chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Cough, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: dizziness; sweating/sweating profusely; bad cough; diarrhea; losing his voice; he never experienced being this sick before./has been feeling very sick since he received it last Thursday, 22Jul2021; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: PA9484), via an unspecified route of administration on 22Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Jul2021, the patient experienced dizziness, sweating/ sweating profusely, bad cough, diarrhea, losing his voice, he never experienced being this sick before. /has been feeling very sick since he received it last thursday, 22jul2021. Caller wanted to know what to do regarding his adverse events after getting the Pfizer BioNTech Covid-19 Vaccine shot because he was never sick like this before. The outcomes of all reported events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: dizziness; sweating/sweating profusely; bad cough; diarrhea; losing his voice; he never experienced being this sick before./has been feeling very sick since he received it last Thursday, 22Jul2021; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: PA9484), via an unspecified route of administration on 22Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Jul2021, the patient experienced dizziness, sweating/ sweating profusely, bad cough, diarrhea, losing his voice, he never experienced being this sick before. /has been feeling very sick since he received it last thursday, 22jul2021. Caller wanted to know what to do regarding his adverse events after getting the Pfizer BioNTech Covid-19 Vaccine shot because he was never sick like this before. The outcomes of all reported events were unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: a lot of pain in the joints, the shoulder and the neck; a lot of pain in the joints, the shoulder and the neck; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 57-year-old), via an unspecified route of administration on 25Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced a lot of pain in the joints, the shoulder and the neck. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202100973686 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Second dose of the vaccinewhich is an ongoing cutaneous rash all over the body; This is a spontaneous report from a contactable consumer (patient) via Pfizer- sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on Feb2021 for COVID-19 Immunization and No reaction reported. Patient received second dose last Mar2021. She cannot remember the exact dates on when she received the first and second dose of the vaccine. Patient report very bad reaction after receiving the second dose of the vaccine which is an ongoing cutaneous rash all over the body on an unspecified date in 2021. The patient underwent lab tests and procedures which included Had Covid: Positive (She also mentioned that she had Covid last December 2020). The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 17Jul2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient inquired about the timing of second dose if can it be a little longer than 3 weeks. She was reading on the internet and saw where her period could last 14 days instead of like 5 days. She read where women have been experiencing different/changes in menstrual cycles. On an unspecified date in Jul2021, the patient experienced some dizziness after the first vaccine dose. The patient inquired if any was available regarding menstrual changes and one dose help prevent the infection after getting one dose. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neuralgia
Clinical narrative: Having what feel like nerves pain that shot all the way from my thumb  to the injection site/ arm is what not getting any better; headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jul2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included carpal tunnel syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 27Jul2021 at 12:00, the patient had felt like nerves pain that shot all the way from the thumb to the injection site and headache, but the arm was what not getting any better. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nerves pain that shot all the way from the thumb to the injection site and headache was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: Canker sore under tongus; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular, administered in Arm Right on 09Jun2021 10:00 (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunization at school/student health clinic. Medical history included ongoing multiple sclerosis from 2015, high blood pressure, spasms, tinnitus, cholesterol, sleep, bone disorder, nausea and stroke from 2020 to Sep2020. Concomitant medications included melatonin taken for sleep disorder from 2014 and ongoing; vitamin d3 taken for bone disorder, spasms from 2016 and ongoing; promethazine taken for nausea from 2016 and ongoing; zolpidem taken for sleep disorder from 2016 and ongoing; calcium carbonate, lycopodium clavatum, potassium carbonate, quinine sulfate, salicylic acid (TINNITUS RELIEF) taken for tinnitus from 2017 and ongoing; cyclobenzaprine taken for muscle spasms from 2018 and ongoing; atorvastatin taken for cardiovascular disorder, cholesterol from 2020 and ongoing; propranolol taken for cardiovascular disorder, hypertension from 2020 and on-going; acetylsalicylic acid (ASPIRIN (E.C.) taken for cerebrovascular accident from 2020 and ongoing. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW018B), via an intramuscular route, administered in Arm Right on 17May2021 10:00, as dose 1, single for covid-19 immunization. Prior vaccination (within four weeks) was none. The patient reported that few Days after second dose on 12Jun2021, developed a very large canker sore under my tongue. Which the patient still had. The patient never had one before. And the dentist stated it was very large. The event resulted in physician office. The patient did not receive treatment receive. Relevant tests were none. The event was reported as non-serious. The outcome of event was reported as resolving.   Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts were been completed and no further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseated; This is a spontaneous report from contactable consumer(patient).An unspecified age of male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported.On an unspecified date, the patient experienced nauseated.It was reported that the one where you take a shot for every 3 weeks and then go four weeks. He just has a question.When a person gets the shot do they get nauseated for 24 hours and then it might go away. The outcome of the event was unknown.  Communication: Attempted to clarify several times with caller the name of the shot. Caller unable to clarify the name. Caller repeatedly kept stating he only has a question. No further details provided. Caller declined to proceed with the report and requested transfer. Full report details not obtained. The caller was provided with  phone number of (Withheld) option 3 and hours of operation prior to attempted warm transfer.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Heavy menstrual bleeding, Hypersensitivity, Loss of personal independence in daily activities
