chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Migraine, Pain
Clinical narrative: Around 12 hours after the Moderna booster I woke up with a terrible headache. Mostly at the back of my head and neck. I took ibuprofen but it did nothing for the pain. A few hours later I developed a fever. It started at 101 and throughout the day went up to 104. Ibuprofen did not bring it down. I also experienced hot flashes and chills, congestion and body aches all on the right side of my body.  I couldn?t touch or lie on my right  arm the first night after the shot.  The intense and painful headache/migraine  lasted almost 24 hours.  The next morning around 7am the fever broke and headache subsided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Sleep disorder
Clinical narrative: Around 12 hours after the Moderna booster I woke up with a terrible headache. Mostly at the back of my head and neck. I took ibuprofen but it did nothing for the pain. A few hours later I developed a fever. It started at 101 and throughout the day went up to 104. Ibuprofen did not bring it down. I also experienced hot flashes and chills, congestion and body aches all on the right side of my body.  I couldn?t touch or lie on my right  arm the first night after the shot.  The intense and painful headache/migraine  lasted almost 24 hours.  The next morning around 7am the fever broke and headache subsided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Computerised tomogram, Condition aggravated, Cough
Clinical narrative: Develope shortness of breathe and coughing  in September. I was not able to walk long distance, I had chest pain. I was treated as an asthma Flare up with steriods. No beinfit for steriods when to the ER I diagnosed with unprovoked pulmonary emboli in both lungs
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer increased, Laboratory test, Pulmonary embolism, Scan with contrast
Clinical narrative: Develope shortness of breathe and coughing  in September. I was not able to walk long distance, I had chest pain. I was treated as an asthma Flare up with steriods. No beinfit for steriods when to the ER I diagnosed with unprovoked pulmonary emboli in both lungs
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Develope shortness of breathe and coughing  in September. I was not able to walk long distance, I had chest pain. I was treated as an asthma Flare up with steriods. No beinfit for steriods when to the ER I diagnosed with unprovoked pulmonary emboli in both lungs
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Migraine
Clinical narrative: Sweats, chills, migraine headache, joint pain
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Headache continues so far 30 days  Sporadic Shortness of breath  No adverse events on shot 1 or 2
Age: 69.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Balance disorder, Dizziness, Inflammation, Middle ear effusion, Vertigo
Clinical narrative: Healthy athletic male with no history of ear/vestibular issues. Received Pfizer booster and flu vaccine together. Typical inflammatory symptoms occured and resolved after 24-36 hrs, as is typical for pt.  However, 5 days post-vaccination he had onset of  dizziness, disequilibrium, and vertigo.  These continued and when seen by physician on day 14 post-vaccination, prominent bilateral middle ear effusions were seen.  Medical treatment plan initiated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Ophthalmological examination, Therapeutic response unexpected, Vision blurred, Visual impairment
Clinical narrative: Drastic vision change.  Could not focus on anything up close.  For example unable to read a large computer screen for five weeks.  Able to see long  distance much better and no longer required glasses to see far away.  Have worn glasses all of my adult life.  Gradual improvement in process.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Severe Joint Pain - 2 days Fatigue - 3 days Lightheadedness - ongoing (has lasted 7 days so far. Usually occurs when walking) Heart Palpitations - ongoing (has lasted 7 days so far. Usually occurs when walking) Mild Chest Pain - ongoing (has lasted 7 days so far) Shortness of Breath - ongoing (has lasted 7 days so far)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Palpitations
Clinical narrative: Severe Joint Pain - 2 days Fatigue - 3 days Lightheadedness - ongoing (has lasted 7 days so far. Usually occurs when walking) Heart Palpitations - ongoing (has lasted 7 days so far. Usually occurs when walking) Mild Chest Pain - ongoing (has lasted 7 days so far) Shortness of Breath - ongoing (has lasted 7 days so far)
