chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Sneezing
Clinical narrative: nauseous; chills; brain fog/really felt stuff going on throughout my blood vessels; sneezes; Hot and cold body aches overnight; took Ibuprofen which made me feel better but super tired all day; This is a spontaneous report from a contactable nurse (patient) received by Pfizer . A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date at 8.30 as second dose, single for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The reporter reported that patient received her second round of the vaccine. The patient got shot at 08:30 in the morning. Round 2 of Pfizer and feel "yucky" for 12-24 hours later. Also asked if us did not know what yucky means, reporter would said "nauseous, chills, brain fog, sneezes and I really felt stuff going on throughout my blood vessels". Hot and cold body aches overnight. The patient took Tylenol 12 hours after, nada. 24 hours later when woke up the next day at 08:30am, thankfully patient was not working at the hospital, took Ibuprofen which made feel better but super tired all day. By 48 hours, patient was good to go. The microchip has successfully in filtrated body". There was no contact information available for the patient. No PQC reported.  Therapeutic measures were taken as a result of nauseous, chills, brain fog/really felt stuff going on throughout my blood vessels, sneezes, hot and cold body aches overnight, took ibuprofen which made me feel better but super tired all day. The outcome of events was resolved.  Information about Batch/Lot number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: caught a cold; cough type symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that: a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, received "first dose and then caught a cold and cough type symptoms on an unknown date and now her HCP has prescribed to her a steroid Prednisone to assist". Therapeutic measures were taken as a result of caught a cold cough type symptom. Outcome of the events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: fast heart beat and heart palputations; fast heart beat and heart palputations; This is a spontaneous report received from a contactable consumer (Patient) from a Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 19Jan2021 as 1st DOSE, SINGLE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. It was reported that caller had a reaction to vaccine after first dose, wondering fast heart beat and heart palpitations, after vaccine went to emergency room for increased of these upped dosage of blood pressure meds scheduled for next tuesday to get second dose. Outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Rash, Rash macular, Vaccination site mass
Clinical narrative: Headache; Rash/rash and the splotches on his wrists had resolved; Chills; Threw up; Big red splotches on his both wrists; Soreness at injection site; Lump around injection site about the size of a small marble; This is a spontaneous report from a contactable consumers (the patient and his wife). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9265; Expiration Date: May2021) via an unspecified route of administration in left arm on 28Jan2021 at 12:00 PM (at the age of 71-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation (reported as to build up immunity to Covid-19) at hospital. Medical history included Diabetic, Pancreatic carcinoma, Blood pressure high, Whipple surgery (11 year survivor, tumors were encapsulated, had Whipple surgery) from an unknown date and unknown if ongoing. The concomitant medication were not reported. There were no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not take any other vaccinations within four weeks prior to the first dose. On 28Jan2021, on the way to home after vaccination at 12:00, the patient noticed a lump around the injection site about the size of a small marble. Around 21:30, he started getting a slight headache, then broke out in a rash under his arms and down his chest; looked like small chicken pox. He also got slight chills, and threw up once, and had big red splotches on both wrists. The consumer called their doctor friend, who told him to take two Benadryl, which he did. He then fell sleep in his recliner until about 3:30 next day. Then he went to bed and woke up about 5:30-6:00 and now seems fine. He just had a little soreness around the injection site. The patient further stated that the rash went away after taking the Benadryl, it almost cured him. He only threw up once and hardly ever throws up. The rash and the splotches on his wrists had resolved, then clarified that there night be a real slight redness on his wrists and where the rash was. He further stated that the soreness at the injection site was just muscle soreness. The consumer wanted to know if he should get the 2nd dose. The AEs didn't require a visit to Emergency room/Physician office. The outcome of the event soreness at the injection site was not recovered and all other events were recovered on 28Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Headache; Rash/rash and the splotches on his wrists had resolved; Chills; Threw up; Big red splotches on his both wrists; Soreness at injection site; Lump around injection site about the size of a small marble; This is a spontaneous report from a contactable consumers (the patient and his wife). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9265; Expiration Date: May2021) via an unspecified route of administration in left arm on 28Jan2021 at 12:00 PM (at the age of 71-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation (reported as to build up immunity to Covid-19) at hospital. Medical history included Diabetic, Pancreatic carcinoma, Blood pressure high, Whipple surgery (11 year survivor, tumors were encapsulated, had Whipple surgery) from an unknown date and unknown if ongoing. The concomitant medication were not reported. There were no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not take any other vaccinations within four weeks prior to the first dose. On 28Jan2021, on the way to home after vaccination at 12:00, the patient noticed a lump around the injection site about the size of a small marble. Around 21:30, he started getting a slight headache, then broke out in a rash under his arms and down his chest; looked like small chicken pox. He also got slight chills, and threw up once, and had big red splotches on both wrists. The consumer called their doctor friend, who told him to take two Benadryl, which he did. He then fell sleep in his recliner until about 3:30 next day. Then he went to bed and woke up about 5:30-6:00 and now seems fine. He just had a little soreness around the injection site. The patient further stated that the rash went away after taking the Benadryl, it almost cured him. He only threw up once and hardly ever throws up. The rash and the splotches on his wrists had resolved, then clarified that there night be a real slight redness on his wrists and where the rash was. He further stated that the soreness at the injection site was just muscle soreness. The consumer wanted to know if he should get the 2nd dose. The AEs didn't require a visit to Emergency room/Physician office. The outcome of the event soreness at the injection site was not recovered and all other events were recovered on 28Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen arm/arm is swollen 5x the normal size at the site; Horrendous pain at the injection site; This is a spontaneous report from a contactable consumer (reported for herself).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in arm (unspecified left or right) on 28Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Patient's medical history included ongoing sinusitis. Concomitant medication(s) included amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN CLAVULANIC ACID) 500 mg tablets, at 1 tablet every 12 hours for 10 days for sinusitis, from an unspecified start date to unspecified date in Jan2021. It was reported by the patient that she heard that they (unspecified) had extra doses close to where she lived, and they said to go get one if they wanted it, so she went and got her 1st dose of the vaccine on 28Jan2021 (reported as yesterday), but she forgot that she had been taking antibiotics for a sinus infection since an unknown date. Since she got the vaccine on 28Jan2021 (reported as yesterday), she did not take her antibiotic (missed dose) on 28Jan2021 or 29Jan2021 (reported as last night or today). The antibiotic reported was, Amoxicillin Clavulanate 500 mg tablets, 1 tablet every 12 hours for 10 days. And she had a reaction to the vaccine. The patient stated that in Jan 2021, her arm was swollen 5x the normal size at the site, and she had horrendous pain at the injection site. The patient stated that she followed the directions and she used cold compresses and kept moving her arm, but the pain was so bad she wanted to chop her arm off. At 4 am on 29Jan2021, she took 2 Tylenol. She was not sure if that was okay because she had heard people saying things about that, but she did a little research and found that it was recommended not to take it prior to getting the vaccine. The patient stated that now her arm was just swollen, and she was not in as much pain. The patient asked if she should continue taking the antibiotics are not or should she not have gotten the vaccine or should she call her doctor. The outcome for the event swollen arm/arm was swollen 5x the normal size at the site was not recovered and for other event was recovering. Information on lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia, Rash, Somnolence, Vaccination site paraesthesia
Clinical narrative: big rash on her abdomen; arm getting stiff; it feels like went to sleep; Tingling in my injection arm but it was like more in my hands; Tingling in my injection arm but it was like more in my hands; it feels like went to sleep; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 03Feb2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation.  Medical history included contraception from an unknown date and unknown if ongoing. Historical Vaccine BNT162B2 from 15Jan2021 to 15Jan2021 (On my first dose I did not ever call back again. I called initially when I got the numbness and called my physician right way. This was back in 15Jan, I got the first dose but 24 hours after that first dose I did get a headache that lasted for 30 hours. I took Tylenol and Ibuprofen every three hours and nothing touched it but that was the first dose). Concomitant medication included ethinylestradiol, levonorgestrel (LEVONORGESTREL AND ETHINYL ESTRADIOL) taken for contraception, start and stop date were not reported. The patient experienced tingling in my injection arm but it was like more in my hands; it feels like went to sleep on 03Feb2021, big rash on her abdomen on 04Feb2021, arm getting stiff on 03Feb2021  it feels like went to sleep on 03Feb2021 and tingling in my injection arm but it was like more in my hands on 03Feb2021.  