chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (the patient). A 87-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: E69265), via an unspecified route, administered in right arm on 03Feb2021 13:30 (at the age of 87-year-old) as a single dose for COVID-19 immunization. Medical history included aortic valve disease from an unknown date and unknown if ongoing, cardiac pacemaker insertion from an unknown date and unknown if ongoing, eye injury from an unknown date and unknown if ongoing. Allergic to products tetanus, penicillin, sulfa and codeine. Concomitant medications included dulaglutide (TRULICITY), lisinopril (LISINOPRIL), clopidogrel (CLOPIDOGREL), rosuvastatin calcium (CRESTOR), metformin (METFORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination, the patient had not been tested for COVID-19. On 04Feb2021 05:00 PM, the patient experienced mild hives from something in the medications he had been taking but the next day, Thursday, after the Pfizer vaccine increased hives breaking out in new locations. He had a history of reactions. Discussed this with the nurses prior to receiving the shot. The patient did not receive any treatment for hives. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Very tired; headache; This is a spontaneous report received from a contactable consumer or other non hcp. A adult female patient of unspecified age 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 Feb2021 as 1ST DOSE, SINGLE for COVID-19 immunization. It was reported as unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. There was no information provided if the patient was pregnant at the time of vaccination. Patient was not tested for COVID-19 since the vaccination. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced very tired and headache. There was no treatment received for the adverse event as reported. The outcome of events was recovering.   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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: body aches; Fever; headache; This is a spontaneous report from a contactable other healthcare professional reported (Patient).  A 58-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot no: EM9809) via unspecified route of administration, administrated in left arm on 04Feb2021 15:00, as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included simvastin, ADVIL PM. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination: Simvastin and Advil PM.  On 05Feb2021 at 13:00 patient experience with fever, headache and body aches. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient had been not tested for COVID-19. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Slight dizziness; headache; This is a spontaneous report from a contactable consumer other healthcare professional. A 30-years-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number E29269; Expiration date: not reported) via unspecified route of administration in left arm on 05Feb2021 at 02:45 PM (at the age of 30-years-old) as single for COVID-19 immunization. The patient medical history included anxiety, obesity and arthritis. The concomitant medications included Buspirone, hydroxyzine and vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Buspirone, hydroxyzine and vitamin D within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. The patient did not have any allergies to medications, food, or other products. On 05Feb2021 at 02:55 PM (10 min after injection), the patient experienced slight dizziness and headache. Patient adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the adverse event. It was reported that adverse event was not serious. The seriousness criteria was not resulted in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. The outcome of the event was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; muscle soreness in my legs; fatigue; mild headache; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, in left arm on 04Feb2021 15:30 (at 30-years age) as 2nd dose single for COVID-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number:EL3248), via an unspecified route of administration, administered in left arm on 14Jan2021 16:00 (at 30-years age) as a 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Facility where COVID-19 vaccine was administered was at a workplace clinic. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 at 3 a.m. the following morning patient experienced chills, muscle soreness in his legs, fatigue, and a mild headache. These symptoms continued intermittently throughout the day ending around 4 p.m. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well day after shot; This is a spontaneous report received from a non-contactable consumer (patient). An adult of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling well day after shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: headache; fever; pain; This is a spontaneous report from a contactable pharmacist. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown), intramuscular on an unspecified date in Jan2021 as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced headache, fever, pain for 24 hours after receiving the vaccine. The clinical 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; muscle aches; fatigue; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old non-pregnant female patient who received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247, Expiration date unknown), via an unspecified route of administration on 04Feb2021 at 11:00, administered in left arm, at single dose for covid-19 immunization (at the age of 47-years) in clinic. Patient did not pregnant at the time of vaccination. Patient's medical history included hypertension, GERD (Gastrooesophageal reflux disease), and obesity. Patient's concomitant medications included labetalol, Losartan, and HCTZ (hydrochlorothiazide) within 2 weeks of vaccination. The patient had Keflex allergy to medications, food, or other products. 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 has not been tested for COVID-19 since the vaccination. On 05Feb2021, the patient experienced headache, muscle aches and fatigue. The patient did not receive any treatment for the events. The outcome of events was not recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness and pain in the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient partner). A 67-years-old 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 on 25Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced soreness and pain in the arm. Patient put ice and took Advil and that helped, and her symptoms were more pronounced. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Injection site pain