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Hypoaesthesia oral, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: Member waited in the Immunization's waiting area for 30 minutes plus. The member stated he felt fine when checking out with the team, before leaving. The member came back to the clinic shortly after leaving and stated he was having a reaction. The member's face was bright red and the member stated that his lips felt tingly and numb. The provider was notified and examined the pt as well as asked about swelling in the throat. The member denied SOB and swelling in the throat. The Immunization's team was directed to give benadryl 50 mg. Benadryl was given IAW provider's order. The patient remained in the care of the Immunization's team after the medication was given. After 45 minutes of observation the patient's condition got worse. The patient complained of itchiness in arms and the patient had notable hives and redness on the arms, back, and chest. The patient denied SOB and swelling in the throat. The medical provider was consulted again and ordered epi be given to the patient since did not improve and got worse. Epi was given and the patient was transferred to the local ER, in case his symptoms continue to progress and not improve.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: severe chills; fever up to 102.5; headache; nausea; swollen armpit lymph node(s); achey; dizzy feeling; sore arm; Weak to walk; This is a spontaneous report from a contactable consumer (patient, self-reported). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWO171 and expiry date was no reported), via an unspecified route of administration, administered in Arm right, on 07May2021, as DOSE 2, SINGLE for COVID-19 immunization at Pharmacy or drug store (at the age of 58-year-old) at Pharmacy or drug store. Patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient medical history included enlarged thyroid. Patient had no known allergy. The patient was not diagnosed with COVID prior vaccination. Concomitant medications included dietary supplements and herbal remedies. The patient did not receive any other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWO153 and expiry date was not reported), via an unspecified route of administration, administered in Arm right, on 16Apr2021, (at the age of 58-year-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced major sore arm, unable to sleep well and tired. The patient was not tested for COVID post vaccination. On 07May2021 at 23:00, the patient experienced severe chills, fever up to 102.5, headache, nausea could barely eat toast, swollen armpit lymph nodes, achey, weak to walk, a bit dizzy feeling and sore arm. The patient underwent lab test and procedure included fever (Body temperature) 102.5 on 07May2021. The patient did not receive any treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: severe chills; fever up to 102.5; headache; nausea; swollen armpit lymph node(s); achey; dizzy feeling; sore arm; Weak to walk; This is a spontaneous report from a contactable consumer (patient, self-reported). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWO171 and expiry date was no reported), via an unspecified route of administration, administered in Arm right, on 07May2021, as DOSE 2, SINGLE for COVID-19 immunization at Pharmacy or drug store (at the age of 58-year-old) at Pharmacy or drug store. Patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient medical history included enlarged thyroid. Patient had no known allergy. The patient was not diagnosed with COVID prior vaccination. Concomitant medications included dietary supplements and herbal remedies. The patient did not receive any other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EWO153 and expiry date was not reported), via an unspecified route of administration, administered in Arm right, on 16Apr2021, (at the age of 58-year-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced major sore arm, unable to sleep well and tired. The patient was not tested for COVID post vaccination. On 07May2021 at 23:00, the patient experienced severe chills, fever up to 102.5, headache, nausea could barely eat toast, swollen armpit lymph nodes, achey, weak to walk, a bit dizzy feeling and sore arm. The patient underwent lab test and procedure included fever (Body temperature) 102.5 on 07May2021. The patient did not receive any treatment for the events. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: Patient was found unresponsive on 11/05/2021. Was taken to Hospital, tested positive for Covid-19, and was admitted on 11/05/2021. She was released from hospital on 11/08/2021.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chills, Constipation, Cough, Dyspnoea
Clinical narrative: Symptom onset 10/02/2021. Symptoms: Congestion, fever, cough, shortness of. breath, abdominal discomfort, headache, fatigue, myalgia, chills, eye pressure, change in taste, constipation. Admitted to Hospital on 10/03/2021. Has received breathing treatments.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Ocular discomfort, Pyrexia
Clinical narrative: Symptom onset 10/02/2021. Symptoms: Congestion, fever, cough, shortness of. breath, abdominal discomfort, headache, fatigue, myalgia, chills, eye pressure, change in taste, constipation. Admitted to Hospital on 10/03/2021. Has received breathing treatments.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Taste disorder
