chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous report was received from a non-healthcare professional concerning a female patient, who received COVID-19 vaccine  and thinks she wasn't administered the full dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Feb 2021, the patient received their second of two planned doses (Batch number not provided) for prophylaxis of COVID-19 infection. On 07 Feb 2021, the patient received their second dose of the vaccine. The patient reported that the person that administered the vaccine was in a rush and she thinks the person did not administer the full dose. No adverse event was reported by the patient after being given the vaccine. Treatment information was not provided. Action taken in response to the events was not reported. The outcome of the event, thinks she wasn't administered a full dose, was considered resolved on 07 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A spontaneous report was received from a nurse concerning a patient who received COVID-19 Vaccine and the second vaccine dose was administered 9 weeks after the first (inappropriate schedule of vaccine administered).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter. On unknown date, the patient received their second dose for prophylaxis of COVID-19 infection. On unknown date, the patient received the second dose 9 weeks after the first dose. Treatment information was not provided. The patient received both scheduled doses of prior to the event; therefore, action taken with the drug in response to the events is not applicable. The outcome for the event, received the second vaccine dose was administered 9 weeks after the first (inappropriate schedule of vaccine administered), was recovered on an unknown date.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their second dose for prophylaxis of COVID-19 infection 9 weeks after the first dose. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of vaccine administered.
Sex: U
Vaccine: FLUX
Symptoms: Bell's palsy, Dysphagia, Influenza, Lagophthalmos
Clinical narrative: bells palsy; flu; Could not open or close his right eyelid; Hard time eating & drinking; Initial information received on 05-Feb-2021 regarding an unsolicited valid serious case received from a consumer (patient).  This case involved a patient of unknown age who experienced bells palsy (facial paralysis), flu (influenza), could not open or close his right eyelid (lagophthalmos) and hard time eating & drinking (dysphagia), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient experienced bells palsy (facial paralysis), flu (influenza), could not open or close his right eyelid (lagophthalmos) and hard time eating & drinking (dysphagia), (latency: unknown) following the administration of suspect vaccine.  Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event facial paralysis.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a patient of unknown age who experienced facial paralysis, influenza, lagophthalmos and dysphagia after vaccination with suspect INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Moreover, medical condition at the time of vaccination and laboratory test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Eyelid exfoliation, Lymphadenopathy, Ocular hyperaemia, Pharyngeal swelling, Swelling face
Clinical narrative: swelling in throat glands; red eyes; face swelling; scaling on her eye lashes; Initial information was received on 27-Jan-2021 regarding an unsolicited valid non-serious case from a consumer or consumer or other non-professional (patient).  This case involves a 82 year old female patient who experienced red eyes (ocular hyperaemia), swelling in throat glands (pharyngeal swelling), face swelling (swelling face) and scaling on her eye lashes (eyelid exfoliation), after she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  In 2017, patient was taking the FLUZONE QUADRIVALENT as previous vaccination with no side effects.  Medical history, medical treatment, family history and concomitant medication were not provided.  On 08-Oct-2017, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UI840AA, 04-Jun-2018] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious red eyes (ocular hyperaemia), swelling in throat glands (pharyngeal swelling), face swelling (swelling face) and scaling on her eye lashes (eyelid exfoliation), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was reported at the time of reporting that, patient looked Asia and she is Irish.   It was also reported that, patient was not wanting to take the COVID vaccine but wanted to know if she would have the same side effects as the FLUZONE HIGH-DOSE and her physicians suggested her, not take the COVID vaccine due to  FLUZONE HIGH-DOSE side effects.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was reported as unknown for all the reported events.   At the time of reporting, the result of assessment reported as not reported.
