chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site haemorrhage
Clinical narrative: Some minor bleeding at the injection site.; Arm soreness; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/lot number: EL9265) via an unspecified route of administration in right arm on 02Feb2021 13:30 as 1st dose, single dose for COVID-19 immunization/has all the risk factors and doesn't want to get Covid. Medical history included heart bypass surgeries in Jul1987 and Aug1995, ongoing asthma from 2016, ongoing prediabetes from 2008, angioplasty in Dec1997. Concomitant medications included ongoing clopidogrel bisulfate (PLAVIX) at 75mg daily from 2006 for Blood thinner; ongoing acetylsalicylic acid (BABY ASPIRIN) at 81mg daily from 1996 for Blood thinner and other medications. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). It was reported that when the needle was withdrawn from his skin, he experienced some minor bleeding at the injection site on 02Feb2021 at 13:30; also arm soreness on 02Feb2021 was reported. When the nurse removed the needle from his arm he had some bleeding. He could not see it but was able to feel it. He felt it was a fair amount of a teaspoon to a teaspoon and a half. He asked if any of the vaccine leaked out. He was wondering if this means he did not get the full dose of the vaccine. A visit to emergency room or physician office was not required. The outcome of the event some minor bleeding at the injection site was recovered on 02Feb2021 and arm soreness was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: a little bit of swelling at the injection site; This is a spontaneous report from a contactable consumer (patient's wife). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The concomitant medication included anticoagulant. On Feb2021 the patient experienced a little bit of swelling at the injection site. The Caller reporting AE information for husband (77 year old, male) who experienced "a little bit of swelling at the injection site" after receiving the first dose of the Covid vaccine yesterday. Caller asked if there is a problem with taking an anticoagulant and receiving the Covid vaccine. Caller stated that her and her husband were reading the papers that were given to them, during the 15-minute hold time, after receiving their injections. Caller stated that the papers say to mention if you are on an anticoagulant. Caller stated that her husband takes an anticoagulant, but did not mention it to the vaccination provider because he was unaware that he needed to and it wasn't on the questionnaire that they filled out prior to receiving the vaccine. Caller asked, will the injection site bruise. Caller stated, thank you very much for your help. The event was reported as non-serious. The outcome of the event was unknown. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site mass
Clinical narrative: large lump at the ejection site; arm swelled up; Very painful and couldn't use his arm for several days; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient has medical history, but the conditions were reported as unknown. It was unknown whether the patient had allergies to medications, food or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient's concomitant medications were not reported. It was unknown whether the patient received any other vaccines in four weeks prior vaccination and any other medications within 2 weeks of vaccination. The patient experienced large lump at the ejection site, arm swelled up, and very painful and couldn't use his arm for several days on an unspecified date. It was unknown whether the patient received any treatment for the events. The outcome of all the events was reported as unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Administration site bruise, Body temperature, Hot flush, Malaise, Night sweats
Clinical narrative: Hot flashes; A little bit of uncomfortable feeling; Night sweats; Black and blue where the shot was; Swollen at injection site; next morning it was bruised; When the needle was taken out it started to bleed/Left arm bleeding at injection; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264, NDC number; Expiry Date: unknown), via intramuscularly, administered in left arm on 28Jan2021 17:15 as single dose for covid-19 immunisation (prevention). The patient medical history was not reported. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. There was no family history. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. No previous history immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations (within 4 weeks). Flu shot a couple of months ago. No AE following prior vaccinations. The patient experienced when the needle was taken out it started to bleed/left arm bleeding at injection on 28Jan2021 17:30, night sweats on 02Feb2021, hot flashes, a little bit of uncomfortable feeling on an unspecified date, black and blue where the shot was, swollen at injection site was on 29Jan2021 10:00. She got first shot on 28Jan2021, and she is not on blood thinners. After the nurse took the needle out, it started to bleed. She said maybe she hit a vein. There was a little bit of uncomfortable feeling where vaccine was. The next day, she was black and blue where the shot was (The next morning it was bruised ("black and blue"). She got it around 5:15 pm. There was no prescriber. She did not speak with anyone in safety department, but she did speak with someone and she was going to change her over to someone else, but she never got to speak with anyone. She had a night sweats (It was after midnight at unknown time) and never had hot flashes ever. She felt very warm, and it went away. She took her temperature, and she did not have a temperature. If she gets second shot, she would like to know if she should get it in the right arm or left arm. Her next shot is due on 18Feb2021. There was no relevant test. No ER or physician's office required. There was no investigation assessment. There was no PQC (product quality complaint). The outcome of event hot flashes, a little bit of uncomfortable feeling was unknown and for other events it was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discolouration, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: Hot flashes; A little bit of uncomfortable feeling; Night sweats; Black and blue where the shot was; Swollen at injection site; next morning it was bruised; When the needle was taken out it started to bleed/Left arm bleeding at injection; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264, NDC number; Expiry Date: unknown), via intramuscularly, administered in left arm on 28Jan2021 17:15 as single dose for covid-19 immunisation (prevention). The patient medical history was not reported. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. There was no family history. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. No previous history immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations (within 4 weeks). Flu shot a couple of months ago. No AE following prior vaccinations. The patient experienced when the needle was taken out it started to bleed/left arm bleeding at injection on 28Jan2021 17:30, night sweats on 02Feb2021, hot flashes, a little bit of uncomfortable feeling on an unspecified date, black and blue where the shot was, swollen at injection site was on 29Jan2021 10:00. She got first shot on 28Jan2021, and she is not on blood thinners. After the nurse took the needle out, it started to bleed. She said maybe she hit a vein. There was a little bit of uncomfortable feeling where vaccine was. The next day, she was black and blue where the shot was (The next morning it was bruised ("black and blue"). She got it around 5:15 pm. There was no prescriber. She did not speak with anyone in safety department, but she did speak with someone and she was going to change her over to someone else, but she never got to speak with anyone. She had a night sweats (It was after midnight at unknown time) and never had hot flashes ever. She felt very warm, and it went away. She took her temperature, and she did not have a temperature. If she gets second shot, she would like to know if she should get it in the right arm or left arm. Her next shot is due on 18Feb2021. There was no relevant test. No ER or physician's office required. There was no investigation assessment. There was no PQC (product quality complaint). The outcome of event hot flashes, a little bit of uncomfortable feeling was unknown and for other events it was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Hot flashes; A little bit of uncomfortable feeling; Night sweats; Black and blue where the shot was; Swollen at injection site; next morning it was bruised; When the needle was taken out it started to bleed/Left arm bleeding at injection; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264, NDC number; Expiry Date: unknown), via intramuscularly, administered in left arm on 28Jan2021 17:15 as single dose for covid-19 immunisation (prevention). The patient medical history was not reported. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. There was no family history. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. No previous history immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations (within 4 weeks). Flu shot a couple of months ago. No AE following prior vaccinations. The patient experienced when the needle was taken out it started to bleed/left arm bleeding at injection on 28Jan2021 17:30, night sweats on 02Feb2021, hot flashes, a little bit of uncomfortable feeling on an unspecified date, black and blue where the shot was, swollen at injection site was on 29Jan2021 10:00. She got first shot on 28Jan2021, and she is not on blood thinners. After the nurse took the needle out, it started to bleed. She said maybe she hit a vein. There was a little bit of uncomfortable feeling where vaccine was. The next day, she was black and blue where the shot was (The next morning it was bruised ("black and blue"). She got it around 5:15 pm. There was no prescriber. She did not speak with anyone in safety department, but she did speak with someone and she was going to change her over to someone else, but she never got to speak with anyone. She had a night sweats (It was after midnight at unknown time) and never had hot flashes ever. She felt very warm, and it went away. She took her temperature, and she did not have a temperature. If she gets second shot, she would like to know if she should get it in the right arm or left arm. Her next shot is due on 18Feb2021. There was no relevant test. No ER or physician's office required. There was no investigation assessment. There was no PQC (product quality complaint). The outcome of event hot flashes, a little bit of uncomfortable feeling was unknown and for other events it was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My sister and I and our husbands we all got the vaccine and had a little sore arm after; This is a spontaneous report from a contactable consumer. The female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number and Expiration date: unknown), via an unspecified route of administration on an unknown date as 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Patient reported that her sister and patient and their husbands they all got the vaccine and had a little sore arm after. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. ;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: I have some discomfort in my right arm; tingling in my fingers on the right arm where I got the shot similar to Carpal Tunnel; arm, under armpit hurts; arm, under armpit hurts; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264), via unspecified route of administration in the right upper arm on 02Feb2021 as a 1st dose, single for COVID-19 immunisation. The patients medical history included Asthmatic, bronchial asthma, Hyperthyroid and Grave's disease. The patient concomitant medications included Levothyroxine sodium (SYNTHROID) at a dose of 88 microgram tablet by mouth once daily for grave's disease. On 03Feb2021, the patient experienced discomfort in her right arm (also reported as: arm, under armpit hurts) and tingling in her fingers (Tingling started about 2 hours ago) on the right arm where she got the shot similar to Carpal Tunnel. The patient was not so much concerned about the hurting under the arm, as much as the tingling into fingers. Physician advised her to take paracetamol (TYLENOL) Extra strength after the shot, she had no discomfort after the shot, then she took another at 8PM, and did not took one next day (reported as one in the morning), when the pain was kicked in. The outcome of the events was unknown. The outcome of the event tingling in fingers were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Dizziness, Heart rate abnormal, Loss of personal independence in daily activities, Low density lipoprotein
