chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint swelling, Oropharyngeal pain, Peripheral swelling
Clinical narrative: Hands started swelling and it will go up some and then down; Elbow started swelling and now my knee is hurting; Sore throat; I want to sleep a lot; I have to take nap during the day and this is unusual for me; Elbow started swelling and now my knee is hurting; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hands started swelling and it will go up some and then down, elbow started swelling and now my knee is hurting, sore throat, i want to sleep a lot; i have to take nap during the day and this is unusual for me, elbow started swelling and now my knee is hurting on an unspecified date. Clinical course was re-ported as I got the injection 2 weeks ago and about 4 days later my hands started swelling and it will go up some and then down and I have been putting Voltaren lotion (Treatment) on it and about 5 days ago my elbow started swelling and now my knee is hurting but it isn't started swelling yet and I wondered if this is a side effect of the things, I checked on it. I have a sore throat and tiredness. I want to sleep a lot. It makes me (incomplete sentence), during the day I run down, and I have to take nap during the day, and this is unusual for me. We are scheduled to get our next one in one week from today and I wonder if this a side effect or is it going to continue, get worse or not. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of hands started swelling and it will go up some and then down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Headache, Nasal congestion
Clinical narrative: headache; congestion; Tightness in chest; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), Solution for injection, via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation. Medical history included diabetes mellitus.Concomitant medications included Vitamin B6 and Glipizide. On an unspecified date, the patient experienced headache, congestion and tightness in chest. The outcome of event was unknown. Patient got the First vaccine which she got 3 weeks ago today and she was due to get the second of the Pfizer vaccine. She confirmed it was the Pfizer COVID 19 vaccine. She said everything was going really well up until the middle of last week and then for about 4 days she had headaches that wouldn't go away. She had cold symptoms like congestion, she had tightness in the chest and finally they started going away yesterday except the headache and it is a different kind of headache almost like a migraine it was sharp. She wanted to know, should she go ahead and get the second dose as scheduled today at 3:40 PM even though she has possibly been exposed. She did have blood tests done and it was really high on the B6 her levels. So she stopped her over the counter vitamin on B6. Her diabetic numbers according to one doctor are not on a good level. Her 3 months numbers had been really good. The other doctor said it was fine, the doctor she has been with said it was fine, but her primary was on vacation and someone else read her fasting blood sugar. She is borderline diabetic, but she doesn't take Glipizide anymore because she eats a vegan no sugar, little fruit, and very little carb diet. The outcome of headache was not recovered and all other events were recovering.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: The site where the injection is was really swollen and it hurts; It was rash were the vaccine is; Fever; Chills; Body ache; Headache; Not feeling well; Tired; The site where the injection is was really swollen and it hurts; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: FL9266), via an unspecified route of administration on 21Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: not provided), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient stated I wanted to know, I took my first vaccine 3 weeks ago, nothing happened I was okay but yesterday on 21Feb2021, I took the second vaccine and the site where the injection was really swollen, and it hurts, and it was rash where the vaccine is and then at night, I had a fever, chills, my body ache and I had headache. Patient stated, I couldn't take the second one in time, like Saturday because we had a winter, winter snow weather so, I took it yesterday. Patient further stated, the rash where the injection is, only in my arm this reaction was not there until, not when they gave it to me, later like 6 hours later I still have it. I am not feeling well, and I am just tired and my body aches, so I don't know I need to know what I need to do. Patient stated, not sure, I can't talk 8 minutes. I am not feeling well. Maybe another time. Patient was not willing to provide further information, hence limited information available over the call. The patient underwent lab tests and procedures which included body temperature: fever on an unspecified date. The outcome of the events injection is really swollen, and it hurts, Body ache, Not feeling well and Tired was not recovered and Fever, Chills, Headache and rash where the injection was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: The site where the injection is was really swollen and it hurts; It was rash were the vaccine is; Fever; Chills; Body ache; Headache; Not feeling well; Tired; The site where the injection is was really swollen and it hurts; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: FL9266), via an unspecified route of administration on 21Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: not provided), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient stated I wanted to know, I took my first vaccine 3 weeks ago, nothing happened I was okay but yesterday on 21Feb2021, I took the second vaccine and the site where the injection was really swollen, and it hurts, and it was rash where the vaccine is and then at night, I had a fever, chills, my body ache and I had headache. Patient stated, I couldn't take the second one in time, like Saturday because we had a winter, winter snow weather so, I took it yesterday. Patient further stated, the rash where the