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Musculoskeletal discomfort, Palpitations
Clinical narrative: rapid heartbeat; edema extended from her shoulder to her elbow (redness, swelling and edema at injection site); redness at the injection site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (caregiver).  This case involves a 51 year old female patient who experienced rapid heartbeat (tachycardia), redness at injection site (vaccination site erythema), edema extended from her shoulder to her elbow (swelling and edema at injection site) (extensive swelling of vaccinated limb), after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date in Oct-2020, the patient received a 0.5 mL dose (frequency once) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (pre-filled syringe, lot number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in Oct-2020, the patient developed a non-serious rapid heartbeat (tachycardia), redness at injection site (vaccination site erythema), edema extended from her shoulder to her elbow (swelling and edema at injection site) (extensive swelling of vaccinated limb), within few hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that the patient did not experience dyspnea. Reporter is concerned that patient may also react to the COVID vaccine and is asking for any available information  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The patient was recovered from all the events at the time of reporting.  There will be no information available on the batch number for this case.
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Peripheral swelling, Tachycardia
Clinical narrative: rapid heartbeat; edema extended from her shoulder to her elbow (redness, swelling and edema at injection site); redness at the injection site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (caregiver).  This case involves a 51 year old female patient who experienced rapid heartbeat (tachycardia), redness at injection site (vaccination site erythema), edema extended from her shoulder to her elbow (swelling and edema at injection site) (extensive swelling of vaccinated limb), after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date in Oct-2020, the patient received a 0.5 mL dose (frequency once) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (pre-filled syringe, lot number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in Oct-2020, the patient developed a non-serious rapid heartbeat (tachycardia), redness at injection site (vaccination site erythema), edema extended from her shoulder to her elbow (swelling and edema at injection site) (extensive swelling of vaccinated limb), within few hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that the patient did not experience dyspnea. Reporter is concerned that patient may also react to the COVID vaccine and is asking for any available information  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The patient was recovered from all the events at the time of reporting.  There will be no information available on the batch number for this case.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After receiving vaccine client states she feels lightheaded.  Vital signs obtained. BP 130/73, pulse 75, O2 sat 98%. Client states she is feeling better.  Client discharged home.  Client advised to call if symptoms return or worsen.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle aches and pains 530 am; Fever 100.4/feeling feverish 6am; Shaking/shivering since 3am
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle aches and pains 530 am; Fever 100.4/feeling feverish 6am; Shaking/shivering since 3am
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Injection site pain
Clinical narrative: Lightheadedness, soreness at site, high blood sugar
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After client received vaccine client states he felt dizzy.  Vitals obtained bp 120/78, pulse 100, O2 sat 97%. Client stated he feels better. Client discharged home.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever 99.0-100.8 from 2/12 pm to 2/14 pm; Arm soreness from from 2/12 pm to 2/14 pm; Tiredness from 2/12 pm to 2/14 pm; Chills on 2/13 from 3:30pm-5:00 pm; Cold and clammy episode on 2/15 at around 12 pm... called 911, but symptoms subsided by the time they got to me and my vitals were within normal parameters.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: After client received vaccine client stated she had tingling in left arm.  Vital signs obtained by EMS: BP 164/100, repeat 155/87, Pulse 90, O2 sat 98%; Client stated she feels better.  Client discharged home by EMS.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity, Syncope