Clinical narrative: her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse.  An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9265) via an unspecified route of administration, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse.  An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9265) via an unspecified route of administration, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain, Pain in extremity
Clinical narrative: Sore arm; chest pain; body aches; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in arm left on 02Feb2021 04:15 (at the time of 23-years-old) as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient had not covid. Post vaccination, the patient had not testet covid. No other vaccine received in four weeks. The patient previously took bnt162b2 (Pfizer, lot number: EL3248) on 14Jan2021 04:45 (at the time of 23-years-old) am in left arm dose 1 for covid-19 immunisation. The patient experienced sore arm, chest pain and body aches on 02Feb2021 12:00. The patient not received treatment for events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Weight, Weight increased
Clinical narrative: she may have gained weight; nausea; a real bad headache; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 77-year-old patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Feb2021 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 12Jan2021 as 1st dose (at the age of 77-years-old) for COVID-19 immunization. Patient had no other vaccines on the same day as her COVID vaccine. Patient medical history and concomitant medications were not reported. Patient woke up this morning (03Feb2021) with nausea and a real bad headache and wanted to know if she can take Tylenol but she is wondering if it is contraindicated with the product. Patient stated that the first dose did not do anything to her like this second dose has done. Patient further stated that she believes her symptoms are listed on her fact handout sheet as known side effects of the product. Patient lab data and procedures included patient weight as 265 or 270 pounds, she believes she might have gained weight during the pandemic. The outcome of the events was unknown.   Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 77-year-old female consumer reported that included patient's complete age, description about the adverse event with the onset date.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Pruritus, Rash
Clinical narrative: big itching in the body/strong itching; pain in the back and stomach/hurts in her upper back; pain in the back and stomach/hurts in front of her upper stomach; broke out in rash all over her body; This is a spontaneous report from a contactable consumer or other Non-health care professional.   An 80-years-old female patient received second 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 25Jan2021 as 2ND DOSE, SINGLE for indication of COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. The following 4 days patient was fine and after that she described her side effects as big itching in the body, pain in the back and stomach - She went to Hospital and doctors were not able to give any treatment recommendations. She wants to consult with Pfizer about her condition and seek for recommendations. patient broke out in rash all over her body and she was concerned about it. Patient stated that she had a strong itching for three days. Reported that hurts upper back and front of upper stomach. Has insurance and no one answered what she needs. Stated that she is in the shower every half hour. Stated that the itching is bad and she wanted to know what to do. Stated that she is healthy and has no problems and she had the vaccine a week ago and did not have any symptoms until three days ago when the itching started very hard then her back thing and then her stomach thing. Stated that she had no symptoms from the first one. Patient had taken her second dose of vaccine a week ago and did not have any symptoms until three days ago when she experienced, strong itching (pruritis), hurts in her upper back/front of her upper stomach (abdominal pain upper), rash all over her body. Stated that she called Medical Information before and they did nothing. Case number not provided. Outcome of events was unknown.  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Pruritus, Vomiting
