chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Felt awful like they had the flu; Felt awful like they had the flu; This is a spontaneous report from a contactable consumer through a Pfizer-sponsored program. This consumer reported similar events for three patients. This is the second of the three reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had felt awful like having the flu. The outcome of the events, 'felt awful like having the flu', was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082187 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: began shivering; This is a spontaneous report from a non-contactable consumer.  A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 at 09:00 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported.  On 25Jan2021 at 16:30, the patient began shivering. Putting on another layer of clothing alleviated the problem. It was also reported that the patient's husband had forgotten to turn up the heat that morning so the house was colder than usual. The clinical outcomes of shivering was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some very pain/soreness at the injection site; This is a spontaneous report from a non-contactable consumer (patient).  A 32-year-old female patient receive  the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN 5318, expiry date: 31May2021), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that in the morning on 27Jan2021, the patient experienced some very pain/soreness at the injection site  but was less intense than what the experienced with a non-Pfizer influenza shot on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sensation of foreign body
Clinical narrative: Something stuck in my throat; Nausea; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 22Dec2020 (12:30) at a single dose on the left deltoid, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy to lobster, and had used steroids. The patient's concomitant medications were not reported. On 24Dec2020, the patient had something stuck in the throat; and had nausea. The patient had an emergency room visit due to the reported events; and had received a three-day course of oral prednisone and antihistamine, and then diphenhydramine (BENADRYL). The patient had no respiratory, cardiovascular, dermatological or gastrointestinal manifestations. The outcome of the events, 'something stuck in the throat' and 'nausea', was recovered on an unspecified date. The reporter had considered that there was a reasonable possibility that the events were related to the suspect vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the site of injection; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 26Jan2021 12:45 PM at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included azelastine hydrochloride/fluticasone propionate (DYMISTA) and cetirizine hydrochloride. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 26Jan2021 16:00, the patient experienced pain at the site of injection. The event was considered as non-serious by the other healthcare professional. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Pain in extremity, Peripheral swelling
Clinical narrative: He mentioned experiencing side effects like soreness of arm,/pain in his arm; swollen and pain in his arm; Headache; Hearing impaired; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just took the first dose of vaccine. On an unspecified date, he mentioned experiencing side effects like soreness of arm, swollen (also reported as not swollen, for clarification) and pain in his arm, headache and hearing impaired; nothing major. He also wanted to know if it is safe to take the multivitamins. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: His allergies are really bad; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A male patient of an unspecified age received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced his allergies are really bad on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable healthcare professional via a sales representative. This healthcare professional reported same events for two patients. This is the first of two reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as Pfizer COVID-vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of received bnt162b2 (BNT162B2 reported as Pfizer COVID-vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter mentioned that she had two X-Ray techs call in sick due to fever and chills with their second dose on an unspecified date. She said there have been a ton of people who have not gotten sick with their second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021084275 same reporter/drug/events, different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort
Clinical narrative: felt across her chest a lot of pressure; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt across her chest a lot of pressure. Patient thought that it was just a heart burn but then confirmed that it's not. Patient wanted to know if this was a side effect because she is having second thoughts to take the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Nausea
Clinical narrative: felt across her chest a lot of pressure; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt across her chest a lot of pressure. Patient thought that it was just a heart burn but then confirmed that it's not. Patient wanted to know if this was a side effect because she is having second thoughts to take the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diabetic foot infection, Disease recurrence
