chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypoaesthesia, Paraesthesia, Speech disorder, Swelling face
Clinical narrative: Puffy on the left side of face from left eye to lip; Tingly on the left side of face from the left eye down to lip; Hard to talk; Face felt heavy; tingly numbness, when she pokes the left side of her face; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration in Arm Left on 19Mar2021 09:15 (age at vaccination 50 years) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included psoriasis. Patient stated she was diagnosed in Sep2020 but has had for a while. Patient stated she received a Flu shot a while back in Dec2020 but does not have any further information to provide. There was no family medical history relevant to AE. Concomitant medications included risankizumab rzaa (Skyrizi) taken for psoriasis from Nov2020 to an unspecified stop date. Skyrizi was received in Nov2020, Dec2020, and Mar2021. Patient was taking COVID Vaccine because of Covid prevention. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. AE did not require a visit to emergency room or physician office. There was no AE following prior vaccinations. There was no prior vaccinations within 4 weeks. On 19Mar2021, patient just got the Pfizer Covid Vaccine around 9:15am this morning, about an hour ago the left side of her face started to get puffy, she stated it's not really big, it was a little tingly like when you go to a dentist and had that gas and get home and itches and then she stated she's trying to get that feeling back. Patient clarifies she was puffy on the left side of her face from the left eye down to her lip. It had not swollen up anymore it was just about the same. Patient clarifies she can tell she was better since her talking was better, it was like she was really having to move her mouth since it was heavy. She feels like the swelling has gone down a lot. When she says tingly numbness, when she pokes the left side of her face, she cannot really feel her fingernail but on the other side she can feel it. It's not constant but she was aware of it. Patient did not receive the treatment for events. There were no relevant tests. The outcome of events was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Hyperhidrosis, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Body chilling; sweating; sore throat; sense of smell slightly lost; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9263), via an unspecified route of administration in left arm on 16Feb2021 09:15 AM (at the age of 36-years-old) as a dose 1, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6201), via an unspecified route of administration in left arm on 16Feb2021 (at the age of 36-years-old) as a dose 2, single for COVID-19 immunization. The patients medical history was not reported. The patients concomitant medications (other medications the patient received within 2 weeks of vaccination) included Cephaalosporin, Amoxicillin. The patient had no allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient was not been tested for COVID-19. Post vaccination, the patient had underwent lab test which includes Nasal Swab (SARS-CoV-2 test) test resulted as negative on 19Jan2021. On unspecified date patient stated that he experienced Body chilling sweating sore throat lasts for two months, and the sense of smell slightly lost. Patient had not received any treatment for the events reported. The outcome of events was not recovered.  Location of injection information is available for all vaccines received on the same date.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip disorder, Lip swelling, Nasal congestion, Pain in extremity, Taste disorder
Clinical narrative: my nose stuffed up; my bottom lip swelling up; soreness in my arm; weird petroleum jelly kind of taste on my lips; bumps on inside the bottom lip; bumps tongue; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution of injection), dose 1 via an unspecified route of administration on 20Mar2021 11:30 (at the age of 62-years-old) (Lot Number: EP7534) as dose 1, single for covid-19 immunisation. The patient medical history included ongoing blood pressure high, ongoing asthma and anaphylaxis from an unknown date and unknown if ongoing, anaphylaxis to drugs and insects and shell fish from unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) 50 mg two times a day taken for high blood pressure, start and stop date were not reported; amlodipine (AMLODIPINE) 5 mg one time a day taken for high blood pressure. 