Clinical narrative: Right arm became very painful and unable to move due to the stiffness of the upper arm.  Could NOT use or lift arm at all for 24 hours.  At 10:30pm on the 13th, my husband and I decided to try and move my arm slowly up and down to help "loosen the stiffness" when my husband lifted my right arm to about shoulder height, the pain was so bad I fainted. I have never fainted before in my life.  I was out for about 2-3 minutes.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Insomnia, Muscle spasms
Clinical narrative: Arm pain (painful 5/10 to move arm at all), chills, low grade fever, body aches, muscle cramping, headache, low back pain, nausea, difficulty sleeping- onset 2000 after 1400 shot and ongoing next day at 0640
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain (painful 5/10 to move arm at all), chills, low grade fever, body aches, muscle cramping, headache, low back pain, nausea, difficulty sleeping- onset 2000 after 1400 shot and ongoing next day at 0640
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Hyperhidrosis, Lymphadenopathy
Clinical narrative: After receiving the 2nd dose of the COVID vaccine on Sunday  morning, Feb. 14, my left underarm began to hurt in the evening.  I was tired that day but no other symptoms.  Through the night I had chills and sweats.  In the morning there was a large lump in my left underarm.  Swollen lymph glands about 3 inches wide and 2 inches deep.  This has continued through Monday and now Tuesday morning it is the same.  No sign of it growing larger or smaller.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash/hives on lower legs very itchy in morning and evening. Started 3 days after vaccination, symptoms mostly gone after being present for 3 weeks. No treatment seeked.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Arm was very achy the first 12-14 hours.  Kept me awake that night.  Injection site was very sore to touch.  After 5 days, still have severe joint pain in left shoulder (side which injection was given) which is constant.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: started to have a headache the day after the shoot, tried to sleep it off. Had chills and felt slightly weak. Went away after the day after the side affects.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Paraesthesia, Sneezing
Clinical narrative: summary of her symptoms: 1 hr post vaccination - feeling tired and sneezing excessively for a couple of days. 3rd day post vaccination-skin tingling sensation all over that resolved with oatmeal bath. 5th day post vaccination-was seen by pcp who told she was fine. received a call from pa from office to inform her she had an allergic rxn and was not to receive the second vaccine. today-she is asymptomatic.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Bell's Palsy, Fever, Fatigue, Headache, and Dizziness
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Bell's Palsy, Fever, Fatigue, Headache, and Dizziness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Radiculitis brachial
Clinical narrative: developed s/s consistent with brachial neuritis in R arm a few days post vaccination; required medical treatment and 10 day course of oral steroids; imagining and physical therapy ordered as well; as of today (2/16/21) condition has improved with majority of R arm function regained
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: On Tylenol 500 mg every 6 hours from Tuesday to Friday; On Ibuprofen 600 mg every 6 hours from Tuesday to Friday fever from Tuesday to Thursday; headaches, joint pain and pain on injection site from Tuesday to present; fatigue from Tuesday to present; tachycardia/ shortness of breath on exertion Thursday and Friday
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: On Tylenol 500 mg every 6 hours from Tuesday to Friday; On Ibuprofen 600 mg every 6 hours from Tuesday to Friday fever from Tuesday to Thursday; headaches, joint pain and pain on injection site from Tuesday to present; fatigue from Tuesday to present; tachycardia/ shortness of breath on exertion Thursday and Friday
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain, moderate
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Panic reaction
Clinical narrative: Client c/of nausea and dizziness.  states that she hand's had anything to eat since am.  client started having symptom after getting out of car to walk her dog.  Pt voice that she suffers from panic disorder and was having an episode.  Pt assessed, vital signs are as follows:  BP 130/84, HR 80, O2 97%.  Client cleared to go home after stating she felt better.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Intermittent facial tingling/numbness-still occuring
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pericarditis, Pyrexia, Tachycardia