That was tingling in my injection arm but it was like more in my hands last time but this time more in palm of hand, up in elbow and it feels like went to sleep kind of but there is haven't any numbness. There is tingling like it fall to sleep and wake up. In last couple of hours it feels like it is getting better. Last time it lasted about 20 hours and this time it is getting better already. I don't feel in my in my palm as much. My arm feels still would more close to the elbow. It is still little bit tingly but everywhere else it feels like it is going away." She said that she noticed the rash on her abdomen this morning at 0500 04Jan2021 when she left for work. She said that she took a shower last night and it was not there last night. She stated that she has not taken anything yet for her rash. Therapeutic measures were taken as a result of tingling in my injection arm but it was like more in my hands; it feels like went to sleep and  tingling in my injection arm but it was like more in my hands. The outcome of the events Tingling in my injection arm but it was like more in my hands; it feels like went to sleep was resolved, big rash on her abdomen was not resolved, Tingling in my injection arm but it was like more in my hands was resolving and other events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A female of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On an unspecified date, the patient experienced that she has Epstein Barr Virus (EBV). The patient inquired if she can take the 2nd dose. The outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Irritability
Clinical narrative: dizzy; irritable; More irritable and dizzy again; This is a spontaneous report from a Pfizer Sponsored Program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 27Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autism spectrum disorder. Concomitant medications were not reported. The patient reported, started to get dizzy, irritable. He was more irritable and dizzy again. His general practitioner said he would be ok, to drink fluids, and could take a Tylenol for the site pain. Heard it's much stronger reaction to the 2nd shot than the first. Asking if should be concerned? Outcome of the events was not resolved.  Information about lot/ Batch number requested  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: a few aches and pains; he had a headache; This is a spontaneous report from a contactable consumer (parent). A 55-year-old male patient (son) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After received the 2nd dose, the patient experienced a few aches and pains and had a headache on an unspecified date. Patient's wife reported that can my husband get the COVID vaccine (probably by Moderna) if he's taking Xeljanz. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both legs, stomach and top of feet; This is a spontaneous report from a non-contactable consumer (reported herself). An elder female patient of unspecified age (65 plus Years) (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown, reason: Unable to locate or read the details), via an unspecified route of administration, in left arm, on 27Jan2021 at 12:00 PM, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine was received in four weeks. On 28Jan2021, at 04:00 PM, after the vaccination, the patient experienced rash on both legs, stomach and top of feet. The patient did not have covid prior vaccination. The patient had not been tested for covid post vaccination. The outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Crepitations, Lymphadenopathy
Clinical narrative: Significant lymph node swelling and crepitus along the left neck, clavicle, and underarm; Significant lymph node swelling and crepitus along the left neck, clavicle, and underarm; This is a spontaneous report from a Non-contactable Nurse (patient herself). A 28-years-old-non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 02Jan2021 as a 1st dose single  for covid-19 immunisation. The patient medical history includes known allergies of penicillin, asthma, fibromyalgia, anxiety, depression. Concomitant medications included Breo inhaler, Lexapro (ESCITALOPRAM OXALATE), Claritin (CLARITHROMYCIN), Flonase (FLUTICASONE PROPIONATE). Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested COVID-19 since the vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03-Jan-2021 the patient experienced significant lymph node swelling and crepitus along the left neck, clavicle, and underarm. as resulted in patient visit Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included CT scan with unknown results on unspecified date. The outcome of the events was recovered on unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache; Fatigue; Slight chills within 24 hours.; Minimal soreness at injection sight; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 ( Formulation: Solution for injection, Lot number: EL3249, Expiry date: 28Jan2021), dose 1 via an unspecified route of administration in right arm on 28Jan2021 at 07:30 as 1ST DOSE, single for covid-19 immunisation. Patient's History of all pervious immunization with the Pfizer vaccine considered as suspect included, Hepatitis A vaccine, (Lot/Expiry date: 06Sep2015) administered via R deltoid, Influenza Quad NPT vaccine (Lot/Expiry date: 15Oct2015; 02Oct2020) administered via R deltoid, Influenza Fluzone high dose Tri PF (Lot/Expiry date: 14Oct2019 administered via R deltoid, Pneumovax 23 (Lot/Expiry date: 02Nov2016). Patient' had Environmental Allergies since, Long Term 40years + and no other known allergies. Patient did not receive any other vaccine in four weeks. The patients concomitant medications in two weeks included Good sence acetaminophen for headache as a dose of 100 mg 2x/day on 28Jan2021 (Lot/Batch number: 0FE2766C) which is ongoing. Meloxicam (MOBIC) 15 mg daily since, 29Jan2021 which is ongoing. Ergocalciferol (VIT D) and Trazodone 100 mg daily since, 28Jan2021 which is ongoing. On 29Jan2021, patient experienced Slight chills within 24 hours at 6:00AM and fatigue at 9:30. Patient also experienced, Minimal soreness at injection sight on 28Jan2021 and headache on an unspecified date at 10:30. primary infection site was Right Deltoid. There were no any predisposing factors. Culture was not performed. Patient did not receive treatment for the events. Events did not require hospitalization or visit to Emergency room or Physician Office. Since, vaccination patient has not been tested for covid. Treatment received for the event headache. The outcome of the event headache was unknown and other events were resolved.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Lymphadenopathy