Clinical narrative: got diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot. However, it got irritated again after the first dose; got diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot. However, it got irritated again after the first dose; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history included diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot on an unspecified date. The patient's concomitant medications were not reported. The patient stated that she got a diabetic ulcer infection on her foot before she got the vaccine, it got infected and irritated before she took the shot. However, it got irritated again after the first dose on an unspecified date.  The patient reported she was scheduled to get the second dose on 26Jan2021 (tomorrow) and she was getting ready to start antibiotic on 25Jan2021 (today). She asked if she can take her antibiotic because she will be getting her second dose. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Lip swelling
Clinical narrative: upper lip swelling; cheeks turned to red; cheeks turned to red and burning; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that this female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced mild reactions such as upper lip swelling, cheeks turned to red, and burning that lasted for 2 hours. The outcomes of upper lip swelling and cheeks turned to red was unknown. The outcome of burning was recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: More localized pain at the injection site than is usual for a vaccine; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for herself and one patient (her nurse). This is the first of two reports. A female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at a single dose for Covid-19 immunization. Medical history included blood group O+. Concomitant medications were not reported. It was reported that the patient experienced more localized pain at the injection site than is usual for a vaccine. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085284 same reporter, same drug, same event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experience fever and chills on unspecified dates. The outcome of the events was recovered on unspecified dates.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: rigors; This is a spontaneous report from a contactable physician. A male patient of an unspecified age started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced rigors on an unspecified date. Patients presented within 12-24 hours and persisted for 12-24 hours. The AE subsided after 48 hours.  No follow-up attempts are possible. Information about batch/Lot number cannot be obtained.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: heart palpitations/ my heart would race; hot flashes; flushing; shortness of breath; heavy feeling in my chest; my head would explode; rise in my blood pressure; several bathroom breaks; anxiety; heart beat a little faster; unforgiving fatigue; nightmares; injection site was minimally painful; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration at the age of 76 years, on 22Jan2021 13:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and obesity from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE). The patient reported that the vaccination was given at approximately 1:30 pm on Friday 22Jan2021, and during the wait time after the shot was given, the patient had no problems, other than what the nurse said was probably anxiety when the patient's heart beat a little faster. The patient stopped at the grocery store, home for a bite to eat and then the unforgiving fatigue. The patient slept from 5:30 pm on Friday 22Jan2021 until 8:30 am on Saturday 23Jan2021 (with several bathroom breaks, but in bed, asleep). One of the problem during that time was nightmares of epic proportions. On Saturday 23Jan2021, the patient began to have semi-serious (enough that patient contemplated an ER visit) heart palpitations, flushing every couple of hours (similar to "hot flashes") and shortness of breath with a heavy feeling in chest, not gasping to breathe. Each and every time the patient got up to work, even across the room, patient's heart would race, as if the patient had been running, and would feel as though my head would explode (patient was assuming it was due to a rise in my blood pressure). These after-effects continued all day Saturday and all day Sunday. The patient did not have the fatigue issue and the injection site was minimally painful. On Monday, 25Jan2021, the heart situation was almost completely gone and I am having very small problems with breathing. The only time the patient seemed to have anything with breathing was when the patient does any extended activity (which is usually one of the normal causes of my asthma). Given the side effects, patient was concerned about my second shot as the patient have heard that shot seems to affect people much worse. The outcome of the events heart palpitations, shortness of breath and heavy feeling in my chest was recovering while other events were unknown.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Head discomfort, Heart rate increased, Hot flush, Nightmare
Clinical narrative: heart palpitations/ my heart would race; hot flashes; flushing; shortness of breath; heavy feeling in my chest; my head would explode; rise in my blood pressure; several bathroom breaks; anxiety; heart beat a little faster; unforgiving fatigue; nightmares; injection site was minimally painful; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration at the age of 76 years, on 22Jan2021 13:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and obesity from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE). The patient reported that the vaccination was given at approximately 1:30 pm on Friday 22Jan2021, and during the wait time after the shot was given, the patient had no problems, other than what the nurse said was probably anxiety when the patient's heart beat a little faster. The patient stopped at the grocery store, home for a bite to eat and then the unforgiving