chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Caller had a reaction from the pneumonia vaccine 15 yrs ago/ left arm swelling; Caller had a reaction from the pneumonia vaccine 15 yrs ago/ like edema; Caller had a reaction from the pneumonia vaccine 15 yrs ago/ rash; Information has been received from a 63 years old female patient via other company, referring on herself. The patient's medical history and concomitant therapies were not reported. As concurrent conditions was reported an allergies to phenoxyethonal (something that they put in lotions and perfumes). The patient's historical vaccines included shingles and flu vaccines without trouble. On an unspecified date in 2006, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, anatomical location, administration route, lot number and expiration date were not reported) as prophylaxis. On an unknown date, the patient had a reaction from the vaccine, she experienced her left arm swelled, like edema and rash. The outcome of arm swelled, like edema and rash was unknown and the casuality assessment between the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was reported as related.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Expired dose administered to patient; This spontaneous report has been received from a registered nurse referring to a 26 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 07-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S023220 with expiration date of 20-OCT-2020  (strength, dose, route, frequency and anatomical location were not provided) for prophylaxis. No adverse event reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Moderate pain at the injection site for 36 hours, fatigue 24-48 hours post-vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Impaired quality of life, Pain
Clinical narrative: shingles (herpes zoster); Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or around April 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Received Moderna Vaccine on 01/06/2021. Reported 5 days after injection 1/11/2021 noted redness, swelling, itching at injection site along with lymphadenopathy axillary, left side, breast left side and chest left side along with fever 100.3F to 100.4 F. Reported right axillary lymphadenopathy as well but not as severe as left side. Reports called PCP on 1/14/2021 and was advised to f/u with medical evaluation 1/15/2021 went to ER where was diagnosed with lymphadenopathy and small P.E. Reported given topical Benadryl cream for itching of injection site. Reports site was fine until day 5. Reports today still has large lymph node swellling on left axillary, breast area. Denies itching of site today. Denies fever today.  Reports today, history of P.E. 4 years ago and lymph node swelling over 25 years ago after receiving a flu vaccine. Denies any vaccine since then until 1/6/2021 COVID-19 vaccine (Moderna).  Was seen in E.R. and discharged home with only topical Benadryl cream.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Chills, Electrocardiogram, Headache
Clinical narrative: Symptoms developed 16 hours after injection of the 2nd dose (booster). Symptoms included body aches, nausea, chills, fever, headache, chest tightness. All symptoms resolved within 24 hours with the exception of chest tightness which fully resolved 8 days after the shot.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Symptoms developed 16 hours after injection of the 2nd dose (booster). Symptoms included body aches, nausea, chills, fever, headache, chest tightness. All symptoms resolved within 24 hours with the exception of chest tightness which fully resolved 8 days after the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles and other zoster-related conditions; shingles and other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 01-NOV-2015, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited  to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medications, and supplies: diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffered such losses, and damages in the future. The outcome of the event s was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Pt had mild arm pain 1-2 days after the injection. Then it healed. On day #7 had a 3x5 inch hive develop only at the injection site. Has been using claritin daily with some improvement
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; dose of VAQTA that was inadvertently administered after labeled expiry date; This spontaneous report was received from a certified medical assistant and refers to a 18-monht-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-JAN-2021, the patient was inadvertently vaccinated with expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25unites/0.5 ml, 1 injection, lot # S032359 was confirmed to be valid, expiration date 11-JAN-2021 (route and site of administration were not provided) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: Temperature: 51.4 F; This solicited report was received from an office manager and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, Intramuscularly (IM), lot # T007024 was confirmed to be valid, expiration date 23-APR-2022, (site of administration was not provided) for prophylaxis. The administered dose was exposed to the temperature of 51.4 degrees Fahrenheit (F) for 2 hours. There was no previous temperature excursion. The call was because of a digital data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dysstasia, Fatigue, Hallucination
