chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Whole part of my left face became swelled and very tender to the touch; Whole part of my left face became swelled and very tender to the touch; I was feeling like tingling like if you have eaten something sour; I have a salivary gland clog; swollen lymph node/left side of the salivary gland started to swell; I have a salivary gland clog; swollen lymph node/left side of the salivary gland started to swell; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EL9266; Expiration Date: May2021) (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, the patient experienced her left side of the salivary gland started to swell and feeling like tingling like if you have eaten something sour, on 18Feb2021, the whole part of her left face became swelled and very tender to the touch and on unspecified date in Feb2021, patient experienced swollen lymph node. The clinical details of the events as follows: She stated that on Saturday 13Feb she received her first dose of the Pfizer covid vaccine and on Wednesday night, her left side of the salivary gland started to swell. Next day it was tender and swollen. She went to the urgent care and they prescribed her antibiotic for it and night at around 10:30, she was eating something, and she was feeling like tingling like if you have eaten something sour and then whole part of her left face became swelled and very tender to the touch. She really did not think it was anything related to the vaccine because, she had the shot five days ago and had no reaction, nothing. She went to the urgent care today, who said she had the Covid shot who was a Nurse Practitioner, who thought that she had a salivary gland clog and she put her on antibiotic (Treatment) and she was talking to her daughter and her daughter said, she just read Pfizer again and swollen lymph node which was her gland is a side effect. Treatment: Consumer stated the only thing, she went to Urgent care and she gave her antibiotic and she actually taken one dose of that antibiotic, which she thought was Amoxicillin. She wanted to know if its ok to take antibiotic before her next dose of the covid vaccine. She wanted to know if it is possible side effects of the vaccine happened 5 days later. She has an ENT appointment on Monday. No Investigation Assessment was provided. This case reported as non-serious. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: bad diarrhea side effect after receiving  COVID-19 vaccine; This is a spontaneous report from a program.  This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bad diarrhea side effect after receiving covid-19 vaccine on Feb2021. Outcome of the event was unknown. Information on the lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Vaccination site pain
Clinical narrative: injection site feels sore; I feel chilly and numb; I feel chilly and numb; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program  Support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Feb2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. On an unspecified date in 2021 the patient experienced injection site feels sore, i feel chilly and numb. Verbatim and Event Description: Took a second shot yesterday, the injection site feels sore and I feel chilly and numb. Can I take Tylenol. Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 13Feb2021 13:30 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN SINGLE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. on an unspecified date the patient experienced nausea and headache. She wanted to know what to do, and Potential AE realized after call. The event outcome was Unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness after taking the 2nd dose a week ago/she was dizzy; Her head started spinning; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself) from a Pfizer Sponsored Program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that after receiving the second dose of vaccine a week ago on 13Feb2021 she experienced dizziness, she was dizzy, and her head started spinning. She wanted to know if that is connected to the vaccine. If it is, how long is it expected to last. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: cold; feeling sick; This is a spontaneous report from a contactable consumer (patient) received via Pfizer. A male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 1, single, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced cold and feeling sick. He reported that he was feeling sick/felt like he was getting sick before the dose was given. By morning of the dose, he felt better, but "right away, felt under the weather. The patient reported that when he gets sick, it typically turns into bronchitis because he has a history of asthma. Prednisone is typically used for treatment. The patient was prescribed prednisone to take, but he is not taking it at this time because he knows it will decrease immune system and doesn't want to interfere with the vaccine working. The patient stated that he has no fever and loss of taste. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: profuse bleeding at injection site; This is a spontaneous case received from a contactable consumer (patient) via Medical Information Team. An 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9262) via an unspecified route of administration in left arm on 06Feb2021, 12:00 (age at vaccination 87-year-old) as single dose for COVID-19 immunisation. Patient medical history includes ongoing blood pressure started on an unknown date, stents on an unspecified date in Sep2020. Concomitant medications include Clopidogrel for blood thinner, Carvedilol, Felodipine, and Olmesartan for blood pressure. Patient historical vaccine includes Flu vaccine on an unknown date for flu immunisation. On 06Feb2021 it was reported as patient received first dose and reports profuse bleeding at injection site for 8 hours. She takes blood thinner, Clopidogrel. The Pfizer COVID-19 Vaccine injection was just a little needle going in. The bleeding was from the injection site and she bled down through her sweater and had to give pressure but she could not get enough pressure on the site. she knew it started a little bit at that point when she got the injection initially; but she was not aware it was going on until a couple or few hours later. She just had a little band-aid that they put on the injection site because it was not a problem at the time they injected her to their or her awareness. Bleeding went on for about 8 hours; and she recovered completely that day as far as she is aware. She has taken the flu injection and something else for surgery, she has never had any kind of reaction like this profuse bleeding. She has been on blood thinner Clopidogrel and never had this profuse bleeding before. The outcome of the event was recovered on 06Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site erythema, Pain in extremity
Clinical narrative: Sore arm; raised knob/Knot and redness at the injection site; bruised; This is a spontaneous report from a contactable consumer (patient, self-reported). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date: Jun2021), via Intramuscular, in Arm Left, on 13Feb2021 at 11:30 AM (age at vaccination: 71 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date: May2021), via Intramuscular, in Arm Right, on 27Jan2021 (age at vaccination: 71 years), as a single dose for COVID-19 immunization. The patient did not receive any prior vaccinations within 4 weeks. The patient reported that she received the second shot of the Pfizer covid vaccine last Saturday 13Feb, and she still has a raised knob on an unspecified date in Feb2021, not as red as it was before, was seemingly going the direction of her elbow, and looks bruised. She was looking for information related to these symptoms. The patient stated she hasn't really had any problems with it or side effects. However, at the injection site, she still has a knot. It's starting to look like its bruised going down on her arm. She clarified further she still has a knot there where the shot was injected and it's still red and raised, however it looks like it starting to go down her arm. The patient wanted to know if that was part of the vaccine. She knew it has to come from the shot but was that okay. The patient explained about the second day after receiving the second vaccine, she started to feel her arm get sore on 15Feb2021 and it was kind of red. By the third day, it got a little bigger but she knew that's where they put the medicine into the arm/muscle and everything. The injection site has a knot. When probed for the outcome, the caller explained it's kind of been like this. She started out with nothing, then she developed the knot at the injection site and had some redness and its real sore. She was just thinking by this time, the knot should be going away by now. It looks like it's bruised around the knot and was going down her arm. The events did not require a visit to emergency room or physician office. Outcome of the event raised knob/Knot and redness at the injection site was recovering and for all other events, it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Muscle spasms, Pain in extremity
Clinical narrative: pain on both arms; upset stomach; leg cramps; This is a spontaneous report from a contactable consumer or other non hcp Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot No was not reported), via an unspecified route of administration on 12Feb2021 as 1stdose, single for covid-19 immunisation. The patient medical history was not reported, and concomitant medications were not reported.  The patient experienced pain on both arms, upset stomach, leg cramps on Feb2021. Patient is asking if our vaccine is FDA approved. Outcome of the event was unknown. Upon follow-up 12May2021 it was stated that follow-up attempts completed. No further information expected Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain after the 1st dose of the vaccine; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started to feel pain after the 1st dose of the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She's feeling a little tired; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable Female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she's feeling a little tired on 13Feb2021. It was reported that caller received the Pfizer Covid-19 vaccine yesterday and wanted to ask if it was okay to take a glass of wine. She was feeling a little tired. The outcome for event was unknown.   Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: chills; not feeling well; This is a spontaneous report received from a contactable consumer via Pfizer Sponsored Program COVAX Support. A 72-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, patient experienced chills, not feeling well and wanted to know if he can take Tylenol. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced headache on an unspecified date.The outcome of the events was unknown.The patient wanted to know if she can take Tylenol because of a headache.  Information about the Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: the pain of the vaccine was better than after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EK9231) as dose 1, single for covid-19 immunization (at the age of 32-years-old). The patient medical history was not reported. There were no concomitant medications.The patient previously took multivitamin [vitamins nos] and MiraLax (patient stated that she has not taken any medication, even things she used to take those but she has not taken any of those in a while). It was reported that patient received first dose of vaccine and on an unspecified date in 2021 patient experienced the pain and she stated that the pain of the vaccine after second dose which she took on 05Feb2021 was better than after the first dose. Patient stated that she got the product because she was an essential worker, and everyone else at her work had gotten the shot and they were all acting like it was such a great thing. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183644 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had some pain in left arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 12Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had some pain in left arm where the vaccine was administered on Feb2021. Caller just got the 1st dose vaccine the day before this report and had some pain in left arm where the vaccine was administered. Caller asked if he could take 81mg Aspirin and use hot rubs that have methanol content. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sinus congestion
Clinical narrative: congestion in the sinus area; sore in her arm; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller is due for her 2nd dose tomorrow 14Feb. She is asking if she can take her 2nd dose tomorrow since she has developed little congestion in the sinus area. The caller said after the first dose she had a little sore in her arm. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Electrocardiogram, Heart rate, Heart rate decreased
Clinical narrative: cold sweats; balance issues/balance was off; a very serious dizzy spell/dizziness; pulse is a bit lower than normal; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 17Feb2021 12:15 (at the age of 78 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cold sweats, balance issues/balance was off, a very serious dizzy spell/dizziness, pulse is a bit lower than normal on 18Feb2021. Reported as, patient experienced an adverse reaction with the covid vaccine. He had a severe disease spell consisting of cold sweats, balance issues, and dizziness that they had to call (Number). When the paramedics came his EKG read normal but his pulse is a bit lower than normal. On Thursday (18Feb2021), around 10:30 or 11, he got a very serious dizzy spell and cold sweats. Patient states that it was very serious because his balance was off and the dizziness. The patient underwent lab tests and procedures which included electrocardiogram: normal on 18Feb2021, heart rate: a bit lower than normal on 18Feb2021. Outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: cold sweats; balance issues/balance was off; a very serious dizzy spell/dizziness; pulse is a bit lower than normal; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 17Feb2021 12:15 (at the age of 78 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cold sweats, balance issues/balance was off, a very serious dizzy spell/dizziness, pulse is a bit lower than normal on 18Feb2021. Reported as, patient experienced an adverse reaction with the covid vaccine. He had a severe disease spell consisting of cold sweats, balance issues, and dizziness that they had to call (Number). When the paramedics came his EKG read normal but his pulse is a bit lower than normal. On Thursday (18Feb2021), around 10:30 or 11, he got a very serious dizzy spell and cold sweats. Patient states that it was very serious because his balance was off and the dizziness. The patient underwent lab tests and procedures which included electrocardiogram: normal on 18Feb2021, heart rate: a bit lower than normal on 18Feb2021. Outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Facial pain, Headache, Neck pain