fatigue. The patient slept from 5:30 pm on Friday 22Jan2021 until 8:30 am on Saturday 23Jan2021 (with several bathroom breaks, but in bed, asleep). One of the problem during that time was nightmares of epic proportions. On Saturday 23Jan2021, the patient began to have semi-serious (enough that patient contemplated an ER visit) heart palpitations, flushing every couple of hours (similar to "hot flashes") and shortness of breath with a heavy feeling in chest, not gasping to breathe. Each and every time the patient got up to work, even across the room, patient's heart would race, as if the patient had been running, and would feel as though my head would explode (patient was assuming it was due to a rise in my blood pressure). These after-effects continued all day Saturday and all day Sunday. The patient did not have the fatigue issue and the injection site was minimally painful. On Monday, 25Jan2021, the heart situation was almost completely gone and I am having very small problems with breathing. The only time the patient seemed to have anything with breathing was when the patient does any extended activity (which is usually one of the normal causes of my asthma). Given the side effects, patient was concerned about my second shot as the patient have heard that shot seems to affect people much worse. The outcome of the events heart palpitations, shortness of breath and heavy feeling in my chest was recovering while other events were unknown.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Pollakiuria, Vaccination site pain
Clinical narrative: heart palpitations/ my heart would race; hot flashes; flushing; shortness of breath; heavy feeling in my chest; my head would explode; rise in my blood pressure; several bathroom breaks; anxiety; heart beat a little faster; unforgiving fatigue; nightmares; injection site was minimally painful; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration at the age of 76 years, on 22Jan2021 13:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and obesity from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE). The patient reported that the vaccination was given at approximately 1:30 pm on Friday 22Jan2021, and during the wait time after the shot was given, the patient had no problems, other than what the nurse said was probably anxiety when the patient's heart beat a little faster. The patient stopped at the grocery store, home for a bite to eat and then the unforgiving fatigue. The patient slept from 5:30 pm on Friday 22Jan2021 until 8:30 am on Saturday 23Jan2021 (with several bathroom breaks, but in bed, asleep). One of the problem during that time was nightmares of epic proportions. On Saturday 23Jan2021, the patient began to have semi-serious (enough that patient contemplated an ER visit) heart palpitations, flushing every couple of hours (similar to "hot flashes") and shortness of breath with a heavy feeling in chest, not gasping to breathe. Each and every time the patient got up to work, even across the room, patient's heart would race, as if the patient had been running, and would feel as though my head would explode (patient was assuming it was due to a rise in my blood pressure). These after-effects continued all day Saturday and all day Sunday. The patient did not have the fatigue issue and the injection site was minimally painful. On Monday, 25Jan2021, the heart situation was almost completely gone and I am having very small problems with breathing. The only time the patient seemed to have anything with breathing was when the patient does any extended activity (which is usually one of the normal causes of my asthma). Given the side effects, patient was concerned about my second shot as the patient have heard that shot seems to affect people much worse. The outcome of the events heart palpitations, shortness of breath and heavy feeling in my chest was recovering while other events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: he developed a bump on his left elbow; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program Pfizer First Connect. A male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspeciied date, the patient developed a bump on his left elbow by where the shot was given. He stated that it was the size of a half golfball. Outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: experiencing vivid and detailed nightmares /dreams daily; This is a spontaneous report from a contactable physician (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2 reported as COVID Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID Vaccine; unknown lot number and expiration date) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient reported that after the second Pfizer dose patient was experiencing vivid and detailed nightmares /dreams daily. These dreams have persisted for 3 weeks. The outcome of the event was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site warmth
Clinical narrative: Itching that is spreading across my body; warm sensation at injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration (at the age of 41-years-old) on 28Jan2021 15:00 at a single dose in left arm for COVID-19 immunization. Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously took Keflex [cefalexin] and experienced allergy. The patient experienced itching that is spreading across my body and warm sensation at injection site on 28Jan2021 16:00 with outcome of not recovered. Treatment was not received for adverse event. The patient was not pregnant at the time of vaccination. The events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Product leakage