Clinical narrative: 01/17/2021, 8:00 am: EXTREME weakness, fatigue, unable to come to standing, severe pain right arm, extreme confusion and hallucinations. Have supportive care at home. By 01/18/2021, finally able to stand with assistance at 1:00 pm, still residual confusion.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 01/17/2021, 8:00 am: EXTREME weakness, fatigue, unable to come to standing, severe pain right arm, extreme confusion and hallucinations. Have supportive care at home. By 01/18/2021, finally able to stand with assistance at 1:00 pm, still residual confusion.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling; pain (arm pain); The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient) received via a Pfizer-sponsored program. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID vaccine. Medical history and concomitant medications were not reported. He's an RN and thinking about taking the COVID vaccine. He's concerned, he's reading the paperwork on it. Was it the insurance company that would pay- would his supplement pay for this or what. He would probably have another question- how would he know if he has had an allergic reaction to the ingredients. The ingredients were listed he believed that Pfizer would have to know because he did not know what the listing ingredients were, he didn't know if he has ever had an MRNA lipid vaccine or anything like that. He would start with whether or not he's going to have to pay for the vaccine. Then on 08Jan2021, it was reported that after the 1st one, the patient had swelling of arm and pain (arm pain) after the first COVID vaccine dose, both on unspecified dates. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Decreased appetite, Fatigue, Impaired work ability
Clinical narrative: I received my 2nd vaccination on Monday 01/11/21 at 1200 pm in the hospital. on Tuesday 01/12/21 at 0300 I woke up with sever rigors chills and a temperature of 100.4. throughout the rest of that 24 hour period I had severe exhaustion, pain in my upper extremities and weakness in my lower extremities with poor appetite throughout the day. Again on 01/13/21 around 0200, I woke with fever of 101.0. at that time I had to call out of work for my 7 am shift. by Wednesday 01/13 at 1300 my fever had broken, body aches decreased and appetite improved.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: I received my 2nd vaccination on Monday 01/11/21 at 1200 pm in the hospital. on Tuesday 01/12/21 at 0300 I woke up with sever rigors chills and a temperature of 100.4. throughout the rest of that 24 hour period I had severe exhaustion, pain in my upper extremities and weakness in my lower extremities with poor appetite throughout the day. Again on 01/13/21 around 0200, I woke with fever of 101.0. at that time I had to call out of work for my 7 am shift. by Wednesday 01/13 at 1300 my fever had broken, body aches decreased and appetite improved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Feeling abnormal, Hypoaesthesia, Tongue disorder, Trigeminal nerve paresis
Clinical narrative: 2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration.    Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too.  Mildly reduced  tongue coordination continues.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus
Clinical narrative: patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pruritus, Injection site rash, Rash, Urticaria
Clinical narrative: Itchiness began 6 days post vaccine on and around injection site. Rash started shortly after (within hours of itchiness); rash changed from small dots to quarter size hives to rings. The rash moved around the upper arm and is still present at day 10 post vaccine. Continues to itch on and off and occasionally has a burning sensation.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity, Rash, Rash pruritic
Clinical narrative: The next day vaccine arm became sore and lasted 2 days. The second day after vaccine did not have energy. The day after that went away and I was fine. Rash appeared 12 days after vaccine, small red bumps, close to armpits and itchy.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: On day 8 i began to have itching at the sight of the injection around noon and then by that evening there was redness and heat to the deltoid area along with itching and tenderness.  The next morning the warmth and induration spread up the deltoid into the shoulder.  I was treated for cellulitis with 1 gram of Rocephin and I am currently on Keflex 750mg bid for 7 days.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Rash, Urticaria
Clinical narrative: Headache, Large welts across back ,right arm , and right leg
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gaze palsy, Headache, Impaired work ability, Night sweats
Clinical narrative: Received 2nd dose of Covid vaccine on Wednesday January 13th at 1040am, soon after had headache but was able to work. Thursday morning at 0330 severe body aches, chills, headache. Symptoms lessened with Tylenol but would come back through Friday the 15th. Had to call out of work Friday the 15th. Saturday the 16th Woke in a sweat and aches/chills have since stopped. Still experiencing headaches
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Received 2nd dose of Covid vaccine on Wednesday January 13th at 1040am, soon after had headache but was able to work. Thursday morning at 0330 severe body aches, chills, headache. Symptoms lessened with Tylenol but would come back through Friday the 15th. Had to call out of work Friday the 15th. Saturday the 16th Woke in a sweat and aches/chills have since stopped. Still experiencing headaches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area at injection site became red, warm to touch.  Size approximately half dollar.  Mild pain associated with this.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Heart rate increased, Hyperhidrosis, Pharyngeal hypoaesthesia