Clinical narrative: Symptom onset 10/02/2021. Symptoms: Congestion, fever, cough, shortness of. breath, abdominal discomfort, headache, fatigue, myalgia, chills, eye pressure, change in taste, constipation. Admitted to Hospital on 10/03/2021. Has received breathing treatments.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Wheezing
Clinical narrative: Case was vaccinated at Medical Facility - no information has been entered into state vaccination database. Case's symptom onset was 9/28/2021. Symptoms included weakness, fatigue, wheezing. Case was hospitalized on 9/29/21; release date unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Hypoaesthesia, Injection site erythema, Systemic lupus erythematosus
Clinical narrative: Severe headache for 2 days, mild for 2 weeks.  Flare of lupus of skin.  Numbness of fingers of left hand, redness of injection sight noted at day #3, lasted approximately 2 weeks
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, COVID-19, Cough, Decreased appetite, Dyspnoea
Clinical narrative: Had received Covid booster vaccination on 09/25/2021. Symptom onset was 10/02/2021. Symptoms: cough, shortness of breath, loss of taste, sore throat, runny nose, poor appetite, headache, fatigue.  Tested positive on 10/06/2021. Admitted to hospital around 10/11/21. Release date unknown.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Had received Covid booster vaccination on 09/25/2021. Symptom onset was 10/02/2021. Symptoms: cough, shortness of breath, loss of taste, sore throat, runny nose, poor appetite, headache, fatigue.  Tested positive on 10/06/2021. Admitted to hospital around 10/11/21. Release date unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence
Clinical narrative: Mild Diarrhea and severe gas
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Fatigue, Insomnia
Clinical narrative: High Fever lasting two days, Dizziness, Swollen Lymph Nodes in Neck and lower cheek (Left side, now moving to right), Swollen Lymph Nodes in Back (left and right side, under armpit) back pain, Body aches, Chills, Insomnia, Restless Legs, Fatigue
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Restless legs syndrome
Clinical narrative: High Fever lasting two days, Dizziness, Swollen Lymph Nodes in Neck and lower cheek (Left side, now moving to right), Swollen Lymph Nodes in Back (left and right side, under armpit) back pain, Body aches, Chills, Insomnia, Restless Legs, Fatigue
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Headache, Product preparation issue
Clinical narrative: I was a volunteer RN for the vaccine clinic, I reconstituted Pfizer vaccine wrong. Only one dose was administered which was to myself, another RN administered the dose to me. Only 3 vaccines were predrawn from the vial. Sx severe muscle aches (localized  to back), headaches, mild chest tightness and discomfort for 2 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: fever up to 100.5; fatigue; chills; soreness, mostly in legs  symptoms lasted approximately 12 hours, then subsided after taking Tylenol and sleeping.  Sore throat began the next day, and lasted for several days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever up to 100.5; fatigue; chills; soreness, mostly in legs  symptoms lasted approximately 12 hours, then subsided after taking Tylenol and sleeping.  Sore throat began the next day, and lasted for several days.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Balance disorder, Blood test, Computerised tomogram, Extra dose administered, Fall
Clinical narrative: I had the moderna booster shot and the flu shot at the same time one in each arm and 21 days later I had an infusion of Remicade. I believe all of these meds together caused my current situation. I am off balance and have fallen 3 separate times since receiving them, I can hardly walk and both my hands are numb. I feel very unstable on my feet, my gait is almost as if I have cerebral palsy or something. I fell again today trying to get into my chiropractors office.  I'm scared, I go for an MRI on Nov. 23rd. I thought I should say something as I had none of these symptoms prior to getting all of these shots/infusions.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fear, Gait disturbance, Hypoaesthesia, Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: I had the moderna booster shot and the flu shot at the same time one in each arm and 21 days later I had an infusion of Remicade. I believe all of these meds together caused my current situation. I am off balance and have fallen 3 separate times since receiving them, I can hardly walk and both my hands are numb. I feel very unstable on my feet, my gait is almost as if I have cerebral palsy or something. I fell again today trying to get into my chiropractors office.  I'm scared, I go for an MRI on Nov. 23rd. I thought I should say something as I had none of these symptoms prior to getting all of these shots/infusions.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dry skin, Ear discomfort, Rash, Rash erythematous