0n 20Mar2021, patient had the first dose of the Pfizer vaccine and ell fish so we did the extra 30 minutes of observation and during that time the only thing that she noticed was soreness in arm and just weird petroleum jelly kind of taste on lips. Patient goes for lunch and goes out the last evening for a half an hour so and at 11PM, her nose stuffed up and bottom lip swelling up and she took two Benadryl (Treatment) dissolvable 12.5 to equal a total of 25mg so they chewable to children but she could not make it them dissolve faster and stopping allergic reaction quicker. She woke up this morning and half of the lips was normal and other half was still slightly swollen hence worried that, it was not good with the second dose like if she get second dose it might an anaphylactic reaction. Patient was stuffiness like in her nose and then in bottom lip started swelling and it was about 12 hours almost exactly 12 hours later but yes that was where she was with the anaphylaxis. Usually, she get bumps on inside of the bottom lip then on tongue, throat and on nose will start to swell and thats as an urgent situation and shen had an EpiPen and Benadryl so she tried Benadryl first and not had using EpiPen till the time of reporting. Patient got very strange reaction and at 12 hours later, on 21Mar2021 in morning half of her lips was still swollen and she look kind of weird. The patient received treatment of Benadryl for event nasal congestion and lip swelling. The outcome of the events was unknown  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: my nose stuffed up; my bottom lip swelling up; soreness in my arm; weird petroleum jelly kind of taste on my lips; bumps on inside the bottom lip; bumps tongue; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution of injection), dose 1 via an unspecified route of administration on 20Mar2021 11:30 (at the age of 62-years-old) (Lot Number: EP7534) as dose 1, single for covid-19 immunisation. The patient medical history included ongoing blood pressure high, ongoing asthma and anaphylaxis from an unknown date and unknown if ongoing, anaphylaxis to drugs and insects and shell fish from unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) 50 mg two times a day taken for high blood pressure, start and stop date were not reported; amlodipine (AMLODIPINE) 5 mg one time a day taken for high blood pressure. 0n 20Mar2021, patient had the first dose of the Pfizer vaccine and ell fish so we did the extra 30 minutes of observation and during that time the only thing that she noticed was soreness in arm and just weird petroleum jelly kind of taste on lips. Patient goes for lunch and goes out the last evening for a half an hour so and at 11PM, her nose stuffed up and bottom lip swelling up and she took two Benadryl (Treatment) dissolvable 12.5 to equal a total of 25mg so they chewable to children but she could not make it them dissolve faster and stopping allergic reaction quicker. She woke up this morning and half of the lips was normal and other half was still slightly swollen hence worried that, it was not good with the second dose like if she get second dose it might an anaphylactic reaction. Patient was stuffiness like in her nose and then in bottom lip started swelling and it was about 12 hours almost exactly 12 hours later but yes that was where she was with the anaphylaxis. Usually, she get bumps on inside of the bottom lip then on tongue, throat and on nose will start to swell and thats as an urgent situation and shen had an EpiPen and Benadryl so she tried Benadryl first and not had using EpiPen till the time of reporting. Patient got very strange reaction and at 12 hours later, on 21Mar2021 in morning half of her lips was still swollen and she look kind of weird. The patient received treatment of Benadryl for event nasal congestion and lip swelling. The outcome of the events was unknown  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea
Clinical narrative: tightness in chest; mild nausea; This is a spontaneous report from a contactable consumer.   This consumer reported for a 17-year-old (17.9years) daughter (patient) (non-pregnant) female patient that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 23Mar2021 at 13:00 (at the age of 17-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included known allergies to peanut, tree nut, environmental allergies. Concomitant medications were not reported. On 23Mar2021, 10 hours post vaccination at around 10:00 PM, the patient experienced tightness in chest (pro air albuterol used, no relief) and mild nausea. No other vaccine in four weeks. Other medications within 2 weeks of vaccination immunotherapy, breo elipta, pro air (albuterol). Treatment given was pro air albuterol used, no relief. No covid prior vaccination, no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome was not resolved for both the events.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Malaise, Myalgia
Clinical narrative: Injection site pain; Pain all over body; Muscle pain; Slight chills; Not really feeling well; Joint pain; Last night her couldn't sleep; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 07:40 (at the age 69 years) as SINGLE for covid-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications included olmesartan medoxomil taken for high blood pressure who has been on for more than a year and unspecified vitamins for general health. It was reported that during the day when he had the injection in Mar2021, he got the regular injection site pain and discomfort and that went away after day two. Since yesterday, he started having pain all over his body. He adds that it was really intense last night. He adds he also had muscle pain, slight chills, joint pain, not really feeling well. He goes for quick walks sometimes and he does have reaction to some stuff. He adds that for some of those things he has a pen. He has joint pain if he eats wheat.  