Clinical narrative: body aches; fever of 99.5; Feeling unwell, off normal pace; Tiredness; Muscle pain; Chills off and on; Joint pain; Injection site pain; This is a spontaneous report from a contactable consumer (reporter wife). A 88-year-old female patient (reporter wife) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, in muscle near top at the joint, on 25Jan2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was taking COVID-19 vaccine for trying to be immune and tired of being in the house. Prior vaccinations, the patient had normal sore arm muscle that lasted a day or so and did not specify which vaccine sore arm muscle was in reference to. The patient's medical history and concomitant medications were not reported. Historical vaccine included flu shot in Sep2020 or late Aug2020 and had no NDC/Lot/Exp for Flu shot. The patient did not receive any vaccine within 4 weeks prior vaccinations. The reporter wants to report how patient was feeling after COVID-19 vaccine and clarified that patient was not having a real problem, just discomfort. It was reported that on 25Jan2021, the patient had injection site pain. On 26Jan2021, the patient had tiredness, muscle pain, chills off and on which getting better, joint pain, and feeling unwell, off normal pace. On 27Jan2021, the patient had fever of 99.5 which was improved, but was not well. The patient also had body aches on an unknown date which were somewhat better today. The patient had hearing aides so caller had to make the phone calls. Outcome of the events tiredness, muscle pain, and feeling unwell, off normal pace was unknown and for all other events, it was recovering.  Information on Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: body aches; fever of 99.5; Feeling unwell, off normal pace; Tiredness; Muscle pain; Chills off and on; Joint pain; Injection site pain; This is a spontaneous report from a contactable consumer (reporter wife). A 88-year-old female patient (reporter wife) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, in muscle near top at the joint, on 25Jan2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was taking COVID-19 vaccine for trying to be immune and tired of being in the house. Prior vaccinations, the patient had normal sore arm muscle that lasted a day or so and did not specify which vaccine sore arm muscle was in reference to. The patient's medical history and concomitant medications were not reported. Historical vaccine included flu shot in Sep2020 or late Aug2020 and had no NDC/Lot/Exp for Flu shot. The patient did not receive any vaccine within 4 weeks prior vaccinations. The reporter wants to report how patient was feeling after COVID-19 vaccine and clarified that patient was not having a real problem, just discomfort. It was reported that on 25Jan2021, the patient had injection site pain. On 26Jan2021, the patient had tiredness, muscle pain, chills off and on which getting better, joint pain, and feeling unwell, off normal pace. On 27Jan2021, the patient had fever of 99.5 which was improved, but was not well. The patient also had body aches on an unknown date which were somewhat better today. The patient had hearing aides so caller had to make the phone calls. Outcome of the events tiredness, muscle pain, and feeling unwell, off normal pace was unknown and for all other events, it was recovering.  Information on Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Thermal burn
Clinical narrative: face itches; face burns; face tingles; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number and Expiration Date not reported), via an unspecified route of administration on an unspecified date, as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient thought he was fine and then when he was driving, he noticed the right side, the same side as the shot, of his face started to tingle and felt like the medication given for tooth extracted. Adds it itches and burns, too. The patient was wondering if this was something that will wear off. The outcome of all the events was not reported.  Information about lot/batch number 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: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Myalgia
Clinical narrative: I had gotten chills; sweating little bit; Muscle aches; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. On 27Jan2021, the patient got the Pfizer shot on the 20Jan and dose it (as reported). Patient yesterday got into the shower and when patient came back patient had gotten chills and sweating little bit and had muscle aches, Patient asked would that be from the vaccine (Clarified as Covid vaccine Pfizer). Patient was due for his/her second shot on Feb. The outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Loss of personal independence in daily activities, Malaise
Clinical narrative: feels like she is a little drunk; hasn't been able to go to work; she is in the acute stage of feeling sick; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient with unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered, on 27Jan2021, yesterday, as single for COVID-19 immunization and she got the vaccine at the university. The patient's medical history and concomitant medications were not reported. On 27Jan2021, last night, the day of vaccination, the patient was fine. On 28Jan2021, the patient felt like she was a little drunk, not been able to go work and she was in the acute stage of feeling sick and unable to complete a report at this time. No laboratory data was provided. Outcome of the events were unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Heart rate, Heart rate increased, Insomnia, Memory impairment