Clinical narrative: Patient had clots; prolonged menstruation/menstrual bleeding that is non-stop; not feeling good; her psyche was screwed up; from a physiological aspect it was screwed up every single day; sick with allergies and other things; start to say this hurts, that hurts; she has the sniffles; Zero Energy; This is a spontaneous report from a contactable consumer (patient's husband). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 18Jan2021 16:10 (Lot Number: EL1283; at the age of 45-years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included influenza vaccine (FLU VACCINE VII) for immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 44-years), first dose on 28Dec2020 4:10 pm (lot number: EJ1685 expiration date: unknown), administered in arm, but does not know which arm for Covid-19 immunization and experienced zero energy. The husband was calling on behalf of his wife. He wanted to know who is liable for the side effect his wife is experiencing. In 2021 ( a month or two), the patient had prolonged menstruation and was not feeling good. The husband is almost positive the vaccine effected his wife's menstrual cycle. She had menstrual bleeding that is non-stop. She had clots. The patient almost had a month or two straight of bleeding. It screwed everything up. The timing was screwed up, her psyche was screwed up, and from a physiological aspect it was screwed up every single day affecting his life and their livelihood for their family. She has been sick with allergies and other things. She would start to say this hurts, that hurts, she has the sniffles with zero energy. He stated that she falls asleep immediately after work when comes in. The events did not result to emergency room and physician office visit. He also reported that the patient's mom got the COVID vaccine and had hives. Outcome of prolonged menstruation/menstrual bleeding that is non-stop was recovered in 2021, while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Rhinorrhoea, Thrombosis
Clinical narrative: Patient had clots; prolonged menstruation/menstrual bleeding that is non-stop; not feeling good; her psyche was screwed up; from a physiological aspect it was screwed up every single day; sick with allergies and other things; start to say this hurts, that hurts; she has the sniffles; Zero Energy; This is a spontaneous report from a contactable consumer (patient's husband). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 18Jan2021 16:10 (Lot Number: EL1283; at the age of 45-years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included influenza vaccine (FLU VACCINE VII) for immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 44-years), first dose on 28Dec2020 4:10 pm (lot number: EJ1685 expiration date: unknown), administered in arm, but does not know which arm for Covid-19 immunization and experienced zero energy. The husband was calling on behalf of his wife. He wanted to know who is liable for the side effect his wife is experiencing. In 2021 ( a month or two), the patient had prolonged menstruation and was not feeling good. The husband is almost positive the vaccine effected his wife's menstrual cycle. She had menstrual bleeding that is non-stop. She had clots. The patient almost had a month or two straight of bleeding. It screwed everything up. The timing was screwed up, her psyche was screwed up, and from a physiological aspect it was screwed up every single day affecting his life and their livelihood for their family. She has been sick with allergies and other things. She would start to say this hurts, that hurts, she has the sniffles with zero energy. He stated that she falls asleep immediately after work when comes in. The events did not result to emergency room and physician office visit. He also reported that the patient's mom got the COVID vaccine and had hives. Outcome of prolonged menstruation/menstrual bleeding that is non-stop was recovered in 2021, while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Menstruation irregular, Nausea
Clinical narrative: got her period two weeks early.; She had bad menstrual cramps with that irregular period.; nausea; She has gotten her period twice since then and each time she has had very painful menstrual cramps plus some nausea./She had not had super painful; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 15-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in arm left on 13May2021 at 16:45 PM (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medications included melatonin, multivitamin (vitamins NOS) (patient received within 2 weeks of vaccination), both drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not COVID tested post vaccination. The patient experienced got her period two weeks early, she had bad menstrual cramps with that irregular period, nausea, she has gotten her period twice since then and each time she has had very painful menstrual cramps plus some nausea/she had not had super painful, all on an unspecified date in 2021. Adverse event result in doctor or other healthcare professional office/clinic visit. Reported Event: Within days of getting her first Pfizer vaccine, [Redacted] period two weeks early. She had bad menstrual cramps with that irregular period. She has gotten her period twice since then and each time she has had very painful menstrual cramps plus some nausea. She had not had super painful. The patient did not receive any treatment medication for the events. Outcome of the events was unknown. Device date was 29Jul2021.  Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Since the second dose, I have had persistent pain in my right arm in the location of the injections. The pain is a stabbing pain and throbbing. It is not a muscle or joint pain and nothing seems to alleviate this annoyance.; Since the second dose, I have had persistent pain in my right arm in the location of the injections. The pain is a stabbing pain and throbbing. It is not a muscle or joint pain and nothing seems to alleviate this annoyance.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CR8733) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis. The patient had no known allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on an unknown date (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 18:00, since the second dose, the patient has had persistent pain in her right arm in the location of the injections. The pain was a stabbing pain and throbbing. It was not a muscle or joint pain and nothing seemed to alleviate its annoyance. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events since the second dose, the patient has had persistent pain in her right arm in the location of the injections; the pain was a stabbing pain and throbbing; it was not a muscle or joint pain and nothing seemed to alleviate its annoyance was not resolved at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Throat lesion, Tongue disorder
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jul2021 at 12:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypothyroidism from an unknown date and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fluticasone propionate; salmeterol xinafoate (ADVAIR); both for an unknown date for an unknown indication and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jul2021 at 15:45, the patient experienced tingling in extremities, lesions on tongue and throat. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with steroid, Benadryl and Pepcid IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in extremities, lesions on tongue and throat was recovering at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Throat irritation, Tongue ulceration, X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jul2021 at 12:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypothyroidism from an unknown date and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fluticasone propionate; salmeterol xinafoate (ADVAIR); both for an unknown date for an unknown indication and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jul2021 at 15:45, the patient experienced tingling in extremities, lesions on tongue and throat. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with steroid, Benadryl and Pepcid IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in extremities, lesions on tongue and throat was recovering at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Malaise, Nasopharyngitis
Clinical narrative: Fever; Chest pain; Headache; Chills; feeling very sick; Cold; palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration on 26Jul2021 18:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, chest pain, headache, chills on 27Jul2021 and feeling very sick, cold, palpitations on Jul2021. She is calling because she got the first dose of Pfizer COVID-19 Vaccine on Monday that is 26Jul2021 at 6pm. She said, yesterday she had fever, she also experienced chest pain, headache and chills after the first dose and she is still feeling very sick today. So, she wants to know how many days will the side effects or the fever will last after getting the first dose. She is also asking if she can take Moderna Vaccine instead of Pfizer COVID-19 Vaccine for her second dose. She is not sure with the date, she said that her second dose is on 16Aug2021 as far as she can remember. She is still feeling very sick today. When informed Patient stated that Are you going to transfer me or should she tell you her concern. Okay I am just concerned because I didn't feel well since the moment I took the vaccine. I was perfect but now I have cold. I have all the symptoms of COVID-19. I have chest pain, I don't know how to say that 'palpitations' or something. I just want to talk to someone that can answer all this concern that I have now. I am also kind of mad because they gave me all the information after putting the dose instead of giving me the information before. When again asked the permission to probe further questions, patient stated that Well she tell me that somebody is going to answer of the questions through the phone now. I was also calling because I wanted to know like for the experience that you guys have, how long does it takes the fever and all this symptoms to go away. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Fever; Chest pain; Headache; Chills; feeling very sick; Cold; palpitations; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration on 26Jul2021 18:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, chest pain, headache, chills on 27Jul2021 and feeling very sick, cold, palpitations on Jul2021. She is calling because she got the first dose of Pfizer COVID-19 Vaccine on Monday that is 26Jul2021 at 6pm. She said, yesterday she had fever, she also experienced chest pain, headache and chills after the first dose and she is still feeling very sick today. So, she wants to know how many days will the side effects or the fever will last after getting the first dose. She is also asking if she can take Moderna Vaccine instead of Pfizer COVID-19 Vaccine for her second dose. She is not sure with the date, she said that her second dose is on 16Aug2021 as far as she can remember. She is still feeling very sick today. When informed Patient stated that Are you going to transfer me or should she tell you her concern. Okay I am just concerned because I didn't feel well since the moment I took the vaccine. I was perfect but now I have cold. I have all the symptoms of COVID-19. I have chest pain, I don't know how to say that 'palpitations' or something. I just want to talk to someone that can answer all this concern that I have now. I am also kind of mad because they gave me all the information after putting the dose instead of giving me the information before. When again asked the permission to probe further questions, patient stated that Well she tell me that somebody is going to answer of the questions through the phone now. I was also calling because I wanted to know like for the experience that you guys have, how long does it takes the fever and all this symptoms to go away. The outcome of events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Fatigue, Lethargy, Poor quality sleep
