chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Product administration error
Clinical narrative: no additional AE or side effects/symptoms; she was was accidentally given the GARDASIL 9 vaccine today and consumer is currently in 3rd trimester of pregnancy; medical assistant inadvertently administered GARDASIL 9 to a 28-week pregnant patient, because they thought it was a different medication; This spontaneous prospective pregnancy report as received from a physician and from the patient refers to a 28-week pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-NOV-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscular (lot # and expiration date were not reported). The administering medical assistant thought it was a different medication (unspecified). No other adverse event was reported.  The last menstrual period (LMP) was estimated to 06-MAY-2020 and estimated date of delivery (EDD) to 10-FEB-2021.  The pregnancy outcome was pending.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: storage error; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medications and concurrent conditions was not provided. On 08-DEC-2020, the patient was vaccinated with improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). 0.5 ml,  lot # 1637648 with expiration date of 19-JUN-2022 for prophylaxis.  The vaccine experimented temperature of excursión of 14.7 degrees Celsius for 19 hours and 14 minutes. There were no previous temperature excursión. Digital data logger was involved.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu shot, patient got the flu; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who got flu (influenza), while patient received Influenza vaccine.  Medical history, medical treatments and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received Influenza vaccine [Produce by unknown manufacturer, batch number and expiration date not reported] via an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after receiving the suspect vaccine , patient got flu (influenza).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: 5 min after vaccine flu shot pt started to feel dizzy, profusely sweated, was offered water and accepted all left shortly thereafter
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu symptoms; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via social media.  This case involves a patient (age and gender unspecified) who had flu symptoms (Influenza), when he/she received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu symptoms(Influenza), 2 days following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Physical disability, Wheelchair user
Clinical narrative: developed that from a flu shot was disabled for the rest of her life in a wheelchair; Initial information regarding an unsolicited valid serious social media case was received from a non-healthcare professional (consumer) on 11-Dec-2020.  This case involved a female patient of an unknown age who was disabled for the rest of her life in a wheelchair (Physical disability), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the reporter knew a lady who was disabled for the rest of her life in a wheelchair from a flu shot (Physical disability) and reported that it was just a gamble to take.  No relevant laboratory details were provided.  The event of physical disability was assessed as seriousness criterion of disability.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as not resolved.  There will be no information available on the batch number for this case.; Sender's Comments: This case involved an unknown age female patient who presented with physical disability after receiving INFLUENZA VACCINE by an unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Lung disorder, Pneumonia, Product administered to patient of inappropriate age
Clinical narrative: pneumonia; flu; was given the high dose; Initial information was received on 12-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer (Patient).  This case involved a 60 year old patient who developed pneumonia, flu (Influenza) and for whom was given the high dose (Extra dose administered) was reported, while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed pneumonia, flu (Influenza), 2 days following the administration of INFLUENZA VACCINE.  Seriousness criteria was assessed as hospitalization (caused or prolonged) for events flu and pneumonia.  It was also the case of actual medication error due to extra dose administered.  Patient reported that had trouble with lungs.  No relevant laboratory data was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for pneumonia and flu at the time of reporting.  There will be no information available on the batch number for this case.  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 Disclaimer: 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.; Sender's Comments: This case concerns an 60 year old patient who developed pneumonia, flu and was given the high dose was reported after vaccination with INFLUENZA VACCINE. It was unknown if the time to onset is compatible. Howerver, concomitant medications, patient's medical condition and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Injection site swelling, Pain