Clinical narrative: couldnot sleep; Confusion; Itching with a rash; Itching with a rash; she is having a hard time remembering things sometimes since having the vaccine; her heart is beating faster; This is a spontaneous report was received from a contactable consumer (patient).   A 68-year-old female patient of weight 68.04 kilograms and height 165 centimetres received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL8982, Expire Date: 31May2021) via unspecified route of administration in left arm on 22Jan2021 at 2-2:15pm as single dose for covid-19 immunisation. The patient's medical history included diabetes mellitus. The patient had no thyroid, and she does not have any allergies to medication but trees and caffeine, she has been taking allegra for most of her life. There were no concomitant medications. Previously patient took Flu vaccine (she had in Nov2020 or Dec2020 the Flu vaccine, but it was more than a month ago). Reporter states she just came back from her regular doctor because she had the vaccine on 22Jan2021 and the day after she started scratching her arm and her body some. The reporter also explained she had been having confusing and it was bothering her, so she needed to see her doctor about this. Her doctor gave her a shot. The reporter explained the confusion, she was having a hard time remembering things sometimes since having the vaccine. The reporter does not know what kind of shot her doctor gave her for the itching. She then confirmed she had only had the itching and explained it was with a rash and the confusion. Her heart was beating faster she thought since having the vaccine but maybe because it was because of her worry, she was very sensitive person. When she couldn't sleep, she takes a Xanax. When asked if the caller was having trouble sleeping after the vaccine, she clarifies that she was sleeping ok, she had been taking Benadryl due to the itching. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient had no adverse events following prior vaccinations. The patient had no family medical history relevant to adverse event and no relevant tests were done. In Jan2021, the patient had undergone lab tests which included heart rate and the result was faster. Adverse event resulted in physician's office visit. The outcome of events memory impaired, heartbeats increased was unknown, whereas not recovered for confusion, itching with a rash and was recovering from the event could not sleep.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: couldnot sleep; Confusion; Itching with a rash; Itching with a rash; she is having a hard time remembering things sometimes since having the vaccine; her heart is beating faster; This is a spontaneous report was received from a contactable consumer (patient).   A 68-year-old female patient of weight 68.04 kilograms and height 165 centimetres received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL8982, Expire Date: 31May2021) via unspecified route of administration in left arm on 22Jan2021 at 2-2:15pm as single dose for covid-19 immunisation. The patient's medical history included diabetes mellitus. The patient had no thyroid, and she does not have any allergies to medication but trees and caffeine, she has been taking allegra for most of her life. There were no concomitant medications. Previously patient took Flu vaccine (she had in Nov2020 or Dec2020 the Flu vaccine, but it was more than a month ago). Reporter states she just came back from her regular doctor because she had the vaccine on 22Jan2021 and the day after she started scratching her arm and her body some. The reporter also explained she had been having confusing and it was bothering her, so she needed to see her doctor about this. Her doctor gave her a shot. The reporter explained the confusion, she was having a hard time remembering things sometimes since having the vaccine. The reporter does not know what kind of shot her doctor gave her for the itching. She then confirmed she had only had the itching and explained it was with a rash and the confusion. Her heart was beating faster she thought since having the vaccine but maybe because it was because of her worry, she was very sensitive person. When she couldn't sleep, she takes a Xanax. When asked if the caller was having trouble sleeping after the vaccine, she clarifies that she was sleeping ok, she had been taking Benadryl due to the itching. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient had no adverse events following prior vaccinations. The patient had no family medical history relevant to adverse event and no relevant tests were done. In Jan2021, the patient had undergone lab tests which included heart rate and the result was faster. Adverse event resulted in physician's office visit. The outcome of events memory impaired, heartbeats increased was unknown, whereas not recovered for confusion, itching with a rash and was recovering from the event could not sleep.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Rash, Urticaria
Clinical narrative: rash to left side of neck/ rash to right side of neck/ Rash to stomach/ Broke out on her face; Hives; Itching; rash, hives and itching that got worst; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EK9231, Expire Date: Unknown), via an unspecified route of administration, administered in Arm Left on 19Jan2021 at 11:30 (at the age of 67-year-old) UNKNOWN, SINGLE for covid-19 immunization. Medical history included allergic to penicillin since she was a child with ongoing. The patient's Family Medical History, previous immunization with the Pfizer vaccines, Concomitant medications, Prior vaccination within 4 weeks and additional vaccines administered on same date of the Pfizer suspect reported as none. After receiving the vaccine, the patient waited for 15 minutes but there was no reaction. On 24Jan2021 17:00, on the fifth day after the vaccine, the patient experienced rash to left side of neck, hives and itching that got worst. On 25Jan2021 at 08:00, rash to right side of neck, on 26Jan2021 at 08:00, broke out on her face; on 28Jan2021 at 22:00, rash to stomach appeared. On an unknown date the patient had "rash, hives and itching that got worst". The patient was told that it was a reaction to the vaccine. The patient also stated that she broke out on her face on 28Jan2021 (the day of report). The patient had visit on Physician Office. The patient had to have a steroid shot, prednisone and Benadryl. The patient's hives resolved completely after the steroid shot. The outcome of event rash not recovered. The outcome of the event urticaria was reported as recovered on 27Jan2021. The outcome of the event pruritus was reported as recovering. The outcome of the event condition aggravated was unknown.  No further information expected. Follow up attempts are completed.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pruritus