Clinical narrative: Patient developed fever on day 8 post-vaccine followed by tachycardia, dyspnea and chest pain.  Elevated troponin in the ER.  ED echo confirmed pericarditis with likely myocarditis.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin T increased
Clinical narrative: Patient developed fever on day 8 post-vaccine followed by tachycardia, dyspnea and chest pain.  Elevated troponin in the ER.  ED echo confirmed pericarditis with likely myocarditis.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Date and time adverse event started: red toes 2 /10  estimated..caller says she didnt tell me exactly Date and time of vaccination: (list both if they received both shots): 2/8/21 he thinks
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Minor hives on upper back 3 weeks after round 1.  Resolved before receiving round 2. Rash came back with a vengeance round 2. Rash was shingle like in patches on upper back.  Rash then extended to patch on lower back.  It was itching and burning and had papules.  Rash spread to area around umbilicus. Rash extended to spots down left arm. Went to physician on 02/15/2021.  Unsure if shingles or reaction to vaccine.  Prescribed a steroid shot and Zyrtec daily.  Prescribed Valacyclovir.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site rash, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: 13 hrs post vaccine fever, aches chills. 36 hrs pst vaccine swollen left supraclavicular lymph node, still swollen 2.5 wks later. 10 days post vaccination rash on left arm near injection site lasted 3 days. PCP notified and will f/u if node still swollen at 1 month.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever lasted 8+ hours, chills, body ache, headache
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Client attended by onsite EMS.  Client concerned about dizziness after receiving COVID-19 vaccine.  Decided to have bp taken. Pulse/heart rate 107, O2 96%, stated had anxiety.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Throat irritation
Clinical narrative: Pt. states that she received the second vaccine on 2/15/21 at 1720 and then five minutes later she developed shortness of breath, itchy throat, and coughing. pt. was brought to the Emergency room. Pt. currently in hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Pt. states that she received the second vaccine on 2/15/21 at 1720 and then five minutes later she developed shortness of breath, itchy throat, and coughing. pt. was brought to the Emergency room. Pt. currently in hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat irritation
Clinical narrative: Pt. states that she received the second vaccine on 2/15/21 at 1720 and then five minutes later she developed shortness of breath, itchy throat, and coughing. pt. was brought to the Emergency room. Pt. currently in hospital.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 8 days after I received the Moderna vaccine, I got an itchy, hard red patch about the size of a quarter with a smaller patch right below about the size of a nickel at the injection site which lasted for a little over 24 hours.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling cold, Impaired work ability, Nasal injury
Clinical narrative: reports, "I got my second covid vaccine Lot 031L20A vaccine to my left arm around 1540 the day before, 2/10 and I woke up fine".   reports, "around 9 ish, I felt cold but was told it is always cold on this floor and while standing in patient room, 10 minutes later, I felt nausea and dizzy, then realized I was falling to the floor and hit the floor but used both hands to lessen the fall and then hit the left side of my nose".   denies any headache, nose bleeding, hitting head or LOC.    reports,  "someone from the unit took me down to the ED by wheelchair".   reports, " I was fully aware I was falling".   denies any problems with lighting, monitors, headache, visual or gait disturbance".
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinalgia
Clinical narrative: reports, "I got my second covid vaccine Lot 031L20A vaccine to my left arm around 1540 the day before, 2/10 and I woke up fine".   reports, "around 9 ish, I felt cold but was told it is always cold on this floor and while standing in patient room, 10 minutes later, I felt nausea and dizzy, then realized I was falling to the floor and hit the floor but used both hands to lessen the fall and then hit the left side of my nose".   denies any headache, nose bleeding, hitting head or LOC.    reports,  "someone from the unit took me down to the ED by wheelchair".   reports, " I was fully aware I was falling".   denies any problems with lighting, monitors, headache, visual or gait disturbance".