Clinical narrative: clear liquid started leaking down her arm; clear liquid started leaking down her arm; clear liquid started leaking down her arm; after the syringe was inserted, a clear liquid started leaking down her arm/wanted to know if she would have to repeat this process and get the 2nd dose again; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer reporting for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (arm) on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after the syringe was inserted, a clear liquid started leaking down her arm on an unspecified date. Patient wanted to know if she would have to repeat this process and get the 2nd dose again.  Information on Lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever 99-101 degrees; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH-COVID-19 VACCINE; lot number: EL1289; expiration date: unknown) was 80-year-old at the time of vaccination via an unspecified route of administration right arm on 26Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included myasthenia gravis, bipolar disorder, chronic obstructive pulmonary disease (COPD), hypothyroidism, high cholesterol and allergies to ACE inhibitors. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), fluticasone propionate (ALLER FLO), cetirizine hydrochloride (ALLER TEC), aspirin [acetylsalicylic acid] (ASPIRIN), clonazepam and ipratropium bromide (IPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ciprofloxacin (CIPRO) but had allergies. The patient received the most recent COVID-19 vaccine in a hospital. On 28Jan2021 07:00 AM, the patient had injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever 99-101 degrees. The patient who has a medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine on 26Jan2021 with unknown outcome. The patient did not received treatment from the adverse events and the events was considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of all the other events was not recovered.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Product use issue, Pyrexia, Vaccination site pain
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever 99-101 degrees; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH-COVID-19 VACCINE; lot number: EL1289; expiration date: unknown) was 80-year-old at the time of vaccination via an unspecified route of administration right arm on 26Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included myasthenia gravis, bipolar disorder, chronic obstructive pulmonary disease (COPD), hypothyroidism, high cholesterol and allergies to ACE inhibitors. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), fluticasone propionate (ALLER FLO), cetirizine hydrochloride (ALLER TEC), aspirin [acetylsalicylic acid] (ASPIRIN), clonazepam and ipratropium bromide (IPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ciprofloxacin (CIPRO) but had allergies. The patient received the most recent COVID-19 vaccine in a hospital. On 28Jan2021 07:00 AM, the patient had injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever 99-101 degrees. The patient who has a medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine on 26Jan2021 with unknown outcome. The patient did not received treatment from the adverse events and the events was considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of all the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: neck pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored program. This female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient was in neck pain; the patient stated it was not due to the COVID vaccine. She was supposed to take a steroid shot for her neck; the reporter inquired if she could get her second COVID vaccine with a steroid injection scheduled. The clinical outcome of neck pain was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on current available information, the event neck pain is more likely intercurrent and is assessed as unrelated to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: malaise; fever of 101.3; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 26Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on an unknown date. The patient experienced malaise and fever of 101.3 (unknown unit) on 27Jan2021. The patient underwent lab tests which included body temperature: 101.3 on 27Jan2021. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: wife's arm hurts a little bit 2-3 hours after the 1st dose of the vaccine / her arm is starting to hurt and is feeling a bit stiff; wife's arm hurts a little bit 2-3 hours after the 1st dose of the vaccine / her arm is starting to hurt and is feeling a bit stiff; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE  DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband asked if it's okay to take Tylenol because the patient's arm hurts a little bit 2-3 hours after the 1st dose of the vaccine and he's asking if he can drink wine. The husband mentioned that his wife also had an injection and around 4 or 5 hours ago mentioned that her arm was starting to hurt and was feeling a bit stiff. He told her that she could take Tylenol or Advil for it. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Induration, Oedema peripheral, Product use issue
Clinical narrative: BNT162B2 on 25Jan2021; Right armpit, got swollen and hard; Right armpit, got swollen and hard; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program. This female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on 08Jan2021 for COVID-19 immunization. The patient reported after getting the second dose yesterday (as of 26Jan2021), her right armpit got swollen and hard. The clinical outcomes of her right armpit got swollen and hard, and BNT162B2 on 25Jan2021 were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Rhinorrhoea