Clinical narrative: Lymph node swelling on day 7. Lasting to day 14; Back ache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old non-pregnant female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:45 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine within 2 to 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination. The patient experienced lymph node swelling on day 7. lasting to day 14, back ache and fatigue on 23Jan2021. The patient did not received any treatment. The outcome of the events was recovering.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: hollow electric pain in my back that would shoot down my legs whenever I bent it even a little; my feet are feeling numb with occasional pins; my feet are feeling numb with occasional pins; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 28Jan2021 12:15 as single dose for covid-19 immunisation. Medical history included generalized anxiety and major depressive disorder, but no other chronic conditions. No known allergies. Patient was not tested for Covid prior vaccination. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL, brand Zyrtec) at 450mg and cetirizine hydrochloride (ZYRTEC), both received in two weeks. No other vaccine received in four weeks. On 29Jan2021 at 08:00 AM, the day after she experienced what she would describe as hollow electric pain in her back that would shoot down her legs whenever she bent it even a little. On 30Jan2021 (Today) her feet were feeling numb with occasional pins and needles sensations. No treatment was received for events. Patient was not tested for Covid tested post vaccination. The outcome of events not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: patient described having a metallic taste in mouth after receiving the vaccine; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (COVID-19, Pfizer, solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as 1st dose, single dose for Covid-19 immunization. The patient medical history included known allergies: Yes. The patient concomitant medications were not reported. It was unknown if the patient was pregnant. It was unknown if the patient had other vaccine in four weeks or other medications in two weeks. No Covid prior vaccination and no Covid tested post vaccination. On 28Jan2021, the patient described having a metallic taste in mouth after receiving the vaccine. The outcome of the event was reported as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash: upper arms, chest, stomach, buttocks, upper thighs. It lasted for 4 hours. I did not take allergy meds because I figured this was my body's normal reaction so let my body work through it.; This is a spontaneous report from a contactable consumer. A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:45 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypercholesterolaemia, hypertension, psoriasis, Hashimoto disease, Known allergies: mangos and kiwi and Sulfonamide allergy. The patient previously took ciprofloxacin hydrochloride (CIPROS) and experienced drug allergy.  On 29Jan2021 at 16:30, the patient experienced rash: upper arms, chest, stomach, buttocks, upper thighs that lasted for 4 hours. She did not take allergy meds because figured this was her body's normal reaction so let her body work through it on 29Jan2021 16:30. There was no treatment for adverse event, no covid prior vaccination, no test for covid post vaccination. Outcome of the event was recovered on 29Jan2021 at 20:30.   Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pyrexia, Ulcer
Clinical narrative: Most shockingly, I developed labial ulcers; I received my 2nd vaccine around 7 am. At midnight, I woke up with a fever and chills.; I received my 2nd vaccine around 7 am. At midnight, I woke up with a fever and chills; I was very exhausted for the following days.; The lymph nodes in my right axilla got very swollen and sore - probably to the size of half an orange; This is a spontaneous report from a contactable Nurse (Patient). A 26-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation solution for injection, Batch/Lot number: EK9231), via an unspecified route of administration, administered in right arm on 26Jan2021 07:00 AM as 2nd dose single for COVID-19 immunization. The patient medical history includes Seasonal allergies, cats and Mild asthma. The patient concomitant medications included in two weeks was Microgestin 120, multivitamin, Claritin, melatonin. Patient received, first dose of BNT162B2 (Batch/Lot number: EK5730) via unspecified route of administration, administrated in right arm, on o4Jan2021 at 07:00 AM for COVID-19 immunization. On 27Jan2021 at 12:00AM at midnight, patient woke up with a fever and chills. Patient was very exhausted for the following days. The lymph nodes in my right axilla got very swollen and sore - probably to the size of half an orange. Most shockingly, patient developed labial ulcers. patient called her OBGYN and patient stated this was most likely caused from a viral overload and it was a way her body was responding to the vaccine. patient never had any sort of genital ulcers in the past and have had the same partner for 7 years. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain 6-36 hours following vaccination; This is a spontaneous report from a non-contactable consumer. A 24-year-old non-pregnant female consumer reported herself who received first dose of COMIRNATY (BNT162B2, solution for injection) (Batch/Lot Number: EL3247, Expiration date: unknown) via intramuscular route of administration on 26Jan2021 at 03:45 PM in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. On an unknown date in Jan2021, the patient experienced arm pain 6-36 hours following vaccination for which she did not receive any treatment. The outcome of the event was recovered in Jan2021.  