chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Got vaccine 5 days ago (1/7), fever since 11Jan; Second dose on day 24; This is a spontaneous report from a contactable pharmacist reporting for himself. A 25-years-old male patient received the second dose of bnt162b2 (BNT162B2) vaccine, in the left arm on 07Jan2021 18:00 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient received the first dose of BNT vaccine on 14Dec2020. The patient  got vaccine 5 days ago (1/7), fever since 11Jan  on 11Jan2021 with outcome of not recovered. The patient received the second dose on day 24.   The patient underwent lab tests and procedures which included body temperature: 100.3°F   on 12Jan2021.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling of body temperature change
Clinical narrative: She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold and hot feeling on [her] body; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced delayed symptoms after the first injection of the COVID-19 vaccine, received on 06Jan2021. Patient explained feeling fine the first three days post injection, and later on 09Jan2021 having "chills" and weakness. She then described her experience as "cold and hot feeling on her body". She felt good, her breathing was okay. Her oxygen and everything was okay. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting.  The reporter considered that the event was non-serious.   No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lymph node pain, Paraesthesia oral, SARS-CoV-2 test, Sensory loss
Clinical narrative: Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Lip swelling, Swelling face
Clinical narrative: My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging neck, Muscular weakness
Clinical narrative: right hand weakness (no sensory loss) in a multi-focal distribution (radial, ulnar) - C8. Sensation and reflexes intact; This is a spontaneous report from a contactable physician. A male patient of unspecified age (Cardiologist) received 2 single doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified dates, for COVID-19 immunization. Medical history and concomitant medications were not reported. During the next four days after the second vaccine dose, since an unspecified date, the patient developed right hand weakness (no sensory loss) in a multi-focal distribution (radial, ulnar) - C8. Sensation and reflexes were intact. MRI of the cervical spine was unrevealing. EMG/NCV study was being scheduled. Event outcome was unknown. Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Oligomenorrhoea
Clinical narrative: My menstrual cycle has always been regular, this time around it came 8 days late; but now I've been spotting bright red blood for 5 days after my period; This is a spontaneous report from a contactable Nurse (patient). The 42-years-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, lot number: EH9899), intramuscular on left arm on 20Dec2020 19:45 at single dose for covid-19 immunisation. Medical history was none. The patient did not receive other vaccine in four weeks. No Covid prior vaccination, No Covid tested post vaccination, No Known allergies. The patient's concomitant medications were not reported. It was reported "My menstrual cycle has always been regular, this time around it came 8 days late, which didn't concern me, but now I've been spotting bright red blood for 5 days after my period, which NEVER happens. My tubes are tied so I shouldn't be pregnant." The event was onset on 07Jan2021. No treatment received. The patient did not recover from the event.  No follow-up attempts possible. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Costovertebral angle tenderness, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Myalgias; Arthralgias; Costovertebral angle tenderness; Fatigue; This is a spontaneous report received from a contactable physician. A 30-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, in left arm, on 11Jan2021 at 18:45, for COVID-19 immunization. The patient received the first vaccine dose on 21Dec2020 at 16:00, intramuscular, in right arm, for COVID-19 immunization. No other vaccine was given in 4 weeks. The patient's medical history was none. The patient had no COVID before vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). On 12Jan2021 at 13:00 the patient experienced fever, myalgias, arthralgias, costovertebral angle tenderness and fatigue. COVID was not tested after vaccination. No treatment was given. The events were resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: the patient had headaches; This is a spontaneous report from a contactable Physician(patient). A 32-year-old male patient received first dose BNT162B2 (lot number EK5730) , via an unspecified route of administration at Arm Left on 18Dec2020 09:00 at the 32 years old at single dose for COVID-19 immunization.  The medical history was not reported. The patient was not Allergic to medications, food, or other products. There were none concomitant medications. Following the first COVID vaccine dose on 18Dec2020, the patient had headaches that started on the third day 21Dec2020 and ended on the tenth day on 28Dec2020. The patient received medication as treatment for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab on 10Jan2021 Negative. The outcome of the event was recovered.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Fever; chills; headache; joint pain; This is a spontaneous report from a contactable nurse(patient). A 18-year-old female patient received first dose BNT162B2, intramuscular at Arm Left on 11Jan2021 14:00 at the 18 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported.   On 11Jan2021 17:00 the patient experienced Fever, chills, headache and joint pain.There was no treatment received for the adverse events. The patient had no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was Not recovered.   Information about Lot/Batch has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pyrexia
