chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: on 26Jan2021 tested positive for covid; on 26Jan2021 tested positive for covid; This is a spontaneous report from a contactable consumer (one is patient herself) via Pfizer-sponsored program and via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: not reported) on 12Jan2021 via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medication was not reported. On 26Jan2021, the patient underwent COVID-19 (Nasal Swab) and was tested positive for covid virus. She was supposed to get the second dose on 02Feb2021, but she missed it due to contracting the virus, so she is asking does she still need to get the second vaccine. She has not called before, read social media. A Consumer calls for information about if she should be administered with the second dose of the vaccine considering that she is recovering from COVID-19 infection. The Consumer reports that she tested positive for COVID-19 on 26Jan2021 after she received the first dose of the vaccine on 12Jan2021. The outcome of the events was reported as recovering.  Information on the lot/batch number has been requested
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable Other HCP (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: EL1283 and EL9261) via an unspecified route of administration on 14Jan2021, 02:45 AM and 04Feb2021, 02:45 AM at single dose in the left arm for COVID-19 immunization. The patient's medical history included allergy of Bac-trim. Concomitant medications was not reported. It was reported that the patient had not received other vaccine in four weeks and had received other medications in two weeks. The patient was not tested for Covid prior vaccination. The patient was not tested for Covid-19 post vaccination. The patient experienced hives for 24 hours 10 days after the first dose and hives for 48 hours, 3 days after the second dose which was on 07Feb2021. Treatment medications included loratadine and hydrocortizone cream. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, healthcare professional (HCP) caller was calling on behalf of her patient. Patient received the first dose on 15Jan2021 but tested positive for COVID on the 20Jan2021 and the patient was scheduled tomorrow for the 2nd dose. Caller wants to know if the patient can still take the 2nd dose. HCP caller said several patients experienced after taking first dose they would be tested positive for COVID then they would take monoclonal antibody infusion to reduce the risk of complications. HCP wants to clarify if they should take the 2nd dose. The caller said her first patient got the first dose of vaccine then got tested positive, then the call got disconnected. The outcome of the event was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Has just tested positive for covid virus; high fever; wasn't feeling well; headache; This is a spontaneous via medical information team. A contactable consumer (patient) reported that a 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan20021 at single dose for COVID-19 immunization. The patient medical and concomitant medications were not reported. The patient got first dose of the Pfizer covid vaccine on 26Jan2021 and came down with a headache on 26Jan2021, was running a high fever, wasn't feeling well on 29Jan2021 on the weekend. tested positive for covid virus on the 01Feb2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: middle finger is swollen; her left hand started giving her a lot of pain on her middle finger and the fingers on either side of the middle finger; she can't fully grip like she usually did previous to that; middle finger is stiff she can't bend it all the way or straighten it all the way; This is a spontaneous report from a contactable consumer (patient) reported for self via Medical Information Team. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249 and Expiry date: May2021), via unspecified route of administration on Left arm on 18Jan2021 at a single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient reported that, she originally got the first vaccine in Jan. She is trying to find her paper with the dates on it. She says she got it on 18Jan2021 and she knows joint discomfort is one of the things she saw on the paperwork. She was okay until 27Jan2021 then her left hand started giving her a lot of pain on her middle finger and the fingers on either side of the middle finger and it still sore she can't fully grip like she usually did previous to that on 27Jan2021. She wondered if that could be a symptom or something from the vaccine. She contacted her hospital and it had a recording that said if this is an emergency go to the ER if it is something else call your family which she did doctor but she is wondering she has the second dose and she is wondering if she should go ahead and get the second dose she feels like they will probably put it in her left arm again. she uses her hands every day to work and that is a concern. She says it was pain in her middle finger, it was swollen and the fingers on either side and they were hard to open and close and it is ongoing at this time on 27Jan2021. It feels little better at times then it starts hurting again. It is not as bad as the first day it started but her middle finger is stiff she can't bend it all the way or straighten it all the way on 27Jan2021. She is very healthy she has had no other issues with it. Nothing else has happened to her hand. She was just at work one day the 27Jan2021 and she could hardly open and close her hand at work. Patient did not have investigation assessment. The outcome of the events was not recovered.  No follow-up attempts needed. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged anterior axillary lymph node; My breast tumor grew to size of golf ball in six months; This is a spontaneous report from a contactable other health care professional. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0142), intramuscular, administered in Arm Right on 12Jan2021 08:00 AM and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3249) intramuscular, administered in Arm Right on 29Jan2021 08:00 AM as single dose for COVID-19 immunisation. Medical history included breast cancer, restless legs syndrome, insomnia, hypertension, PALB2, CKD, NF1, and few known allergies to codeine, Morphine and Mollusks from an unknown date and unknown if ongoing. The patient's concomitant medications included Lasix, Kdur, anastrozole, requip, Metoprolol, trazadone, nortriptyline, melatonin, MV, Vit C. On 23Jan2021 04:00, the patient experienced enlarged anterior axillary lymph node and reported my breast tumor grew to size of golf ball in six months on an unspecified date. approximately 7-10 days following first injection on 12Jan2021 noted an enlarged anterior axillary lymph node. I watched it for approximately one week. It was slightly larger but definitely not smaller Received 2nd covid vaccine on 29Jan2021. notified provider on 01Feb2021 ordered US done 09Feb2021. I have PALB2 mutation, breast cancer post chemo, a RUL and LLL lung nodules. I am being told it is from my first Covid vaccine and to recheck in two months. My breast tumor grew to size of golf ball in six months. I am unsure of exact date it became enlarged or what day i noticed it. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events Not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: headache; soreness on the injection site/pain in the arm; chills; This is a spontaneous report from a sponsored program  via a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unknown date in Jan2021 she had a slight headache and a little pain in the arm/soreness on injection site, which is no big deal. 5-6 days later she started to have chills that she could not get rid of, they were bad. The outcome of the events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Insomnia
Clinical narrative: fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep from pain and disturbing thoughts, exhaustion; not able to sleep from pain and disturbing thoughts, exhaustion; Disturbing thoughts; This is spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (COVID 19, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 06Feb2021 at 11:00 AM in Left arm at single dose for covid-19 immunisation. Patient was not pregnant. Other medical history was reported as none. No known allergies. Other concomitant medications in two weeks included 500 VitC &100 Vit D per day. No other vaccine in four weeks was reported. On 06Feb2021 at 23:00 (11:00 PM) the patient experienced fever, crushing body aches, diarrhea, headache, stomach pain, light sensitivity, not able to sleep from pain and disturbing thoughts, exhaustion. No covid prior vaccination. No covid tested post vaccination. No treatment for event. Outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Photosensitivity reaction, Pyrexia, Thinking abnormal
Clinical narrative: fever; crushing body aches; diarrhea; headache; stomach pain; light sensitivity; not able to sleep from pain and disturbing thoughts, exhaustion; not able to sleep from pain and disturbing thoughts, exhaustion; Disturbing thoughts; This is spontaneous report from a contactable consumer (Patient). A 71-year-old female patient received first dose of BNT162B2 (COVID 19, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 06Feb2021 at 11:00 AM in Left arm at single dose for covid-19 immunisation. Patient was not pregnant. Other medical history was reported as none. No known allergies. Other concomitant medications in two weeks included 500 VitC &100 Vit D per day. No other vaccine in four weeks was reported. On 06Feb2021 at 23:00 (11:00 PM) the patient experienced fever, crushing body aches, diarrhea, headache, stomach pain, light sensitivity, not able to sleep from pain and disturbing thoughts, exhaustion. No covid prior vaccination. No covid tested post vaccination. No treatment for event. Outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: in a lot pain; The initial case was missing the following minimum criteria: no adverse drug effect. Upon receipt of follow-up information on (05Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer or Other non-HCP (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unknown route of administration on 28Jan2021 at single dose for covid-19 immunisation. Medical history includes Arthritis. Concomitant medications were not reported. The patient's wife reported, her husband had the COVID-19 shot 10 days ago. He has arthritis and has been on a Tylenol regimen for about a year. He stopped taking the Tylenol because he read on website that it might change the effectiveness of the COVID shot. Now he is in a lot pain from not taking the Tylenol. She confirms he received the Pfizer COVID 19 vaccine. The seriousness was reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The caller already took the first dose and tested positive.; The caller already took the first dose and tested positive.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; lot number: Not reported), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. It was reported that, the patient already took the first dose and tested positive on an unknown 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, SARS-CoV-2 test
Clinical narrative: A patient who received the 1st dose of the vaccine last 31Dec2020; was diagnosed with COVID on 06Jan2021; This is a spontaneous report from a contactable pharmacist via the sponsored program. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 vaccine on 31Dec2020 and was diagnosed with COVID on 06Jan2021. The patient was scheduled to receive his second dose on 17Jan2021 but this was waived because of the diagnosis of COVID on 06Jan2021. As of the reporting date, the patient has not received the vaccine ever since the diagnosis. Caller is asking if they should restart the vaccination series/should he get second shot or should he start over. The patient underwent lab tests and procedures which included a positive SARS-COV-2/COVID-19 test on 06Jan2021. The clinical outcome of the event COVID-19 was unknown.  Information about lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Keratitis
