chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: At day 10 after receiving the first dose, a large lump, redness,  itching and hotness started at the injection site.  Over the next two days this spread to my elbow and all around to the inside of my arm.  I understand this is known as Covid Arm.  It lasted for a little over a week and has now gone away completely.  I treated it at home with Benadryl and Cortisone cream for the itching.  Did report it to my Oncologist .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Inappropriate schedule of product administration, Influenza like illness, Movement disorder
Clinical narrative: Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: I developed a mild rash on my neck and mild throat swelling for 24 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: arm was sore; arm was sore, muscular; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (lot number: EH9899) via an unspecified route of administration (left arm, also reported as "in left shoulder") on 29Dec2020 around 09:30am at single dose; and the second dose (lot number: EL1283) intramuscular (left arm, also reported as "in left shoulder") on 19Jan2021 around 10:30 at single dose for Covid-19 immunization (also reported as "prevent Covid"). There were no medical history and concomitant medications. The patient confirmed that she received first dose on 29Dec2020, and she received the second dose on 19Jan2021. There were no additional vaccines administered on same date of the Pfizer vaccine. The patient reported that she took the second dose of the Covid vaccine on 19Jan2021 and stated that her husband was diagnosed being positive for Covid. The patient asked if she was exposed to Covid if she will still be asymptomatic. The patient further stated that she feels great and has no side effects from the vaccine. She later clarified that her arm was sore on an unspecified date, and it occurred with both doses. She added that it was just muscular and starting to get better. The patient further reported that yesterday her husband was diagnosed with a positive test for Covid. She added that she works with Hospice patients. She confirmed that she is not a hcp. She just needs to know if it is safe for her to start seeing patients if she has zero symptoms, and if she needs a negative Covid test. There was no treatment received for the adverse event. The outcome of events was recovering.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: itching in hand on arm that she got shot in; swelling in her hand; This is a spontaneous report from a contactable consumer (the patient).  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246, expiration date unknown), via an unknown route of administration (reported as "through a needle") in the left arm, on 18Jan2021 (at the age of 67-years-old) at an unspecified dose for COVID-19 vaccination.  The patient's medical history was not reported. The patient was administered the vaccine in the Health Department. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 19Jan2021 (reported as "last night") the patient experienced itching in hand on the arm that she got the shot in. She stated that she is experiencing swelling in her left hand as well.  The patient described further that it is not itching as bad and stated that after the itching it swelled up. Treatment was reported as having taken Benadryl for the itching. The clinical outcomes of itching in hand was reported as recovering and the clinical outcome of swelling in hand was reported as not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs) received from contactable pharmacists reported for a 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at 0.3 ml, single for covid-19 immunisation. There were no medical history and concomitant medications. The patient received the first dose of the vaccine and then few days later in Jan2021, tested positive for COVID. The patient was scheduled for the second dose this weekend, on Saturday. They wanted to know what the patient should do and if he should get the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Extra dose administered, Fatigue, Influenza like illness
Clinical narrative: For my first dose, I had quite mild symptoms. I woke up with a migraine the next morning and some soreness at the injection site. Both of these lasted a couple of days and were able to be treated with over-the-counter pain medicine. My second dose, however, provided much worse flu-like symptoms. About 12 hours after I received the injection, I was woken with a migraine much worse than the first, nausea, chills, joint pain, sore throat, and fatigue. While the chills and nausea subsided, the other symptoms persisted until the next day. As of today (2/4/21), all symptoms are gone except for soreness at the injection site.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Migraine, Nausea, Oropharyngeal pain