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Client verbalized feeling anxious after receiving the vaccine.  Client was evaluated by Fire Rescue Paramedics onsite and cleared to go home.  Patient wanted to be transported to the hospital for further evaluation.  Client was transported to Hospital at 10:am.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site discolouration, Injection site pain
Clinical narrative: 1/16/2021( first dose) LOT first (011J20A); 2/13/2021 (second dose) second (028L20A); patient reported she woke up today 02/14/2021 @0700 to sorness amd pink color around the area of injection. dizziness is gone , but the pink color around the injection site and the sorness still present
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: nausea, headache, muscle aches, fatigue, swollen lymphnodes in armpit (left side)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches , shortness of breath, headache
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Myalgia, Rash
Clinical narrative: Delayed injection site reaction.  Felt like the muscle was getting sore again. After shower noticed the rash. I sometimes get this after Emgality shot but not always. It isn't bothersome. Shot was Feb 5. Noticed renewed pain on Feb 15, noticed rash Feb 16. Will monitor.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Flu symptoms, nausea, chills, severe headache
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Stool analysis abnormal
Clinical narrative: Diarrhea for 3 weeks and still going on
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site warmth, Nausea
Clinical narrative: After the vaccination at around 6 PM the injection site (arm) started to feel sore and warm.  The day after the vaccine in the early morning hours I started to feel a headache and I took Aleve and also nausea where I then took Zofran. Once I took medication  hours later I started to feel a bit of  relief but then the symptoms came back again.  On  02/16/2021  my arm didn't feel sore but I still feel the headache.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: I was throwing up all of Friday, had chills, fever, dizzy, weak, and exhaustion.  These symptoms lasted all day Friday.  I could barely get out of bed.  Saturday I was still dizzy, body was weak but no more throwing up.  The effects lasted until Sunday but my stomach is still having issues and still a little weak.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I was throwing up all of Friday, had chills, fever, dizzy, weak, and exhaustion.  These symptoms lasted all day Friday.  I could barely get out of bed.  Saturday I was still dizzy, body was weak but no more throwing up.  The effects lasted until Sunday but my stomach is still having issues and still a little weak.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node (in the armpit) on the side where injection occurred
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Exposure during pregnancy; No additional AE reported; patient inadvertently received a dose of GARDASIL 9 instead of FLU vaccine; This spontaneous prospective pregnancy report was received from an office manager, via field representative and refers to a 30-year-old female patient. Her concomitant medications included prenatal vitamins and loratadine. The patient's pertinent medical history included history of thrombocytopenia. Reported allergies included allergies for tree nuts, mango and gluten.  She became pregnant with last menstrual period (LMP) on 11-OCT-2020 and estimated due date on 18-JUL-2021. On 21-JAN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687291, expiration date 11-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis, instead of influenza virus vaccine (unspecified). The pregnancy outcome was pending. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: administered zoster vaccine live (ZOSTAVAX) at a dose of 0.5 (units not provided); This spontaneous report (split from legal case MARRS # 2008USA010988) was received from an other health professional via a Patient Vaccine Administration Record and from a physician via medical records, and refers to a 64-year-old male patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-MAR-2013 (also reported as "3/18"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (also reported as "historical Zostervax"), dose: 0.5 (units not provided), lot # J000433 was found to be valid for zoster vaccine live (ZOSTAVAX), expiration date was not provided but upon internal validation established as 10-APR-2014, for prophylaxis (route of administration and anatomical location were not provided).  All available medical records will be provided upon request.  This is one two reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA010988:
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: significant local reactions to Bexsero-Itching; significant local reactions to Bexsero-Redness; significant local reactions to Bexsero-swelling; Concerned that this may have been an allergic reaction; This case was reported by a physician via sales rep and described the occurrence of localized itching in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced localized itching, localized erythema, local swelling and allergic reaction. On an unknown date, the outcome of the localized itching, localized erythema, local swelling and allergic reaction were unknown.   It was unknown if the reporter considered the localized itching, localized erythema, local swelling and allergic reaction to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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 provided as follows:   The age at vaccination was not reported. The patient had significant local reactions like redness, swelling & Itching to Bexsero.  The reporter was concerned that this might have been an allergic reaction. The physician was not planning on giving 2nd dose. The reporter did not give consent to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Hypoaesthesia, Joint range of motion decreased, Mobility decreased, Movement disorder