Clinical narrative: the patient came in for her second dose and described swelling at the site of injection that lasted for 2 weeks.  it was red and hot to the touch and painful.  she also had flu-like symptom including a low grade fever and fatigue that lasted for 2 days
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: the patient came in for her second dose and described swelling at the site of injection that lasted for 2 weeks.  it was red and hot to the touch and painful.  she also had flu-like symptom including a low grade fever and fatigue that lasted for 2 days
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: 12/15/2020 5:00 PM Nauseas(worst )  5:30 Pm Headache  6:00 Pm Stomach Pain
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain, Musculoskeletal chest pain, Myalgia
Clinical narrative: PAIN AND EDEMA AT SITE OF INJECTION LEFT ARM WITH DECREASED RANGE OF MOTION LEFT ARM RIB CAGE PAIN ON INSPIRATION MUSCLE PAIN RIGHT AND LEFT THIGHS, WORSENING UPON AMBULATION MUSCLE PAIN AND TINGLING RIGHT UPPER EXTREMITY AND BACK
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Painful respiration, Paraesthesia
Clinical narrative: PAIN AND EDEMA AT SITE OF INJECTION LEFT ARM WITH DECREASED RANGE OF MOTION LEFT ARM RIB CAGE PAIN ON INSPIRATION MUSCLE PAIN RIGHT AND LEFT THIGHS, WORSENING UPON AMBULATION MUSCLE PAIN AND TINGLING RIGHT UPPER EXTREMITY AND BACK
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase normal, Brain natriuretic peptide normal, Chest X-ray normal, Full blood count normal, Malaise
Clinical narrative: PAIN AND EDEMA AT SITE OF INJECTION LEFT ARM WITH DECREASED RANGE OF MOTION LEFT ARM RIB CAGE PAIN ON INSPIRATION MUSCLE PAIN RIGHT AND LEFT THIGHS, WORSENING UPON AMBULATION MUSCLE PAIN AND TINGLING RIGHT UPPER EXTREMITY AND BACK
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate normal, Troponin normal
Clinical narrative: PAIN AND EDEMA AT SITE OF INJECTION LEFT ARM WITH DECREASED RANGE OF MOTION LEFT ARM RIB CAGE PAIN ON INSPIRATION MUSCLE PAIN RIGHT AND LEFT THIGHS, WORSENING UPON AMBULATION MUSCLE PAIN AND TINGLING RIGHT UPPER EXTREMITY AND BACK
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Following first dose, patient became hypotensive, pale, and diaphoretic. Denies syncope. Patient went to nearby emergency department at Hospital. Was monitored for several hours and was discharged in stable condition.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, Body Ache, Fever
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: 4 hours after receiving the vaccine, I had  a fever that went up to 106. Head was throbbing, woke up with stiff neck. For two days, the throbbing on the left and right side of neck was terrible.  Today is the first day I can turn my head and feel better.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: The employee experienced headaches the evening after receiving the vaccine. The next morning he experienced improvements in the headaches but developed chills, fatigue, and fever, all of which have improved somewhat by the afternoon when he reported these adverse effects to our employee health service. As he is recently recovered from COVID, a repeat COVID test may not be helpful. He was advised to call our employee health service and followup with his own doctor if these symptoms do not improve or resolve after 3 days.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Muscle twitching, Neck pain, Swelling
Clinical narrative: Tdap.5ml. Lump near collarbone, swelling, up the neck, soreness. Jaw twitching.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Loss of consciousness
Clinical narrative: Erratic night's sleep-achy limbs-headache.  Upon getting up in the morning I felt nauseous, exhausted & weak.  Had a dizzy spell and passed out.  Diastolic BP 44.  Tired & achy all day.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Erratic night's sleep-achy limbs-headache.  Upon getting up in the morning I felt nauseous, exhausted & weak.  Had a dizzy spell and passed out.  Diastolic BP 44.  Tired & achy all day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Insomnia, Joint range of motion decreased, Pain
Clinical narrative: Initial pain at injection site, extreme fatique.  The pain has never gone away from the site and has limited my range of motion. I also get random shooting pains in that arm.  I find it difficult to get comfortable when trying to sleep as any pressure on that arm is excruciating. I often wake up in pain when I rollover onto that side.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Initial pain at injection site, extreme fatique.  The pain has never gone away from the site and has limited my range of motion. I also get random shooting pains in that arm.  I find it difficult to get comfortable when trying to sleep as any pressure on that arm is excruciating. I often wake up in pain when I rollover onto that side.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Chills, Headache, Mobility decreased
