chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphagia, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling hands and feet; legs are jerking; This is a spontaneous report from a contactable consumer   An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) via an unspecified route of administration, in Arm Right on 20Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included parkinson's disease, cardiac pacemaker insertion and seafood allergy. Concomitant medications were not reported.  The patient received first dose of BNT162B2 (lot number EL1283) on 30Jan2021 at 10:30 on right arm. On 20Feb2021 the patient experienced soreness muscle and joint, stiffness, difficulty swallowing, trouble controlling hands and feet, legs are jerking. All the events were reported as non serious. No treatment was administered for the events. At the time of the reporting the patient had not yet recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling hands and feet; legs are jerking; This is a spontaneous report from a contactable consumer   An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) via an unspecified route of administration, in Arm Right on 20Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included parkinson's disease, cardiac pacemaker insertion and seafood allergy. Concomitant medications were not reported.  The patient received first dose of BNT162B2 (lot number EL1283) on 30Jan2021 at 10:30 on right arm. On 20Feb2021 the patient experienced soreness muscle and joint, stiffness, difficulty swallowing, trouble controlling hands and feet, legs are jerking. All the events were reported as non serious. No treatment was administered for the events. At the time of the reporting the patient had not yet recovered from the events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oxygen saturation decreased
Clinical narrative: Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I got hives on my neck and on the top of my chest; Itching; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiry Date: Jun2021) via unknown route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medication were not reported. Patient stated, "I recently had my shot (clarified as Covid 19 vaccine Pfizer) yesterday, my first one where I go to the site. On the way home I got hives on my neck and on the top of my chest, that was the only place on 13Feb2021. I had no trouble breathing but I was itching on 13Feb2021. Anyway, my concern now was I was trying to find out if I should even think about getting the second shot of the possible, more severe side effects? Treatment was reported as No. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: low grade fever of 100; tired; headache; sore right arm and right shoulder; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) ) via an unspecified route of administration in arm right on 23Feb2021 13:00 (age at vaccination 45 -years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included omeprazole (PRILOSEC) taken for an unspecified indication. The patient previously received first single dose of bnt162b2 on 03feb2021 09:30 AM at right arm as single for Covid-19 immunization (Lot number: EL3247,). On 24Feb2021 05:00 the patient experienced low grade fever of 100 , tired , headache, sore right arm and right shoulder. The events were considered as non serious by the reporter. On 24Feb2021 the patient body temperature was 100.No treatment was given for the events. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm hurting at the injection site; Slight headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9266) via an unspecified route of administration in the left arm on 17Feb2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT), gout, high blood pressure (HBP), high cholesterol, focal segmental glomerulosclerosis (FSGS), rheumatoid arthritis, and penicillin allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient reporting taking concomitant medications. The patient previously received moxifloxacin hydrochloride (AVALOX) from an unknown date for an unknown indication and experienced drug allergy. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient experienced arm hurting at the injection site and a slight headache for a couple days on 18Feb2021 at 06:00. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of arm hurting at the injection site and slight headache were recovered in Feb2021. It was also reported that since vaccination the patient had not been tested for COVID-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) intramuscularly in the left arm on 24Feb2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR DISKUS 250/50) and eletriptan hydrobromide (RELPAX 40 mg), both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm. The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of sore arm was unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Insomnia, Muscle spasms, Pain
Clinical narrative: I got like really sick last night; I couldn't sleep; My body was really hot, I think I had a fever; Chills; Leg cramps; Body aches; Arm is really sore; This is a spontaneous report from a contactable consumer.A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.The patient previously received first single dose of bnt162b2 on 28Jan2021 for Covid-19 immunization. The patient stated she just want to report that she got the vaccine yesterday (confirmed as 17Feb2021) and on 17Feb2021 she got like really really sick last night, she couldn't sleep, her body was really, really hot and then she also had chills with it. So, she think she had a fever but she just didn't have the thermometer to check exactly what it was. And she had really bad leg cramps and body aches and she just felt really sick, she couldn't sleep, her arm is really sore and she just wanted to report it because she know as an employee that is our responsibility to report it. She stated she took Tylenol and Advil last night .She took 1 Advil last night and 1 Tylenol this morning. The outcome of the events were recovering.  Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I got like really sick last night; I couldn't sleep; My body was really hot, I think I had a fever; Chills; Leg cramps; Body aches; Arm is really sore; This is a spontaneous report from a contactable consumer.A 25-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.The patient previously received first single dose of bnt162b2 on 28Jan2021 for Covid-19 immunization. The patient stated she just want to report that she got the vaccine yesterday (confirmed as 17Feb2021) and on 17Feb2021 she got like really really sick last night, she couldn't sleep, her body was really, really hot and then she also had chills with it. So, she think she had a fever but she just didn't have the thermometer to check exactly what it was. And she had really bad leg cramps and body aches and she just felt really sick, she couldn't sleep, her arm is really sore and she just wanted to report it because she know as an employee that is our responsibility to report it. She stated she took Tylenol and Advil last night .She took 1 Advil last night and 1 Tylenol this morning. The outcome of the events were recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Eczema, Hepatic cyst, Osteoporosis, Renal cyst