No follow up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; body aches; fever; headache; This is a spontaneous report from a non-contactable nurse.  A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 13Jan2021 23:00 (Batch/Lot Number: EL3248), age at vaccination of 26-years-old, as single dose, for covid-19 immunisation.  Medical history included coeliac disease from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (Sulfonamide allergy), drug hypersensitivity from an unknown date and unknown if ongoing (Cephalosporins), gluten sensitivity from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 23Dec2020 23:00 (Batch/Lot Number: EK9231), age at vaccination of 26-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 (09:00 am) the patient experienced chills, body aches, fever (101F) and headache for 3 days. Facility type vaccine: Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatments were given for the events. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 14Jan2021. The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea
Clinical narrative: Nausea; tiredness; chills; feeling unwell; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 21-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On an unspecified date with outcome of unknown, The patient experienced nausea, tiredness, chills, feeling unwell. The outcome of the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at injection site; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 28-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247) via an unspecified route of administration on 28Jan2021 13:45 as 1st dose single for covid-19 immunisation.  Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Concomitant medications included spironolactone (SPIRONOLACTONE) 100 mg. On 28Jan2021 09:00, the patient experienced arm soreness at injection site. The outcome was recovered.    No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: some soreness at injection site; sleepiness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some soreness at injection site, sleepiness. patient also reported she experienced some soreness at injection site lasting for 2-3 days and sleepiness after she received her first covid vaccine (vaccine manufacturer not clarified with caller). Seriousness reported as non-serious. The outcome of event was unknown.  Information on the batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is spontaneous report received from contactable consumer (patient).  This 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 16Feb2021 15:30 (at the age of 55-year-old) at single dose for COVID-19 immunisation, administered at Workplace clinic. No other vaccine was received in four weeks. Relevant medical history included aortic valve disease and ''carbapenem'' (as reported) allergies. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), simvastatin, metoprolol tartrate and multivitamin (unspecified). On 18Feb2021 at 07:00, the patient developed soreness at injection site. The event was reported as non-serious. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Chain of enlarged, non-painful supraclavicular lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 15Feb2021 at 03:00 PM as 1st dose, single for COVID-19 immunization. Medical history included seasonal allergies. Concomitant medications included ibuprofen, paracetamol (TYLENOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ethinylestradiol, norgestimate (SPRINTEC), melatonin. Patient was not pregnant. Patient did not receive any other vaccine in four weeks. Patient had no COVID prior vaccination. On 23Feb at 5:00pm, Patient noticed chain of enlarged, non-painful supraclavicular lymph nodes. Measured the most easily isolated lymph node, which was just over 2cm in diameter. All other side effects were mild, and only lasted for about 36 hours after vaccination. It was unknown that treatment was received for the adverse event. Patient had not been COVID tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear.; This is a spontaneous report from a contactable Consumer (patient, reported for self)  A 60-Years-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EM9809; Expiration date: UNKNOWN), via an unspecified route of administration, administered in Left arm on 07Feb2021 as single dose for COVID-19 immunisation. Other medical history includes Asthma from an unspecified date and unknow if ongoing. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had earlier received first dose of BNT162B2 (Lot number: EL3247, Vaccine location: Left arm) on 17Jan2021. The patient did not receive any other vaccines within four weeks nor received any other medications in two weeks prior to the COVID vaccine. The patient had no known allergies. Patient's concomitant medications were not reported.  On 12Feb2021 (at 09:30 PM) the patient experienced adverse event, Ringing in ear. Thought it would go away. Still experiencing the constant ringing 17 days after the vaccine. It was unknown If patient received treatment for the event. The patient was not tested for COVID-19 since the vaccination. The adverse event was non-serious. Outcome of the event was reported as not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Rash pruritic