Clinical narrative: patient called to report that 1 day post vaccination of both into same deltoid muscle patient experiencing temperature of 102F, headache, chills, and decreased range of motion of effected arm; prescribing MD recommended Benadryl and Tylenol with instruction to call back if symptoms persist >48 hrs
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache, onset ~45 minutes after injection
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest pain, Chills, Constipation, Dizziness, Dyspepsia
Clinical narrative: Severe pain at being injection 20 minutes later, dizziness, loss of control feeling,  heavy sweating at neck only, chills. Severe at indigestion at next meal in evening; breathing trouble after eating -- (2 week symptom occurring) --  constipation for next 3 days. Sharp pain from injection to inside of chest. Upper leg/hip and chest cramps.  3rd daily ingestion causing black and tarry stools, ringing in R ear. Ringing, pulsing in ear still present.  Dr from f/u on 10/28/20 -- Knot in head with fluid (still present). PCP  f/u 12/18/20 for ENT referral.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Faeces discoloured, Feeling abnormal, Hyperhidrosis, Injection site pain
Clinical narrative: Severe pain at being injection 20 minutes later, dizziness, loss of control feeling,  heavy sweating at neck only, chills. Severe at indigestion at next meal in evening; breathing trouble after eating -- (2 week symptom occurring) --  constipation for next 3 days. Sharp pain from injection to inside of chest. Upper leg/hip and chest cramps.  3rd daily ingestion causing black and tarry stools, ringing in R ear. Ringing, pulsing in ear still present.  Dr from f/u on 10/28/20 -- Knot in head with fluid (still present). PCP  f/u 12/18/20 for ENT referral.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Melaena, Muscle spasms, Nodule, Pain, Tinnitus
Clinical narrative: Severe pain at being injection 20 minutes later, dizziness, loss of control feeling,  heavy sweating at neck only, chills. Severe at indigestion at next meal in evening; breathing trouble after eating -- (2 week symptom occurring) --  constipation for next 3 days. Sharp pain from injection to inside of chest. Upper leg/hip and chest cramps.  3rd daily ingestion causing black and tarry stools, ringing in R ear. Ringing, pulsing in ear still present.  Dr from f/u on 10/28/20 -- Knot in head with fluid (still present). PCP  f/u 12/18/20 for ENT referral.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Impaired work ability, Pain in extremity, Somnolence
Clinical narrative: I got it about 10 am I went home I attempted to work from home for about an hour and had a headache, took a 3 hour nap  and felt much better after waking up, I felt like I couldn't concentrate. I felt fine this morning  12/16/2020  and I went to work just fine. I don't have a headache and don't feel like I need a nap, my arm still hurts but that is usual. I called my provider and asked if I could take Tylenol, but they were unsure so I did not take medication
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Blood test, Dizziness, Dry mouth, Euphoric mood
Clinical narrative: @ ~5 min felt cotton mouth.  Got up to ask if he could go early.  Then at 10 min post injection, felt eyes feeling weird and he felt "high".   As in lightheaded.  @ 10 min, skin surrounding the eyes are puffy.  Given 25 mf benedryl.  No immediate SOB or wheeze. No lip or mouth or throat swelling.  Taken to ED.  Given IM epi 1:1000 0.3ml.  Pepcid and more benedryll PO.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: @ ~5 min felt cotton mouth.  Got up to ask if he could go early.  Then at 10 min post injection, felt eyes feeling weird and he felt "high".   As in lightheaded.  @ 10 min, skin surrounding the eyes are puffy.  Given 25 mf benedryl.  No immediate SOB or wheeze. No lip or mouth or throat swelling.  Taken to ED.  Given IM epi 1:1000 0.3ml.  Pepcid and more benedryll PO.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injected limb mobility decreased, Injection site swelling, Pain
Clinical narrative: Fever , chills,  Body Ache all over body,  Joint Pain (worse in hips ) Injection site swollen  The PT cannot life her arm
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever , chills,  Body Ache all over body,  Joint Pain (worse in hips ) Injection site swollen  The PT cannot life her arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Burning and itching at injection site
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Erythema multiforme, Gait inability, Peripheral swelling, Rash, Skin lesion
Clinical narrative: Patient was diagnosed with erythema multiforme seven days after receiving her first Hep B vaccine. She started showing signs of a  minor rash around her diaper area and her legs approximately four days after receiving the shot. The rash progressed over the next few days into lesions that resembled hives and spread all over her torso, back, neck, ears, face as well as both arms and legs and both hands and feet. The red lesions became more severe and she experienced swelling of her feet on day 8 after the vaccine to the point that it made her not want to walk. We had a visit with a nurse practitioner on day 7 and after conferring with Patient's doctor, she was diagnosed with erythema multiforme. No medications were given. The lesions finally cleared by day 13.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Choking, Hypophagia, Rash, Retching, Swelling face
