chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Mass, Rash erythematous
Clinical narrative: broke out with some red rashes on chest and on face, on the bottom of face/it has behind my ear that was the rashed I have; I got a lump on the back of my ear and it is only on the left side where I took the injection; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiry date: unknown), via an unspecified route of administration, on 24Jan2021, at single dose, for covid-19 immunization. Medical history included diabetes mellitus and urinary tract infection (UTI). Concomitant medication included amlodipine; ciprofloxacin; losartan; metformin; metoprolol; insulin human, insulin human injection, isophane (NOVOLIN 30/70); insulin human, insulin human injection, isophane (NOVOLIN 70/30); rosuvastatin and unspecified antibiotics that was taken from 11Jan2021 to 15Jan2021 for UTI. On 24Jan2021, on the same day of vaccination, the patient broke out with some red rashes on chest and on face, on the bottom of face and got a lump on the back of ear and it was only on the left side were she took the injection. The patient stated, "it's just on my chest, it's just red rashes on my chest and it has behind my ear that was the rashes I have. But it is on the left side only, it is not all over." The patient was wondering if it was normal to break out like that as it occurred on the same day she received the vaccine and asked what she should do. The date of the second dose was reported to be on 14Feb2021. No treatment was given for the events. The patient reported she does her blood sugar twice a day (unknown results). The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: My shoulder, my arm is really hurting; My shoulder, my arm is really hurting; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had the Pfizer vaccine yesterday, and reported that "my shoulder, my arm is really hurting." The outcome of the events was unknown.   No follow-up attempts are possible. Information on Lot/ Batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), 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 is going to have an appointment for the second shot of COVID-19 vaccine on 07Feb2021. Now in the meantime, the patient come down with shingles on unspecified date and was wondering if the patient can make the appointment to have the second shot.  Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Limb discomfort, SARS-CoV-2 test
Clinical narrative: slight pain in his arm the shot was given; if he moved his arm, he would have slight discomfort; some slight tenderness in his shoulder; Yesterday, his temperature was 97 something. This morning, he got up at 6am and his temperature was around 98.8; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261; expiry date: unknown) via an unspecified route of administration in the left arm, on 26Jan2021 at 8:30 to 9 AM, at a single dose, for Covid-19 immunization. Medical history in Mar2020 included had a temperature for 7 days. He tested positive for COVID and it took a while to test negative. At the end of Mar2020 until the first of Apr2020, his temperature was 97 something. He has checked his temperature every day since then. There were no concomitant medications. The patient had no previous immunization with the Pfizer vaccine. He did not receive additional vaccines on the same date bnt162b2 was given. The patient had his first COVID-19 shot yesterday morning about 8:30 or 9:00. He hadn't really looked at the list of side effects, but yesterday afternoon (26Jan2021), he had slight pain in the arm where the shot was given. If he moved his arm, he would have slight discomfort. The pain was mostly gone today. He also had some slight tenderness in his shoulder, but it's certainly less than what it was yesterday. He saw other things that were listed including fever. He wanted to know if Pfizer had any information as what to amount of fever people typically experience after having the shot.  Yesterday (unspecified date in Jan2021), his temperature was 97 something. This morning, he got up at 6 am and his temperature was around 98.8. And then he had to take his wife to therapy and when he got back 3 hours later, he took it now and his temperature was 99 degrees. He was just wondering if Pfizer had an idea of how much fever is normal from the shot?  He hasn't had any other reactions. The events did not require Emergency Room or Physician's Office visit. The patient underwent lab tests and procedures which included body temperature: 97 something on 26Jan2021, 98.8 and 99 on 27Jan2021; sars-cov-2 test: positive on an unspecified date in 2020 and negative on an unspecified date in 2020. Outcome of the event "slight pain in his arm the shot was given" was recovering, while for the other events was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight pain in his arm the shot was given; if he moved his arm, he would have slight discomfort; some slight tenderness in his shoulder; Yesterday, his temperature was 97 something. This morning, he got up at 6am and his temperature was around 98.8; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261; expiry date: unknown) via an unspecified route of administration in the left arm, on 26Jan2021 at 8:30 to 9 AM, at a single dose, for Covid-19 immunization. Medical history in Mar2020 included had a temperature for 7 days. He tested positive for COVID and it took a while to test negative. At the end of Mar2020 until the first of Apr2020, his temperature was 97 something. He has checked his temperature every day since then. There were no concomitant medications. The patient had no previous immunization with the Pfizer vaccine. He did not receive additional vaccines on the same date bnt162b2 was given. The patient had his first COVID-19 shot yesterday morning about 8:30 or 9:00. He hadn't really looked at the list of side effects, but yesterday afternoon (26Jan2021), he had slight pain in the arm where the shot was given. If he moved his arm, he would have slight discomfort. The pain was mostly gone today. He also had some slight tenderness in his shoulder, but it's certainly less than what it was yesterday. He saw other things that were listed including fever. He wanted to know if Pfizer had any information as what to amount of fever people typically experience after having the shot.  