Clinical narrative: rash on left arm which was itchy, red and warm; troubles with memory; This is a spontaneous report was received from a contactable consumer or other non hcp. Follow up (24Feb2021) received from a contactable consumer was processed together with initial information.   An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 22Feb2021 as 2nd dose, single for covid-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included metoprolol, amiodon and hydralazine all used for high blood pressure and dates were unspecified. On 27Jan2021, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number- EL9262) first dose, single for covid-19 immunisation. On 23Feb2021, next day of vaccination the patient developed rash on left arm (the opposite arm from where she got the vaccine) states it itches, and it was red and a little warm. It was reported that the patient applied some hydrocortisone. She also had troubles with her memory. The patient had not recovered from the rash on left arm and the outcome of the event troubles with memory was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Migraine, Pyrexia
Clinical narrative: Fever; chills; migraines; brain fog; fatigue; This is a spontaneous report from a non-contactable female physician (doctor of acupuncture) reported for herself via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), as single dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after receiving first dose of vaccine the patient experienced fever, chills, fatigue, migraines, and brain fog. This patient was willing to be contacted and followed as she gets her second dose in a few weeks. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: severe headaches; dizziness; fatigue; fever; chills; muscle aches; severe joint pain; tachycardia; This is a spontaneous report from a contactable pharmacist. A adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Jan2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient previously received the first dose of BNT162B2(lot unknown) on an unknown date for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Clinical course was reported as: On 09Jan2021, symptoms started about 30 minutes after receiving the Pfizer Covid vaccine. The patient experienced severe headaches, nausea, fever, chills, muscle aches, severe joint pain, congestion, dizziness and tachycardia. Her fever did not resolve for 2 days (100.8 - 101.5) and her headache was also consistent for 2 days. Tachycardia started about 3 hours after vaccination. Heart rate was between 130-150 bpm. She had to contact her doctor to receive medication to help with heart rate. It took about 3 days to control the tachycardia. The patient underwent lab tests and procedures which included body temperature and heart rate measurement. Patient received treatment for the adverse events. She is still getting headaches, nausea, fatigue and joint pain and taking medication for tachycardia. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Myalgia, Pyrexia, Tachycardia
Clinical narrative: severe headaches; dizziness; fatigue; fever; chills; muscle aches; severe joint pain; tachycardia; This is a spontaneous report from a contactable pharmacist. A adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Jan2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient previously received the first dose of BNT162B2(lot unknown) on an unknown date for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Clinical course was reported as: On 09Jan2021, symptoms started about 30 minutes after receiving the Pfizer Covid vaccine. The patient experienced severe headaches, nausea, fever, chills, muscle aches, severe joint pain, congestion, dizziness and tachycardia. Her fever did not resolve for 2 days (100.8 - 101.5) and her headache was also consistent for 2 days. Tachycardia started about 3 hours after vaccination. Heart rate was between 130-150 bpm. She had to contact her doctor to receive medication to help with heart rate. It took about 3 days to control the tachycardia. The patient underwent lab tests and procedures which included body temperature and heart rate measurement. Patient received treatment for the adverse events. She is still getting headaches, nausea, fatigue and joint pain and taking medication for tachycardia. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Nausea
Clinical narrative: body and headache; chills; body and headache; low grade fever; nautiated for 48 hours; Very weak for 2 days after.; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old non pregnant female patient received second dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 17Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included in two weeks Lisinopril was taken.No known allergies.The patient previously took first dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 28Jan2021 13:30 as 1ST dose, single for COVID-19 immunization and experienced chills, headache and 101 fever. Took some Ibprofane temp went down and was fine the next day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks.On 17Feb2021, the patient experienced with 8 hours later, chills, body and headache, low grade fever and nauseated for 48 hours. very weak for 2 days after. No treatment was received for the events. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body and headache; chills; body and headache; low grade fever; nautiated for 48 hours; Very weak for 2 days after.; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old non pregnant female patient received second dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 17Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included in two weeks Lisinopril was taken.No known allergies.The patient previously took first dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 28Jan2021 13:30 as 1ST dose, single for COVID-19 immunization and experienced chills, headache and 101 fever. Took some Ibprofane temp went down and was fine the next day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks.On 17Feb2021, the patient experienced with 8 hours later, chills, body and headache, low grade fever and nauseated for 48 hours. very weak for 2 days after. No treatment was received for the events. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.