Clinical narrative: Lethargic; Swollen left eye; Both temples were swollen; Redness on both temples if tired; Tired; Cannot get enough sleep; Sleepiness; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW013) via an unspecified route of administration in the right arm on 10Apr2021 at 11:00 (at the age of 55-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on an unknown date in May2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B. The patient had no known allergies to medications, food or other products. The patient received unspecified medications within two weeks of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, two weeks after second dose of vaccination, the patient experienced lethargy, swollen left eye, both temples were swollen, redness on both temples, was tired and she couldn't get enough sleep, also experienced sleepiness and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargy, swollen left eye, both temples were swollen, redness on both temples, tired and couldn't get enough sleep, sleepiness and itchy were not resolved at the time of this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Somnolence, Swelling face
Clinical narrative: Lethargic; Swollen left eye; Both temples were swollen; Redness on both temples if tired; Tired; Cannot get enough sleep; Sleepiness; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW013) via an unspecified route of administration in the right arm on 10Apr2021 at 11:00 (at the age of 55-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on an unknown date in May2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B. The patient had no known allergies to medications, food or other products. The patient received unspecified medications within two weeks of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, two weeks after second dose of vaccination, the patient experienced lethargy, swollen left eye, both temples were swollen, redness on both temples, was tired and she couldn't get enough sleep, also experienced sleepiness and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lethargy, swollen left eye, both temples were swollen, redness on both temples, tired and couldn't get enough sleep, sleepiness and itchy were not resolved at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling in arm; Pain in arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140) via an intramuscular route of administration in the left arm on 28Dec2020 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included an allergy to almonds and bee stings. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) for an unknown indication from an unknown date and unknown if ongoing and unspecified birth control medication for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 29Dec2020, the patient experienced swelling and pain in arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling and pain in arm was resolved on an unknown date.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hyperhidrosis, Hypoaesthesia, Inappropriate schedule of product administration, Weight decreased
Clinical narrative: 1st dose in Apr2021, 2nd dose on18Jul2021; I was 130 time of shot im 118 now; not been able to get food down; yesterday my arm right went without feeling; sweating like crazy; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 18Jul2021 (Lot number was not reported) (at the age of 49-year-old) as single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19.  Medical history was none. No known allergies. There were no concomitant medications. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left in Apr2021 (Lot number was not reported) (at the age of 49-year-old) as single dose for COVID-19 immunisation. The patient reported that: "I was 130 time of shot IM 118 now", "not been able to get food down", "yesterday my arm right went without feeling" and "sweating like crazy"  in 2021. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Skin disorder
Clinical narrative: Face bumps appeared next to both temples on the face; Patient received the 2nd dose, 17 days after the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), on 04Mar2021 13:00 (lot number: EN6202) as dose 1, single; then on 21Mar2021 13:00 (lot number: EN6206) as dose 2, single - both via an unspecified route of administration, administered in the right arm at the age of 51-years-old for COVID-19 immunization. The patient has no relevant medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Mar2021, the patient received the 2nd dose, 17 days after the 1st dose. On 25Mar2021 14:00, the patient developed face bumps which appeared next to both temples on the face. They continued to grow in size and the patient was unable to get rid of them. Doctors say told the patient that the vaccine resulted in biofilm to emerge on her face. It still has not gone away, through multiple injections. The patient stated that she needs help to remove this. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, prolongation of existing hospitalization, and disability or permanent damage. Treatment for the event included Hylenex Recombitant (hyaluronidase) and Kenalog. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash macular
Clinical narrative: Splotchy pink rash starting at left collarbone, covers left side of torso and left thigh; Rash is hot to the touch.; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 29Jul2021 at 10:15 AM (at the age of 25-years-old) (Batch/Lot Number: EW0177) dose number unknown, single, for COVID-19 immunization. Medical history included allergies to iodine and shellfish. The patient did not have COVID prior to the vaccination, was not pregnant, and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 29Jul2021 at 21:15, the patient experienced a splotchy pink rash starting at the left collarbone, which covered the left side of her torso and left thigh. There was no pain, itchiness, or discomfort. The rash was hot to the touch. The patient was not tested for COVID post vaccination. As treatment, the patient took 25mg of Benadryl. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: I missed 2 periods right after getting my second shot.; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received second dose of BNT162B2(Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date of Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The concomitant medication includes oral birth control for over a decade started on an unspecified date. The patient wanted to report that I missed 2 periods right after getting my second shot. My periods returned normally the 3rd month after my vaccine. I have read that there is no evidence of correlation there, but I know other women who have experienced this. my hope is for you to catalog my experience and investigate it if appropriate. The outcome of the event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia, Pain in jaw, Visual impairment