He normally has some pain but that goes away. This is kind of different and it was really pain all over the body. He was wondering if these are signs of infection. He was asking if he can have this kind of reaction after this, after so long after the injection. Muscle pain was all over. He had chills that did not go away, and kind of trouble sleeping from them. Started last night when he went to sleep. It was just when he woke up that he was really sweaty when he woke up. Not really feeling well started last night. He felt fine now. He was going to get back to his normal routine. Once he gets off of the phone, he was going to go for a walk. States that last night couldn't sleep because his "body felt like a war zone". His main question was if can expect to get a reaction and side effects from the shot so many days later. He thought it would be 1 to 2 days normally after the second vaccination that these occur, but he has them after the first shot. The clinical outcome of the event pain all over body, muscle pain, slight chills, not really feeling well, joint pain, insomnia was unknown and recovered for injection site pain in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Injection site pain; Pain all over body; Muscle pain; Slight chills; Not really feeling well; Joint pain; Last night her couldn't sleep; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 07:40 (at the age 69 years) as SINGLE for covid-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications included olmesartan medoxomil taken for high blood pressure who has been on for more than a year and unspecified vitamins for general health. It was reported that during the day when he had the injection in Mar2021, he got the regular injection site pain and discomfort and that went away after day two. Since yesterday, he started having pain all over his body. He adds that it was really intense last night. He adds he also had muscle pain, slight chills, joint pain, not really feeling well. He goes for quick walks sometimes and he does have reaction to some stuff. He adds that for some of those things he has a pen. He has joint pain if he eats wheat.  He normally has some pain but that goes away. This is kind of different and it was really pain all over the body. He was wondering if these are signs of infection. He was asking if he can have this kind of reaction after this, after so long after the injection. Muscle pain was all over. He had chills that did not go away, and kind of trouble sleeping from them. Started last night when he went to sleep. It was just when he woke up that he was really sweaty when he woke up. Not really feeling well started last night. He felt fine now. He was going to get back to his normal routine. Once he gets off of the phone, he was going to go for a walk. States that last night couldn't sleep because his "body felt like a war zone". His main question was if can expect to get a reaction and side effects from the shot so many days later. He thought it would be 1 to 2 days normally after the second vaccination that these occur, but he has them after the first shot. The clinical outcome of the event pain all over body, muscle pain, slight chills, not really feeling well, joint pain, insomnia was unknown and recovered for injection site pain in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: Also got a cough; I have a cough too; Did have a fever when they gave me the shot; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EN6207 and Expiration date: Not reported), via an unspecified route of administration on 17Mar2021 (age at vaccination 74-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes, cold. There were no concomitant medications. It was reported that she went in with the cold, she had cough too, she did have a fever when they gave me the shot. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322551 same reporter/SD, different patient/AE
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Peripheral swelling
Clinical narrative: arm is all red; swollen from elbow; Arm is all swollen; This is a spontaneous report from a contactable consumer (reported for her brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm is all red, swollen from elbow, arm is all swollen. Reporter stated, her brother had a shot yesterday (Further confirmed as 23Mar2021) afternoon and his arm is all swollen and it is all red. she wanted to know Is that a normal side effect or should we be concerned. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Fatigue, Malaise
Clinical narrative: nauseated; feeling sick; I can't taste; I can't taste and smell/can't smell anything now; diarrhea; Sleeping constantly; exhausted; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of (Age 60; Unit: Unknown) received first dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Mar2021 the patient experienced nauseated, she can't taste, she can't taste and smell/can't smell anything now, diarrhea, sleeping constantly, exhausted, and on 18Mar2021 she experienced feeling sick. Patient stated she felt great when she went to get the vaccine, and she had no symptoms before. Patient stated she had a one of those black jellybeans she tasted that and salt she can taste but she cannot taste too much more. She can't smell anything. Patient asked were these adverse effects of the vaccine? How long will it last? Does