Clinical narrative: For my first dose, I had quite mild symptoms. I woke up with a migraine the next morning and some soreness at the injection site. Both of these lasted a couple of days and were able to be treated with over-the-counter pain medicine. My second dose, however, provided much worse flu-like symptoms. About 12 hours after I received the injection, I was woken with a migraine much worse than the first, nausea, chills, joint pain, sore throat, and fatigue. While the chills and nausea subsided, the other symptoms persisted until the next day. As of today (2/4/21), all symptoms are gone except for soreness at the injection site.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Temperature of 100.1; cough; This is a spontaneous report from a contactable consumer. who is the patient.  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982, expiration date unknown), via an unspecified route of administration in the left arm on 16Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 vaccination.  Medical history included blood pressure, restless leg syndrome, cholesterol, triglycerides, unknown rash, Vitamin B-12 deficiency and Viamin D deficiency. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure, fenofibrate (FENOFIBRATE), doxepin (DOXEPIN), levocetirizine dihydrochloride (XYZAL), clonazepam (CLONAZEPAM), colecalciferol (VITAMIN D3) and cyanocobalamin (VITAMIN D12). It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. The patient stated that she started yesterday, 19Jan2021, with a cough and today, 20Jan2021, the patient developed a temperature of 100.1.  After taking Tylenol "at 12" her temperature was 99.6. She noted that her normal temperature is 96.8. Treatment information included Tylenol. The clinical outcome of cough was not recovered and the clinical outcome of fever was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever/high fever; nausea/urge to throw up; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's parent). A 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever/high fever and nausea on 16Jan2021, the day after receiving the second dose of the Pfizer-Biontech Covid19 vaccine. The patient had the fever in the morning the next day and the urge to throw up. When the fever went away, she felt nauseous. Outcome of the events was recovered on 16Jan2021.  Information on batch/lot number was requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: same day: fatique,headache,fever, next day fever[101] redness at site, dizziness,headache next day ;fatigue,redness down to elbow next symptoms gone except for soreness at site and redness to elbow
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: same day: fatique,headache,fever, next day fever[101] redness at site, dizziness,headache next day ;fatigue,redness down to elbow next symptoms gone except for soreness at site and redness to elbow
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Chills, Dyspnoea, Fatigue, Influenza
Clinical narrative: I had the Pfizer vaccine on Jan 8 and 29 with significantly different side effects. After the first shot, I had a fever blister after 7 days, a pain in my lower spine area after 8 days and an excruciating pain in my right jaw from day 10-12. All symptoms cleared up without treatment. These may or may not have been due to the shot but are unusual for my normal events. After the second shot, hmy symptoms were much worse. I had aches and pains similar to the flu, chills, shortness of breath, a temperature that oscillated between 96.5 and 101.6 degrees, I was quite fatigued and my PulseOx varied between 91 and 97. The PulseOx was also unstable as it changed while the reading was being taken. All of these symptoms seem to be normal side effects but most people don't have them all.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Pain in jaw, Spinal pain
Clinical narrative: I had the Pfizer vaccine on Jan 8 and 29 with significantly different side effects. After the first shot, I had a fever blister after 7 days, a pain in my lower spine area after 8 days and an excruciating pain in my right jaw from day 10-12. All symptoms cleared up without treatment. These may or may not have been due to the shot but are unusual for my normal events. After the second shot, hmy symptoms were much worse. I had aches and pains similar to the flu, chills, shortness of breath, a temperature that oscillated between 96.5 and 101.6 degrees, I was quite fatigued and my PulseOx varied between 91 and 97. The PulseOx was also unstable as it changed while the reading was being taken. All of these symptoms seem to be normal side effects but most people don't have them all.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Fatigue, Feeling abnormal, Influenza like illness, Nausea
Clinical narrative: Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of  nausea and  left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of  nausea and  left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness on arm; This is a spontaneous report from a contactable consumer (reporting for her husband).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had tenderness on his arm, that was it. He didn't experience any other side effects. The clinical outcome of tenderness on his arm was unknown.   Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: broke out in shingles on opposite side; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL9261), via an unspecified route of administration on 15Jan2021 11:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood cholesterol increased and high blood pressure. She takes other stuff for cholesterol and high blood pressure. The patient experienced broke out in shingles on opposite side on 15Jan2021. She was treating it with a steroid shot and taking acyclovir, 5 a day for 7 days and also methyl prednisone and it is a packet and takes 6 a day. Her doctor also gave her a compound to rub on it. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she felt like she got hit by a train after receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2 of 2 reports. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose on an unknown date in Dec2020 (reported as either 15Dec2020 or mid Dec2020) for COVID-19 vaccination.  Relevant medical history was unknown.  Concomitant medications were unknown. On an unknown date in Dec2020, the patient felt like she got hit by a train and laid in bed all day after receiving the COVID-19 vaccine. It was unknown if the patient received any treatment for event, felt like she got hit by a train and laid in bed all day. The clinical outcome of felt like she got hit by a train and laid in bed all day was recovered on an unknown date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Immediately after receiving the vaccine, I had pain at the injection site and swelling that has persisted more than 48 hours later. I experienced chills 24 hours after receiving the vaccine. Then around 8pm on 2/3/2021, I started feeling very nauseous and had a fever of 100.1 F. Now on 2/4/2021, I don't have a fever anymore and I feel fine, but I still have pain and swelling at the injection site.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Immediately after receiving the vaccine, I had pain at the injection site and swelling that has persisted more than 48 hours later. I experienced chills 24 hours after receiving the vaccine. Then around 8pm on 2/3/2021, I started feeling very nauseous and had a fever of 100.1 F. Now on 2/4/2021, I don't have a fever anymore and I feel fine, but I still have pain and swelling at the injection site.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient).  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one.  He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia
Clinical narrative: fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient).  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one.  He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Salivary hypersecretion
Clinical narrative: fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient).  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one.  He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Persistent Dry Cough; This is a spontaneous report from a non-contactable other health professional (HCP). A 41-year-old male patient received the 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 persistent dry cough on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left clavicular lymphadenopathy; This is a spontaneous report from a non-contactable nurse, the patient.  A 38-year-old non pregnant 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 left arm on 13Jan2021 at 09:00 AM (at the age of 38-year-old) as a single dose for COVID-19 immunization. Medical history was none.  The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 10:00 AM, the patient experienced left clavicular lymphadenopathy. No treatment was given for the event.  The clinical outcome of left clavicular lymphadenopathy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pyrexia, Tremor
Clinical narrative: Fever, chills, severe shakes.  Began at 6:00 PM.  Intensified at 8:00 PM (~ 12 hours after shot).  Continued for 5 hours until 3:00 AM.  Prevented sleep.  Following day, minor chills, no major impact.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Vaccination site pain
Clinical narrative: injection site pain; nausea; diarrhea; feeling unwell; This is a spontaneous report from a non-contactable other healthcare professional, the patient.  A 20-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3247, via an unspecified route of administration on 19Jan2021 at 12:30 (at the age of 20 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 20Jan2021 at 08:00AM, the patient experienced injection site pain, nausea, diarrhea, feeling unwell. The patient did not receive treatment for the events. The clinical outcome of injection site pain, nausea, diarrhea, feeling unwell was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vertigo
Clinical narrative: chills; piercing headache; fatigue; vertigo; This is a spontaneous report from a contactable Nurse (patient) A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 13:15 at single dose in left arm for COVID-19 immunisation at the age of 32-year-old. Lot number was ek9231. Medical history included alpha thalassemia, chronic anemia, lactose intolerant, attention deficit disorder (ADD). The patient was not pregnant. Concomitant medications included colecalciferol (VITAMIN D) supplement, multivitamin, escitalopram oxalate (LEXAPRO). The patient had chills, piercing headache, fatigue, and vertigo with first vaccine administration on unknown date. The outcome of the events was unknown. The patient did not have COVID-19 prior to vaccination, and the patient was not COVID-19 test positive post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: stated that she had a headache; stated that she had a little bit of muscle pain; This is a spontaneous report from a contactable consumer, the patient. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 on 19Jan2021 for COVID-19 vaccination.  Relevant medical history was unknown.  Concomitant medications were unknown. On an unknown date, the patient had headache and a little bit of muscle pain. It was unknown if the patient received treatment for the events. The clinical outcome of headache and a little bit of muscle pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches, headache x 3 days, weakness, fatigue, chills