Clinical narrative: Eczema; osteoporosis; hair loss; I have a cysts in my kidneys and liver; I have a cysts in my kidneys and liver; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced eczema, osteoporosis, and hair loss. I use special shampoo for my scalp. I have a cysts in my kidneys and liver on an unspecified date. Therapeutic measures were taken as a result of hair loss and included treatment with special shampoo. The outcome of the events was reported as unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He received first Pfizer vaccine and then developed covid; He received first Pfizer vaccine and then developed covid; This is a spontaneous report received from a contactable consumer (patient wife). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration Date: Not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient received first Pfizer vaccine and then developed COVID on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid Virus after receiving the 1st dose; got covid Virus after receiving the 1st dose; This is a spontaneous report received from a contactable consumer (patient wife) via a Pfizer-sponsored program . This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that, the patient got covid Virus after receiving the first dose of vaccine on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195278 same reporter/drug/event, different patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: My sugar has spiked; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6201), via an unspecified route of administration administered in arm right on 22Jan2021 (at the age of 75-years-old) as single dose for covid-19 immunisation. Medical history included diabetes for years, blood pressure/high blood pressure for years, cholesterol, and Afib (atrial fibrillation). Concomitant medications included amlodipine taken for blood pressure; losartan potassium taken for blood pressure; carvedilol (CARVIDIL) taken for high blood pressure (unsure how long she has been taking it); isosorbide taken for blood pressure; furosemide (20 mg) taken for water pill; rosuvastatin calcium (CRESTOR) taken for cholesterol; spironolactone taken for blood pressure; eicosapentaenoic acid ethyl ester (VASCEPA) taken for fish oil; apixaban (ELIQUIS) taken for Afib; insulin glargine (LANTUS) taken for diabetes; semaglutide (OZEMPIC) taken for diabetes. Consumer stated, she had the COVID Vaccine of Pfizer on the 22nd, 2 days ago and she had noticed her sugar has spiked in Jan2021. It was this possibly from the shot. Originally called to report that her blood sugars were spiking after taking the Pfizer Covid vaccine. It did not have any new events to report. Patient stated she (social media withheld) it and read that the Pfizer shot can trigger increased blood sugar, wanted to know if this was true. Patient stated she had been on all of her concomitant medications for a while. Treatment: Consumer stated she was taking semaglutide (OZEMPIC), 0.5 mg, once a week and she thought it was insulin glargine (LANTUS), '8 mg' once a day.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyshidrotic eczema, Movement disorder
Clinical narrative: lost part of mobility in the small finger of the right hand, can't lift it all the way above; wrist pain and it locked; little bumps on the back of her hand; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: Not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has had both doses of the covid vaccine. On an unspecified date in Jan2021, she experienced wrist pain and it locked up. There were a little bump on the back of her hand and lost mobility in the little finger of her right hand. The outcome of the events was reported as unknown.  Information on the lot batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Not reported), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received 1st dose of COVID vaccine in Jan2021 then tested positive for COVID on 10Feb2021. He was wondering what to do about 2nd dose. The outcome of the events was reported as unknown.  Information about lot/Batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Not reported), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received 1st dose of COVID vaccine in Jan2021 then tested positive for COVID on 10Feb2021. He was wondering what to do about 2nd dose. The outcome of the events was reported as unknown.  Information about lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus, Urticaria
Clinical narrative: headache; arm was sore; whole body was itchy all over; hives; This is a spontaneous report from a contactable consumer (patient) from sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, arm was sore, she got 2 hives and whole body was itchy all over. The events were considered as non-serious. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Body temperature increased, Diarrhoea haemorrhagic, Muscle spasms
Clinical narrative: diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was  Health Department. The outcome of the events were recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: diarrhea w/ bright red blood; Severe stomach cramping; extreme nausea; back cramps; temp range 97.4 - 99.4; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 09:30 (lot number: EN6204) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, migraines, and thyroid disorder. The patient's concomitant medications included cyclobenzaprine, levothyroxine, telmisartan (TELMI), and topiramate (TROKENDI XR). The patient previously took erythromycin and morniflumate (FLOMAX) and experienced allergies to both. The patient experienced severe stomach cramping, diarrhea with bright red blood, extreme nausea, back cramps, temperature range 97.4 - 99.4, so sick and she had to lay on bathroom floor throughout night on 10Mar2021 20:00. There was no other vaccine in four weeks. The patient was not pregnant at the time of report. Prior to vaccination, patient has no COVID and patient was not tested for COVID post vaccination. The vaccination facility type was  Health Department. The outcome of the events were recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive to covid-19; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program - General Company Information.  A male consumer received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 22Jan2021, the patient tested positive to covid-19. On 23Jan2021, the patient had the Bamlanivimab infusion antibody drug against covid-19. When the patient went back to the hospital to get the scheduled second shot of the suspect vaccine, the patient mentioned that he had the infusion. At the site, they told patient that due to the infusion, he had to wait 90 days. The outcome of the event was unknown. Information about Lot/Batch number is requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neuropathy peripheral, Paraesthesia