Clinical narrative: Numbness / in her left hand; Tingling in her left hand; Continues to have mild discomfort; Decreased range of motion / unable to lift her left arm independently / has used physical therapy; unable to lift her left arm independently / has used physical therapy; Left side of her neck became sore / increasingly worse; Left arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis and rheumatoid arthritis. Concomitant products included methotrexate.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd November 2020, 5 days after receiving Shingrix, the patient experienced neck pain. On 4th November 2020, the patient experienced joint range of motion decreased and injected limb mobility decreased. On an unknown date, the patient experienced pain in arm, numbness in hand, tingling of extremity and discomfort. The patient was treated with prednisone and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the pain in arm, joint range of motion decreased and injected limb mobility decreased were recovered/resolved and the outcome of the neck pain and discomfort were not recovered/not resolved and the outcome of the numbness in hand and tingling of extremity were unknown.   It was unknown if the reporter considered the pain in arm, neck pain, joint range of motion decreased, injected limb mobility decreased, numbness in hand, tingling of extremity and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm. The patient had left arm soreness for approximately two days. On days three and four, she felt fine. On 2nd November 2020, the left side of her neck became sore and became increasingly worse. On 4th November 2020, she had a decreased range of motion. She was unable to lift her left arm independently. She also had numbness and tingling in her left hand. She had taken prednisone and had used physical therapy. The patient's range of motion was back to baseline, but she continued to have mild discomfort. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Numbness / in her left hand; Tingling in her left hand; Continues to have mild discomfort; Decreased range of motion / unable to lift her left arm independently / has used physical therapy; unable to lift her left arm independently / has used physical therapy; Left side of her neck became sore / increasingly worse; Left arm soreness; This case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoarthritis and rheumatoid arthritis. Concomitant products included methotrexate.   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd November 2020, 5 days after receiving Shingrix, the patient experienced neck pain. On 4th November 2020, the patient experienced joint range of motion decreased and injected limb mobility decreased. On an unknown date, the patient experienced pain in arm, numbness in hand, tingling of extremity and discomfort. The patient was treated with prednisone and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the pain in arm, joint range of motion decreased and injected limb mobility decreased were recovered/resolved and the outcome of the neck pain and discomfort were not recovered/not resolved and the outcome of the numbness in hand and tingling of extremity were unknown.   It was unknown if the reporter considered the pain in arm, neck pain, joint range of motion decreased, injected limb mobility decreased, numbness in hand, tingling of extremity and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm. The patient had left arm soreness for approximately two days. On days three and four, she felt fine. On 2nd November 2020, the left side of her neck became sore and became increasingly worse. On 4th November 2020, she had a decreased range of motion. She was unable to lift her left arm independently. She also had numbness and tingling in her left hand. She had taken prednisone and had used physical therapy. The patient's range of motion was back to baseline, but she continued to have mild discomfort. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient only received a portion of the 0.5ml dose, less than one cc is what fell out of the syringe; A spontaneous report was received from a healthcare professional concerning a 42-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and only a portion of the 0.5 ml dose, less than one cc is what fell out of the syringe.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of Covid-19 infection.  On 01 Feb 2021, It was stated that the patient only received a portion of the 0.5 ml dose, less than one cc is what fell out of the syringe.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, the patient only received a portion of the 0.5 ml dose, less than one cc is what fell out of the syringe, were considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273. There were no reported AEs associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product substitution issue