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore  and where she got the shot was a little red, warm, and swollen. There were no relevant tests  done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen  was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous report from a contactable health professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1685), via an unspecified route of administration on 18Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified multivitamin, as well as levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fish oil/tocopheryl acetate (OMEGA 3). The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020 (at the age of 49-years-old) for COVID-19 immunization. On 19Jan2021, the patient experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills was resolved on an unspecified date in Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous report from a contactable health professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1685), via an unspecified route of administration on 18Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified multivitamin, as well as levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fish oil/tocopheryl acetate (OMEGA 3). The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020 (at the age of 49-years-old) for COVID-19 immunization. On 19Jan2021, the patient experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills was resolved on an unspecified date in Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Injection site rash, Injection site vesicles, Rash erythematous
Clinical narrative: diagnosis : delayed cutaneous hypersensitivity  reaction symptoms: red rash on upper right arm with itching and small blisters symptom duration : started on Monday Feb. 1st and symptoms  continue to improve on Feb.4th (day of filling out this form). Only intermittent itching and not as red currently, although the blistering has moved up my arm
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: diagnosis : delayed cutaneous hypersensitivity  reaction symptoms: red rash on upper right arm with itching and small blisters symptom duration : started on Monday Feb. 1st and symptoms  continue to improve on Feb.4th (day of filling out this form). Only intermittent itching and not as red currently, although the blistering has moved up my arm
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: has a bruise further down on his arm/it is just a darker spot than his skin; This is a spontaneous report from a contactable consumer.  A 90-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date (at an unknown age) as a single dose for COVID-19 vaccination.  Medical history was not provided. Concomitant medication included an unspecified blood thinner. It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. On an unspecified date the patient took his first shot and afterward he had a bruise further down on his arm. The reporter stated that it has lightened up on his arm. The reporter clarified that it does not hurt, it is just a darker spot than his skin and the reporter noticed it was there. Treatment information, if any, was not provided. The clinical outcome of bruising of arm was unknown.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Pt accidentally received Pneumovax that was expired in Sep. 2020.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body height, Dizziness postural, Feeling abnormal, Pain in extremity
Clinical narrative: head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she went to sit up and get out of bed/ Her head feels like it is swimming mostly when she gets in and out of bed. When she lays her head down and picks her head up; foggy headed/ floaty heady feeling/ she puts her head down, it is like woah this is strange; arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for 2 patients. This is the first of 2 reports. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiration date: 30Apr2021), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient is taking medication for ongoing blood pressure and ongoing thyroid. Ongoing concomitant medication included metoprolol succinate for blood pressure and levothyroxine sodium (SYNTHROID) for thyroid. She received the vaccine on Saturday 16Jan2021. It went very well. On 16Jan2021, she had a little bit of arm tenderness that lasted for 24-36 hours. Her arm was a little sore. The odd thing is that something took place when she got into bed on Sunday night 17Jan2021 which was 30 hours after the vaccine. Her head started to spin when she put her head down on the pillow. She was very dizzy. She was light headed/ foggy headed. That passed until she went to sit up and get out of bed. It happened again. It has been happening on and off for the last 3 days. She has checked her blood pressure because she is on a low dose blood pressure medicine. Her blood pressure was okay. Everything else seems to be normal. She gets that dizziness for a very short period of time. Her head is not a headache. It is so hard to explain. It is like a floaty heady feeling. She did have a little achiness in her arm. When she puts her head down, it is like woah this is strange. Her head feels like it is swimming. It is mostly when she gets in and out of bed. When she lays her head down and picks her head up. She provided that her height as 5'1" to 5'1.5".  The event arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm recovered on 18Jan2021; outcome for all other events was not recovered.; Sender's Comments: Linked Report(s) same reporter/drug, similar event,  different patient