Clinical narrative: Keratitis; Conjunctivitis; This is a spontaneous report from a contactable Physician reported for a 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Patient medical history included chronic granulomatous disease and recurrent immune mediated keratitis (recurrent immune mediated keratitis in the past).  Concomitant medications included azathioprine (IMURAN), itraconazole, piroxicam and sulfamethoxazole, trimethoprim (BACTRIM) On 30Jan2021, the patient experienced keratitis and conjunctivitis 1 day after vaccination. The events were resulted at Doctor or other healthcare professional office/clinic visit. The patient's father had exposure work (negative COVID19 PCR 10 days ago). The patient had no covid symptoms. Pending covid-19 test. The patient received topical NSAID as treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Chills, Fall, Pain
Clinical narrative: fever between 104 & 105; looses her balance; she ache's all over.; Chills; falling over; This is a spontaneous report from a Pfizer-sponsored program received from a contactable female consumer. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982, Pfizer COVID-19 vaccine NDC/EXP: Unknown,) in her right arm via an unspecified route of administration on 29Jan2021 10.30 (at the age of 69-years-old ) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer since Feb2020. Caller said that she had breast cancer with radiation last June and July. She asks if this could be affecting her receiving her vaccine now. The patient concomitant medications were not reported. On 31Jan2021 patient experienced a fever between 104 & 105, looses her balance, she aches all over, having chills, and falling over and this has been going on for just under a week. She says she got the shot last Friday and the symptoms started Sunday (On 31Jan2021). The patient body temperature included fever between 104 & 105 fahrenheit , fever 100.4 for 4 days ,104.5 fahrenheit ,103 fahrenheit,101 fahrenheit. Caller said that her fever temperature has been 104.5 degrees Fahrenheit a couple times, and went down to 103 degrees Fahrenheit, was down to 101 degrees Fahrenheit and is back up today. Caller said she just took a couple of Tylenol 650mg UPC, Caller said she took 650mg today, that was the first she took, two 650mg.Therapeutic measures were taken as a result of fever between 104 & 105, chills and pain. The outcome of the events were unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever between 104 & 105; looses her balance; she ache's all over.; Chills; falling over; This is a spontaneous report from a Pfizer-sponsored program received from a contactable female consumer. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982, Pfizer COVID-19 vaccine NDC/EXP: Unknown,) in her right arm via an unspecified route of administration on 29Jan2021 10.30 (at the age of 69-years-old ) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer since Feb2020. Caller said that she had breast cancer with radiation last June and July. She asks if this could be affecting her receiving her vaccine now. The patient concomitant medications were not reported. On 31Jan2021 patient experienced a fever between 104 & 105, looses her balance, she aches all over, having chills, and falling over and this has been going on for just under a week. She says she got the shot last Friday and the symptoms started Sunday (On 31Jan2021). The patient body temperature included fever between 104 & 105 fahrenheit , fever 100.4 for 4 days ,104.5 fahrenheit ,103 fahrenheit,101 fahrenheit. Caller said that her fever temperature has been 104.5 degrees Fahrenheit a couple times, and went down to 103 degrees Fahrenheit, was down to 101 degrees Fahrenheit and is back up today. Caller said she just took a couple of Tylenol 650mg UPC, Caller said she took 650mg today, that was the first she took, two 650mg.Therapeutic measures were taken as a result of fever between 104 & 105, chills and pain. The outcome of the events were unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Inappropriate schedule of product administration, Lymphadenopathy, Off label use
Clinical narrative: developed a pain under my arm near armpit area on the side of the injection; swollen gland; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 17Jan2021 09:15 as a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), asthma, IBS (inflammatory bowel disease), diverticulosis, osteoarthritis, lactose intolerant, penicillin allergy and hives. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included famotidine and montelukast. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: E1284) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 31Dec2020 at 15:15 as a single dose for covid-19 immunization. The patient previously took codeine but had hallucination, pantoprazole sodium but joint pain, and diclofenac sodium but had anemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient first dose was on 31Dec2020 while the second dose was on 17Jan2021. It was reported that on 19Jan2021 (About 36 hours after injection), the patient developed a pain under her arm near armpit area on the side of the injection. It appeared to be a swollen gland. It lasted about 2 days and was moderate pain that she treated with 600 mg Ibuprofen. Soreness remained for another day or two after the pain subsided. The events were considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events swollen glands and axillary pain were recovered in an unspecified date in 2021 while the outcome of the other events was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia lasted 10-15 mins; This is a spontaneous report from a contactable physician. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), dose 1st, parenteral on 15Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient first dose of the Pfizer covid vaccine on the 15Jan2021, right after the injection, patient experienced tachycardia lasted 10-15 mins, Patient informed the doctor about this on 19Jan2021. No other symptoms of anaphylactic reaction. The reporter enquired if any isolated tachycardia event with covid vaccine and if it was safe to give second covid shot. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Headache, Hypertension