Clinical narrative: A red, itchy rash appeared mainly in the center of my neck 3 days after vaccine; continued to be itchy/dry after almost one week, but appearance got better and no longer red; treated w/hydrocortisone cream (OTC) and resolved itself after ~10 days. Other symptoms included slight burning of skin along my chin, lower cheeks, ear lobes, and scalp, but no visible rash in those places. (These also resolved after ~10 days.)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin burning sensation
Clinical narrative: A red, itchy rash appeared mainly in the center of my neck 3 days after vaccine; continued to be itchy/dry after almost one week, but appearance got better and no longer red; treated w/hydrocortisone cream (OTC) and resolved itself after ~10 days. Other symptoms included slight burning of skin along my chin, lower cheeks, ear lobes, and scalp, but no visible rash in those places. (These also resolved after ~10 days.)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Localized rash appeared around injection site within 4 hours of administration for both doses  2nd Dose administration 02/19/2021: site appeared red, it was itchy and sore, tender to the touch?dissipated within 7 days; body aches and pains, low grade fever?eased with oral antipyretics and pain reliever, dissipated within 3 days  Booster administration 11/15/2021: site appears red; it is sore and tender to touch and movement; minimal body aches and pains; onset of cervical aching and a headache ranking 6/10 apps 10 hrs following administration, eased with oral pain reliever
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Localized rash appeared around injection site within 4 hours of administration for both doses  2nd Dose administration 02/19/2021: site appeared red, it was itchy and sore, tender to the touch?dissipated within 7 days; body aches and pains, low grade fever?eased with oral antipyretics and pain reliever, dissipated within 3 days  Booster administration 11/15/2021: site appears red; it is sore and tender to touch and movement; minimal body aches and pains; onset of cervical aching and a headache ranking 6/10 apps 10 hrs following administration, eased with oral pain reliever
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation
Clinical narrative: Breast milk production significantly decreased and has not returned to normal, met with lactation consultants and began supplements, pumping and nursing routine and no change or increase.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Paraesthesia
Clinical narrative: Day of vaccine (fri) - cold sore started on left side of mouth within hours of vaccine.  I took famciclovir (500mg).  Sunday the left side of my face was tingling.; Day of vaccine (fri) - cold sore started on left side of mouth within hours of vaccine.  I took famciclovir (500mg).  Sunday the left side of my face was tingling.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6207 and expiry date was not reported), via an unspecified route of administration, in Right arm, on 07May2021 at 08:30 AM (age at vaccination: 52 years), as dose 2, single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: Sulpha. Concomitant medication included estrogens conjugated. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6207 and expiry date was not reported), via an unspecified route of administration, in Right arm, on 09Apr2021 at 09:00 AM (age at vaccination: 52 years), as dose 1, single dose for COVID-19 immunization at pharmacy or drug store. The patient did not received other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 09May2021 at 09:00 AM, the patient experienced day of vaccine (fri) - cold sore started on left side of mouth within hours of vaccine. I took famciclovir (500mg). Sunday the left side of my face was tingling. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Cholelithiasis, Cholelithotomy, Laboratory test, Pancreatitis
Clinical narrative: Nov 1 entered ER vomiting ..said I had pancreatitis....needed a procedure to remove gall stones and then operation to remove gall bladder. Procedure happened with no problems. Went to have surgery on Nov.  5 ....never touched me and I went into cardiac arrest for 10 minutes. Never had gall bladder removed
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nov 1 entered ER vomiting ..said I had pancreatitis....needed a procedure to remove gall stones and then operation to remove gall bladder. Procedure happened with no problems. Went to have surgery on Nov.  5 ....never touched me and I went into cardiac arrest for 10 minutes. Never had gall bladder removed
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature abnormal, Fatigue, Palpitations