Yesterday (unspecified date in Jan2021), his temperature was 97 something. This morning, he got up at 6 am and his temperature was around 98.8. And then he had to take his wife to therapy and when he got back 3 hours later, he took it now and his temperature was 99 degrees. He was just wondering if Pfizer had an idea of how much fever is normal from the shot?  He hasn't had any other reactions. The events did not require Emergency Room or Physician's Office visit. The patient underwent lab tests and procedures which included body temperature: 97 something on 26Jan2021, 98.8 and 99 on 27Jan2021; sars-cov-2 test: positive on an unspecified date in 2020 and negative on an unspecified date in 2020. Outcome of the event "slight pain in his arm the shot was given" was recovering, while for the other events was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Cold chills; Fever; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on his left arm, intramuscular on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had Cold chills, fever and not feeling too well. He took one Tylenol for fever. The outcome of the events was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: where he broke the skin with a nail that was a little rusty; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first single dose of BNT162B2 (Solution for injection, lot number: GL3249, exp date not reported) , intramuscular on 09Jan2021 12:00 for COVID-19 immunization; and tetanus vaccine, intramuscular (anatomical location: right arm) on 25Jan2021 at unspecified dose/frequency as tetanus shot. Patient received his first COVID shot at a Hospital. Patient had no relevant medical history. There were no concomitant medications. The patient was due for his second shot this Saturday, 30Jan2021. Patient went to a physician's office to receive a tetanus shot on Monday, 25Jan2021. On the same date (25Jan2021), he had a little incident where he broke the skin with a nail that was a little rusty.  He was wondering if that was an inhibitor to the vaccine. Patient wanted to know and or have a heads up if getting the Tetanus shot will cause him to have to reschedule his second COVID-19 vaccine. No Emergency Room visit required for the events. No relevant test/s performed. The outcome of events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: started developing a rash. Like red patches on her arms/showed up on her stomach, chest and thighs. They flare-up.; It's a little bit itchy; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC8982), via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history included blood pressure high, thyroid disorder (reported as thyroid), and cholesterol high. Concomitant medications included lisinopril and hydrochlorothiazide both for blood pressure high, levothyroxine, and atorvastatin for cholesterol high; all were taken from an unspecified date. On 26Jan2021 afternoon, the patient started developing a rash. Like red patches on her arms, she put the Cortisone on her arms and it went away. But then it showed up on her stomach and chest and thighs. They flare-up. It's a little bit itchy. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Migraine, Pain in extremity, Photosensitivity reaction
Clinical narrative: dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization).  The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, "turn off the lights in the office/has to have the lights low, still sensitive", and "dull achiness on the right side of temple area/headaches". The patient had not recovered from really bad migraine, head was sensitive, and "dull achiness on the right side of temple area/headaches". The outcome of the events "turn off the lights in the office/has to have the lights low, still sensitive" and arm hurt worse with second dose was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood triglycerides, Body mass index, Chest discomfort, Dizziness
Clinical narrative: rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports.   A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone.  She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Palpitations
Clinical narrative: rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports.   A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone.  She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports.   A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone.  She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales Representative. The consumer reported on three patients. This is the first of three reports. A female patient of an unspecified age received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the 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) : US-PFIZER INC-2021117324 same reporter/product/event, different patient;US-PFIZER INC-2021117244 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales Representative. The consumer reported on three patients. This is the second of three reports. A patient of an unspecified age and gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the 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) : US-PFIZER INC-2021117236 same reporter/product/event, different patient;US-PFIZER INC-2021117324 same reporter/product/event, different patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling
Clinical narrative: when she woke up in the morning her gum on her right face was swollen; 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 expiration date were not reported), via an unspecified route of administration on 06Jan2021 at a single dose (at the age of 41-years-old) for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included amlodipine for high blood pressure. The patient took the COVID vaccine and worked at the hospital six days after the first dose, when she woke up in the morning her gum on her right face was swollen (12Jan2021) and she took the vaccine on left side. She figured it was something with her gum and it was not related. She went to the dentist and everything, and he (dentist) cleared that nothing was wrong with her gum. The patient did not receive treatment for the event. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event "gum on her right face was swollen" with BNT162b2 can not be fully excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache, Somnolence