Clinical narrative: she is in such pain; face & neck pain; headache; back pain; shoulder pain; face & neck pain; This is a spontaneous report from a contactable consumer (reporter's husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included 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 an unspecified date as single dose for covid-19 immunisation. On 18Feb2021, the patient experienced headache, back, shoulder pain, face & neck pain and she is in such pain. Patient had their 2nd Pfizer vaccine dose yesterday. She was fine up until last night, but she was in such pain this morning and the middle of the night. Caller stated his wife was having a headache, back pain, shoulder pain, and face & neck pain which started last night. Caller enquired about anything that she can take and how soon can she take Tylenol. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she is in such pain; face & neck pain; headache; back pain; shoulder pain; face & neck pain; This is a spontaneous report from a contactable consumer (reporter's husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included 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 an unspecified date as single dose for covid-19 immunisation. On 18Feb2021, the patient experienced headache, back, shoulder pain, face & neck pain and she is in such pain. Patient had their 2nd Pfizer vaccine dose yesterday. She was fine up until last night, but she was in such pain this morning and the middle of the night. Caller stated his wife was having a headache, back pain, shoulder pain, and face & neck pain which started last night. Caller enquired about anything that she can take and how soon can she take Tylenol. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: she had just a "slight" arm ache when she tried to raise her arm/little bit of an ache in her arm; bruise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, and Expiration date: Unknown), intramuscular, administered in right arm (she was reported as right-handed) on 12Feb2021 07:30 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3302, and Expiration date: Unknown), intramuscular, administered in left arm on 22Jan2021 (at the age of 68-year-old) for COVID-19 immunization. The patient did not receive any other vaccine (within 4 weeks) since her flu shot which was in late Oct, early Nov, exact date was unknown. It was reported that the patient received both doses exactly 3 weeks apart, on 22Jan2021 and 12Feb2021. After the first vaccine she had no reaction, she could not even feel where the provider injected the shot in her arm. After the second one, on the other arm, "she had just a "slight" arm ache when she tried to raise her arm/little bit of an ache in her arm". She realized when she went to raise her arm, she was like "geez, that hurts". She clarified it did not hurt, but she could feel something. The patient got the second shot at 7:30 am and the ache came in 6 hrs after vaccination (mid-afternoon), it lasted until next morning when she "couldn't feel anymore" at 8 am. This went away probably maybe by 26-28 hours. This ache in her arm was gone by noon the next day. It was nothing. She additionally experienced a sore arm and bruise 68 hours after her 2nd dose was administered, in Feb2021. She heard after the vaccines there would be a feeling and there would be a reaction, she was curious that to assure that her body was "creating a reaction" should she had a reaction. She was hearing everybody else having reactions and that having a reaction means your body was creating antibodies. She was wondering if she had antibodies and was protected. She was asking should she get a test. Investigation assessment was not provided. No further details were provided or obtained. The outcome of the event "she had just a "slight" arm ache when she tried to raise her arm/little bit of an ache in her arm" reported as resolved on 13Feb2021. The outcome of event bruise was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Haematocrit, Nodule, Swelling
Clinical narrative: knot above her collar bone; like a node just above my collar bone and half inch from my neck and the swelling that was around it; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on Feb2021 (at the age of 68-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included diabetes mellitus and hypertension. The concomitant medication(s) included atorvastatin 10 mg, metformin 1000 mg, hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) 37.5 mg half per day, pantoprazole 40 mg and mometasone furoate monohydrate (MOMETASONE FUROATE) 15 mcg nasal spray 2 squirts a day. The 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, administered on an unspecified date (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient reported on Feb2021, next night around 19:00 following vaccination, I noticed like a node just above my collar bone and half inch from my neck and it's still there and the swelling that was around it has gone down from what I can hardly tell swelling was there but the little node as still there. So I need to know what I should do, if that has come from the vaccine and it's on the left side which was the left arm where I got the injection. The patient underwent lab tests and procedures which included glycosylated haemoglobin of blood work AIC with unknown results on unspecified date and HTC with unknown results on an unspecified date.  Patient took Tylenol for the event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lethargy, Pain