Clinical narrative: Nose filled up I sneezed; felt a little bit itchy; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection), via an unspecified route of administration on 27Jan2021 at 01:45 as unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, last night about 8 o'clock she had nose filled up and she sneezed and felt a little bit itchy, but no rash developed. The events assessed as non-serious. She took the Benadryl for the treatment and had no other health issues. The outcome of the events was recovered.  Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Malaise, Somnolence
Clinical narrative: Extreme tiredness; Sleepiness; Chills; Not feeling well; Dizziness; This is a spontaneous report from a contactable Consumer. This Consumer (Patient) of unspecified age and gender reported that the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration, on 15Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, in the afternoon the patient experienced extreme tiredness, sleepiness, not feeling well and chills. The patient got feeling that it would go away and it has not really gone away. The patient thought by this time it would be over, and was feeling sleepy, tired, not feeling well. The patient was treated with 2 pills for dizziness. The outcome of events is not recovered. Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Nausea, Vaccination site pain
Clinical narrative: very nauseous; pain in underarm; hurt a little at injection site; This is a spontaneous report from a contactable Consumer(patient). A 68-year-old female received first dose of BNT162b2 (BNT162b2, solution for injection; Lot number: EL9263, Expiration date: Unknown), via unspecified route of administration in the left arm on 25Jan2021 (patient was 68-year-old at the time of vaccination), at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Jan2021, the patient experienced hurt a little at injection site. On 26Jan2021, the next day patient experienced very nauseous and had pain in her underarm. The patient still having pain under her underarm. She has been looking up information. She doesn't know if it is because it is in a lymph node or what. The arm pain she noticed 1-2 hours after the shot. It was just sore to the touch. She got the vaccine in her left arm. She got it to be able to see her grandchildren and start living again. Patient got the first shot on 25Jan2021. The Patient was heard that vaccine was supposed to be given 3 weeks later, but they got appointments for 4 weeks later. The outcome of the event injection site pain is recovered on 26Jan2021. The outcome of the event Nausea was Recovering, and Axillary pain was not recovered.   Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pruritus, Swelling face
Clinical narrative: left side of face swollen, could be swelling down underneath neck, it's not bad, but noticeable; left side face itching; could tell mouth was swollen, left side of mouth would pull; itching under chin and around the bone; This is a spontaneous report from a contactable consumer (patient). A 74 years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EL3249, Expiration date: unknown) via intramuscular route of administration in left arm on 26Jan2021 11:00 2ND DOSE, SINGLE for COVID-19 immunisation (age at vaccination was 74 years). The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EL0142 or EL0140, Expiration date: unknown) via unspecified route of administration on 05Jan2021 single dose for COVID-19 immunisation. patient medical history included high blood pressure, remembers getting stung by wasp years ago and the same thing happened to her arm and at that time the doctor suggested for her to get an EpiPen and she got one, but never had to use it, getting stung by wasp years ago and the same thing happened to her arm and at that time the doctor suggested for her to get an EpiPen and she got one, but never had to use it. Patient's concomitant medication was not reported. Patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jan2021 the patient experienced itching under chin and around the bone at 19:30, left side face itching, could tell mouth was swollen at 11:30pm, left side of mouth would pull. On 28Jan2021 at 11:30pm patient experienced left side of face swollen, could be swelling down underneath neck, it's not bad, but noticeable (all events were ongoing). The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: injection site soreness; Headache; This is a spontaneous report from a contactable consumer(wife reported for husband). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation; Solution for injection, Lot number: EL9263 and Expiration date not reported), via an unknown route of administration on 25Jan2021, 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported .It was reported that, they got their first shot on 25Jan2021. She heard the vaccine was supposed to be given 3 weeks later, but they got appointments for 4 weeks later. Her and her husband got the vaccine together. On 25Jan2021 patient only had a little injection site soreness, and a headache that went away the next day. He went online to sign up. They got a call 9 days after. The injection site soreness he experienced from 25Jan2021 to 26Jan2021. He had a headache that day, 25Jan2021, and the 26Jan2021. He recovered completely from both of those. The outcome of the events was reported as recovered on 26Jan2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium test, Culture stool, Diarrhoea, Investigation, Muscle spasms