Clinical narrative: felt very sleepy; very tired; Headache; elevated temperature; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable consumer (patient herself) reported that a 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, UPC/NDC number and expiration date were unknown), via an unspecified route of administration in the left deltoid (also reported as left shoulder) on 16Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included hypertension, for which she was taking medication for it and had a torn redness on her rotator cuff; from an unknown date and unknown if ongoing. Concomitant medications included cortisone injection as she had a torn redness on her rotator cuff, as she guessed and she was taking an unspecified medication for hypertension. The patient just wanted to report that after taking the vaccine (Covid-19 Vaccine) on the 16Jan2021, she felt very sleepy and then very tired, slightly headache and she had elevated temperature. The patient further stated that she had elevated temperature and lastly, after she had the injection, she got really, really sleepy. The patient stated that before she had the injection, she had a cortisone injection, so she didn't know.  The events did not require any visit to the physician office or to the emergency room. Therapeutic measures were taken as a result of felt very sleepy, very tired, headache, and elevated temperature, which included paracetamol (TYLENOL). The outcome of all the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales Representative. The consumer reported on three patients. This is the third of three reports. A patient of an unspecified age and gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117236 same reporter/product/event, different patient;US-PFIZER INC-2021117244 same reporter/product/event, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via intramuscular route of administration in the left arm on 29Dec2020 at a single dose because "a coworker came down with Covid." Medical history included migraine and headache. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient reported that her arm hurt with first dose on an unspecified date. There were no relevant tests conducted. The outcome of the event was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure measurement, Cardiac stress test, Dizziness
Clinical narrative: started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter).  A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on  28Jan2021at  09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation .  Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined),  and Prediabetes  Concomitant medication(s) include takes medication for breast cancer and  prediabetes. No other vaccines were given within 4 weeks  No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced  started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and  just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is  feeling better now. Patient  checked her blood pressure and it was 127/72.  The patient underwent lab tests and procedures which included blood glucose: High 146  on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021,  cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown    Information on the lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: started to feel dizzy after getting the first dose of the COVID-19 Vaccine today; just checked her blood sugar, and her blood sugar was high at 146.; This is a spontaneous report from a contactable consumer (patient's daughter).  A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the right arm on  28Jan2021at  09:30 (at the age of 60-years-old) as a SINGLE DOSE for covid-19 immunisation .  Medical history included breast cancer female from 17Feb2019 (taking medicine for the breast cancer for 2 years), Cardiac disorder from an unknown date (problems with her heart about 2 weeks ago, and had to have her heart examined),  and Prediabetes  Concomitant medication(s) include takes medication for breast cancer and  prediabetes. No other vaccines were given within 4 weeks  No Additional Vaccines were administered on Same Date of the Pfizer Suspect. On 28Jan2021, The patient experienced  started to feel dizzy after getting the first dose of the COVID-19 Vaccine today and  just checked her blood sugar, and her blood sugar was high at 146. No Physician office visit and No Emergency room visit required due to the events. Reporter stated her mother is  feeling better now. Patient  checked her blood pressure and it was 127/72.  The patient underwent lab tests and procedures which included blood glucose: High 146  on 28Jan2021; blood pressure measurement: 127/72 on 28Jan2021,  cardiac stress test: unknown results on an unknown date, heart resistance test: unknown result on an unknown date. Caller asked what Pfizer recommends for the dizziness. The clinical outcome of the event dizzy was recovering which blood glucose high was unknown    Information on the lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Soreness/at injection site; Overwhelming fatigue/Tiredness; Headache; pain a lot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, and chronic fatigue, both from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. Patient had the first Pfizer vaccine (unspecified vaccine) on 23Jan2021 and since then had expected some soreness which patient had at the injection site on an unspecified date in 2021. And they even on that might be tiredness. Well patient already have chronic fatigue so patient know about tiredness. Patient did remember the headache (2021) were also which already have with chronic fatigue which patient have. Now chronic fatigue likes very tired but normal not act tired as with this vaccine. This morning patient tried to get in card to go to the grocery store to get some groceries and have to comeback that how tired and fatigue that was. Now patient just wondered "the fatigue it was a very "pain a lot" (not clarified) byproduct of this vaccine. It must be (incomplete sentence)." The "things" (not clarified) patient was concerned was, patient heard on the news that the second vaccine would be rougher or have more side effects than the first and that's the reason patient called and the second vaccine which patient was due to have on February 13th would have more side effects than this first one. With the first one expected this overwhelming fatigue. It has been relatively now. Headache, soreness on the injection site but patient thought the tiredness would go away but it has not. Now patient questioned if the second vaccine will that be Pfizer also. The patient had not recovered from the event fatigue. The outcome of the other events was unknown.   Information on lot/batch number has been requested
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling hot, Headache, Pain