Clinical narrative: 100.4 F temperature; swollen lymph node in armpit of injection arm; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at right arm on 11Jan2021 at 07:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 11Jan2021 at 23:30, The patient experienced 100.4 F temperature and swollen lymph node in armpit of injection arm. The patient outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Throwing up; body ache; feeling feverish; sweating; chills; headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).   This 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot # EK4176), intramuscular, on 12Jan2021 at 05:45 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. No other vaccine was received in four weeks. Medical history included anemia, possible COVID in Mar2020, obgyn related health conditions. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot # EL1284), intramuscular left arm, on 22Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 24 years old for both doses. Concomitant medications were unknown. On 13Jan2021 at 04:00 AM, the patient experienced throwing up, body ache, feeling feverish, sweating, chills, headache. No treatment was received for the event. Outcome was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up; body ache; feeling feverish; sweating; chills; headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient).   This 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot # EK4176), intramuscular, on 12Jan2021 at 05:45 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. No other vaccine was received in four weeks. Medical history included anemia, possible COVID in Mar2020, obgyn related health conditions. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot # EL1284), intramuscular left arm, on 22Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 24 years old for both doses. Concomitant medications were unknown. On 13Jan2021 at 04:00 AM, the patient experienced throwing up, body ache, feeling feverish, sweating, chills, headache. No treatment was received for the event. Outcome was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia, Nasal discomfort, Vaccination site pain
Clinical narrative: Loss of sense of taste and smell; Loss of sense of taste and smell; High pressure feeling in his nose; Injection site pain; Muscle soreness; This is a spontaneous report from a non-contactable Other HCP. A 23 year old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine) lot number not reported, via an unspecified route of administration on 11Jan20201 11:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Jan2021 the patient experienced, within half hour from vaccine administration, injection site pain and muscle soreness both with outcome of unknown. On 13Jan2021 he experienced loss of sense of taste and smell, mixed with high pressure feeling in his nose with outcome of unknown. The patient reported that "with loss of taste and smell, what is my next step, do I stay home, do I go back to work, what do I do. My work wants to know if I can come back or not. I also know someone that I work with that had a metallic taste in his mouth". The action taken was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive after taking the 1st dose; Tested positive after taking the 1st dose; This is a spontaneous report from a contactable physician via a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient tested positive after taking the 1st dose and about to get the 2nd dose on 12Jan2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "test positive after taking the 1st dose".
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: he was tested positive 9 days later; he was tested positive 9 days later; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient got his 1st dose of Covid-19 Vaccine last 22Dec2020. He said that he has tested positive 9 days later which was on 31Dec2020. He was asking if he could get the 2nd dose of vaccine tomorrow or should he wait for the scheduled vaccine which was 3 weeks later, since he mentioned that it has been 12 days since he was tested positive. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: The patient had his initial shot of the Pfizer COVID Vaccine, then tested positive for COVID-19; The patient had his initial shot of the Pfizer COVID Vaccine, then tested positive for COVID-19; He and his work partner both work up feeling awful the next day with all the side effects that can possible happen; Their arms killed them for about a day; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on arm on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had his initial shot of the Pfizer COVID Vaccine, then tested positive for COVID-19. It was reported the patient and his work partner both work up feeling awful the next day with all the side effects that can be possible happen. His work partner he was speaking of also tested positive as well. As the patient work partner woke up with 103 fever, so the patient got tested because of him, since they shared a station for 24 hours. The other symptoms they experienced were that they felt like they got shot in the arm. Their arms killed them for about a day. The outcome of the event was unknown. Lot and batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electrocardiogram, Hyperhidrosis, Loss of personal independence in daily activities, Magnetic resonance imaging neck
Clinical narrative: joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No.  Information on the Lot/Batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal, Muscle spasms, Musculoskeletal chest pain, Pain in extremity, X-ray
Clinical narrative: joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: has some soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got her shot yesterday (11Jan2021) and had some soreness in the arm but that was it. The outcome of the event was unknown.  Information on the lot/Batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Chest discomfort, Insomnia, Mammogram, Ultrasound scan