Clinical narrative: Elevated heart rate, dizzy, sweating, throat numb
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: 14 days post vaccination developed: chest pain, back pain,  paresthesia of bilateral upper extremities. CXR, EKG and Lab work done. Symptoms not disabling yet present; musculoskeletal pain in upper extremities with paresthesia
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Fever of 101.9, disorientation, pain in arm, ache red spot of 7 inches in diameter
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Starting after vaccine had redness, itching around injection site. It was hot to the touch. About two inches in diameter. Contacted pcp who advised hydrocortisone for itch and monitoring. Symptoms seemed to drastically improve and were not noticeable for a few days. Starting 1/17/21 the injection site began itching again and felt very hot and was noticeably red. Overnight the size of the redness increased to about 4 inches in diameter and became increasingly uncomfortable. I reached out to my PCP and sent pictures. He prescribed keflex for presumed cellulitis.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Petechiae, Rash, Skin lesion
Clinical narrative: Petechial rash developed on bilateral lower extremities. Nonpuritic. Coalesced into purpural lesions on the bilateral posterior knees. Rash resolved within one week.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Petechial rash developed on bilateral lower extremities. Nonpuritic. Coalesced into purpural lesions on the bilateral posterior knees. Rash resolved within one week.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Urine analysis
Clinical narrative: Hematuria noted about 1 1/2 days after receiving the first COVID vaccine.  No treatment, pushed fluids and cleared up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Dizziness
Clinical narrative: I got the shot and i was ok the first day but the next day I felt groggy and week. I went and had breakfast and then i got the chills, then i started sitting up but i felt awful so i went back to bed and dizziness weakness headache, redness around injection site.  My whole left side felt like it was achy and almost like it was numb. I lost bladder control, I had a couple of accidents.  I stayed in bed until next day, couldn't get out of bed, couldn't eat. Got up Saturday, not feeling good, queasy, diarrhea but not as bad as Friday. Every time i would try to do something i would fall asleep. went and had covid test for surgery. Sunday I felt better but not to par. Today i feel the best so far.  Put antibiotic cream on injection site because it was itching, and it is still hard and warm to touch.  Today i have a small cough that I didn't have before.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Hypoaesthesia, Injection site erythema, Injection site pruritus
Clinical narrative: I got the shot and i was ok the first day but the next day I felt groggy and week. I went and had breakfast and then i got the chills, then i started sitting up but i felt awful so i went back to bed and dizziness weakness headache, redness around injection site.  My whole left side felt like it was achy and almost like it was numb. I lost bladder control, I had a couple of accidents.  I stayed in bed until next day, couldn't get out of bed, couldn't eat. Got up Saturday, not feeling good, queasy, diarrhea but not as bad as Friday. Every time i would try to do something i would fall asleep. went and had covid test for surgery. Sunday I felt better but not to par. Today i feel the best so far.  Put antibiotic cream on injection site because it was itching, and it is still hard and warm to touch.  Today i have a small cough that I didn't have before.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Nausea, Pruritus, Somnolence, Urinary incontinence
Clinical narrative: I got the shot and i was ok the first day but the next day I felt groggy and week. I went and had breakfast and then i got the chills, then i started sitting up but i felt awful so i went back to bed and dizziness weakness headache, redness around injection site.  My whole left side felt like it was achy and almost like it was numb. I lost bladder control, I had a couple of accidents.  I stayed in bed until next day, couldn't get out of bed, couldn't eat. Got up Saturday, not feeling good, queasy, diarrhea but not as bad as Friday. Every time i would try to do something i would fall asleep. went and had covid test for surgery. Sunday I felt better but not to par. Today i feel the best so far.  Put antibiotic cream on injection site because it was itching, and it is still hard and warm to touch.  Today i have a small cough that I didn't have before.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever running three days so far, hives from head to toe
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: swelling of lymph node(?) or gland under left arm about 12 hours after injection, swelled to about 3 times normal size, any movement or pressure cause intense pain, started to decrease in size after 2 days
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient was 17 years old and 11 months when given the vaccine. this vaccine is approved for 18 years old and above. she did not have an adverse reaction.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING, NO RASH. TOOK CLARITIN