Clinical narrative: full body and face rash (described as hives), decreased PO intake with perceived choke/gag and facial swelling;  no V/D, no SOB;  and low grade fever
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling at injection site
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: .5 inch bruise at injection site, slight swelling,  sore muscle, ibuprofen,  ice bag,
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Last night I started running a low grade fever (98.9) and experienced chills until I went to bed.  This morning I feel fatigued and have a slight headache.  The injection site is pretty sore.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Immediate post-injection reaction, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Vaccinator Nurse noted upon vaccination there was bleeding from site and immediate bruising. Extended post vaccination monitoring to 30 minutes and asked patient to not leave before being reevaluated. Visual monitoring in post vaccination space by this RN.    Upon reassessment @ 1352 pt stated she felt the need to use her inhaler and chest tightness. Pt denies SOB and able to transfer independently to wheelchair. Pt began to cough and was immediately transferred to ED per FNP.      Upon ED arrival, pt was transferred to back hall 9, report given to RN and assessed by physician. Vital signs 98% on RA, t- 98.2, HR 78.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: Vaccinator Nurse noted upon vaccination there was bleeding from site and immediate bruising. Extended post vaccination monitoring to 30 minutes and asked patient to not leave before being reevaluated. Visual monitoring in post vaccination space by this RN.    Upon reassessment @ 1352 pt stated she felt the need to use her inhaler and chest tightness. Pt denies SOB and able to transfer independently to wheelchair. Pt began to cough and was immediately transferred to ED per FNP.      Upon ED arrival, pt was transferred to back hall 9, report given to RN and assessed by physician. Vital signs 98% on RA, t- 98.2, HR 78.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest X-ray, Cough, Full blood count, Metabolic function test
Clinical narrative: Vaccinator Nurse noted upon vaccination there was bleeding from site and immediate bruising. Extended post vaccination monitoring to 30 minutes and asked patient to not leave before being reevaluated. Visual monitoring in post vaccination space by this RN.    Upon reassessment @ 1352 pt stated she felt the need to use her inhaler and chest tightness. Pt denies SOB and able to transfer independently to wheelchair. Pt began to cough and was immediately transferred to ED per FNP.      Upon ED arrival, pt was transferred to back hall 9, report given to RN and assessed by physician. Vital signs 98% on RA, t- 98.2, HR 78.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Vaccinator Nurse noted upon vaccination there was bleeding from site and immediate bruising. Extended post vaccination monitoring to 30 minutes and asked patient to not leave before being reevaluated. Visual monitoring in post vaccination space by this RN.    Upon reassessment @ 1352 pt stated she felt the need to use her inhaler and chest tightness. Pt denies SOB and able to transfer independently to wheelchair. Pt began to cough and was immediately transferred to ED per FNP.      Upon ED arrival, pt was transferred to back hall 9, report given to RN and assessed by physician. Vital signs 98% on RA, t- 98.2, HR 78.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever of 101, chills, severe headache, nausea. Started at 5 am following day, still ongoing at 1 pm (24 hours after injection)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Nausea, Tremor
Clinical narrative: Nausea, tremors, and decrease in HR.  Patient taken to ED.  No epinephrine injection administered.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Sleep disorder, Spinal fusion surgery
Clinical narrative: Patient began to have symptoms of fussiness and inconsolable crying for 12-16 hrs.  Was unable to sleep and had reduced appetite and fluid intake.  No rashes, fever, vomiting, diarrhea or respiratory symptoms were reported or observed. Symptoms could not explained by  illness or any other physical finding  on exam.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Patient started to develop maculopapular rash and itching starting ~15 minutes after the vaccine administration. The patient did not report shortness of breath or other respiratory symptoms. The patient was given IV diphenhydramine 50 mg, famotidine 20 mg IV, and methylprednisolone 125 mg IV. The patient's symptoms resolved and was sent home with a Medrol dose pack and antihistamine.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Persistant joint pain since getting vaccination
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Pruritus, Urticaria
Clinical narrative: hives/itching, headache, fatigue,  joint pain, still have headache and fatigue, itching is gone.