Clinical narrative: Thyroiditis; Tremor; heart palpitations; inability to regulate body temp; Extreme fatigue; weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).   A 54-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration in right arm on 10Feb2021 (at the age of 54 years-old) as dose 2, single for COVID-19 immunization. The patient medical history reported as none. The concomitant therapy reported as other medications in two weeks reported as prenatal vitamins. The patient was not a pregnant at the time of vaccination.The patient previously took doxycycline and experienced allergies (Known allergies: doxycycline). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in right arm on 20Jan2021 at 01:00 PM (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Facility type vaccine reported as doctor's office/urgent care. No other vaccine in four weeks. No Covid prior vaccination and not Covid tested post vaccination. Other medications in two weeks reported as prenatal vitamins. On 18Feb2021, 8 days after vaccination the patient experienced thyroiditis, tremor, heart palpitations, inability to regulate body temp, extreme fatigue and weakness. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a medication management for the adverse events. The patient underwent lab tests and procedures which include body temperature with results inability to regulate body temp on 18Feb2021. The clinical outcome of all events was not recovered.  No follow attempts are required. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis, Tremor
Clinical narrative: Thyroiditis; Tremor; heart palpitations; inability to regulate body temp; Extreme fatigue; weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).   A 54-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration in right arm on 10Feb2021 (at the age of 54 years-old) as dose 2, single for COVID-19 immunization. The patient medical history reported as none. The concomitant therapy reported as other medications in two weeks reported as prenatal vitamins. The patient was not a pregnant at the time of vaccination.The patient previously took doxycycline and experienced allergies (Known allergies: doxycycline). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in right arm on 20Jan2021 at 01:00 PM (at the age of 53 years-old) as dose 1, single for COVID-19 immunization. Facility type vaccine reported as doctor's office/urgent care. No other vaccine in four weeks. No Covid prior vaccination and not Covid tested post vaccination. Other medications in two weeks reported as prenatal vitamins. On 18Feb2021, 8 days after vaccination the patient experienced thyroiditis, tremor, heart palpitations, inability to regulate body temp, extreme fatigue and weakness. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a medication management for the adverse events. The patient underwent lab tests and procedures which include body temperature with results inability to regulate body temp on 18Feb2021. The clinical outcome of all events was not recovered.  No follow attempts are required. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Got a large rash on upper left leg.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, diabetes and heart disease. The patient had no known allergies to medications, food, or other products. The patient did take unspecified other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 11Jan2021 (at the age of 70-years-old) as a single dose for COVID-19 immunization and experienced rash on my upper arms (both). On an unknown date in 2021, after second dose, the patient experienced a large rash on upper left leg and it was still on his leg on 12May2021, he would have it for about a week or two then go away and come back in about a week. It has been that way since the second dose. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event got a large rash on upper left leg was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: After my second dose I have tightness on the left side of my chest. It's not painful but it's persistent.This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 at 15:30 as dose 2, single for covid-19 immunisation. The patient's medical history included asthma. Concomitant medication included escitalopram oxalate and ibuprofen taken for an unspecified indication. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0168, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 03:30 PM as dose 1, single for COVID-19 immunization. The patient had occasional heart palpitations after first dose. Doctor told him to just pay attention to it as long as that wasn't bad. After his second dose on 11May2021 11:00, the patient had tightness on the left side of his chest. That was not painful but was persistent. The outcome of event was not recovered. No follow-up attempts are required. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Vaccination site pain