Clinical narrative: runny nose; chill; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced a runny nose, had a chill and had 97.8 degree Fahrenheit body temperature. Outcome of the events was unknown.   Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety attack; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history included dental work done from an unknown date and unknown if ongoing. Concomitant mediations were not reported. The patient reported that she had the COVID vaccine and dental work done, inquired if that was okay; while asking, the patient mentioned she didn't want to answer questions due to having an anxiety attack. The clinical outcome of anxiety attack was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: About 20 min after vaccine i felt a slight thickening of back of tongue.came and went within seconds. i am conerned about second dose; This is a spontaneous report from a contactable Consumer (patient). A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Jan2021 13:30 at single dose for COVID-19 immunization in hospital. Medical history included atrial fibrillation. Concomitant medications in two weeks included apixaban (ELIQUIS), metoprolol succinate (TOPROL XL), levothyroxine sodium (SYNTHROID), semaglutide (OZEMPIC).  There was no other vaccine in four weeks. The patient previously had known allergies to epinephrine. About 20 min after vaccine she felt a slight thickening of back of tongue. It came and went within seconds. She was concerned about second dose. The event onset time was also reported as 18Jan2021 13:00. The event did not result in emergency room visit or physician office visit. There was no treatment for the event. There was no covid prior vaccination or covid tested post vaccination. The event was resolved on 18Jan2021.   Information on batch/lot has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash
Clinical narrative: flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, light rash arms, and trunk; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jan2021 01:00 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to receiving bnt162b2. The patient was not diagnosed with covid prior to vaccination. The patient was not pregnant. Medical history included allergies to tree nuts, bees, penicillin, and sulfa. Concomitant medications were included hormones, fluticasone propionate, salmeterol xinafoate (ADVAIR), and esomeprazole sodium (NEXIUM). The patient experienced flushing of face within 10 minutes (as reported), light rash arms, and trunk on 23Jan2021 01:15 PM (as reported). The patient was not tested for covid post-vaccination. The patient received Benadryl as a corrective treatment. Outcome of the events was recovered on an unspecified date in Jan2021.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Fatigue, Headache, Malaise
Clinical narrative: maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in all of fingers and toes and around eyes; puffiness in all of fingers and toes and around eyes; she was not feeling great; fatigue; headache; soreness in her arm at the injection site; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her right arm, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she was not feeling great, had fatigue and headache. On 25Dec2020, she had swelling in her right middle finger, states that has now progressed to swelling in all her fingers, toes and around her eyes. Also reported that on 21Dec2020, she had soreness in her arm at the injection site that went away the same day. The patient also mentioned that she tested negative for Covid. The patient is also a little low iron but not too remarkable. The outcome of the event vaccination site pain was recovered in 21Dec2020, not recovered for peripheral swelling and puffy eyes while unknown for the other events.   Information on Lot/Batch has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Peripheral swelling, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: maybe a little low iron but not too remarkable; swelling in middle finger of right hand/puffiness in all of fingers and toes and around eyes; puffiness in all of fingers and toes and around eyes; she was not feeling great; fatigue; headache; soreness in her arm at the injection site; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her right arm, via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 23Dec2020, she was not feeling great, had fatigue and headache. On 25Dec2020, she had swelling in her right middle finger, states that has now progressed to swelling in all her fingers, toes and around her eyes. Also reported that on 21Dec2020, she had soreness in her arm at the injection site that went away the same day. The patient also mentioned that she tested negative for Covid. The patient is also a little low iron but not too remarkable. The outcome of the event vaccination site pain was recovered in 21Dec2020, not recovered for peripheral swelling and puffy eyes while unknown for the other events.   Information on Lot/Batch has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Vaccination site movement impairment
Clinical narrative: severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: we noticed our arms wore sore/right arm soreness following injection; This is a spontaneous report from a contactable consumer (patient's husband) reporting for a patient. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247, Expire Date: 31May2021), intramuscular (right arm) on 24Jan2021 13:30 at SINGLE DOSE (first dose) for covid-19 immunisation. Medical history included reported as none. The patient did not COVID virus prior vaccination. Patient did not have prior vaccinations within 4 weeks. There were no concomitant medications. The patient experienced arms were sore/right arm soreness following injection on 24Jan2021 before bed. It has improved, it was way better and that she was good. No treatment was given and no lab tests were done. Outcome of the event was recovering. The event did not require emergency room visit or physician office visit.