Age: 20.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Discomfort, Erythema, Oedema, Swelling
Clinical narrative: Patient received both vaccinations on 14 DEC, after the vaccination she noticed some discomfort over the area, on 15 DEC in the morning she noticed redness, swelling, and increased discomfort.  On 16 DEC she called the clinic, area over left triceps demonstrated a 5x6 cm area of mild edema/redness.  Suspect local reaction, treated with warm/cold compresses, Tylenol for discomfort.  discussed return precautions.  Note is in database
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Unevaluable event
Clinical narrative: no adverse event
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Unevaluable event
Clinical narrative: NO ADVERSE EVENT
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Pt. stopped by the pharmacy today, 12/16/20, to report that her arm was so sore after her pneumovax shot that she thought she might have broken her arm.  She reports she's never had her arm hurt so bad after receiving a vaccine. She didn't report any swelling, just extreme pain for almost 2 weeks.  She took ibuprofen and acetaminophen for the pain.  I asked her if she had iced her arm and she stated sshe didn't think to try that.   Today, her arm is feeling much better but she can still feel a little discomfort when using her arm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: redness, itching to face, armpit, and neck
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site swelling
Clinical narrative: Swelling and numbness at injection side. Increased blood pressure 199/99. Immediate headache. Workplace clinic called hospital ER, clinic administered Benadryl. Symptoms resolved.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on back developed approximately 1 week after injection per patient recollection
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The patient got a rash on the upper chest and neck approximately 3 hours after vaccination. The rash was self limiting and no treatment currently needed.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Chills, Feeling cold, Feeling hot, Nausea
Clinical narrative: At approximately 3:45 pm 12/15/2020 patient was given the first of a two injection series new employee Hepatitis B vaccination. After receiving the vaccination she was observed for 15 minutes with no reported adverse reaction. At approximately 4:30 pm after returning home 12/15/2020 she stated felt anxious. At approximately 6:30 pm 12/15/2020 she had nausea/vomiting, hot/cold chills, temperature 99.6. She reports at 3:00 pm 12/16/2020 she is still having a low grade fever of 99.6 and nausea/vomiting. No reported pain, swelling or rash at injection site. She will be contacting her physician today for an appointment.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: At approximately 3:45 pm 12/15/2020 patient was given the first of a two injection series new employee Hepatitis B vaccination. After receiving the vaccination she was observed for 15 minutes with no reported adverse reaction. At approximately 4:30 pm after returning home 12/15/2020 she stated felt anxious. At approximately 6:30 pm 12/15/2020 she had nausea/vomiting, hot/cold chills, temperature 99.6. She reports at 3:00 pm 12/16/2020 she is still having a low grade fever of 99.6 and nausea/vomiting. No reported pain, swelling or rash at injection site. She will be contacting her physician today for an appointment.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Patient had hives around injection site and surrounding area
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Musculoskeletal chest pain
Clinical narrative: Pt presents to the ED for c/o L anterior chest wall pain after receiving covid19 vaccination today around 1030. Pt reports she received the first dose in the L bicep. Pt reports after she received that shot she started having L anterior chest wall pain. Pt states she doesn't have any chest tightness but does have stabbing pain to the L anterior chest wall. Pt denies any difficulty breathing or hives or any allergic reaction. Pt was hooked up to cardiac/sp02 and BP monitoring equipment. Medication: Ibuprofen Route: PO Dose:800 mg Patient tolerated medication well; no adverse reaction noted. Medication: Tylenol Route: PO Dose:975 mg Patient tolerated medication well; no adverse reaction noted.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: she reported sores in mouth that were painful
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient is complaining of a sore arm at injection site 3+ months after the injection.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Pt was found unresponsive in his crib the morning after his vaccinations, emergency services called, patient pronounced dead at hospital
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Received Pfizer Covid Vaccine - Had fever of 102 and flu like symptoms. Took Tylenol and temp resolved to 99.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site scab
Clinical narrative: ONE MONTH AFTER INJECTION PT REPORTED WITH A SMALL SCAB FORMED ON THE INJECTION SITE. NO OTHER COMPLAINTS FROM THE PT.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Hyperhidrosis, Memory impairment, Pallor, Unresponsive to stimuli