Clinical narrative: received his first dose of the Moderna COVID19 vaccine. 12 days later, he received the Pfizer; received his first dose of the Moderna COVID19 vaccine. 12 days later, he received the Pfizer; A spontaneous report was received from a consumer concerning a 74-year-old male patient who receive his first dose of Moderna Covid-19. 12 days later, he received the Pfizer vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: not provide) intramuscular for prophylaxis of COVID-19 infection. Twelve days later the patient was given the Pfizer vaccine. The pharmacist on the phone did not want to provide any further information.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The events were considered resolved.; Reporter's Comments: This case concerns a 74 year old male patient who received their first of two planned doses of mRNA-1273 (batch number not provide) intramuscularly for prophylaxis of COVID-19 infection. Twelve days later the patient was given the Pfizer vaccine. There were no reported adverse events in this case of product substitution issue and Inappropriate schedule of product administration.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Feeling cold, Hypertension, Impaired work ability
Clinical narrative: It started with tingling in my tongue (which I ignored), then it became numbness that spread down my throat I also became short of breath. That's when I notified one of the nurses. They checked my blood pressure. I vaguely remember hearing it was high (189/?). They called 911 and the paramedics came. Shortness of breath became worse and chest pains started. The paramedic gave me Benadryl and then epinephrine since I was increasingly getting worse. I was shaking  and I felt lethargic. I could not control the shaking and I felt cold. I do not remember a lot of details when I got to the Emergency Room. Looking at my record they gave me: LORazepam (ATIVAN), methylPREDNISolone sod suc(PF)(SOLU-MEDROL) and famotidine. I went home that night with the condition that I see my primary care physician. I felt like I have the flu and soreness of arm the next couple days. I went back to work after four days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Paraesthesia oral, Pharyngeal hypoaesthesia, Tremor
Clinical narrative: It started with tingling in my tongue (which I ignored), then it became numbness that spread down my throat I also became short of breath. That's when I notified one of the nurses. They checked my blood pressure. I vaguely remember hearing it was high (189/?). They called 911 and the paramedics came. Shortness of breath became worse and chest pains started. The paramedic gave me Benadryl and then epinephrine since I was increasingly getting worse. I was shaking  and I felt lethargic. I could not control the shaking and I felt cold. I do not remember a lot of details when I got to the Emergency Room. Looking at my record they gave me: LORazepam (ATIVAN), methylPREDNISolone sod suc(PF)(SOLU-MEDROL) and famotidine. I went home that night with the condition that I see my primary care physician. I felt like I have the flu and soreness of arm the next couple days. I went back to work after four days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Cold sweat, Dizziness, Dysphonia
Clinical narrative: Several days after 1st Covid-19 vaccine I have incidents at least 2 times per day feeling shakiness, feeling like blood sugar was low, feeling weak and dizzy and clammy This lasted for 2 weeks post the 1st vaccine. Also experienced headache for 10 days post vaccine. After dose 2, Flushing on face and chest. Tingling and heaviness on chest. Feeling short of breath and feeling tightness in throat Tingling of arms. BP was 141/101 (normally runs low). I was informed that I was having a panic attack and was released by the staff. Chest tightness, heaviness and difficulty breathing continued. On Saturday 2/13 I went to urgent care and was prescribed an inhaler and steroids for shortness of breath. I continue with feeling heaviness in my chest, difficulty with shortness of breath, and hoarseness in my voice/tightness in my throat especially with increased activity or talking.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Flushing, Headache, Panic attack
Clinical narrative: Several days after 1st Covid-19 vaccine I have incidents at least 2 times per day feeling shakiness, feeling like blood sugar was low, feeling weak and dizzy and clammy This lasted for 2 weeks post the 1st vaccine. Also experienced headache for 10 days post vaccine. After dose 2, Flushing on face and chest. Tingling and heaviness on chest. Feeling short of breath and feeling tightness in throat Tingling of arms. BP was 141/101 (normally runs low). I was informed that I was having a panic attack and was released by the staff. Chest tightness, heaviness and difficulty breathing continued. On Saturday 2/13 I went to urgent care and was prescribed an inhaler and steroids for shortness of breath. I continue with feeling heaviness in my chest, difficulty with shortness of breath, and hoarseness in my voice/tightness in my throat especially with increased activity or talking.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Throat tightness, Tremor