Clinical narrative: Soreness at injection site; but not real bad; both injections; Some slight shoulder ache' 2nd injection; Some slight diarrhea after 2nd injection.  Came upon approx 36 hrs after injection; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 59-year-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EW0176, expiration date was not reported) via an unspecified route of administration, administered in arm right on 03May2021 14:45 (age at vaccination 59-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EW0162, expiration date: not reported) via unspecified route of administration, administered in arm right on 12Apr2021 15:45 as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID test post vaccination. On 05May2021 11:00, the patient experienced soreness at injection site; but not real bad; both injections, some slight shoulder ache' 2nd injection, some slight diarrhea after 2nd injection. came upon approx 36 hrs after injection, lasted approx 24 hours. No treatment received for AE. The outcome of the events soreness at injection site; but not real bad; both injections and some slight shoulder ache' 2nd injection was recovered on an unspecified date in May2021. The outcome of the event some slight diarrhea after 2nd injection, came upon approx 36 hrs after injection was recovered on 06May2021.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021535850 same patient/drug, different dose/event
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy spots around my waist and on my back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262, Expiration Date: May2021) via intramuscular route of administration, administered in left upper arm on 20Jan2021 at 18:30 (at the age of 63-year-old ) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atenolol daily, taken for rapid heartbeat; celecoxib (CELEXA [CELECOXIB]) daily, taken for depression; bupropion hydrochloride (WELLBUTRIN) daily, taken for an unspecified indication; levothyroxine sodium (SYNTHROID) daily, taken for thyroid disorder and rosuvastatin daily, taken for blood cholesterol abnormal, start and stop date were not reported for all. The patient did not receive prior vaccination within four weeks. Four days after the first vaccine on 24Jan2021, the patient experienced itchy spots around the waist and on the back. Seriousness Criteria was reported as not serious. AE required visit to Physician Office (dermatologist). Relevant tests was none. The patient went to dermatologist and was given prescription for clobetasol to put on affected areas. The patient received treatment with Benadryl, Clobetasol 0.05 cream. The outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test, Swelling
Clinical narrative: Swelling; lymph node armpit swelled and were sore; lymph node armpit swelled and were sore; This is a spontaneous report from a contactable consumer (patient). This is second of two reports. A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207, Expiry date were not reported) via unspecified route of administration, administered in left arm (upper) on 09Mar2021 14:45 (ag at vaccination 71-year-old) as dose 2, single for COVID-19 immunization (Pharmacy or Drug store). The patient had no medical history. The concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200, Expiry date was not reported) via an unspecified route of administration in left arm (upper) on 16Feb2021 14:45 for COVID-19 immunization. On 09Mar2021, the patient had lymph node armpit swelled and were sore and swelling on 10Mar2021. It was reported that no treatment was taken for the event swelling. On 17Dec2020, the patient underwent sars-cov-2 test which was positive, the symptoms were included loss of smell, fatigue, otherwise no symptoms. The patient had not administered vaccine at military facility. The outcome of the event swelling was recovered on 11Mar2021, and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLU3
Symptoms: Device connection issue, No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: had gone to administer the shot the needle disconnects and product splashed on the nurse with no adverse event reported; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency (under reference: 00821026).  This case is linked to case 2021SA351020.  This case involves adult patient (unknown gender) who had gone to administer the shot when the needle disconnects and product splashed on the nurse while giving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ765AC, expiry date: 30-Jun-2022) (occupational exposure to product).  A Product Technical Complaint (PTC) details: Global PTC number: 100168466 Main Investigation ID: 200176567 lot number: UJ765AC Expiry date: 30-Jun-2022 Sample status: Requested & Awaited Requested Start Date: 21-Oct-2021 Issue status: In Process End date: not applicable  Conclusion: A complaint for 372- FLUZONE HIGH DOSE vaccine, batch UJ765AC was reported and the complaint stated that Doctor calling in a PTC for FLUZONE HD PFS. Caller states that the hub on the end of the syringe is loose (like it's stripped) and needle will not properly attach. When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere. Product splashed on the nurse and the patient.  It was a case of occupational exposure to product [Latency: on the same day].  It was reportedthat the hub on the end of the syringe is loose (like it's stripped) and needle will not properly attach. Product splashed on the nurse and the patient.  Number of units affected: 17 PFS affected so Far. Information to be gathered on the type of needle that was used by the end-user: 25G Mckesson 1.5' same brand and size has been used for prior administration with no issue.  At time of reporting, no adverse event reported.