Clinical narrative: 11 minutes after first dose of Covid Pfizer vaccine, patient became unresponsive, pale, diaphoretic with possible seizure activity. Patient dropped all belongings, leaned to the left side, with eyes rolling back in her head.  Episode lasted about a minute. Patient could not remember what had happened. Vitals were BP 110/60, HR 64, RR 22. Patient was advised to go to ED for further evaluation but she refused. Patient was given a snack and an RN stayed with her for about 20 more minutes to monitor.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: :1039: Responded to notification of potential adverse reaction after receiving COVID-19 vaccination.  Pt had been escorted from observation area to emergency area with PA with c/o tightness in throat.  On my arrival, pt was eupneic, p/w/d, ambulatory, NAD.     Vitals @ 1039: P72, 100% pulse ox on RA Vitals @ 1056: P72, 98% pulse ox on RA, 112/78 seated.   Administered 25mg diphenhydramine po per PA @ 1050, pt swallowed with water.   Called 911 for EMS response @ 1103 per instruction from provider.   Vitals @ 1103: 98% pulse ox on RA, P74, denies shortness of breath or pain.   Off phone with EMS @ 1108, en route.   EMS on site @ 1115, report given to medic.    Pt left with EMS en route to ED @ 1116.   Report called to ED Charge Nurse @ 1121.      Patient presented to   vaccination clinic.  Patient received her vaccination at approximately 1021.  Patient reports symptoms onset at approximately 1038 with tightness of the throat and difficulty swolowing.  She described it as a swelling of the throat sensation.  She states she had a sensation moving from her head to her toes as in a "wave ".     Patient denied shortness of breath, chest pain denies nausea.  Patient denies hives or rashes or pruitis.     Patient was assessed and  moved to the emergency area.   Her symptoms continued with some improvement.  At this point time 25 mg of Benadryl was administered orally. Approximately 10 to 15 minutes after administration the patient developed numbness tingling around the upper lip, the right upper extremity.  She denied shortness of breath or chest pain.  She denied increasing severity of the throat sensations.   Pertinent past medical history: Reactions bee stings currently carries EpiPen.    She is not had any previous reactions to vaccinations.      Allergic reaction.   The patient symptoms seem to continue with the numbness tingling around the lips after administration of the Benadryl.  Hand tingling of the right upper extremity also continued although it was decreasing.   Her symptoms of the tightness of the throat remain the same. She did not develop shortness or breath or chest tightness or pain.    At this time I feel be prudent to evacuate the patient to higher level care.   Patient was evacuated at 11:16 by ambulance service.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal swelling, Sensory disturbance, Throat tightness
Clinical narrative: :1039: Responded to notification of potential adverse reaction after receiving COVID-19 vaccination.  Pt had been escorted from observation area to emergency area with PA with c/o tightness in throat.  On my arrival, pt was eupneic, p/w/d, ambulatory, NAD.     Vitals @ 1039: P72, 100% pulse ox on RA Vitals @ 1056: P72, 98% pulse ox on RA, 112/78 seated.   Administered 25mg diphenhydramine po per PA @ 1050, pt swallowed with water.   Called 911 for EMS response @ 1103 per instruction from provider.   Vitals @ 1103: 98% pulse ox on RA, P74, denies shortness of breath or pain.   Off phone with EMS @ 1108, en route.   EMS on site @ 1115, report given to medic.    Pt left with EMS en route to ED @ 1116.   Report called to ED Charge Nurse @ 1121.      Patient presented to   vaccination clinic.  Patient received her vaccination at approximately 1021.  Patient reports symptoms onset at approximately 1038 with tightness of the throat and difficulty swolowing.  She described it as a swelling of the throat sensation.  She states she had a sensation moving from her head to her toes as in a "wave ".     Patient denied shortness of breath, chest pain denies nausea.  Patient denies hives or rashes or pruitis.     Patient was assessed and  moved to the emergency area.   Her symptoms continued with some improvement.  At this point time 25 mg of Benadryl was administered orally. Approximately 10 to 15 minutes after administration the patient developed numbness tingling around the upper lip, the right upper extremity.  She denied shortness of breath or chest pain.  She denied increasing severity of the throat sensations.   Pertinent past medical history: Reactions bee stings currently carries EpiPen.    She is not had any previous reactions to vaccinations.      Allergic reaction.   The patient symptoms seem to continue with the numbness tingling around the lips after administration of the Benadryl.  Hand tingling of the right upper extremity also continued although it was decreasing.   Her symptoms of the tightness of the throat remain the same. She did not develop shortness or breath or chest tightness or pain.    At this time I feel be prudent to evacuate the patient to higher level care.   Patient was evacuated at 11:16 by ambulance service.