injection is, only in my arm this reaction was not there until, not when they gave it to me, later like 6 hours later I still have it. I am not feeling well, and I am just tired and my body aches, so I don't know I need to know what I need to do. Patient stated, not sure, I can't talk 8 minutes. I am not feeling well. Maybe another time. Patient was not willing to provide further information, hence limited information available over the call. The patient underwent lab tests and procedures which included body temperature: fever on an unspecified date. The outcome of the events injection is really swollen, and it hurts, Body ache, Not feeling well and Tired was not recovered and Fever, Chills, Headache and rash where the injection was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste about 1.5 hours after. I couldn't taste the chocolate in my ice cream; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 22Feb2021 18:45 (age at vaccination 27years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Feb2021 20:30 the patient experienced loss of taste about 1.5 hours after. I couldn't taste the chocolate in my ice cream. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Lymphadenopathy, Parosmia, Pyrexia
Clinical narrative: Metal taste; Metallic smell; swollen lymph nodes in armpit; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 09Feb2021 at 13:30 (at the age of 73-years-old) in left arm as a single dose for covid-19 immunization. Medical history included peripheral arterial occlusive disease and prior to vaccination, the patient was not diagnosed with covid-19 from an unknown date and unknown if ongoing. The patient previously took codeine and experienced allergy. No other vaccine in four weeks. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included rivaroxaban (XARELTO); atorvastatin (ATORVASTATIN); estradiol (ESTRADIOL) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. It was reported that within 24 hours of vaccination the patient experienced chills and fever lasting 24 hours, swollen lymph nodes in armpit which dissipated after 10 days, metal taste and smell which lingered on 10Feb2021 at 13:00. The patient did not receive any treatment. The outcome of all the events was resolved in Feb2021 with sequelae (lasting effects).  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Headaches; Fevers; Chills; Injection site pain; Swelling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 65-years), administered in arm right on 02Feb2021 as dose 1, single for COVID-19 immunization. Medical history included diabetes, asthma and high blood pressure from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other medications in two weeks. The vaccination facility type was reported as other. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 21Feb2021, the patient experienced headaches, fevers, chills, injection site pain and swelling. The treatment was not received for all the events. The clinical outcome of the events was reported as recovered on unspecified date in Feb2021.   Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Nausea, Oropharyngeal pain
Clinical narrative: soreness of arm; Fever; Chills; Body ache; Nausea; Vomiting; Throat pain; Ear pain; Headache; This is a spontaneous report from a non-contactable consumer (reported for herself). A 32-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in Feb2021 at 09:15 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation at Workplace clinic. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) at a dose of 75 mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date in Jan2021 at 13:00 as dose 1, single for covid-19 immunisation at Workplace clinic. On 19Feb2021 at 18:00, the patient experienced soreness of arm, fever, chills, body ache, nausea, vomiting, throat pain, ear pain and headache. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: soreness of arm; Fever; Chills; Body ache; Nausea; Vomiting; Throat pain; Ear pain; Headache; This is a spontaneous report from a non-contactable consumer (reported for herself). A 32-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in Feb2021 at 09:15 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation at Workplace clinic. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) at a dose of 75 mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date in Jan2021 at 13:00 as dose 1, single for covid-19 immunisation at Workplace clinic. On 19Feb2021 at 18:00, the patient experienced soreness of arm, fever, chills, body ache, nausea, vomiting, throat pain, ear pain and headache. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Runny nose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Batch/lot number: Not Provided, Expiration date: Not Provided), via an unspecified route on 21Feb2021 (age at vaccination: 65-year-old) as a single dose for covid-19 immunization. Medical history included overweight, weighs a little over 200, probably a lot over. The patient concomitant medications were not reported. Patient got her first dose 21Feb2021 and they told her don't take anything but Tylenol for pain, but she needs some decongestant for sneezing and her nose running, she would like to know if she can take Claritin or something for it. She says she was told that some things may counteract the vaccine, so she doesn't want to take something if it might do that. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site reaction