Clinical narrative: wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all that night; Breast discomfort/describes the breast discomfort as a contracting feeling of encapsulation; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) injection intramuscularly in right arm on 21Dec2020 around 11:00 am at a single dose of COVID-19 immunization. Vaccination facility type was at medical center. Relevant medical history included acne, migraine, and chronic neck and upper back pain; all were ongoing, and breast implant, tennis elbow in left arm and she had the flu shot in Oct but she never got any reaction. She thought a side effect of spironolactone. Concomitant medications included rizatriptan benzoate (MAXALT, strength: 5mg, tablet) at 5mg tablet as needed for migraine, naproxen sodium (ALEVE, strength: 500mg, tablet) at 500 mg tablet, one tablet as needed for pain, and spironolactone (strength: 5mg tablet) (if her skin was breaking out she will take two tablets that night and if her face was not bad she will take one tablet) from Aug2020 for acne, breaking out; all were ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations were reported as none. On 26Dec2020 she started feeling breast discomfort. She described the breast discomfort as a contracting feeling of encapsulation, reported it kept her up at night, she would have a heard time falling asleep or get no sleep at all that night. Her breast comfort started to lessen. The patient was breast discomfort or tenderness but she did not experience any breast discomfort till after she got the covid vaccine. She stated the breast discomfort was like a feeling that something was crawling inside, states it is like creepy crawlers. She also experienced a wet and cold sensation on her chest on 29Dec2020 and was still occurring once in a while, intermittently. At first it was just on the left breast, and the next night she felt the sensation across her chest, it felt like she spilled water and felt wet but it was not wt. She felt it while she was bed. She had breast implants. Last week she contacted her primary care doctor and she was sent to get a mammogram and ultrasound. She went to have the mammogram and ultrasound on Friday 08Jan2021 and everything was fine. She was thinking what she was experiencing was from the vaccine. The patient declined any treatment. No emergency room and no physician office required for the events. The outcome of event breast discomfort was resolving, of wet and cold sensation on chest was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient's husband). This reporter reported similar events for two patients. This is 2nd of 2 reports. A 77-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 11Jan2021 12:00 PM at single dose for covid-19 immunisation. Patient's medical History and family medical history was none. No additional vaccines administered on same date of COVID vaccine. No other vaccines were received within 4 weeks prior to the first administration date of COVID vaccine. The patient's concomitant medications were none.The patient got the Pfizer Covid-19 vaccine yesterday and had sore arm on12Jan2021. The patient's soreness in arm didn't start until this morning, 24 hours later. It's not a real big problem for her and it's getting better and almost gone. The outcome of the event was recovering.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026388 same reporter/product/Event, different patient.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged supraclavical lymph node enlargement on same side as vaccine dose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot 5730, expiration date unspecified), intramuscular on 21Dec2020 13:30 at single dose (left arm) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On an unspecified date, after initial dose, the patient experienced enlarged supraclavical lymph node enlargement on same side as vaccine dose 24 hours later and lasted 17 days. There was no treatment for the event. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Outcome of event was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report from a contactable nurse for self. A 65-year-old female patient received second shot of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on Right deltoid on 12Jan2021 12:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Patient received first bnt162b2 on unknown date. Concomitant medication included apixaban (ELIQUIS). The patient experienced blurred vision on 13Jan2021 morning. Was holding something and couldn't read it. Wears contacts and usually has sharp vision. Had to keep adjusting and holding what she was looking at. Outcome of event was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  blurred vision due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Speech disorder, Vomiting
Clinical narrative: throwing up; Sweating; Lightheaded; the patient can barely speak to her/she just whispered it; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC9231, expiry date Apr2021), intramuscular in the left arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from 13Apr2020 and she got a plasma donation, in Apr2020 because she was not in good shape when she had COVID. There were no concomitant medications. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. The reporter said that the patient's doctor told her to still get the COVID vaccine and on 10Jan2021, she had been throwing up, sweating, and lightheaded and these were the side effects with the second dose. The caller stated that no one else had side effects like these. It was reported that the patient had no other family and the reporter felt really bad for the patient and wanted to get her some sort of information. The patient said that she was feeling a little better than she did last night, but she was laying in bed. The patient's symptoms started yesterday 10Jan2021, the next day after receiving the vaccine. The reporter said that the patient can barely speak to her. She said that the patient said that she was feeling a little better, but she just whispered it. The reporter asked if it was because the patient had antibodies. Clinical outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the eleventh (11th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A 79 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) on 05Jan2021, for COVID-19 immunization. Medical history and concomitant medications were none. On 11Jan2021 the patient was tested positive for COVID 19. He was sick before then but did not get tested until 11Jan2021. Events outcome was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. He was sick before then but did not get tested until 11Jan2021.,Linked Report(s) : US-PFIZER INC-2021021527 same reporter/drug/AE, different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: arm was inflamed, and so swollen; arm was inflamed, and so swollen; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2, 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. Patient had a reaction after the vaccine. The first vaccine her arm was inflamed, and so swollen, she couldn't move it. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Headache, Middle insomnia