Clinical narrative: nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EL9265, Expiration date: unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing blood pressure and acid reflux. Concomitant medication(s) included vitamin c, VITAMIN D3, calcium, zinc, blood pressure medication and acid reflux medication. The patient did not want to take the vaccine but her son insisted she took it so she went with him. The patient reported that she got the first dose of the vaccine and she did not think she paid much attention that day. The first day the patient threw up at breakfast and felt real nauseated then continued to have nausea with an upset stomach all day long and she did not know if that was making her headache or what, but she was nauseated all day long. The second day, she had a stomach upset. She went out that day and came home. She could not remember if she ate anything or not but then the next day she got nauseated with an upsets stomach. One night, she had itching all over her body then she feels like just blah. She took a Benadryl toward the morning because she could not stand the itching and thought if it was some type of allergy or something, maybe it could cut it down and she finally got to sleep. She wanted to know about the second dose because she heard a lot of people were super sick with the next vaccine and if she was having problems right now, whether she should take the another one. She saw the date range 17Feb2021-24Feb2021 and COVID 19 vaccine. She regularly took a blood pressure medication and an acid reflux. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: Severe headache; fever 101.6; nausea; chills; muscle aches; joint pain; This is a spontaneous report from a contactable 57-year-old female Nurse (patient, self-reported). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1284 and Expiry date: unknown), dose 2 via an intramuscular route of administration, in the right arm, on 02Feb2021 at 14:45 (age at the time 57-year-old), as single for COVID-19 immunisation in the public health clinic. The patient's medical history included fibromyalgia, migraine, anxiety, and depression. The patient was allergic to depo. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications included vitamin D3, zinc, unspecified multivitamin, duloxetine, which was received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899 and Expiry date: unknown), dose 1 via an intramuscular route of administration, in the left arm, on 05Jan2021 at 01:00 (age at the time 57-year-old), as single for COVID-19 immunisation. On 02Feb2021 at 17:00, two hours and 15 minutes after vaccination, the patient experienced severe headache, fever 101.6, nausea, chills, muscle aches, joint pain. The patient underwent lab tests and procedures which included fever 101.6 on 02Feb2021. Events were considered non serious by the reporter. Therapeutic measures in response to the event were not taken. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe headache; fever 101.6; nausea; chills; muscle aches; joint pain; This is a spontaneous report from a contactable 57-year-old female Nurse (patient, self-reported). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1284 and Expiry date: unknown), dose 2 via an intramuscular route of administration, in the right arm, on 02Feb2021 at 14:45 (age at the time 57-year-old), as single for COVID-19 immunisation in the public health clinic. The patient's medical history included fibromyalgia, migraine, anxiety, and depression. The patient was allergic to depo. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications included vitamin D3, zinc, unspecified multivitamin, duloxetine, which was received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899 and Expiry date: unknown), dose 1 via an intramuscular route of administration, in the left arm, on 05Jan2021 at 01:00 (age at the time 57-year-old), as single for COVID-19 immunisation. On 02Feb2021 at 17:00, two hours and 15 minutes after vaccination, the patient experienced severe headache, fever 101.6, nausea, chills, muscle aches, joint pain. The patient underwent lab tests and procedures which included fever 101.6 on 02Feb2021. Events were considered non serious by the reporter. Therapeutic measures in response to the event were not taken. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: Pain in the arm; Feeling tired; Feeling a little off; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that her daughter had the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and had adverse events like pain in the arm, feeling tired, and feeling a little off on an unspecified date in 2021. After receiving the first dose of the vaccine her arm was killing her. Now 3 weeks later mom explains that her daughter still feels off, she feels tired and her arm still hurts. She would like to know if that was normal as her daughter is due for the second dose on Friday (05Feb2021) and she still has the pain in her arm and still feels a little achy and off. She wanted to know if it has been reported in the clinical trials. The outcome of events was unknown.   This follow-up (Case closure) 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.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face is swole up around her eyes/ describes the sweling as water bags under the eyes; This a spontaneous report from two contactable consumers. This female consumer (patient) and her son reported. A female patient of an unspecified age 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 02Feb2021 at 17:30 as 1ST dose, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified the patient experienced face was swollen up around her eyes, no difficulty breathing. Swelling was worse on the right side of her face, but she received the shot in her left arm. She described the swelling as "water bags under the eyes". She also reported having had a flu shot about 3 weeks ago. She was concerned about the side effects and the second dose. Swelling of face can be a sign of severe allergic reaction but would typically occur within the first hour. It was reported that patient might had a mild, delayed allergic response. The patient was also referred back to HCPs for treatment / to have a plan for the second dose and let vaccinator know about the reaction when she goes for the second dose. Outcome of the event was unknown.  