the vaccine give you covid 19? Can she get the second shot? Does she get tested for covid? The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: nauseated; feeling sick; I can't taste; I can't taste and smell/can't smell anything now; diarrhea; Sleeping constantly; exhausted; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of (Age 60; Unit: Unknown) received first dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Mar2021 the patient experienced nauseated, she can't taste, she can't taste and smell/can't smell anything now, diarrhea, sleeping constantly, exhausted, and on 18Mar2021 she experienced feeling sick. Patient stated she felt great when she went to get the vaccine, and she had no symptoms before. Patient stated she had a one of those black jellybeans she tasted that and salt she can taste but she cannot taste too much more. She can't smell anything. Patient asked were these adverse effects of the vaccine? How long will it last? Does the vaccine give you covid 19? Can she get the second shot? Does she get tested for covid? The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Neck pain, Pain in extremity
Clinical narrative: Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Malase; Headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 02:15 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. Medical history included glaucoma, migraine both from an unknown date and unknown if ongoing. Concomitant medication included almotriptan (ALMOTRIPTAN), diclofenac (DICLOFENAC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with covid-19.On 23Mar2021 22:00 patient experienced Arm pain, spread to shoulder, neck, and headache, malase. patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the events was reported as resolving at the time of this report.  No follow up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Arm pain, spread to shoulder, neck; Malase; Headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 02:15 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. Medical history included glaucoma, migraine both from an unknown date and unknown if ongoing. Concomitant medication included almotriptan (ALMOTRIPTAN), diclofenac (DICLOFENAC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with covid-19.On 23Mar2021 22:00 patient experienced Arm pain, spread to shoulder, neck, and headache, malase. patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the events was reported as resolving at the time of this report.  No follow up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Macule, Nausea, Pain
Clinical narrative: her arm was killing her; swollen real bad, with a red spot at the injection site and a big knot; felt dizzy; felt nauseated; and had body aches; big knot in; itches; States she had most all the side effects except fever; she had a headache; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 21Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 01Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big knot in, itches, states she had most all the side effects except fever on 22Mar2021, her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot on an unspecified date, she had a headache on 21Mar2021, felt dizzy, felt nauseated, and had body aches on 23Mar2021. Clinical course was reported as she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 at 12:20PM in the left arm. She didn't have any side effects except a sore arm. Adds she had the second shot on Monday 21Mar2021 at 1220PM in the left arm. She had most all the side effects except fever. Her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot; she had a headache; felt dizzy; felt nauseated; and had body aches. She is most concerned about the knot which is a red raised place the size of half dollar and it itches. The clinical outcome of the events fever, headache, felt dizzy, felt nauseated was recovered on 23Mar2021, and other event had body aches was recovering and big knot in event was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia, Vaccination site swelling
Clinical narrative: her arm was killing her; swollen real bad, with a red spot at the injection site and a big knot; felt dizzy; felt nauseated; and had body aches; big knot in; itches; States she had most all the side effects except fever; she had a headache; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 21Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9810) via an unspecified route of administration in Arm Left on 01Mar2021 12:20 (age at vaccination 68years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced big knot in, itches, states she had most all the side effects except fever on 22Mar2021, her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot on an unspecified date, she had a headache on 21Mar2021, felt dizzy, felt nauseated, and had body aches on 23Mar2021. Clinical course was reported as she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 at 12:20PM in the left arm. She didn't have any side effects except a sore arm. Adds she had the second shot on Monday 21Mar2021 at 1220PM in the left arm. She had most all the side effects except fever. Her arm was killing her, swollen real bad, with a red spot at the injection site and a big knot; she had a headache; felt dizzy; felt