Clinical narrative: has a puncture mark and rough circle around the injection site; Shoulder soreness; This is a spontaneous report from a contactable consumer reported for himself. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3249; Expiration date was not reported), via intramuscular administered in left arm (left shoulder) on 05Feb2021 15:00 (at the age of 71-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none. Stated he was a healthy as a horse. The patient previously took first dose of BNT162B2 (Lot Number: EK4176; Expiration date: Unknown) via intramuscular (injection) in left shoulder as dose 1, single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer suspect; prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations included none. The patient experienced had a puncture mark and rough circle around the injection site, shoulder soreness on an unspecified date. The caller explained onsite where the injection was, there was a round circle around it. Probably a week later vaccination, he noticed it was still something there. He checked in the mirror and it showed he still had the puncture mark and the rough circle around the injection site. Caller explained tit had pretty much stayed the same. Time of vaccination was given around 3pm. His next appointment at the (hospital name) was 10Mar2021 and the doctor told him to stop in and show him what the injection site looked like. Stated that he had absolutely nothing happen to him with either of the COVID-19 vaccines. He had a sore shoulder for 24 hours and then he has been feeling absolutely fine, his shoulder was fine. Investigation assessment and relevant tests included none. AE did not require visit to Emergency Room or Physician Office. Clinical outcome of event puncture mark and rough circle around the injection site was not recovered and shoulder   Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Headache, Pyrexia
Clinical narrative: Cough; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 20Feb2021 (age at vaccination was 79 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Jan2021 (age at vaccination was 79 years) as dose 1, single for COVID-19 immunization. The caller stated that she wanted to report that she had a reaction to the second dose of the Pfizer COVID vaccine received on Saturday, 20Feb2021. On 20Feb2021, the patient experienced cough, chills, fever and headache. The caller stated she was in an out of the place in less than half an hour, they were very organized, stated she went home and started having a cough later on in the day, also experienced chills, temperature and headache, stated it was like the flu. Stated she took Tylenol and went to bed. Was able to get up the next day and got on couch. Chills progressed during the day, by 6 pm she was underneath blankets. The caller stated the symptoms were gone by Monday, 22Feb2021. The outcome of the events was resolved on 22Feb2021.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia
Clinical narrative: Chest pain focused in the middle of chest, sharp and feels like increased pressure. Pain comes and goes; best way to describe it is severe heartburn; This is a spontaneous report from a non-contactable Pharmacist. A 28-years-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number EN6200), via an unspecified route of administration on 22Feb2021 at 09:30 AM (at the age of 28-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number EN5318), via an unspecified route of administration on 01Feb2021 at 08:00 AM (at the age of 28-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included ADHD, seasonal depression (all from an unknown date and unknown if ongoing). Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); caffeine; bupropion; colecalciferol (VITAMIN D) (all taken for an unspecified indication, start and stop date were not reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Feb2021 at 18:00PM, the patient experienced Chest pain focused in the middle of chest, sharp and feels like increased pressure. Pain comes and goes, best way to describe it is severe heartburn (although never had heartburn prior to this). Therapeutic measures were taken as a result of chest pain focused in the middle of chest, sharp and feels like increased pressure. pain comes and goes (chest pain), best way to describe it is severe heartburn (dyspepsia) and Took tums with no improvement. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear congestion, Ear discomfort, Fatigue, Pain
Clinical narrative: Ears are clogged and congestion; Ears are clogged and congestion; Chills; Fever; Aches, pains; Fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: GN 6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 10:30 (at the age of 58-years-old) as DOSE 2, SINGLE for covid-19 immunisation at clinic/facility. Patient was not pregnant at the time of vaccination. Medical history included back pain from an unknown date and unknown if ongoing. Concomitant medications included gatifloxacin, loteprednol etabonate (LOTREL G) taken for HBP, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Pfizer EL9263) via unspecified route in left arm on 29Jan2021 10:00 as dose 1, single for covid-19 immunisation. Other vaccine on the same date, other vaccine in four weeks, covid prior vaccination, covid tested post vaccination, known allergies included none. The patient experienced ears are clogged and congestion, chills, fever, aches, pains, fatigue on 20Feb2021 06:00. Reported events occurred after second dose. AE resulted in none of the above (unspecified). No treatment was received. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Ears are clogged and congestion; Ears are clogged and congestion; Chills; Fever; Aches, pains; Fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: GN 6200; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 10:30 (at the age of 58-years-old) as DOSE 2, SINGLE for covid-19 immunisation at clinic/facility. Patient was not pregnant at the time of vaccination. Medical history included back pain from an unknown date and unknown if ongoing. Concomitant medications included gatifloxacin, loteprednol etabonate (LOTREL G) taken for HBP, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Pfizer EL9263) via unspecified route in left arm on 29Jan2021 10:00 as dose 1, single for covid-19 immunisation. Other vaccine on the same date, other vaccine in four weeks, covid prior vaccination, covid tested post vaccination, known allergies included none. The patient experienced ears are clogged and congestion, chills, fever, aches, pains, fatigue on 20Feb2021 06:00. Reported events occurred after second dose. AE resulted in none of the above (unspecified). No treatment was received. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: chills; injection site pain; myalgia; fever; fatigue; headache; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unspecified date the patient experienced chills , injection site pain, myalgia, fever, fatigue, headache. The patient underwent lab tests and procedures which included body temperature: 37.5 c on mild fever (37.5 C). The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: chills; injection site pain; myalgia; fever; fatigue; headache; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unspecified date the patient experienced chills , injection site pain, myalgia, fever, fatigue, headache. The patient underwent lab tests and procedures which included body temperature: 37.5 c on mild fever (37.5 C). The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: bruise at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bruise at the injection site on an unspecified date. The outcome of the event injection site bruising was unknown. Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: 12 hours after 2nd dose had flu like symptoms (fever, aches in joints that I currently have problems in) which lasted around 24 hours.; Following day had very low grade fever for a couple of hours; headache that lasted most of the day; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Right on 16Feb2021 13:15 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications Atenolol 25mg, Vitamin D within 2 weeks of vaccination. Patient didn't had COVID-19 prior to vaccination. Medical history included asthma from an unknown date and unknown if ongoing, blood pressure increased from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included Atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration in Arm left on 26Jan2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. On 17Feb2021 the patient experienced 12 hours after 2nd dose had flu like symptoms (fever, aches in joints that I currently have problems in) which lasted around 24 hours, following day had very low-grade fever for a couple of hours, headache that lasted most of the day. Therapeutic measures were taken as a result of 12 hours after 2nd dose had flu like symptoms which lasted around 24 hours following day had very low-grade fever for a couple of hours, headache that lasted most of the day was 1 Advil every 8 hrs-first dose 8 hrs after onset. Patient was not tested for covid-19 to post vaccination. The outcome of the events influenza like illness, pyrexia, headache was recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation in the face; This is a Spontaneous report based on the information received by Pfizer from Reference Number: GL-020821-3546). A contactable Other HCP reported similar events for two patients. This is 1st for 2 report.  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced inflammation in the face where previous filler (Restylane) was injected in. Inflammation occurred within days of 2nd covid vaccination. The outcome of event was unknown. No other information provided.   No follow-up attempts are needed. Information about Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223811 same reporter/product/event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: inflammation in the face; This is a Spontaneous report from a contactable Other HCP reporting for a patient based on the information received by Pfizer Reference Number: GL-020821-3457).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took restylane on unspecified date. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that on an unspecified date, the patient experienced inflammation in the face where previous filler (Restylane) was injected in. Inflammation occurred within days of 2nd covid vaccination. No other information provided. The outcome of event was unknown.  No follow-up attempts are needed. Information on Lot/Batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling; This is a spontaneous report based on the information received by Pfizer from a contactable Other-HCP via GALDERMA Laboratories LP. (Galderma Reference Number: GL-020821-3448). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Past drug included Restylane-L, injected in tear troughs, since 14Sep2021, unknown if ongoing, for unspecified indication. Patient experienced swelling occurred to tears troughs 24 hours following 2nd vaccine, on an unspecified date. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself) communicated to Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration on 06Jan2021 (Lot number and Expiration date: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as single for covid-19 immunisation. On an unspecified date in Jan2021, the patient experienced joint pain. The patient stated that the reason she called, 06Jan2021 was her second dose of the COVID-19 vaccine. She said she had some joint pain after the second dose, and it run away after three days and she was calling to see how long the vaccine lasts. She wanted to know if it is for 3 months or if a year. Patient stated the only thing that she wanted to know was it going to expire in 3 month or a year. The patient outcome of the event was resolved on an unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: sore arm; low-grade fever; vomited; intense malaise; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL8982), via an unspecified route of administration in the left arm on 20Jan2021 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included seizure, controlled on meds and migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included valproic acid, rizatriptan benzoate (MAXALT) and colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously cefuroxime and doxycyclin and experienced drug hypersensitivity. Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EH9899), via an unspecified route of administration in the left arm on 30Dec2020 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated that ill-effects started 16 hours after injection, sore arm, brief low-grade fever, vomited, intense malaise for 24 hours followed by 2.5 days of fatigue on 21Jan2021 10:00. The patient did not receive any treatment. The clinical outcome for the events was recovered on an unspecified date in 2021 for all events except intense malaise and fatigue which recovered on an unspecified date in Jan2021.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Muscle tightness, Skin tightness, Throat tightness