Clinical narrative: she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme/debilitating fatigue. Patient already have chronic fatigue and after receiving the vaccination, it made the chronic fatigue worse/ extremely tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included  chronic fatigue. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced extreme/debilitating fatigue. Patient already have chronic fatigue and after receiving the vaccination, it made the chronic fatigue worse. Patient was extremely tired. Patient called to make sure that the side effect is common. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Headache
Clinical narrative: the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included High Blood Pressure. Concomitant medication included amlodipine for High Blood Pressure. The patient previously took first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and experienced "gum on my right face was swollen". It was reported that patient received the second dose and when she woke up, she had headache and then noticed the gums were swollen but not as big as the first time in Jan2021. No treatment received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; Tiredness and all of that; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient of unspecified age (niece) who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, 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. The consumer's niece got the Pfizer-BioNTech COVID-19 Vaccine and did not have difficulty breathing; but did experience fever, chills, headache, tiredness and all of that on an unspecified date. Outcome of the events was unknown.  Information about Lot/batch no has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Glossodynia, Headache, Oral pain, Oropharyngeal pain
Clinical narrative: Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Headache; Eyes are sore; Soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), via an unspecified route of administration on the upper right arm, first dose at age 84 years on 15Jan2021, at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient had the COVID Vaccination on the 15Jan2021 and he had minor soreness in his arm for 2 days and it went away, it was gone by the 18Jan2021. On 23Jan2021, he started with the symptoms similar to the thrush of the mouth and he went to the doctor 27Jan2021 and they told him it was not thrush because he did not have the white coating in his mouth, and thought it was reaction to the Covid-19 Vaccination (Covid-19 Vaccine by Pfizer) and he has a sore throat and all inside his mouth is sore, his tongue is sore he has headache and his eyes are sore. Patient's doctor told him to take Vitamin C and Vitamin D and Zinc, and he took his first dose this morning 27Jan2021, after breakfast which are Vitamin C and Vitamin D, but he haven't taken the Zinc yet. The outcome of the event soreness in arm was recovered on 18Jan2021, while for the rest of the events, it was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Headache; Eyes are sore; Soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), via an unspecified route of administration on the upper right arm, first dose at age 84 years on 15Jan2021, at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient had the COVID Vaccination on the 15Jan2021 and he had minor soreness in his arm for 2 days and it went away, it was gone by the 18Jan2021. On 23Jan2021, he started with the symptoms similar to the thrush of the mouth and he went to the doctor 27Jan2021 and they told him it was not thrush because he did not have the white coating in his mouth, and thought it was reaction to the Covid-19 Vaccination (Covid-19 Vaccine by Pfizer) and he has a sore throat and all inside his mouth is sore, his tongue is sore he has headache and his eyes are sore. Patient's doctor told him to take Vitamin C and Vitamin D and Zinc, and he took his first dose this morning 27Jan2021, after breakfast which are Vitamin C and Vitamin D, but he haven't taken the Zinc yet. The outcome of the event soreness in arm was recovered on 18Jan2021, while for the rest of the events, it was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia, SARS-CoV-1 test
Clinical narrative: this morning she got fever; she is not feeling; she just had her arm sore last night.; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother-in-law) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing COVID-19 from an unknown date. The patient's concomitant medications were not reported. The patient had COVID 19 and she still tested positive for it. She has had it for like almost two months now and they said that it was probably within her sinuses or something and they said that's why she was testing positive. They told her to go on and get her vaccine because she won't have anymore symptoms. So she went and got the vaccine and tonight she was fine. She just had her arm sore last night and this morning (27Jan2021), she got fever and she was not feeling well, she was feeling really bad. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, lot EZ8982), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included asthma Concomitant medications included montelukast sodium (SINGULAIR), budesonide, formoterol fumarate (SYMBICORT) and adapalene (ADARET). The patient experienced migraine (taking Imitrex as treatment) on an unspecified date. The outcome of event was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I am kind of feeling like hot like feverish; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old male patient received bnt162b2 (BNT162B2 also reported as Pfizer Covid 19 vaccine, lot EL8482), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for Covid-19 immunisation . Medical history was none. There were no concomitant medications. The patient experienced kind of feeling like hot like feverish on 27Jan2021 and took Tylenol as treatment. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever; This is a spontaneous report from a contactable consumer (patients brother).  A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on 28Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), on unknown date for COVID-19 immunization). The brother reported that the patient is currently experiencing high fever, on an unspecified date. The event was reported as non-serious. The patient had tests and procedures which included body temperature: high on unknown date. The clinical outcome of high fever was not recovered.  Information on the lot number has been requested.