clinical narrative: Encounter for laboratory testing for COVID-19 virus Lab test negative for COVID-19 virus Generalized abdominal pain
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Malaise
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Father states patient wasn't feeling well 5-10 minutes after receiving the 3rd pfizer covid vaccine. He states she looked like she was going to fall over. He caught her and we placed on the floor to sit while the dad was fanning her. We offered to call the paramedics, but patient declined. Gave her water and candy which she drank and ate. She felt better afterwards. She stayed another 30 minutes and left on her recognizance. She states she feels better and went home with her dad.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Medium, Additional Details: Patient had vasovagal syncope shortly after receiving a Moderna (0.25ml) booster shot.....she woke up before EMS arrived and had vomiting and dizziness....EMS arrived and took the patient to the hospital for further evaluation
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Medium, Additional Details: Patient had vasovagal syncope shortly after receiving a Moderna (0.25ml) booster shot.....she woke up before EMS arrived and had vomiting and dizziness....EMS arrived and took the patient to the hospital for further evaluation
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Menometrorrhagia
Clinical narrative: Pt had previously normal not heavy regular menses before vaccine. The cycle following vaccine menses 5-7  days with large clots kept her from leaving house. Menses have not gone back to normal but started to get better in June or July.  Below from visit notes. She has been getting more clotting with menses recently as well. Clotting was very bad after covid vaccine lasting 2 days for several months, she couldn't leave her bath tub, couldn't go to work.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Neck pain, Pain in extremity
Clinical narrative: I have lost over 65% of my hair and it is still happening. It is breaking off in the middle of the hair and not at the scalp. Nothing else in my life has changed for this to happen.  My arm is still really sore and can't be touched along with neck pain that is not going away.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac disorder, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Heart problems.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Tremor, Vomiting
Clinical narrative: Arm started hurting pretty badly about 4 hours after getting the shot. Around 9 PM I started vomiting and shaking uncontrollably. This lasted about two hours. I started shaking again but less so around 11PM--seemed similar to chills but the shaking was pretty spasm like.  Headache afterwards. Sweating the next day but the majority of the effect was the day of.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Loss of personal independence in daily activities
Clinical narrative: Chest pain ( Heart) with any sort of stimulation. Causes great delay to my routine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitus became extremely loud approximately 1 month after 2nd shot and has not quieted down since.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PATIENT WAS TO HAVE RECEIVED BOOSTER DOSE OF MODERNA COVID-19 VACCINE (0.25ML) BUT PATIENT WAS ADMINISTERED A FULL DOSE (0.5ML).  PATIENT STATES SHE HAD NO ADVERSE EVENT AFTER RECEIVING IMMUNIZATION.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: 5-hydroxyindolacetic acid in urine, Activated partial thromboplastin time, Activated protein C resistance test, Angiogram, Angiogram cerebral
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antiphospholipid antibodies, Antithrombin III, Aphasia, Beta-2 glycoprotein antibody
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chromogranin A, Blood cortisol, Blood fibrinogen, Blood glucose, Blood homocysteine
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood magnesium, Blood osmolarity, Blood sodium, Blood test
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Cardiac monitoring, Cardiolipin antibody, Coagulation factor IX level
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation factor VII level, Coagulation factor XI level, Coagulation factor XII level, Creatinine urine, Differential white blood cell count
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Drug screen, Dyskinesia, Echocardiogram, Eye pain
Clinical narrative: Ischaemic stroke
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Faecal elastase test, Fatigue, Fine motor skill dysfunction, Full blood count, Gene mutation identification test
Clinical narrative: Ischaemic stroke