Clinical narrative: hoarseness; Tightness in face; Tightness in throat; Tightness in neck; This is a spontaneous report from a contactable consumer. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: En6203), dose 1 via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:30 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, overweight, food allergy (melons and squashes) from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN) and lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported received other medications in two weeks. The patient previously took codeine (Codeine and other narcotics used during surgery) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type vaccine at Public Health Clinic/ Administration facility. On 24Feb2021 at 15:45, the patient experienced tightness in face and neck, throat, throat clearing- like something caught in throat and hoarseness. Adverse event resulted in Doctor or other health care professional office/clinic visit. No treatment received. The outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Rash
Clinical narrative: Disseminated rash/whole body rash; This is a spontaneous report from a contactable nurse. This nurse reported for a 50-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 19Feb2021 (at age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ovarian cancer from an unknown date and unknown if ongoing, had ongoing chemotherapy. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on an unspecified date for COVID-19 immunization. On 22Feb2021 it was reported that, patient was undergoing chemotherapy (chemotherapy not captured as suspect) but patient got COVID vaccine it was the Pfizer vaccine and did end up with rash it was disseminated rash; had whole body rash. Therapeutic measures were taken as a result of disseminated rash/whole body rash as patient had received Benadryl. The patient underwent lab tests and procedures which included blood count: unknown results on 22Feb2021. The outcome of event was unknown. When probed for causality, nurse stated; she got the injection on that Friday and then on that following Monday that was the 22nd and she had a whole body rash.  No follow up attempts are needed; Information about Lot and batch number could not be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pruritus
Clinical narrative: swollen lymph nodes armpit; itchy skin; mild headache; mild chills; This is a spontaneous report from a contactable consumer.  A 67-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 16Feb2021 09:00 AM (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus and Chronic lymphocytic leukaemia from an unknown onset and unknown ongoing and concomitant medications include Insulin Glargine (TOUJEO), Metformin, Dapagliflozin Propanediol Monohydrate (FARXIGA), Simvastatin. On 21Feb2021 06:00 AM, after the vaccination, the patient experienced swollen lymph nodes armpit, itchy skin, mild headache, mild chills. Patient received treatment with antihistamine and Tylenol. The events assessed as non-serious. No other vaccines were taken in four weeks. Patient was not found covid prior vaccination. Patient was not tested covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Swelling and pain of lymph nodes in left axilla; Chills; lowgrade fever occurring 18 to 30 hours after 2nd dose; This is a spontaneous report from a contactable physician (patient). A 68-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an intramuscular route on 21Feb2021 14:30 (at the age of 68-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included hypothyroidism and Known allergies to Sulfa, PCN, verapamil. The patient concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 24Jan2021 14:30 (at the age of 68-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 at 13:00, the patient experienced chills and low grade fever occurring 18 to 30 hours after 2nd dose and swelling and pain of lymph nodes in left axilla. The patient did not receive treatment for events. The outcome of the events was resolved on unspecified date of 2021.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red patchy rash on stomach, right side; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 23Feb2021 11:30 (age at vaccination: 52 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypertension, obesity, latex allergy and Motrin allergy. Concomitant medication(s) included lisinopril; fluoxetine hydrochloride (PROZAC) and paracetamol (TYLENOL) 500, multivitamin and pr. On 23Feb2021 18:00, the patient experienced red patchy rash on stomach, right side. The patient required physicians office visit. The patient did not have any other vaccine if four weeks. The patient did not receive any treatment for the adverse event. The patient did not have covid prior to vaccination nor was tested since vaccination. The outcome of the event was not recovered.  Information on the lot batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills; severe body aches; fever; fatigue; This is a spontaneous report from a contactable consumer. A 23-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL3247, Expiration date: Unknown, Solution for injection), on 22Feb2021 around 09:30 AM on left Arm as Dose 2 single for covid 19 immunization (age at vaccination: 23-Year-old). Medical history included unspecified known Allergies. Concomitant medications were reported as unknown. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL3247,Expiration date: unknown, solution for injection) on 01Feb2021 on left Arm as Dose 1 single for covid 19 immunization. The patient had not received any other vaccine and other medication in four weeks. The patient had not affected with covid19 before or after vaccination. On 22Feb2021 patient experienced chills, severe body aches, fever and fatigue. No therapeutic treatments were received. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.