chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: Acute pain in my left neck and shoulder; Acute pain in my left neck and shoulder; Muscle spasm; I guess where you can lay your hand on the top of your shoulder, it started feeling a little stiff; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 12Feb2021 as dose 1, single for covid-19 immunisation. Medical history included blood pressure and cholesterol from an unknown date to unknown if it is ongoing. Concomitant medications included amlodipine taken for blood pressure, atorvastatin taken for cholesterol and metoprolol succinate. On an unspecified date in Feb2021, patient stated the top of her shoulder, not her arm but where you can lay your hand on the top of your shoulder, it started feeling a little stiff Saturday night. Sunday it was getting stiffer and it was going into her neck and Monday it was to the point where she could not know how to 'adjust' her head off the pillow when she lied down. Tuesday morning she went to the urgent care. Doctor gave some of the medicine but it was not quite affective. Later she clarified that the treatment medications were not working properly it worked when she took it and it was just Tylenol. Tylenol which she just took before but she stopped taking it when she got the vaccine because she read that it was helpful. She was acetaminophen or tylenol and she was taking the arthritis pain extended release tablets. Patient stated that something else that he gave her was tizanidine. It's a muscle relaxer and together they have helped significantly plus he told me to keep ice on it and those 3 things helped. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: little headache; This is a spontaneous report from a contactable consumer (patient). A 5-decade-old (her late 40's, as reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Feb2021, the patient experienced little headache which could be related to the vaccine, but she reported that this was all a very small price to pay for protection. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient in his late 40s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle soreness and fatigue, which he has had on and off since then.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Myalgia, Oral blood blister, Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: I believe the vaccine has caused an autoimmune flare; I believe the vaccine has caused an autoimmune flare; Extreme muscle pain; blood blisters in mouth tissue plus tissue swelling; blood blisters in mouth tissue plus tissue swelling; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date: was not reported) via an unspecified route of administration on 22Feb2021 at 15:30 (73-year-old at vaccination) as a Dose number unknown, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included Lupus, Rheumatoid arthritis, Hashimoto's thyroid disorder. There were no concomitant medications within two weeks of vaccination. The patient previously took Penicillin, Levaquin and had allergies to it. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was not tested for Covid post vaccination. On an unknown date in 2021, the patient had experienced extreme muscle pain; blood blisters in mouth tissue plus tissue swelling. She had Lupus and RA and she believed the vaccine had caused an autoimmune flare (which she wasn't had for over a year). She does not take any medications for her autoimmune issues because she doesn't tolerate them well. She was hesitated to get the vaccine and now felt that it would be a mistake to get the second dose. If her symptoms get worse, she worried her doctor would want to put her on prednisone which she hate's taking it. No treatment received for the resulted events. The outcome of the event was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information was expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Soreness in arm and neck. Approx. 14 hours after injection began/ body ache; Slight fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), dose 2 via an unspecified route of administration on 16Feb2021at 08:00 (age at vaccination: 38-year-old),  as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported, age at vaccination: 38-year-old), on an unknown date for covid-19 immunization. No covid prior vaccination and not tested for covid post vaccination. On 16Feb2021 at 22:00 approx 14 hours after the injection, the patient experienced soreness in arm and neck, slight fever, chills and body aches. No treatment was received for the events. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number can not be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chilling; aches; pain; fever; This is a spontaneous report from a contactable Consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. This Consumer reported for a female patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced chilling, Aches, Pain, Fever on an unspecified date. The outcome of event was unknown.  Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204976 Original Case : 2021171190  Same product/Event, diferent patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash pruritic
Clinical narrative: Left arm is red, and itchy; Left arm is red; Arm still sore; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 21Feb2021 at 16:30 pm (age at vaccination was 66 years) as dose 2, single for COVID-19 immunization. The patient had known allergy to Penicillin. Concomitant medications the patient received within 2 weeks of vaccination included biotin, calcium pantothenate, chromic chloride, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide (CENTRUM VITAMINTS), calcium, vitamin C [ascorbic acid] (VITAMIN C) all taken for an unspecified indication. The patient took demerol and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EI9262, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 31Jan2021 at 15:30 pm (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Feb2021, after 2nd dose of COVID vaccine, the patient's left arm was red and itchy, that just started today, 3 days after her shot. That didn't happen after the first shot. Arm was still sore, but that also happened after first shot. Although her arm hurt much more after the second shot, when compared to the first. No treatment was received for the adverse events. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Vaccination site pain