Clinical narrative: I had an odd "mole-like" large spot suddenly appear on my left forearm/another similar looking spot has appeared about 3 inches away from the first one; Today I was very lethargic most of the day; chills, achiness, headache, and a fever of 100.6 deg F; chills, achiness, headache, and a fever of 100.6 deg F; chills, achiness, headache, and a fever of 100.6 deg F; chills, achiness, headache, and a fever of 100.6 deg F; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route at right arm on 18Feb2021 at 11:00, (lot number=EN5318) (age at vaccination 58-year-old) as dose 2, single for COVID-19 immunization in the workplace clinic. The patient had known allergies zithromax. The patient medical history included hypertension from an unknown date and unknown if ongoing. The patient had taken 4 hypertension medications in 2 weeks. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at right arm on 28Jan2021 at 02:30 PM (lot number: EN5318) as dose 1, single for COVID-19 immunisation. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was very lethargic most of the day and had chills, achiness, headache and a fever of 100.6 deg F on 19Feb2021 at 6:30 AM and had an odd "mole-like" large spot suddenly appear on my left forearm/another similar looking spot has appeared about 3 inches away from the first one on 21Feb2021. The patient did not received treatment for the events. The event odd "mole-like" large spot suddenly appear on my left forearm/another similar looking spot has appeared about 3 inches away from the first one was not recovered and the outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin lesion removal
Clinical narrative: I had an odd "mole-like" large spot suddenly appear on my left forearm/another similar looking spot has appeared about 3 inches away from the first one; Today I was very lethargic most of the day; chills, achiness, headache, and a fever of 100.6 deg F; chills, achiness, headache, and a fever of 100.6 deg F; chills, achiness, headache, and a fever of 100.6 deg F; chills, achiness, headache, and a fever of 100.6 deg F; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route at right arm on 18Feb2021 at 11:00, (lot number=EN5318) (age at vaccination 58-year-old) as dose 2, single for COVID-19 immunization in the workplace clinic. The patient had known allergies zithromax. The patient medical history included hypertension from an unknown date and unknown if ongoing. The patient had taken 4 hypertension medications in 2 weeks. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at right arm on 28Jan2021 at 02:30 PM (lot number: EN5318) as dose 1, single for COVID-19 immunisation. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was very lethargic most of the day and had chills, achiness, headache and a fever of 100.6 deg F on 19Feb2021 at 6:30 AM and had an odd "mole-like" large spot suddenly appear on my left forearm/another similar looking spot has appeared about 3 inches away from the first one on 21Feb2021. The patient did not received treatment for the events. The event odd "mole-like" large spot suddenly appear on my left forearm/another similar looking spot has appeared about 3 inches away from the first one was not recovered and the outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: felt muscle twitching; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer (patient) of unknown age reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Feb2021 as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Feb2021 the patient felt muscle twitching. The event outcome was unknown.  Information on lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Investigation, Pain, Vaccination site pain
Clinical narrative: received the vaccine in the right arm in which she experienced injection site soreness; pain in my hip joint; I am having pain there, from my hip down to my knees and this is on my right side; This is a spontaneous report from a contactable consumer via medical information team. This female consumer reported for herself.  A 70-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3306), via unspecified route of administration, in right arm on unspecified date (at the age of 70- year-old) as a dose 2, single and received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL0140), via unspecified route of administration on 27Jan2021 in right arm as a dose 1, single for COVID-19 immunization. Patient medical history included blood pressure high and high cholesterol. The concomitant medication of patient was not reported. On unspecified date the patient reported a side effect after receiving both doses of the COVID vaccine. Patient stated that she received the vaccine in the right arm in which she experienced injection site soreness and patient was still experiencing pain in her hip joint, slightly down her right leg and thigh. Patient also reported that she was having pain there, from her hip down to her knees and this was on her right side. Patient stated that she was on hold for 4 hours and wanted to talk to somebody about the vaccine because she got the two doses of vaccination and was on hold from 3 O clock this afternoon. Patient also stated that she read paper and on the side effects, on her right side her hip and her knee it was like she was having pain there, from her hip down to her knees and this was on her right side the side she got the vaccination. The patient underwent lab tests and procedures for blood work, and she dont know it was last week or the week before. Patient received the treatment of baby aspirin (Lot number: 86395886) and stated it didn't even help. The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain
Clinical narrative: back pain/ worsened back pain; arthritis got really bad/worse; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age (reported as 76; unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history included arthritis. Concomitant medications were not reported. The patient received 1st dose of vaccine on 02Feb2021. She said, the following day she woke up with back pain. Patient said, "I got up with it being pretty painful". Patient was evaluated by HCP and was prescribed meloxicam (on 09Feb2021). She said her arthritis got really bad/worse after the 1st dose of the vaccine (2021). She had 2nd dose schedule for Tuesday and was asking if she can continue taking her meloxicam. Reported worsened back pain after the first dose. Has taken medications a week after. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Flushing
Clinical narrative: face flushed which patient described that it felt like her face stung (had pain); face flushed which patient described that it felt like her face stung (had pain); This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, administered in the right arm on 29Jan2021 10:30 (at the age of 66-year-old) as single dose for covid-19 immunisation. Medical history included asthma, high blood pressure, high cholesterol, sulfa allergy and cobalt allergy. The patient was not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks and did not have covid prior to vaccination. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN); atorvastatin (LIPITOR [ATORVASTATIN]); azelastine (MANUFACTURER UNKNOWN); fluticasone (MANUFACTURER UNKNOWN); alendronate sodium (MANUFACTURER UNKNOWN); trazodone (MANUFACTURER UNKNOWN); gabapentin (MANUFACTURER UNKNOWN); montelukast sodium (SINGULAIR).  The patient experienced face flushed which patient described that it felt like her face stung (had pain) on 29Jan2021 10:30. It was reported that no treatment was given in response to the events. The patient was not tested for covid post vaccination. The patient recovered from the events on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paranoia
Clinical narrative: paranoid; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program  Support.   A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included methotrexate taken for an unspecified indication, start and stop date were not reported. On an unspecified date, when patient took her vaccine, there was no serum injected on her. It was just a single and a quick prick on her arm. Patient does not know if that was because she got the Pfizer or just being paranoid. The event was reported as non-serious by the patient. Patient asked if we had info on how the vaccine should be administered and asked if she can get the vaccine at a different vaccination site. Patient saw her Rheumatologist Thursday and she said that if patient was taking Methotrexate that it was recommended that she stop it before she had her COVID-19 Vaccine. Patient reported she already had one dose of Pfizer COVID-19 Vaccine injection and was due to have her second dose of Pfizer COVID-19 Vaccine on Wednesday. Patient was trying to find out if she had to stop taking the Methotrexate and if so, how long after taking the second dose of Pfizer COVID-19 Vaccine until she can restart Methotrexate. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Vaccination site pain
Clinical narrative: Moderate/severe injection site pain with active movement peaked at 9-15hr mark; Elevated temperature 99.5-100.0; Insomnia; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration, administered in the left arm on 17Feb2021 11:30 (at the age of 31-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks and did not have covid prior to vaccination. On 17Feb2021 at 05:00 pm, the patient experienced moderate/severe injection site pain with active movement peaked at 9-15hr mark and elevated temperature at 99.5-100.0 in the evening, responsive to 325mg acetaminophen (TYLENOL). The patient also experienced insomnia on the night of 17Feb2021, and no treatment was given in response to the event. The events were reported as non-serious. The patient was not tested for covid post vaccination. The patient recovered from all the events on an unspecified date.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms; This is a spontaneous report from a contactable consumer or other non-healthcare professional from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medications included acetaminophen taken for an unspecified indication, start and stop dates were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) for covid-19 immunization. On an unspecified date in 2021, the patient experienced sore arms. The reporter stated that she had her 2nd dose of vaccine yesterday (11Feb2021) while waiting for more than two and half hours on the line, she decided to take a medicine called acetaminophen. She later found out that taking medicine before having the vaccine is the wrong thing to do, she said that she did not feel any side effects aside from having sore arms. She was concerned if the second shot will be diminished or if she can take another second dose because of the medicine she took prior to taking the 2nd dose. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: high blood sugar levels; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 73 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high blood sugar levels on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included high blood glucose.  Follow-up attempts are completed. No further information is expected.