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; This is a spontaneous report from contactable other healthcare professional via Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 (also reported as Pfizer COVID 19 Vaccine, lot no. and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had difficulty breathing after receiving the vaccine on unspecified date. The outcome of the event was unknown. The patient and the healthcare professional who also received the vaccine were in the same recovery room after receiving the vaccine.   Information about lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Received vaccine on 01/12/2021 at 1530 - woke up at 0330 01/13/21 with chills, body aches, headache, nausea, dizziness. This lasted for 48 hours.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore at the injection site; This is spontaneous report from a contactable consumer (patient). A 65-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 at 10:30 A.M (lot number: EK5730) and second dose on 08Jan2021 at 10:15 (lot number: EL0140); both taken via unspecified routes of administration, in the left arm, at single doses, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medication included rosuvastatin calcium (SUVASTATIN). The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the facility. On 18Dec2020, at 15:00, the patient's arm was sore at the injection site. On 08Jan2021, at 16:00, the patient's arm was sore at the injection site. The patient did not receive treatment for the event. Outcome of the event was recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Pain, Tachycardia
Clinical narrative: tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vomiting
Clinical narrative: Moderna Covid-19 Vaccine EUA - Severe dizziness, violent vomiting, fatigue.  Foggy brain and felt horrible.  Could not turn head without extreme  dizziness which lead to vomiting.  Could not move for 20 hours.  Slept all day.  Called doctor twice - prescribed Meclizine. - 12.5 mg.  Could eat or keep down liquids.  Took Tylenol every 4 hours.  Starting improving  morning of 1/18/21.  Still having improved dizzy spells as of 0335 pm.  Still sleeping but able to keep down  food and liquids.   Normal vitals throughout reaction.  Can someone contact me about advice on the 2nd vaccine?
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Night sweats, Pain
Clinical narrative: severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contactable Physician (patient). A 55-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 in Dec2020 three weeks ago at 12:00 noon in the left arm for covid-19 immunization and experienced mild pain at the injection site which lasted two days and then was gone. The patient experienced severe body aches, severe chills, night sweats, and fatigue on 07Jan2021. Event details: The patient reported that he received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. He did not know the exact date. After the first dose there was mild pain at the injection site which lasted two days and then was gone. He received the second dose of the Pfizer COVID 19 vaccine on 06Jan2021 at 12:00 noon in the left arm. He noticed 12 hours later severe body aches, severe chills, and night sweats. He also felt fatigue. Everything had mostly resolved except for the night sweats and they were still pretty severe. All events were reported as serious by reporter per medically significant. The outcome of event night sweats was not resolved, outcome of other events was resolved on 10Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe body aches, severe chills, fatigue and night sweats, and the administration of the COVID 19 vaccine, bnt162b2, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eosinophil percentage increased, Respiratory tract congestion, Rhinitis
Clinical narrative: eosinophil count is 12.2%; Congestion; rhinitis; Cough; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is an MD received the COVID vaccine on 21Dec2020. She quickly developed rhinitis, cough, and congestion which have persisted. Her eosinophil count is 12.2%. She received a Medrol pack, but it did not relieve her symptoms. She has delayed her second injection for now. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Culture negative, Death
Clinical narrative: resident expired; This is a spontaneous report from a contactable healthcare professional.  An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization.  Medical history included metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia.  Known allergies was none.  The patient took unspecified concomitant medication.  On 11Jan2021, the resident expired.  The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021.  There was no treatment given for the event. The patient died on 11Jan2021.  An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient.  The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: resident expired
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Around 12 hours after time of vaccine dose until 28 hours post-vaccine, I felt very nauseous, had intense body aches, chills, shivering, body weakness, rapid heart rate (around 120), decreased O2 sat (around 90), and difficulty breathing. Symptoms came on very suddenly (around 10pm on the day of the vaccine) and ended very suddenly (around 2pm the next day). Body was still weak once recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain
Clinical narrative: Around 12 hours after time of vaccine dose until 28 hours post-vaccine, I felt very nauseous, had intense body aches, chills, shivering, body weakness, rapid heart rate (around 120), decreased O2 sat (around 90), and difficulty breathing. Symptoms came on very suddenly (around 10pm on the day of the vaccine) and ended very suddenly (around 2pm the next day). Body was still weak once recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Constipation, Headache, Inflammation, Pain in extremity
Clinical narrative: started off slight headache and sore arm, next day had constipation and extreme abdominal pain including inflammation of entire area.