Sex: F
Vaccine: FLUR4
Symptoms: Migraine
Clinical narrative: migraine; Initial information received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (under reference: US-SA-SAC20211111000298).  This case involves adult female patient who experienced migraine when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious migraine (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "I do not know when she received the shot, her age, etc., but she is internal, so you can find her in the system and contact her."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event (migraine).  At the time of reporting, the outcome was unknown for the event (migraine).  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious media case from a consumer/non-healthcare professional.  This case involves a female patient (unknown age) who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past 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 unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "This case has been received from Media, the following potential adverse event has been found on a public post for Flu Shot. Since this is a public post on the Sanofi flu shots, we are assuming the consumer is referring to the Sanofi flu vaccine. wife got it, i did not, she got the flu, I did not. so, no thanks, I will pass!!!"  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test positive, Chills, Fatigue, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Mild fatigue; Fever; Chills; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional under reference number - US-SA-SAC20211029001074.  This case involves 67-years old male patient who experienced mild fatigue (fatigue), fever (pyrexia) and chills, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Vascular occlusion, Kidney stone and Rotator cuff tear.  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MELOXICAM (MELOXICAM); BUSPIRONE (BUSPIRONE); IBUPROFEN (IBUPROFEN); and TERAZOSIN (TERAZOSIN).  On 25-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 26-Sep-2021, the patient developed a non-serious mild fatigue (fatigue), fever (pyrexia) and chill one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: On 08-Jan-2020 - Antibody test - Positive On 07-Jan-2020 - COVID-19 - Negative  It was reported "Patient treated with antibiotics."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were additional lab data/results available.  It was not reported if the patient received a corrective treatment for events.  At time of reporting, patient had recovered from events.  There will be no information available on batch number for this case.
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who experienced sore arm (pain in extremity) after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and Coronavirus disease (COVID-19) VACCINE  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and COVID-19 VACCINE.  It was reported "I got both the Fluzone high dose: and the Pfizer COVID booster on the same day. The only side effect was sore arm for several hours"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment for the event  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Feeling hot, Rash, Rash pruritic
Clinical narrative: her body felt like it was on fire; she developed an itchy, rash across her back and her body; Initial information was received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 34 year-old female patient who developed itchy, rash across her back and her body felt like it was on fire (rash pruritic) and (feeling hot), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Jan-2019, the patient received (once) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in Jan-2021, the patient developed an itchy, rash across her back and her body felt like it was on fire (rash pruritic) and (feeling hot) either that evening or the next evening following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "The caller is requesting the ingredients for FLUBLOK of the 2019/2020 flu season. She said that she had a reaction to it. The caller stated that she received Flu Blok Quad on 1/30/2019. Either that evening or the next evening she developed an itchy, rash across her back and her body felt like it was on fire. Those symptoms resolved in less than a day. The rash was not treated. She would like to obtain a flu vaccination this flu season and would like the ingredient".  Details of laboratory data were not reported.  The rash was not treated and it was unknown if patient received any corrective treatment for feeling hot.   On an unknown date, patient had recovered from the events.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Migraine
Clinical narrative: migraine; Initial information was received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from other health professional under reference number - US-SA-SAC20211110001044.  This case involves an unknown age and unknown gender patient who experienced migraine, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine.  On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious migraine (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "I realized that my latest migraine coincided with my Oct 28 fluzone hd vaccine. Before that time, I had not made a mental connection on the coincidental timing because I get migraines all of the time at any time of year. I took Advil and zomitriptan and the migraine completely resolved."  No additional laboratory data was reported.  It is unknown if the patient experienced any additional symptoms/events  It was not reported if the patient received a corrective treatment for the event (migraine).  At time of reporting, the outcome was recovered for the event migraine.  There will be no information available on batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: pentacel for 5 doses of DTAP, upon learning this I told her it is not liscenced as a 5 dose series with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves adult and unknown gender patient for whom it was reported "DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] for 5 doses of dtap, upon learning this I told her it is not liscenced as a 5-dose series".  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  It was case of actual medication error due to Inappropriate schedule of vaccine administered [Latency: on the same day].  At the time of reporting, no adverse event was known.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.