Clinical narrative: Several days after 1st Covid-19 vaccine I have incidents at least 2 times per day feeling shakiness, feeling like blood sugar was low, feeling weak and dizzy and clammy This lasted for 2 weeks post the 1st vaccine. Also experienced headache for 10 days post vaccine. After dose 2, Flushing on face and chest. Tingling and heaviness on chest. Feeling short of breath and feeling tightness in throat Tingling of arms. BP was 141/101 (normally runs low). I was informed that I was having a panic attack and was released by the staff. Chest tightness, heaviness and difficulty breathing continued. On Saturday 2/13 I went to urgent care and was prescribed an inhaler and steroids for shortness of breath. I continue with feeling heaviness in my chest, difficulty with shortness of breath, and hoarseness in my voice/tightness in my throat especially with increased activity or talking.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chest pain, Mobility decreased, Pain in extremity
Clinical narrative: At times, moderate to severe pain in left arm, left elbow, left wrist and fingers ,At times, a searing, burning pain that comes and goes. Also went into left chest muscles and left shoulder. Kept me awake a few nights after the shot. When pain was bad, little or no strength in left arm.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: At times, moderate to severe pain in left arm, left elbow, left wrist and fingers ,At times, a searing, burning pain that comes and goes. Also went into left chest muscles and left shoulder. Kept me awake a few nights after the shot. When pain was bad, little or no strength in left arm.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site cellulitis, Paraesthesia, Peripheral swelling
Clinical narrative: On 2/9/21 I woke up with a raised,  red, swollen rash on my left arm probably 2" x 2" in size.  I had a scratchy throat, mild headache and chills.  I went to Urgent Care (per my primary care's instructions).  Diagnosis was Cellulitis (skin infection caused by bacteria at the injection site) and put on 100mg Doxycycline twice a day for 7 days.  Over the next few days the rash increased in size and I still was getting chills and tingling sensations on my skin especially my face so I contacted my Primary Care and had a follow-up appointment with them on 2/11/21.  I was told to stop the Doxycycline because they did not think it was Cellulitis, but was a reaction to the Vaccine (Covid Arm).  On 2/15/21 I saw my Dermatologist because I am still having tingling sensations on my face and my Rosacea is acting up - they put me on a topical cream Ketoconazole.  The rash on my arm is just a little red at the outer edge, but slowly disappearing.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rosacea, SARS-CoV-2 test negative
Clinical narrative: On 2/9/21 I woke up with a raised,  red, swollen rash on my left arm probably 2" x 2" in size.  I had a scratchy throat, mild headache and chills.  I went to Urgent Care (per my primary care's instructions).  Diagnosis was Cellulitis (skin infection caused by bacteria at the injection site) and put on 100mg Doxycycline twice a day for 7 days.  Over the next few days the rash increased in size and I still was getting chills and tingling sensations on my skin especially my face so I contacted my Primary Care and had a follow-up appointment with them on 2/11/21.  I was told to stop the Doxycycline because they did not think it was Cellulitis, but was a reaction to the Vaccine (Covid Arm).  On 2/15/21 I saw my Dermatologist because I am still having tingling sensations on my face and my Rosacea is acting up - they put me on a topical cream Ketoconazole.  The rash on my arm is just a little red at the outer edge, but slowly disappearing.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: On 2/9/21 I woke up with a raised,  red, swollen rash on my left arm probably 2" x 2" in size.  I had a scratchy throat, mild headache and chills.  I went to Urgent Care (per my primary care's instructions).  Diagnosis was Cellulitis (skin infection caused by bacteria at the injection site) and put on 100mg Doxycycline twice a day for 7 days.  Over the next few days the rash increased in size and I still was getting chills and tingling sensations on my skin especially my face so I contacted my Primary Care and had a follow-up appointment with them on 2/11/21.  I was told to stop the Doxycycline because they did not think it was Cellulitis, but was a reaction to the Vaccine (Covid Arm).  On 2/15/21 I saw my Dermatologist because I am still having tingling sensations on my face and my Rosacea is acting up - they put me on a topical cream Ketoconazole.  The rash on my arm is just a little red at the outer edge, but slowly disappearing.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Culture urine, Dysarthria, Fatigue, Mobility decreased
Clinical narrative: She had her 2nd COVID-19 vaccine 2 days ago. Yesterday she developed sudden onset of weakness and tiredness. She had a hard time sitting up, trying to lift her arms, had a hard time articulating how she felt and what was wrong, her speech seemed a little slurred, and she felt nauseated. Her daughter denied facial droop and localizing weakness. She continued to be "out of it" and weak until her daughter put her in bed about 7 hours later. She slept well and got up twice during the night to use the bathroom and seemed ok. She is feeling better today. Pt reports she kept hearing the telephone ringing all night and thought she heard someone yelling about the phone.