Clinical narrative: Diarrhea; cramping; injection site sore; lost weight, she was usually 140 pounds but she had lost 04 pounds down to 136 over the last week; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248 and Expiration date was not reported) via an unspecified route of administration on 14Jan2021 at 10:00 AM  (patient age at time of the vaccination was 67 years) in the left arm as a single dose for COVID-19 immunisation. Patient medical history included atrial fib and stomach problems. Family medical history was reported as none. The patient concomitant medication included acetylsalicylic acid (ASPIRIN) at dose of 325 mg, once daily by mouth from taking for years to ongoing for atrial fib. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021, the patient had diarrhea and cramping and it was persisted. The patient also experienced injection site a little sore on same date but that went away. She also lost weight, she was usually 140 pounds but she had lost 04 pounds down to 136 over the last week since the 15Jan2021. The patient visited to physician/emergency room for diarrhea. The patient was not hospitalized for the event diarrhea. The patient was unsure if diarrhea was related to stomach problems because two years ago she had stomach problems. Added she has not been able to go back to work since she started having diarrhea. The patient underwent lab tests and procedures for investigation which included: Covid Test: Negative on 20Jan2021, C difficile: Negative, E coli: Negative on 25Jan2021. The patient mentioned she had stool cultures that were still pending. She was scheduled for the second dose of the vaccine 05Feb2021. The outcome of the events diarrhea, cramping and weight loss was not recovered. The outcome of the event injection site sore was recovered on 19Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Weight, Weight decreased
Clinical narrative: Diarrhea; cramping; injection site sore; lost weight, she was usually 140 pounds but she had lost 04 pounds down to 136 over the last week; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248 and Expiration date was not reported) via an unspecified route of administration on 14Jan2021 at 10:00 AM  (patient age at time of the vaccination was 67 years) in the left arm as a single dose for COVID-19 immunisation. Patient medical history included atrial fib and stomach problems. Family medical history was reported as none. The patient concomitant medication included acetylsalicylic acid (ASPIRIN) at dose of 325 mg, once daily by mouth from taking for years to ongoing for atrial fib. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021, the patient had diarrhea and cramping and it was persisted. The patient also experienced injection site a little sore on same date but that went away. She also lost weight, she was usually 140 pounds but she had lost 04 pounds down to 136 over the last week since the 15Jan2021. The patient visited to physician/emergency room for diarrhea. The patient was not hospitalized for the event diarrhea. The patient was unsure if diarrhea was related to stomach problems because two years ago she had stomach problems. Added she has not been able to go back to work since she started having diarrhea. The patient underwent lab tests and procedures for investigation which included: Covid Test: Negative on 20Jan2021, C difficile: Negative, E coli: Negative on 25Jan2021. The patient mentioned she had stool cultures that were still pending. She was scheduled for the second dose of the vaccine 05Feb2021. The outcome of the events diarrhea, cramping and weight loss was not recovered. The outcome of the event injection site sore was recovered on 19Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Nervousness
Clinical narrative: Nosebleed/blew her nose and it was bleeding; she is starting to get nervous; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received 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 single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated that she took the Covid-19 vaccine on Monday, and woke up this morning and blew her nose and it was bleeding, and it's still bleeding. States that it is not bleeding a lot, like it is not dripping out of her nose, but if she blows her nose, there is blood on the tissue, and if she tilts her head back she can feel it trickle down her throat. The patient asked if this is something that has been reported before, and what does she need to do? Will it go away? Does she need to go to the doctor or the emergency room? States that she always thought that if you can make it past the first 3 days, then you'll be okay, but it's been more than 3 days since getting the vaccine, so she is starting to get nervous. No further details provided. The outcome of the event was unknown.  Follow-up (19Apr2021): 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: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: I began to have some skipped heart beats; This is a spontaneous report from a contactable consumer (patient). This is 1st of two reports. A 86-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248, expiry date not reported) via an unspecified route of administration on 13Jan2021 (at the age of 86-years-old) as a 1st dose, single for COVID 19 immunisation.The patient medical history included skipped heartbeats and was taking a medicine (Unspecified medication), that for 4 years and it had been working. Concomitant medication were not reported. On an unspecified date, the patient began to have some skipped heart beats. The patient was supposed to take the second dose on 02Feb2021. He did not have any skipped heart beats with the unspecified medication he used but after the vaccination, he began to have some skipped heart beats. The outcome of the event was unknown.   Consumer was informed about Pfizer Medical information department and was unwilling to complete the report, hence further probing could not be done. Limited information was available over the call.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pyrexia