Clinical narrative: tingling in face and fingertips; heightened neuropathy in feet; Headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6703) via an unspecified route of administration, administered into the left arm on 09Mar2021 17:00 as a single dose for COVID-19 immunisation. Medical history included guillain-barre syndrome survivor and breast cancer survivor. Patient was not pregnant. Concomitant medications included levothyroxine sodium (LEVOXYL),  hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN+HCTZ/MYLAN) and letrozole (LETROZOLE). On 09Mar2021, patient experienced headache and fatigue. On 10Mar2021, she had heightened neuropathy in feet. On 12Mar2021, she experienced tingling in face and fingertips. The patient did not receive treatment for the events reported. Outcome of events was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Intermittent, indescribable cool feeling in chest,was feeling odd; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6206 and expiration date was not reported) via unknown route of administration on left arm on 08Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) for two weeks. Past drug medication included Codeine and experienced Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 patient had intermittent, indescribable cool feeling in chest and was feeling odd. As a result, patient had doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse events. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Nodule, Pyrexia
Clinical narrative: Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pain/ Large golf ball size nodule on collar bone (lymph gland?); Fever 101 for 3 days; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FN6198 or EN6198 and Expiration date were not provided) on 02Mar2021 15:15 via unspecified route of administration in left arm at SINGLE DOSE for COVID-19 immunization. The patient's medical history included stage 4 metastatic breast cancer, allergies to Penicillin and Cephalexin. The patient's concomitant medications included palbociclib (IBRANCE), letrozole and cetirizine hydrochloride (ZYRTEC). On 07Mar2021, the patient experienced cellulitis in left arm, painful spots in arm as if a bruise but not bruised but knots in arm where there was pain, bright red in left arm and felt hot from elbow to hand, severe swelling of left arm from elbow to hand, peeling of skin on left forearm, large golf ball size nodule on collar bone (lymph gland), fever 101 for 3 days and headache. The patient visited doctor or other healthcare professional office due to events and treated with antibiotics. The patient did not take other vaccine in four weeks. The patient did not have Covid prior to vaccination and not tested post vaccination. At time of report, the patient was recovering from all the events.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pain/ Large golf ball size nodule on collar bone (lymph gland?); Fever 101 for 3 days; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FN6198 or EN6198 and Expiration date were not provided) on 02Mar2021 15:15 via unspecified route of administration in left arm at SINGLE DOSE for COVID-19 immunization. The patient's medical history included stage 4 metastatic breast cancer, allergies to Penicillin and Cephalexin. The patient's concomitant medications included palbociclib (IBRANCE), letrozole and cetirizine hydrochloride (ZYRTEC). On 07Mar2021, the patient experienced cellulitis in left arm, painful spots in arm as if a bruise but not bruised but knots in arm where there was pain, bright red in left arm and felt hot from elbow to hand, severe swelling of left arm from elbow to hand, peeling of skin on left forearm, large golf ball size nodule on collar bone (lymph gland), fever 101 for 3 days and headache. The patient visited doctor or other healthcare professional office due to events and treated with antibiotics. The patient did not take other vaccine in four weeks. The patient did not have Covid prior to vaccination and not tested post vaccination. At time of report, the patient was recovering from all the events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Eye swelling, Headache, Lip swelling
Clinical narrative: severe body aches; headaches; running a temperature 101.8F; swelling in her bottom lip and eye area; wasn't feeling well after receiving the second dose; swelling in her bottom lip and eye area; This is a spontaneous case received from a contactable consumer. A 27-year-old female patient  received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration on 18 Mar 2021 as single dose for covid-19 immunisation. The patient medical history included fibromyalgia. The patient concomitant medications were not reported. The patient was wasn't feeling well after receiving the second dose of Pfizer's COVID vaccine on 18 Mar 2021. She is having severe body aches, headaches (head pressure), and is running a temperature 101.8F, and swelling in her bottom lip and eye area. She was taking children's strength acetaminophen chewable and has taken a few doses today. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: severe body aches; headaches; running a temperature 101.8F; swelling in her bottom lip and eye area; wasn't feeling well after receiving the second dose; swelling in her bottom lip and eye area; This is a spontaneous case received from a contactable consumer. A 27-year-old female patient  received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration on 18 Mar 2021 as single dose for covid-19 immunisation. The patient medical history included fibromyalgia. The patient concomitant medications were not reported. The patient was wasn't feeling well after receiving the second dose of Pfizer's COVID vaccine on 18 Mar 2021. She is having severe body aches, headaches (head pressure), and is running a temperature 101.8F, and swelling in her bottom lip and eye area. She was taking children's strength acetaminophen chewable and has taken a few doses today. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: soreness in the tongue; This is a spontaneous report received via Medical information team from contactable consumer (patient herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 19Mar2021 at single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that patient got the first dose of the Pfizer COVID-19 vaccine today and about 40 minutes after getting injected, she developed soreness in the tongue on 19Mar2021. She emphasized that it wasn't swelling but only soreness. She said that she was sure that it came from the vaccine because she was fine before coming in the vaccination centre. Outcome of the event of soreness in the tongue was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Hypoacusis