nauseated; and had body aches. She is most concerned about the knot which is a red raised place the size of half dollar and it itches. The clinical outcome of the events fever, headache, felt dizzy, felt nauseated was recovered on 23Mar2021, and other event had body aches was recovering and big knot in event was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: rash; redness; hives; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient (age at the time of vaccination was 60yrs) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Verbatim: COPD, depression from an unknown date and unknown if ongoing Verbatim: Depression , anxiety from an unknown date and unknown if ongoing Verbatim: Anxiety , seasonal allergy from an unknown date and unknown if ongoing Verbatim: allergic to ragweed , seasonal allergy from an unknown date and unknown if ongoing Verbatim: pollen in the air , mycotic allergy from an unknown date and unknown if ongoing Verbatim: mold, hypothyroidism from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for depression from 2014 and ongoing; buspirone (BUSPIRONE) taken for anxiety from 2014 and ongoing; methylphenidate hydrochloride (RITALIN) taken for depression from 2018 to an unspecified stop date; trazodone (TRAZODONE) taken for insomnia from 2016 and ongoing; formoterol fumarate, mometasone furoate (DULERA) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity, start and stop date were not reported; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication from Mar2021 to an unspecified stop date. On 10Mar, patient broke out in a rash, and it developed inside and behind her legs, her knees, arms, and stomach. She said there was a lot of redness, and little bumps. She said it felt like hives. Consumer said she already went to the doctor and was told that it could have been a large local delayed reaction to the 1st dose. Then on 22Mar, since the rash was not going away, she was put on Prednisone. She wants to know if the rash is associated with the vaccine, and if it would still be safe for her to receive the second dose of the covid vaccine was scheduled for Saturday, 27Mar2021. On 10Mar2021 the patient experienced rash, redness and hives. Therapeutic measures were taken as a result of the events. The outcome for the event rash was recovering while for others it was unknown. No follow-up attempts are possible. No further information is expected.   Follow-up (24Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (Patient) reported that:  Patient characteristics: Age at time of onset of reaction/event: 60
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Illness, Malaise
Clinical narrative: broke out in hives; I started feeling really bad ;not feeling well; she was sick; brain fog/like foggy head; headache; sore throat; completely without energy; little bit of sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via unspecified route of administration on 06Mar2021 (at the age of 88-year-old) in dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications not reported. Patient queried for and like to know if it was possible to experience side effects 2 weeks after receiving the vaccine. Reporter stated that her symptoms did not start until last Friday in the afternoon. She reports that for 2-3 days on 19Mar2021 she was sick and experienced brain fog, headache, sore throat, and was completely without energy. She reports that these symptoms got better but then completely broke out in hives on 22Mar2021. She states that she was covered in hives. She reports that she has not done anything different in her life since receiving the vaccine, which was why she was attributing these side effects to the vaccine. She said she already spoke with her doctor who was recommending she wait on receiving the second dose, which was due 27Mar2021. Reporter would like to know how long she can wait before receiving her second dose of the vaccine. Patient went on 06Mar2021, got her first vaccine and she was fine except the little bit of sore arm and it was okay about till the last Friday. Friday on 19Mar2021 she started feeling really bad, like foggy head, sore throat, headache and just basically not feeling well and then that subsided. On Wednesday that was subsided. Monday morning on 22Mar2021 and then she dropped out into bunch of hives so now she was dealing with hives. So she had an appointment with her doctor and she was just wondering that if she should take her second shot because she will due to take it on 27th which was this coming Saturday. She was a kind of leery right now because she so full of hives. It was like crazy. Anyway she just thought she report these side effects. Reporter queried for was it possible to get a reaction 2 weeks later. Almost It was, almost 2 weeks before she got the reaction. she need to know if she need if she can take If that safe to take second vaccine, the second dose. Reporter stated that she was surprise after for almost 2 weeks that she would reaction. Outcome of event little bit of sore arm was unknown and broke out in hives was not recovered and recovered for all events on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Urticaria