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: :1039: Responded to notification of potential adverse reaction after receiving COVID-19 vaccination.  Pt had been escorted from observation area to emergency area with PA with c/o tightness in throat.  On my arrival, pt was eupneic, p/w/d, ambulatory, NAD.     Vitals @ 1039: P72, 100% pulse ox on RA Vitals @ 1056: P72, 98% pulse ox on RA, 112/78 seated.   Administered 25mg diphenhydramine po per PA @ 1050, pt swallowed with water.   Called 911 for EMS response @ 1103 per instruction from provider.   Vitals @ 1103: 98% pulse ox on RA, P74, denies shortness of breath or pain.   Off phone with EMS @ 1108, en route.   EMS on site @ 1115, report given to medic.    Pt left with EMS en route to ED @ 1116.   Report called to ED Charge Nurse @ 1121.      Patient presented to   vaccination clinic.  Patient received her vaccination at approximately 1021.  Patient reports symptoms onset at approximately 1038 with tightness of the throat and difficulty swolowing.  She described it as a swelling of the throat sensation.  She states she had a sensation moving from her head to her toes as in a "wave ".     Patient denied shortness of breath, chest pain denies nausea.  Patient denies hives or rashes or pruitis.     Patient was assessed and  moved to the emergency area.   Her symptoms continued with some improvement.  At this point time 25 mg of Benadryl was administered orally. Approximately 10 to 15 minutes after administration the patient developed numbness tingling around the upper lip, the right upper extremity.  She denied shortness of breath or chest pain.  She denied increasing severity of the throat sensations.   Pertinent past medical history: Reactions bee stings currently carries EpiPen.    She is not had any previous reactions to vaccinations.      Allergic reaction.   The patient symptoms seem to continue with the numbness tingling around the lips after administration of the Benadryl.  Hand tingling of the right upper extremity also continued although it was decreasing.   Her symptoms of the tightness of the throat remain the same. She did not develop shortness or breath or chest tightness or pain.    At this time I feel be prudent to evacuate the patient to higher level care.   Patient was evacuated at 11:16 by ambulance service.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Palpitations
Clinical narrative: 1-2 minutes later patient felt nausea, palpitations, and lightheaded
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose normal, Dizziness, Fatigue, Hypoaesthesia oral
Clinical narrative: My symptoms started about 15 minutes after shot. Initially I felt slight dizziness begin in my head. Then I felt slight uncomfortable feeling in my lungs, throat, and tongue. They were very slight so I left the vaccine center about 25 minutes after injection. On drive home my lips started to feel numb as well as my tongue & throat. Arriving home very tired. BP 135/ 80 P70 R20 T97.6 Blood sugar 101. Slept for about 4 hours. Called in sick for 7PM shift. Too weak & tired.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, Oropharyngeal discomfort, Pharyngeal hypoaesthesia, Respiratory tract irritation
Clinical narrative: My symptoms started about 15 minutes after shot. Initially I felt slight dizziness begin in my head. Then I felt slight uncomfortable feeling in my lungs, throat, and tongue. They were very slight so I left the vaccine center about 25 minutes after injection. On drive home my lips started to feel numb as well as my tongue & throat. Arriving home very tired. BP 135/ 80 P70 R20 T97.6 Blood sugar 101. Slept for about 4 hours. Called in sick for 7PM shift. Too weak & tired.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: My symptoms started about 15 minutes after shot. Initially I felt slight dizziness begin in my head. Then I felt slight uncomfortable feeling in my lungs, throat, and tongue. They were very slight so I left the vaccine center about 25 minutes after injection. On drive home my lips started to feel numb as well as my tongue & throat. Arriving home very tired. BP 135/ 80 P70 R20 T97.6 Blood sugar 101. Slept for about 4 hours. Called in sick for 7PM shift. Too weak & tired.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swollen tongue, Throat tightness
Clinical narrative: "Pfizer-BioNTech COVID-19 Vaccine EUA": Acute onset of tongue swelling, throat tightness, and diffuse erythema approximately 5 minutes after receiving COVID-19 vaccine. Patient transferred to emergency department. Patient treated with Epinephrine 0.3 mg IM X1 dose, Dexamethasone 10 mg IV x1 dose,  Diphenhydramine 25 mg IV x1 dose. Patient discharged same day with resolution of symptoms.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Product design issue, Product quality issue, Syringe issue
Clinical narrative: When injecting the vaccine fluid, the vaccine administrator noted about 4 drops of liquid that leaked from the area of the syringe tip / needle hub connection.  This particular dose was administered by a pharmacist who has experience administering vaccines.  In speaking with a few other nurses who administered COVID-19 Pfizer vaccinations at the same clinic (this was the first clinic day), the consensus was that they all did not like the syringes/needles provided by Pfizer.  It was a shared opinion that they felt "cheap" and "flimsy".  Going forward, our site is not going to use the Pfizer supplied syringes/needles but will be using our own syringes and needles for vaccine administration.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Hot flush, Injection site pain, Malaise