Clinical narrative: dizziness; headache; muscle pain; chills; since then, she cannot get her blood pressure under control. It is a pretty high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: Number: Unknown) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. Medical history included cancer and bladder infection (cancer survivor and did get a bladder infection) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she had received our 1st vaccine shot last 28Jan2021 and since then, she cannot get her blood pressure under control. It is a pretty high on 28Jan2021, reason why she took losartan and hydroxyzine. She also mentioned that she used to be a cancer survivor and did get a bladder infection. There are also some little side effects such as dizziness, headache, muscle pain, and chills on an unspecified date. Therapeutic measures were taken as a result of since then, she cannot get her blood pressure under control. it is a pretty high and included treatment with losartan and hydroxyzine. The clinical outcome of the events was reported as unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: dizziness; headache; muscle pain; chills; since then, she cannot get her blood pressure under control. It is a pretty high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: Number: Unknown) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. Medical history included cancer and bladder infection (cancer survivor and did get a bladder infection) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she had received our 1st vaccine shot last 28Jan2021 and since then, she cannot get her blood pressure under control. It is a pretty high on 28Jan2021, reason why she took losartan and hydroxyzine. She also mentioned that she used to be a cancer survivor and did get a bladder infection. There are also some little side effects such as dizziness, headache, muscle pain, and chills on an unspecified date. Therapeutic measures were taken as a result of since then, she cannot get her blood pressure under control. it is a pretty high and included treatment with losartan and hydroxyzine. The clinical outcome of the events was reported as unknown.   Information on Lot/Batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Hypoaesthesia oral, Pain
Clinical narrative: flushed tachycardia; numb lips; chest pain; shortness of breath; chills; aches; This is a spontaneous report from a contactable nurse. The 34-Year old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: El3246) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 18Jan2021 the patient experienced 5 minutes after injection, flushed tachycardia and numb lips. 3 days later chest pain, shortness of breath, tachycardia, chills, aches. Covid negative. Still not fully resolved. The patient underwent lab tests and procedures which included viral test: negative on 20Jan2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Viral test
Clinical narrative: flushed tachycardia; numb lips; chest pain; shortness of breath; chills; aches; This is a spontaneous report from a contactable nurse. The 34-Year old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: El3246) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 18Jan2021 the patient experienced 5 minutes after injection, flushed tachycardia and numb lips. 3 days later chest pain, shortness of breath, tachycardia, chills, aches. Covid negative. Still not fully resolved. The patient underwent lab tests and procedures which included viral test: negative on 20Jan2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: nausea; Headache; Mild muscle soreness at injection site; alternating chills/sweats starting 12 hours post-2nd dose; alternating chills/sweats starting 12 hours post-2nd dose; fever (100.3) taken under arm; restlessness preventing sleep most of the night; restlessness preventing sleep most of the night; periodic dizziness; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00 PM, (lot number: EL3247), at the age of 50-year-old at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of the vaccine on 21Jan2021 01:30 PM (lot number: EL3247) on Left arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 00:00, 12hours post vaccination of second dose, the patient experienced mild muscle soreness at injection site within a couple hours; alternating chills/sweats starting; Fever (100.3) taken under arm; restlessness preventing sleep most of the night; periodic dizziness and some nausea; and headache. The outcome of the events was recovering. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Sleep disorder, Thermometry, Vaccination site pain
Clinical narrative: nausea; Headache; Mild muscle soreness at injection site; alternating chills/sweats starting 12 hours post-2nd dose; alternating chills/sweats starting 12 hours post-2nd dose; fever (100.3) taken under arm; restlessness preventing sleep most of the night; restlessness preventing sleep most of the night; periodic dizziness; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00 PM, (lot number: EL3247), at the age of 50-year-old at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of the vaccine on 21Jan2021 01:30 PM (lot number: EL3247) on Left arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 00:00, 12hours post vaccination of second dose, the patient experienced mild muscle soreness at injection site within a couple hours; alternating chills/sweats starting; Fever (100.3) taken under arm; restlessness preventing sleep most of the night; periodic dizziness and some nausea; and headache. The outcome of the events was recovering. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia
Clinical narrative: General flu like symptoms.; Aching muscles; exhaustion; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 11Feb2021 12:15 PM at Left arm as single dose for covid-19 immunisation. Medical history included hypertension, hypertension (controlled). Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The concomitant medication included atorvastatin calcium (LIPITOR) at 10, amlodipine besilate (NORVASC) at 10, Lisinopril at 2.5. The patient historical vaccine included bnt162b2, lot number=EL3247), first dose on 21Jan2021 12:30 PM at Left arm SINGLE DOSE for covid-19 immunisation. The patient experienced general flu like symptoms, Aching muscles and exhaustion on 12Feb2021 05:30 AM. The patient did not received treatment for the events. The outcome of the events recovering.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he have all symptoms of COVID headache, runny nose, cold; he have all symptoms of COVID headache, runny nose, cold; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. Medical history included abdominal discomfort from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole sodium (NEXIUM) taken for stomach, start and stop date were not reported. The patient got the first vaccine on 23Jan2021 Pfizer Covid vaccine and second one will be on Saturday, 13Feb2021 but his colleague tested positive on Monday, they are working at the same room and now he have all symptoms of COVID headache, runny nose, cold. Onset of the events reported as Feb2021. There was no treatment in response to events. The events were reported as non-serious. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness
Clinical narrative: dizziness; heaviness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose on an unspecified date for COVID-19 immunization. The patient had her second covid vaccine shot and experienced dizziness and heaviness on an unspecified date with outcome of unknown. She asked if these are normal for people to experience once they had the covid vaccine.  Information about lot/batch number requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache before 2nd dose/pretty bad tooth ache; This is a spontaneous report from a contactable consumer (patient reported himself) via Pfizer sponsored Program. A 67-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, toothache before second dose on 11Feb2021. He wanted to take pain medications. Caller stated, "he already had the first dose of Pfizer-BioNTech COVID-19 Vaccine 11 days ago, he was not sure about the exact date. Next dose was coming this Thursday (11Feb2021)". Caller stated he did not have any side effects from the vaccine, when he offered the warm transfer to DSU. Caller wanted to know if he can take Tylenol or Advil for a "pretty bad tooth ache", but his next Dentist appointment was until 11Mar2021. Outcome of the event was unknown. No PQC present.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arthralgia in hands; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unknown date at single dose for covid-19 immunization. Medical history was reported as none and concomitant medications were not reported. The patient experienced arthralgia in hands on 29Jan2021. The event was treated with Acetaminophen. Therapeutic measures were taken as a result of arthralgia in hands. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that a patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 20Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. This Pharmacist reported that she has an employee who was administered their first dose of Pfizer COVID Vaccine on 20Jan2021 and was then diagnosed with COVID last week in Jan2021. She called to ask what is the appropriate timeline for the employee to get the second dose of Pfizer COVID Vaccine. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose administration.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms right now; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received second dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number; unknown) via intramuscular on 09Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she had her second shot today 09Feb2021 asking how long after she can have the possibility of adverse reaction. She stated that, she is experiencing a sore arms right now on an unspecified date in 2021 and consulting what activities she needs to be avoided or chances of getting sick. Outcome of the event was unknown.  Information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: sore arms right now; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received second dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number; unknown) via intramuscular on 09Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she had her second shot today 09Feb2021 asking how long after she can have the possibility of adverse reaction. She stated that, she is experiencing a sore arms right now on an unspecified date in 2021 and consulting what activities she needs to be avoided or chances of getting sick. Outcome of the event was unknown.  Information on about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: Slight injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201) via unspecified route of administration on 11Feb2021 at 13:15 (at the age of 67-year-old) in left arm as a single dose for COVID-19 immunisation. The patient medical history included Crohn's disease, and asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included Allergy Antigen injs (as reported), Humira pen and metoprolol succinate. The patient didn't receive any other vaccine within four weeks prior to the vaccination. The patient experienced slight injection site soreness. On a scale of 1-10, with 10 being the highest. The soreness was maybe a 3. The outcome of the event was recovered on an unknown date in Feb2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Rash erythematous, Swelling face
Clinical narrative: Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of my face and scalp; Severe red rash and swelling on right side of the of my face; extremely tender and hot to the touch/ very painful; Extremely tender and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm at the age of 58-years (non-pregnant at the time of vaccination), on 10Feb2021 at 08:30 AM at single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included alopecia areata and allergy to Xatham gum. Concomitant medication included valsartan at 160 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. It was reported that on 10Feb2021 at 03:00 PM, "severe red rash and swelling on right side of my face. Extremely tender and hot to the touch. Spreading gradually to other areas of my face and scalp. Very painful". The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received diphenhydramine (BENADRYL) and 20 mg prednisone for 5 days and paracetamol (TYLENOL) as treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.