Clinical narrative: severe headache; felt really tired; got up in the middle of the night; muscle aches; her temperature rose to 99.9°F; This is a spontaneous report from a contactable nurse reported for herself .   This female patient of an unspecified age received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 11Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, felt really tired, got up in the middle of the night, muscle aches, her temperature rose to 99.9°F, all in Jan2021 with outcome of recovered on an unspecified date in Jan2021. The events were described as follows: She had the second dose of the COVID-19 vaccine on 11Jan2021. Twelve hours later, she had a severe headache and felt really tired. She also got up in the middle of the night and laid on the floor for a while. She had muscle aches and her temperature rose to 99.9°F. All came back to normal after a lot of water and plenty of rest.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe headache; felt really tired; got up in the middle of the night; muscle aches; her temperature rose to 99.9°F; This is a spontaneous report from a contactable nurse reported for herself .   This female patient of an unspecified age received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 11Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache, felt really tired, got up in the middle of the night, muscle aches, her temperature rose to 99.9°F, all in Jan2021 with outcome of recovered on an unspecified date in Jan2021. The events were described as follows: She had the second dose of the COVID-19 vaccine on 11Jan2021. Twelve hours later, she had a severe headache and felt really tired. She also got up in the middle of the night and laid on the floor for a while. She had muscle aches and her temperature rose to 99.9°F. All came back to normal after a lot of water and plenty of rest.   Information on the batch/lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Conjunctivitis viral, Oral herpes, Pyrexia
Clinical narrative: viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: chills; extreme fatigue; fever of 102.9 for 12 hours; body aches; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot EL1284) intramuscular in Left arm on 11Jan2021 at 18:00 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, endometriosis, polycystic ovarian syndrome (PCOS). Known allergies to latex, and past drug allergy to levothyroxine and armour thyroid. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EH9899) on 21Dec2020 at 18:00 intramuscular in Left arm at single dose for COVID-19 immunization.The patient's concomitant medications were not reported.  On 12Jan2021, within 24 hours of her second COVID-19 vaccination, the patient started with chills, then fever of 102.9 for 12 hours, extreme fatigue and body aches, when fever broke the headache started. She was feeling better by the following morning, so it was approximately 24 hours of symptoms that started approximately 24 hours after the 2nd vaccine. The final outcome of the events was reported as recovered on 13Jan2021, without treatment administration.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; extreme fatigue; fever of 102.9 for 12 hours; body aches; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot EL1284) intramuscular in Left arm on 11Jan2021 at 18:00 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, endometriosis, polycystic ovarian syndrome (PCOS). Known allergies to latex, and past drug allergy to levothyroxine and armour thyroid. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EH9899) on 21Dec2020 at 18:00 intramuscular in Left arm at single dose for COVID-19 immunization.The patient's concomitant medications were not reported.  On 12Jan2021, within 24 hours of her second COVID-19 vaccination, the patient started with chills, then fever of 102.9 for 12 hours, extreme fatigue and body aches, when fever broke the headache started. She was feeling better by the following morning, so it was approximately 24 hours of symptoms that started approximately 24 hours after the 2nd vaccine. The final outcome of the events was reported as recovered on 13Jan2021, without treatment administration.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Headache
Clinical narrative: Headache; Muscle soreness/ muscle soreness and knots; Muscle soreness/ muscle soreness and knots; Severe joint pain; Muscle tightness; Chest pain; Moderate chills; Exhaustion; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on right arm on 11Jan2021 06:30 at single dose for COVID-19 immunisation. Medical history included nail patella syndrome. Concomitant medication included ethinylestradiol, levonorgestrel (LESSINA), escitalopram. There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient previously took amoxicillin and experienced allergies. The patient received the first dose of BNT162B2 (Brand: Pfizer, Lot number: EH9899) on right arm on 21Dec2020 16:00 PM for COVID-19 immunisation. First dose came with moderate muscle fatigue and joint pain, chills, headache and fatigue.  Events occurred 7 days post vaccination. Second dose had almost immediate side effects beginning post vaccination beginning with headache, then muscle soreness. Followed by severe joint pain and muscle tightness, including chest pain. Moderate chills. Exhaustion. Both instances were elevated with ibuprofen, water, and a night's rest. Upon waking after second dose side effects, muscle soreness and knots probably from muscle tightness night before. A muscle relaxant might have helped. All events started from 11Jan2021 17:00. No treatment received for muscle tightness and muscle disorder, treatment was received for the other remain events. The outcome of the event was recovering.