Clinical narrative: I inserted my NuvaRing birth control on 12/14/2020.  I have the Covid19 vaccine on 12/15/2020 at about 8:30am.  The injection site was mildly sore and that continued into the next day.  I woke up on 12/16/2020 feeling a little off and it progressed throughout the day.  I felt a headache that I knew was turning into a migraine, threw up a few times (this is normal for me when I get migraines), and started having hot flashes.  My temperature never went above 98.  After sleeping a few hours and taking some Excedrin migraine I was feeling much better, though still a little sickly, by 4pm.  I really think this is due to my migraines (which I get roughly once a month) even though it was a day later than normal.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: I inserted my NuvaRing birth control on 12/14/2020.  I have the Covid19 vaccine on 12/15/2020 at about 8:30am.  The injection site was mildly sore and that continued into the next day.  I woke up on 12/16/2020 feeling a little off and it progressed throughout the day.  I felt a headache that I knew was turning into a migraine, threw up a few times (this is normal for me when I get migraines), and started having hot flashes.  My temperature never went above 98.  After sleeping a few hours and taking some Excedrin migraine I was feeling much better, though still a little sickly, by 4pm.  I really think this is due to my migraines (which I get roughly once a month) even though it was a day later than normal.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Arm so sore unable to sleep, onset of chills middle of night, no appetite, chills continued off and on through Friday night, extremely large red inflammation around injection site (8? diameter) hot and sore to the touch. Chills ceased Saturday morning and red inflammation subsided by Tuesday.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, On and off phenomenon, Pain in extremity, Sleep disorder
Clinical narrative: Arm so sore unable to sleep, onset of chills middle of night, no appetite, chills continued off and on through Friday night, extremely large red inflammation around injection site (8? diameter) hot and sore to the touch. Chills ceased Saturday morning and red inflammation subsided by Tuesday.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Contraindicated product administered
Clinical narrative: Patient marked that he had received the flu vaccine 7 days ago. This was missed on screening procedure and patient received the vaccine today. Contacted the CDC and instructed to enter a VAERS report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Malaise
Clinical narrative: Patient was feeling nauseated in the morning prior to coming to work and prior to receiving vaccine. He had a banana thinking he would feel better. He then received the vaccine and felt progressively worse experiencing diarrhea, weakness, and malaise.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site muscle weakness, Injection site pain, Pain, Paraesthesia
Clinical narrative: pt noted immediate onset of pain and weakness in R shoulder on 11/10/2020, exacerbated by raising arm. Pain radiated to R arm with corresponding paresthesia of R 3rd, 4th and 5th fingers. Presented to clinic 3 weeks after immunization  12/1/2020 with report of symptoms. Was treated with prednisone taper, which resolved discomfort until the dose began to be tapered down, is also taking Tylenol. (pt unable to take ibuprofen due to reported interaction with her psych meds). presented again today 12/16/2020 via telemed with reported resumption of pain after d/c of the prednisone and continued pain, weakness and paresthesia
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: The vaccine that was given to patient was expired on  08/08/2020 Patient was monitored for 15 minutes, NO adverse reaction, provider in office informed, and we are currently contacting parents to let them know.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dehydration, Injection site rash, Injection site swelling
Clinical narrative: Patient reported injection site swelling and rash, body aches, chills, abdominal distress, dehydration. These adverse events resolved in 2-3 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reported injection site swelling and rash, body aches, chills, abdominal distress, dehydration. These adverse events resolved in 2-3 days.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, SARS-CoV-2 test
Clinical narrative: Diarrhea developed 8 days after receiving RotoTeq vaccine.  Appearance: watery, green with mucous, no blood. Continues yet today (12/16/20)  Stool sample sent to lab for C/S.  Sars/Covid swab negative.   Diaper area excoriation.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: five min after immunization , started experiencing nausea, single episode of vomiting ,