Clinical narrative: Fatigue; headache; soreness at injection site in left arm; joint pain; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL-3247) via an unspecified route of administration, administered in Arm Left on 11Feb2021 11:15 (at the age of 44-years-old) as single dose for covid-19 immunisation. The patient's medical history included anxiety and depression. The patient's concomitant medications included ibuprofen (ADVIL 12 HOUR) and escitalopram oxalate (LEXAPRO). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL-3247) via an unspecified route of administration, administered in Arm Left on 21Jan2021 at 11:15 AM. On 12Feb2021, the patient experienced headache, fatigue, soreness at injection site in left arm, joint pain and flu like symptoms. The patient received treatment for the adverse events experienced. The outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Vaccination site pain
Clinical narrative: Shortness of breath; extreme tiredness; sore at injection site; sweating; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Feb2021 at 13:45 (01:45 PM) (at the age of 52-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included COPD, asthma, adrenal insufficiency, ADHD. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took amoxicillin and experienced drug allergy. On 23Feb2021 at 06:00 AM, the patient experienced shortness of breath, extreme tiredness, sore at injection site, sweating. The patient did not receive treatment for the events. Outcome of the events was unknown.  Information of lot number is requested.  Follow-up  18May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Nausea
Clinical narrative: chills; myalgia; arthralgias; nausea; vomiting; Fever to 101; This is a spontaneous report from a contactable physician (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at health office. The patient medical history included atrial tachycardia and asthmatic bronchitis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) on 25Jan2021 at 09:30 AM (at the age of 65-years-old) administered in arm left as dose 1, single for covid-19 immunisation, and experienced sore arm and severe headache. On 16Feb2021 15:30, the patient experienced chills, myalgia, arthralgias, nausea, vomiting  and fever to 101. No treatment was received for the events. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: chills; myalgia; arthralgias; nausea; vomiting; Fever to 101; This is a spontaneous report from a contactable physician (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The vaccine was administered at health office. The patient medical history included atrial tachycardia and asthmatic bronchitis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) on 25Jan2021 at 09:30 AM (at the age of 65-years-old) administered in arm left as dose 1, single for covid-19 immunisation, and experienced sore arm and severe headache. On 16Feb2021 15:30, the patient experienced chills, myalgia, arthralgias, nausea, vomiting  and fever to 101. No treatment was received for the events. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Migraine, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist.   A 45-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, on 29Jan2021 at 08:00 (at the age of 45-year-old), as single dose, for COVID-19 immunization. The patient's medical history included the IDA (Iron deficiency anemia), anxiety, MDD (Major depression), migraine with aura, vitamin d deficiency and known allergies to metoclopramide. Concomitant medications in two weeks included citalopram (10mg qday), vitamin c (500mg qday), vitamin d3 (50,000 international units qweek), ferrous sulfate (325mg qday), fluticasone propionate (FLONASE ALLERGY RELIEF), folic acid (1mg qday), norethindrone (0.35mg qday) and olopatadine (0.2 percentage ophthalmic solution). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 08Jan2021 at 08:00, as single dose, for COVID-19 immunization and did not develop any side effects after her first dose. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient completed 2 doses of COVID 19 vaccine. Patient did not develop any side effects after her first dose, but developed acute on chronic migraine HA, nausea, low grade fever and back pain after her 2nd shot on 30Jan2021 at 08:00. On the day of the 2nd shot (29Jan2021), patient did not have any symptoms, but woke up the next day (30Jan2021) with symptoms. Her symptoms persisted after more than one week. Events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for events. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Joint swelling, Pruritus, Rash, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN9581, patient was 67-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 11Feb2021 at 01:00 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3302, patient was 67-year-old at the time of vaccination), via an unspecified route of administration, on 18Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. It was reported that no additional vaccines administered on same date of Pfizer suspect. No AE(s) follow prior vaccinations. On an unspecified date in Feb2021, the patient experienced soreness in back and injection arm, has a few itchy spots on his legs and a couple on his arms, on 15Feb2021, the patient experienced rash on both arms, on 16Feb2021, the patient experienced rash went down to his legs, on 17Feb2021, the patient experienced ankles and big toes were slightly swollen. Patient received treatments for events (rash on both arms, rash went down to his legs, has a few itchy spots on his legs and a couple on his arms) with hydrocortisone cream on his arms to keep the itching down. Reported that take second dose on 11Feb2021 and Thursday and Friday acted like he didn't even have the shot. Over the weekend his back and are was real sore. Last night, ankles and both big toes were slightly swollen and has a question about it. On the day of reporting it was reported that, has a few itchy spots on his legs and a couple on his arms. Big toes and ankles are still swollen. He is not talking drastic swelling. Wants to know if it would hurt to take a Benadryl. Doesn't know if that was right or not. The outcomes of all reported events were unknown. Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pyrexia