Sex: U
Vaccine: COVID19
Symptoms: Productive cough, Pulmonary congestion
Clinical narrative: Congestion in my lungs; I am coughing up junk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced congestion in lungs and was reportedly coughing up "junk" on an unspecified date. It was also reported that the patient woke up this morning with a pretty bad side effect. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Condition aggravated, Decreased appetite
Clinical narrative: Friday night between 6 or 6:30 lost apatite, began to feel like had the flu, body aches. fatigue. pain in knee worsened, very tired.  had to take half of a perkaset. and did not help.  could not sleep because of the pain. the next day. felt really  horrible, bad body aches. Could not stay awake. no apatite,  eating made stomach upset  Went to bed early about 9:00 and slept  all night and all that day. just felt like fighting the flu. Had no energy. Felt better on the third day.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Pain, Sleep disorder
Clinical narrative: Friday night between 6 or 6:30 lost apatite, began to feel like had the flu, body aches. fatigue. pain in knee worsened, very tired.  had to take half of a perkaset. and did not help.  could not sleep because of the pain. the next day. felt really  horrible, bad body aches. Could not stay awake. no apatite,  eating made stomach upset  Went to bed early about 9:00 and slept  all night and all that day. just felt like fighting the flu. Had no energy. Felt better on the third day.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, raised, itchy and warm to touch around and at the site of injection. Also, some tenderness throughout arm. This did not happen until 8 days after injection
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Red, raised, itchy and warm to touch around and at the site of injection. Also, some tenderness throughout arm. This did not happen until 8 days after injection
Sex: F
Vaccine: FLU4
Symptoms: Respiratory disorder
Clinical narrative: Respiratory complications; This spontaneous case was received on 07-Jan-2021 from other non-health professional (consumer) via Health Authority (reference number: SEQW21-00081) and concerned an adult, female patient. At the time of this report, the patient was a 39-year-old.    The patient's concurrent conditions included severe asthma and brain tumor that was not cancerous. The patient's concomitant medications were not reported.     On an unknown date in 2018, reported as both 13-Oct-2018 and mid Monday, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was YF41408, expiration date: 30-Jun-2019.    On the same day in the night, after receiving Afluria Quadrivalent, the experienced severe respiratory complications, so she went to the emergency room and was hospitalized. The patient did not exactly remember the treatment measures, but she usually got anything respiratory related, steroid injections, nebulizer, and oxygen.   On an unspecifed date in 2018, a week after the admission, the patient was discharged. She did not remember the admission or the discharge date. The patient stated that since then she had not received any influenza vaccine, but now she was trying to figure out if she will have the same reaction to COVID-19 vaccine.  The outcome of event was not reported.   The reporter did not provide causality assessment.   The event of 'respiratory disorder NOS' was considered serious due to seriousness criteria of hospitalization.  Company comment:The patient developed respiratory disorder (reported as severe respiratory complications) on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality was confounded by patient's medical history of severe asthma. The patient's concomitant medications were not reported. Since the event was not specified, at this moment causal relationship is assessed as unassessable due to lack of information regarding event characteristics.; Sender's Comments: The patient developed respiratory disorder (reported as severe respiratory complications) on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality was confounded by patient's medical history of severe asthma. The patient's concomitant medications were not reported. Since the event was not specified, at this moment causal relationship is assessed as unassessable due to lack of information regarding event characteristics.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Migraine, Oropharyngeal pain, Pain
Clinical narrative: Severe chills, severe migraine, severe body aches, fever reaching 104.3 . 48 hours later GI issues and slight sore throat.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chills, severe migraine, severe body aches, fever reaching 104.3 . 48 hours later GI issues and slight sore throat.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear infection, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Fatigue, headache, diarrhea, arm soreness, swollen glands, ear infection, sore throat, muscle aches-- started two days after and is still occurring on day five
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Fatigue, headache, diarrhea, arm soreness, swollen glands, ear infection, sore throat, muscle aches-- started two days after and is still occurring on day five