Clinical narrative: chills; high fever that is not going down of 104.4; feeling weak; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The patient stated that she had the second part of the COVID vaccine yesterday (date unspecified), and she was experiencing chills and a high fever that was not going down. She stated that her fever was 104.4 (unit not stated). She stated that she was feeling weak and she did not want to complete a report. She just wanted more information on these side effects from the product. The outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-year-old male patient (husband).  A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in deltoid right on 26Jan2021 15:00 as unknown, single for covid-19 immunisation. Relevant medical history and concurrent conditions: diabetes type 2, Hypertension, Stroke(Other Conditions: he has completely recovered), incipient Parkinson's disease(Other Conditions: this was minor and he has very little to no symptoms, Congestive heart failure was ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): The only vaccine they get was the flu shot and has had to have things like typhoid, the shots needed for international travel. He has had a never had a reaction to a vaccine that she knows about and they had been married over 50 years. No additional vaccines administered on same date of the Pfizer Suspect. No Emergency Room and Physician Office visited. Prior Vaccinations (within 4 weeks) was none. AEs following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination) was no. Family Medical History Relevant to AEs was no Relevant Tests was no. Time the Vaccination Was Given was 3pm. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right deltoid. On26Jan2021, the patient experienced, sore arm. No other Products. Investigation Assessment was no. Additional Context: Caller, reporting COVID vaccine and who has a question. She explains her and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm, but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could affect the efficacy of the vaccine. She wants to know does it affect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. Prescribing Healthcare: no address, phone or email are known. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not get through the day without the Tylenol. Today, she is a little tired, but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really yucky. She was healthy. On 28Jan2021, the outcome of event was recovered   Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: The patient medical history and concomitant medications were not reported.  It was reported that patient got the first dose of Pfizer vaccine on 20Jan2021 and yesterday, with a week from the dose, he don't think it was related but he basically woke up and ended up getting very sick having like 101 degrees fever, vomiting, body ache. And he was really serious about quarantining, patient was a teacher and we just teach virtually currently and he was very just like unsure about where he would have got-ten anything and patient was able to get a COVID test today but it's not a rapid test, so he haven't gotten his results. But he just kind of want to reach out as far as like getting his second dose if that was still like okay to do, if that has been seen in anybody else. patient feel much better today, he don't, he likely haven't had a fever, still just have like some fatigue, kind of like normal after being really sick. patient took a Tylenol and have no idea about LOT and expiration date. The outcome of the a week from the dose, woke up and ended up getting very sick, 101 degrees fever recovering and for vomiting and body ache was unknown and for the event fatigue was not recovered.  information on the lot/batch number has been requested.  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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The patient medical history and concomitant medications were not reported.  It was reported that patient got the first dose of Pfizer vaccine on 20Jan2021 and yesterday, with a week from the dose, he don't think it was related but he basically woke up and ended up getting very sick having like 101 degrees fever, vomiting, body ache. And he was really serious about quarantining, patient was a teacher and we just teach virtually currently and he was very just like unsure about where he would have got-ten anything and patient was able to get a COVID test today but it's not a rapid test, so he haven't gotten his results. But he just kind of want to reach out as far as like getting his second dose if that was still like okay to do, if that has been seen in anybody else. patient feel much better today, he don't, he likely haven't had a fever, still just have like some fatigue, kind of like normal after being really sick. patient took a Tylenol and have no idea about LOT and expiration date. The outcome of the a week from the dose, woke up and ended up getting very sick, 101 degrees fever recovering and for vomiting and body ache was unknown and for the event fatigue was not recovered.  information on the lot/batch number has been requested.  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: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oxygen saturation, Paraesthesia
Clinical narrative: tingling and numbness kind of like numbing sensation all over body; numbness kind of like numbing sensation all over body; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 24Jan2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date of Jan2021 after vaccination, the patient experienced tingling and numbness kind of like numbing sensation all over body. It was reported that patient was able to walk around and could work. Patient was feeling fine thought having events. Patient had no fever, no shortness of breath and O2 stats were normal. Outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.