Clinical narrative: Sick; Fever; Chills; Horrible headache; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. This consumer reported that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.The patient previously took first dose of BNT162B2 for COVID-19 immunization and experienced sore arm after the first one. The patient experienced sick, fever, chills, and horrible headache on an unspecified date. It was reported that they had both Pfizer vaccines. Nothing but a sore arm after the first one. But the 2nd one. So sick. Fever, chills, horrible headache. It was short lived. Just 24 hours. The outcome of events was recovered on unknown date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia, Muscle discomfort, Neuralgia
Clinical narrative: nerve pain; tingling; numbness; headache; muscle and joint discomfort; muscle and joint discomfort; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old non-pregnant female patient 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 (at the age of 42-years), administered in arm left on 15Feb2021 at 13:00 as dose 1, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no known allergies. The vaccine facility type was reported as other. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination. On 15Feb2021 at 13:15, the patient experienced nerve pain, tingling, numbness, headache, muscle and joint discomfort. It was further stated that after the vaccine the patient I had nerve pain in my left side of my face. A tingling and numbness lasted 3 days. I had a headache and muscle and joint discomfort as well. The treatment received for the events was reported as unknown. The patient has been tested covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test: pending on 17Feb2021 Pcr covid test type post vaccination. The clinical outcome for all the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-1 test
Clinical narrative: nerve pain; tingling; numbness; headache; muscle and joint discomfort; muscle and joint discomfort; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old non-pregnant female patient 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 (at the age of 42-years), administered in arm left on 15Feb2021 at 13:00 as dose 1, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no known allergies. The vaccine facility type was reported as other. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination. On 15Feb2021 at 13:15, the patient experienced nerve pain, tingling, numbness, headache, muscle and joint discomfort. It was further stated that after the vaccine the patient I had nerve pain in my left side of my face. A tingling and numbness lasted 3 days. I had a headache and muscle and joint discomfort as well. The treatment received for the events was reported as unknown. The patient has been tested covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test: pending on 17Feb2021 Pcr covid test type post vaccination. The clinical outcome for all the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; body ache; possible fever; This is a spontaneous report from a non-contactable consumer.   A 22-Years-old female patient (non pregnant) received first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), (Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 as dose number unknown single, (Age at the vaccination was 22 years old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Feb2021 at 04:00AM, the patient had experienced Chills, body ache and possible fever. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were resolved.   No follow-up attemps are possible. Information about lot/batch number could not be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: face swelled up; Chills; Fever; Runny nose; Body aches; Little weak; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:30 (Batch/Lot Number: E102501262) as a single dose (at age of 58-years old) for covid-19 immunization. Medical history included ongoing blood pressure increased, ongoing gout, blood potassium abnormal from an unknown date and unknown if ongoing. She was medication for high blood pressure. She takes Potassium for Potassium. She was also on a medication for gout. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE(s) following prior vaccinations was no. Prior Vaccinations (within 4 weeks) was no. The patient experienced face swelled up, chills, fever, runny nose, and body aches on 17Feb2021 12:00 and little weak in Feb2021. It was reported that, she went and got the vaccination for COVID and had a lot of side effects. She got it on Tuesday and felt alright. Yesterday, Wednesday 17Feb2021, she had chills, fever, runny nose, body aches, and her faced swelled up. Her body was aching really bad all over. She came home from work yesterday and took some Tylenol for body aches and when she woke up this morning the fever was gone. She sweated it out last night. For the event fever, she has recovered with lasting effects. She was still feeling a little weak and sore. Her face was still swollen, but it was a little better. It was just the left side of the face that swelled. She doesn't think it was a medical emergency. Therapeutic measures were taken as a result of body aches; Tylenol . Adverse events did not result in Emergency Room or Physician Office visit. Relevant Tests was none. The outcome of the event fever resolved with sequelae on 18Feb2021 while the outcome of the events chills, her faced swelled up, runny nose, body aches was recovering. The outcome of the event little weak was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face swelled up; Chills; Fever; Runny nose; Body aches; Little weak; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:30 (Batch/Lot Number: E102501262) as a single dose (at age of 58-years old) for covid-19 immunization. Medical history included ongoing blood pressure increased, ongoing gout, blood potassium abnormal from an unknown date and unknown if ongoing. She was medication for high blood pressure. She takes Potassium for Potassium. She was also on a medication for gout. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE(s) following prior vaccinations was no. Prior Vaccinations (within 4 weeks) was no. The patient experienced face swelled up, chills, fever, runny nose, and body aches on 17Feb2021 12:00 and little weak in Feb2021. It was reported that, she went and got the vaccination for COVID and had a lot of side effects. She got it on Tuesday and felt alright. Yesterday, Wednesday 17Feb2021, she had chills, fever, runny nose, body aches, and her faced swelled up. Her body was aching really bad all over. She came home from work yesterday and took some Tylenol for body aches and when she woke up this morning the fever was gone. She sweated it out last night. For the event fever, she has recovered with lasting effects. She was still feeling a little weak and sore. Her face was still swollen, but it was a little better. It was just the left side of the face that swelled. She doesn't think it was a medical emergency. Therapeutic measures were taken as a result of body aches; Tylenol . Adverse events did not result in Emergency Room or Physician Office visit. Relevant Tests was none. The outcome of the event fever resolved with sequelae on 18Feb2021 while the outcome of the events chills, her faced swelled up, runny nose, body aches was recovering. The outcome of the event little weak was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Mild pain started in left elbow; dizzy/feeling faint; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 at 10:30 hours as dose 2, single (at the age of 75-years-old) for COVID-19 immunisation. The patient medical history was not reported. Patient had no other vaccine in four weeks. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 at 09:30 hours as dose 1, single (at the age of 75-years-old) for COVID-19 immunisation. Concomitant medication(s) included melatonin and famotidine taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for the COVID-19, post vaccination. On 17Feb2021, at 10:30 hours, patient experienced mild pain started in left elbow, then she became dizzy, feeling faint and had rapid heartbeat. Patient did not faint, and symptoms passed after about two to three minutes. Patient received no treatment for all the events. The outcome of all the events was recovered on 17Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: face was flushed after the first dose and was red for most of the day; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Daughter).  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient face was flushed after the first dose and was red for most of the day. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (11May2021): 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen lips; This is a spontaneous report from a contactable consumer or (patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6201), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:30 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 70 years). Medical history included chronic obstructive pulmonary disease from, hypertension, thyroidectomy, cardiac failure congestive, gastrooesophageal reflux disease , osteoporosis. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); amlodipine besylate (AMLODIPINE BESYLATE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); calcium carbonate, colecalciferol (CALCIUM 600 + D); carvedilol (CARVEDILOL); levothyroxine sodium (LEVOTHYROXIN); losartan (LOSARTAN); pantoprazole sodium (PANTOPRAZOLE SODIUM); rosuvastatin (ROSUVASTATIN); risedronate sodium (RISEDRONATE); tiotropium bromide (SPIRIVA). The patient previously took bnt162b2 for covid-19 immunization lot number=EL3247 date=30Jan20210 1:45 PM, vaccine Left arm, dose number 1, anoran and experienced drug hypersensitivity, bevespi aerosphere and experienced drug hypersensitivity. On 23Feb2021 patient experienced swollen lips. No treatment was received as a result of event. The outcome of event was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fatigue; fever; headache beginning in late afternoon; chills beginning that night; This is a spontaneous report from a contactable other hcp (patient herself). A 28-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 14Feb2021 10:30 (age at vaccination: 28 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included allergic rhinitis and uterine fibroids. Concomitant medication(s) included mometasone furoate (FLONASE). The patient previously took pfizer biontech covid 19 vaccine on 24Jan2021 11:00, as DOSE 1, SINGLE for covid-19 immunisation. The patient past drug event included feraheme. On 14Feb2021 09:00, the patient experienced chills beginning that night, On 15Feb2021, the patient experienced fatigue, fever and headache beginning in late afternoon. The patient did not receive any treatment for the adverse events. The patient did not have covid prior to vaccination nor was tested since vaccination. The outcome of all the events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: tightness in my chest; fatigue; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at a workplace clinic facility on 17Feb2021 12:45 (Batch/Lot Number: EL3247) (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. The patient had no covid prior to vaccination and was not covid tested post vaccination. Medical history included high cholesterol and attention deficit hyperactivity disorder (ADD), both controlled by medication. The patient also has a sensitivity to erythromycin but not an allergy. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and unspecified vitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in left arm on 27Jan2021 12:45 PM (Batch/Lot Number: EL3247) (at the age of 61-year-old) for covid-19 immunisation. On 17Feb2021 at 04:00 PM, the patient reported that she has a tightness in her chest that has continued over the last 8 days and since the date of the second shot. The symptom was not severe but, different from how she has ever felt. Otherwise, she had the regular reaction of fatigue, chills and headache but those symptoms only lasted 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The patient also confirmed that she reported the symptoms on February 25th but, she did have symptoms starting the evening of February 17th. She was delayed in reporting because the symptoms are not severe and her main concern was how long the symptoms have lasted. The final outcome of the events was not yet recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 18Feb2021 21:00, patient experienced sore shoulder. There was no treatment for the event. The clinical outcome of event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dizziness
Clinical narrative: Chest tightness; Light headedness; elevated BP; This is a spontaneous report received from a contactable consumer. A 75-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Feb2021 (at the dose of 75-year-old) as single dose COVID-19 immunisation. Medical history included inflammatory bowel disease and allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient received any other medication in two weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 196Feb2021, the patient experienced chest tightness, light headedness and elevated bp. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 19Feb2021. It was unknown if patient received treatment to treat adverse event. The event was recovered on 19Feb2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: has had a rash on her arms for a few days , rash to be itchy on the inside of her elbows; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity Caller states that her mother is allergic to sulfa and almost any antibiotics. The patient's concomitant medications were not reported. It was Reported that, calling on behalf of mother who received the first dose of the Covid vaccine, states that her mother has had a rash on her arms for a few days, in which she believes it could have been there anywhere between 3-4 days to a week. Caller states that the rash comes and goes, is blotchy and has little red spots. Caller states that her mother reports the rash to be itchy on the inside of her elbows and that she has an allergic reaction to a lot of stuff. Caller states that her mother is allergic to sulfa and almost any antibiotics. Caller reports that it's been 5 weeks since her first dose in which she is supposed to receive her second dose tonight. The patient experienced has had a rash on her arms for a few days, rash to be itchy on the inside of her elbows on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fever; soreness; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 24-years-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on Feb2021 (age at vaccination 24years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient had historical vaccine of BNT162B2 (CO-MIRNATY, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on Jan2021 11:00AM (age at vaccination 24years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On unspecified date in Feb2021 the patient experienced headache, fever, soreness, fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Weight, Weight decreased
Clinical narrative: diarrhea; patient has lost 18 pounds in 4 days; This is a spontaneous report from a contactable consumer. A 87-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported) dose 1 via an unspecified route of administration at arm right on 20Feb2021 (at a age of 87-years-old) as a single dose for covid-19 immunisation. Medical history included renal failure from an unknown date and unknown if ongoing. The reporter stated that her fiance was on dialysis, and had a history of kidney failure, fistula from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Reporter stated that she was called for her fiance who had the COVID vaccine last week, on saturday, 20Feb2021 and her fiance has been having diarrhoea since sunday night up until today (reporting day), so for 4 days, give or take a few hours. Reporter stated that her fiance's diarrhoea had never been solid, it was just liquid. Reporter stated that the patient's doctor is out of town and the reporter can't determine if this was mild, moderate, or severe. Reporter was wondering if this could be a side effect from the vaccine, and she was wondering if the patient should get the second dose. The reporter stated on feb2021 that the patient had lost 18 pounds in 4 days and he was now down to 180 pounds. The patient underwent lab tests and procedures which included weight lost 18 pounds on Feb2021 patient had lost 18 pounds in 4 days and he was now down to 180 pounds. Outcome of the event diarrhoea was resolved on 25Feb2021 while outcome of weight lost was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: little bit of pain in the injection site; soreness in the lower part of her leg; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored via Regulatory Authority support. A female patient of an unspecified age received unknown dose of 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 a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. She took aspirin 36 hours before the vaccine and asked how much the efficacy was. The patient experienced little bit of pain in the injection site and soreness in the lower part of her leg on an unspecified date. The outcome of both the events was unknown.  Follow-up attempts completed. No further information expected.