Clinical narrative: Systemic: Bell's Palsy-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: droopy mouth, jaw pain, all symptoms on left side
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Fall, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient went to go sit down and fainted.  He hit his head and was disoriented.  Had him drink some fluid and juice.  He then puked.  NP ruled out concussion
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient went to go sit down and fainted.  He hit his head and was disoriented.  Had him drink some fluid and juice.  He then puked.  NP ruled out concussion
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Musculoskeletal stiffness, Pain
Clinical narrative: since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness".; since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness".; since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness".; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (51-years-old at the time of vaccination),  (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; received tofacitinib citrate (XELJANZ XR), oral from an unspecified date (Batch/Lot Number: ED3279) to an unspecified date, at 11 mg, 1x/day (11MG/TAKE 1 TABLET BY MOUTH ONCE DAILY), via an unspecified route of administration from 2019 (Batch/Lot number was not reported) to an unspecified date, at 5 mg for an unspecified indication. Medical history included Psoriatic arthritis mutilans from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported. Patient confirmed she began Xeljanz "several years, around 2019". She was previously on Otezla, Stelara, Humira, Enbrel and Xeljanz 5 mg dose but they were discontinued due to lack of efficacy. Provided review of prescribed regime, reviewed educational topics, and completed the adherence medications scale (withheld). Educated that Xeljanz may cause changes in WBC and red blood cell count; reviewed importance of doing blood work while taking Xeljanz. She indicated she follows up with her physician quarterly. She indicated that since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness". She stopped medication temporarily due to COVID-19 pandemic and when she received COVID-19 vaccine was instructed to stop medication temporarily. Updated medication list and reviewed allergy list. AE survey completed. The clinical outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anosmia, Arthralgia, Chest pain, Cough
Clinical narrative: Chest Pain  Shortness of Breath Cough Epigastric pain Nausea Vomiting Diarrhea Arthralgias Myalgias Ansomia Dysgeusia Headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Dyspnoea, Headache, Myalgia
Clinical narrative: Chest Pain  Shortness of Breath Cough Epigastric pain Nausea Vomiting Diarrhea Arthralgias Myalgias Ansomia Dysgeusia Headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Chest Pain  Shortness of Breath Cough Epigastric pain Nausea Vomiting Diarrhea Arthralgias Myalgias Ansomia Dysgeusia Headache
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient experiencing continued soreness and swollen area on upper left arm where vaccine was administered - has not subsided as of 8/27/21 patient is contacting her family physician
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Truly have no idea if this was related to vaccine, but because I have seen other reports on line about this same issue, I wanted to just make note of it.  I seemed to have developed acute vertigo for the first time in my life.  First episode came on August 4, 2021.  Resolved in 5 days completely.  And then returned on August 23, 2021- and gone again in 4 days this time.  But I never had it before.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Eye movement disorder, Flushing, Headache
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: eyes were rolling, arms and fingers were tensing up/tightenting and releasing repeatedly, could not respond verbally, had her squeeze my hand for "yes" responses, called EMS and they took over situation, hypotension was per EMS
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Musculoskeletal stiffness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: eyes were rolling, arms and fingers were tensing up/tightenting and releasing repeatedly, could not respond verbally, had her squeeze my hand for "yes" responses, called EMS and they took over situation, hypotension was per EMS
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: eyes were rolling, arms and fingers were tensing up/tightenting and releasing repeatedly, could not respond verbally, had her squeeze my hand for "yes" responses, called EMS and they took over situation, hypotension was per EMS
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Confusional state, Dizziness, Hypotension
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Pt complained of abdominal soreness, then proceeded to faint about 2 min after administration. She responded immediately while she was laying on her back. Needed assistance to transition to a seated position. At this point, she fainted again. EMS was called. Before they arrived, she was attentive and could walk on her own. BP was 110/60, pt refused transport to the hospital. After another 15 min observation, pt walked out on her own. Family member drove her home out of an abundance of caution.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Tremor
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Pt complained of abdominal soreness, then proceeded to faint about 2 min after administration. She responded immediately while she was laying on her back. Needed assistance to transition to a seated position. At this point, she fainted again. EMS was called. Before they arrived, she was attentive and could walk on her own. BP was 110/60, pt refused transport to the hospital. After another 15 min observation, pt walked out on her own. Family member drove her home out of an abundance of caution.