Clinical narrative: broke out in hives; I started feeling really bad ;not feeling well; she was sick; brain fog/like foggy head; headache; sore throat; completely without energy; little bit of sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via unspecified route of administration on 06Mar2021 (at the age of 88-year-old) in dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications not reported. Patient queried for and like to know if it was possible to experience side effects 2 weeks after receiving the vaccine. Reporter stated that her symptoms did not start until last Friday in the afternoon. She reports that for 2-3 days on 19Mar2021 she was sick and experienced brain fog, headache, sore throat, and was completely without energy. She reports that these symptoms got better but then completely broke out in hives on 22Mar2021. She states that she was covered in hives. She reports that she has not done anything different in her life since receiving the vaccine, which was why she was attributing these side effects to the vaccine. She said she already spoke with her doctor who was recommending she wait on receiving the second dose, which was due 27Mar2021. Reporter would like to know how long she can wait before receiving her second dose of the vaccine. Patient went on 06Mar2021, got her first vaccine and she was fine except the little bit of sore arm and it was okay about till the last Friday. Friday on 19Mar2021 she started feeling really bad, like foggy head, sore throat, headache and just basically not feeling well and then that subsided. On Wednesday that was subsided. Monday morning on 22Mar2021 and then she dropped out into bunch of hives so now she was dealing with hives. So she had an appointment with her doctor and she was just wondering that if she should take her second shot because she will due to take it on 27th which was this coming Saturday. She was a kind of leery right now because she so full of hives. It was like crazy. Anyway she just thought she report these side effects. Reporter queried for was it possible to get a reaction 2 weeks later. Almost It was, almost 2 weeks before she got the reaction. she need to know if she need if she can take If that safe to take second vaccine, the second dose. Reporter stated that she was surprise after for almost 2 weeks that she would reaction. Outcome of event little bit of sore arm was unknown and broke out in hives was not recovered and recovered for all events on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia oral, Rash, Rash pruritic, Tongue disorder
Clinical narrative: itchy rashes all over my body; itchy rashes all over my body; the back of my tongue felt thick and tingled; the back of my tongue felt thick and tingled; difficult to swallow; wheezing; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37 years old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Left Arm on 25Feb2021 (at the age of 37-year-old) as Dose 1, single for covid-19 immunization. Facility type vaccination was reported as Other. The patient was non-pregnant at time of vaccination. The patient's medical history included thyroid and asthma. The patient had no known allergies. The patient had received other medications within two weeks of vaccination. Patient was neither diagnosed for covid prior to vaccination nor tested for Covid post vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On 25Feb2021 (30 minutes after receiving the dose 1 vaccination), the patient experienced itchy rashes all over the body, the back of her tongue felt thick and tingled, it was difficult to swallow, and she was wheezing. At the site of injection was red, warm, itchy and raised. This was lasted in 2 days. These events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed steroid pack and OTC Benadryl for resulted events. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erosion, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth, Wheezing
Clinical narrative: itchy rashes all over my body; itchy rashes all over my body; the back of my tongue felt thick and tingled; the back of my tongue felt thick and tingled; difficult to swallow; wheezing; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37 years old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Left Arm on 25Feb2021 (at the age of 37-year-old) as Dose 1, single for covid-19 immunization. Facility type vaccination was reported as Other. The patient was non-pregnant at time of vaccination. The patient's medical history included thyroid and asthma. The patient had no known allergies. The patient had received other medications within two weeks of vaccination. Patient was neither diagnosed for covid prior to vaccination nor tested for Covid post vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On 25Feb2021 (30 minutes after receiving the dose 1 vaccination), the patient experienced itchy rashes all over the body, the back of her tongue felt thick and tingled, it was difficult to swallow, and she was wheezing. At the site of injection was red, warm, itchy and raised. This was lasted in 2 days. These events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed steroid pack and OTC Benadryl for resulted events. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, Nausea, Pain in extremity