Clinical narrative: she felt weak; arm swelled and hurt; arm swelled and hurt; light headedness; fast pulse; had a hard time hearing; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021, the patient got the second dose of vaccine and early evening of that day, her arm swelled and hurt. On 16Mar2021, she felt weak and stayed in bed the whole day. On an unspecified date in Mar2021, she experienced light headedness, fast pulse, and had a hard time hearing. The patient just called to report these events and wanted to know how long would her reactions would last. At the time of report, the outcome of the event arm hurt was recovered on an unspecified date in Mar2021; while the other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: she felt weak; arm swelled and hurt; arm swelled and hurt; light headedness; fast pulse; had a hard time hearing; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021, the patient got the second dose of vaccine and early evening of that day, her arm swelled and hurt. On 16Mar2021, she felt weak and stayed in bed the whole day. On an unspecified date in Mar2021, she experienced light headedness, fast pulse, and had a hard time hearing. The patient just called to report these events and wanted to know how long would her reactions would last. At the time of report, the outcome of the event arm hurt was recovered on an unspecified date in Mar2021; while the other events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: does not feel good; hives on her neck that itched; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated right after she had the shot she had just a couple hives on her neck that itched but they went right away. She stated she took a Benadryl the night before so she thinks this is why it went away. She did not feel good for probably two weeks. The outcome of the event hives on her neck that itched was recovered and the outcome of the other event was unknown.    Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle twitching, Paraesthesia
Clinical narrative: feeling dizzy; tingling sensation and twitching sensation that comes and goes; tingling sensation and twitching sensation that comes and goes; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE; Formulation: Solution for injection, lot number and Expiration date were not provided) on 04Mar2021 (also reported as 16 days ago) via unspecified route of administration at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021 (also reported as last night) the patient experienced feeling dizzy and a tingling sensation and twitching sensation that comes and goes. There was side effect mentioned. There was no PQC present. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle strain
Clinical narrative: back pain; strained her muscle; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer or other non hcp reported that a female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 02Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included muscle strain from 23Mar2021 to 23Mar2021. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced back pain, strained her muscle. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a contactable consumer (Patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unknown date in Mar2021, at single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced swollen lymph nodes. The event was considered as non-serious. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the second dose of vaccine/2-3 days later, she tested positive for COVID/strong chance she was positive for COVID before getting the second dose; received the second dose of vaccine/2-3 days later, she tested positive for COVID/strong chance she was positive for COVID before getting the second dose; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), doses 1 and 2 via unspecified routes of administration on unspecified dates (batch/lot numbers were not reported) (at 56 years old) as single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the second dose of vaccine. 2-3 days later, she tested positive for COVID. It was reported that there was a strong chance she was positive for COVID before getting the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 with a rapid test/asymptomatic at the time of the test and for the 10-day period of isolation; tested positive for COVID-19 with a rapid test/asymptomatic at the time of the test and for the 10-day period of isolation; This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 27Dec2020 10:30 (Batch/Lot Number: EL1284) as a single dose for COVID-19 immunization. Medical history included hypertension, osteopenia, retinal pucker, high cholesterol, and coronary artery disease. Concomitant medications included spironolactone, hctz, atorvastatin, ezetimibe (ZETIA), and hydrochlorothiazide, lisinopril dihydrate (LISINOPLUS). Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. On 21Feb2021 11:00, patient underwent COVID-19 test (nasal swab; rapid test) with result positive in the ER at the hospital. Patient was asymptomatic at the time of the test and for the 10 day period of isolation. Patient recovered from the events on an unspecified date. No treatment received for the events. Case reported as non-serious. Seriousness criteria - results in death, life threatening, disabling/incapacitating, congenital anomaly/birth defect: no, caused/prolonged hospitalization: yes.; Sender's Comments: The reported positive Covid 19 test is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration. However, full immunity is expected 7 days after the 2nd dose.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves male patient (age not reported) who got sick (illness), after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and epirydate not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.