Clinical narrative: warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot; nauseated; fever; didn't feel like herself/feeling bad; mild headache; her left arm was hurting/sore left arm; arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number/expiry date: unknown) (age at the time of vaccination was 62 years), administered in arm left on 05Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included pulmonary embolism from 2012 and unknown if ongoing. Concomitant medications were not reported. On 05Mar2021, the patient received first dose of Pfizer BioNTech Covid vaccine. On 06Mar2021, patient had sore left arm on second and third day after vaccine. On 12Mar2021, the patient had a little bit of a headache. On 13Mar2021, after receiving vaccine the patient arms and thighs were warm to the touch, felt hot and arm hurt at the injection site. The felt nauseated, arm continued to hurt and a mild headache. This lasted 2-4 days where she did not feel like herself. Caller states that she had a side effect starting later on the first or second day. She states on the 8th day after, her left arm was hurting and very warm and hot to the touch and her thighs were hot and she was feeling nauseated. She states on the 11th day after the vaccine she was still feeling nauseated. She states that she had a headache. She states her arm has been hurting for at least a good 10 days. She states that she does not know if she should get second vaccine because they say that people only get side effects the first and second day. States that she was calling because she was due for second one on Friday but she was afraid. No treatment was received, states she was afraid that it would interact with the vaccine. The outcome of the events warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot was recovered on 14Mar2021, mild headache and nauseated resolved on 17Mar2021, fever resolved on 15Mar2021, didn't feel like herself/feeling bad resolved on 17Mar2021, arm hurt at the injection site, her left arm was hurting/sore left arm not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot; nauseated; fever; didn't feel like herself/feeling bad; mild headache; her left arm was hurting/sore left arm; arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number/expiry date: unknown) (age at the time of vaccination was 62 years), administered in arm left on 05Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included pulmonary embolism from 2012 and unknown if ongoing. Concomitant medications were not reported. On 05Mar2021, the patient received first dose of Pfizer BioNTech Covid vaccine. On 06Mar2021, patient had sore left arm on second and third day after vaccine. On 12Mar2021, the patient had a little bit of a headache. On 13Mar2021, after receiving vaccine the patient arms and thighs were warm to the touch, felt hot and arm hurt at the injection site. The felt nauseated, arm continued to hurt and a mild headache. This lasted 2-4 days where she did not feel like herself. Caller states that she had a side effect starting later on the first or second day. She states on the 8th day after, her left arm was hurting and very warm and hot to the touch and her thighs were hot and she was feeling nauseated. She states on the 11th day after the vaccine she was still feeling nauseated. She states that she had a headache. She states her arm has been hurting for at least a good 10 days. She states that she does not know if she should get second vaccine because they say that people only get side effects the first and second day. States that she was calling because she was due for second one on Friday but she was afraid. No treatment was received, states she was afraid that it would interact with the vaccine. The outcome of the events warm to the touch/her left arm was hurting and very warm and hot to the touch and her thighs were hot was recovered on 14Mar2021, mild headache and nauseated resolved on 17Mar2021, fever resolved on 15Mar2021, didn't feel like herself/feeling bad resolved on 17Mar2021, arm hurt at the injection site, her left arm was hurting/sore left arm not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Ocular hyperaemia
Clinical narrative: Headache; Red eyes; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 18Mar2021 01:30 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY) taken for asthma, start and stop date were not reported. Patient previously received flu vaccine for immunisation about two months ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced chills. On 19Mar2021, patient experienced headache, red eyes. Clinical course: patient got chills later in the afternoon on 18Mar2021, and that his chills have improved since then. patient then got a headache, and his headache was real bad and keeps getting worse, and his eyes are really red. Reporter stated that on 23Mar2021 was the worse headache patient ever had in his life. Reporter asked if the patient can get second dose. The events were reported as non serious. Therapeutic measures taken as a result of event headache included Tylenol and ibuprofen and also taking over-the-counter Visine for his red eyes. Events did not result in emergency room or physician office visit. The outcome of the event chills was recovering and headache, red eyes were not recovered.   Follow-up attempts are completed. No further information is expected.