Information about Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: a fever blister bigger than thumbnail; This is a spontaneous report from a contactable consumer (patients daughter) or other non hcp. An 85-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left (Guessing left upper arm near shoulder for both doses) on 13Jan2021 17:30 (at the age of 85-year-old) as 1st dose, 0.3 ml single and second dose via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EL9263) as 2nd dose, 0.3 ml single for COVID -19 immunization. The patient medical history and concomitant medications were not reported. No medical history of previous immunizations was reported. It was reported that patient was on other medications (unspecified), but not related to the fever blister. It was reported that patient did great after first COVID shot. Patient did not receive any other vaccine within 4 weeks. Patient did not require to visit to emergency room or physician office for AES nor been prior vaccinated for AES. Patient did not have any family medical history. On 14Jan2021, the patient woke up with a fever blister bigger than thumbnail or cold sore on her lip after her first dose of vaccination. Patient had not a cold sore or fever blister in years. Reporter stated that this was something unusual; hoping she would not have it again tomorrow. She received her second dose almost an hour ago after physicians advised. Patient received Abreva (had no ndc/lot/exp to provide) as treatment for the event and fever blister was almost gone. She applied Abreva two to four times a day. Abreva controlled the fever blister. The skin was still a little irritated but takes time for it to smooth back over. Fever blister was no longer active. The scab part was gone. At the time of report, event outcome was resolving.    Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash/itchy spots located on his upper chest, shoulder and back; rash/itchy spots located on his upper chest, shoulder and back; This is a spontaneous report from a contactable consumer (Patient himself). This is report 1 of 2. A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: PHFEEL9263, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. No prior vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. On 29Jan2021, the patient experienced rash/itchy spots located on his upper chest, shoulder and back. Caller reported that his only reaction he thinks he had from the shot was itchy spots located on his upper chest, shoulder and back. He states it looks like his rash/spots are subsiding. It`s a lot lighter in color and hasn't spread. It states it has somewhat improved. Caller mentions he was a little hard of hearing. The caller had his Vaccine Record Card but could not determine if the Lot number had an H or K in it. He states it`s kind of scribbled. He gets his wife to look at the card as well. He states the Lot number looks to be "PHFEEL9263" on the card. The person didn't write it very clearly. When probed for concomitant products and medical conditions, the caller states " I was not going to go through my whole medication list. I was pretty healthy. No further details were provided or obtained. The outcome of the events was recovering.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Illness, Pyrexia
Clinical narrative: is not feeling well; feeling quite ill today; fever; chills; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not Provided, Expiry Date: not Provided), dose 2 via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, patient was not feeling well, feeling quite ill today, reported fever, chills and headache after second dose of the vaccine. Reporter mentioned that patient wanted to know if Tylenol or Motrin can be taken as she read conflicting information, that it was not advisable to take pain relivers such as Motrin or Tylenol. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): 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.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His arm to be "a little sore"; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history included broken arm. Concomitant medications were not reported. The patient had reported that the first injection caused his arm to be a little sore on an unspecified date. Patient wants to know if there was specific guidance on which arm to get the second dose in and second dose of the Pfizer vaccine was scheduled next week. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: tiredness; body aches; chills; mild fever (100.7 F); This is a spontaneous report from a contactable consumer (patient herself) reported that a 29-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3248 and expiration date: unknown), via an unspecified route of administration in left arm, on 01Feb2021 at 06:30 AM (at the age of 29 Years) as a single dose for COVID-19 immunisation. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3248, Expiration date: unknown) via an unspecified route of administration in left arm, on 11Jan2021 at 03:15 PM as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported and has no allergies to food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 01Feb2021 at 06:00 PM approximately 12 hours after the 2nd dose the patient experienced tiredness, body aches, chills, and a mild fever (100.7 F). These symptoms had dissipated by the following morning and felt completely normal about 30 hours after the 2nd dose. The consumer considered the events as non-serious. Prior to vaccination the patient was not diagnosed with COVID-19 and not been tested for COVID-19 since the vaccination. No treatment received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 100.7 fahrenheit on 01Feb2021. The outcome of the events was recovered on 02Feb2021 at 12:30.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Eating disorder, Feeling of body temperature change
Clinical narrative: appetite [as] small/little; he couldn't eat much; If I get up and walk to my car in the parking lot and come back, I am out of breath; Very sluggish; Night sweats; getting cold and hot; while walking short distances [he] had no energy/Anytime I exert myself, I have no energy, I feel like I start to sweat again; sweated/Heavy sweats; sweat so much that I had to change the sheets on the bed; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: and Expiration Date not reported) via an unspecified route of administration on Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of the COVID-19 vaccine last Thursday afternoon. He said during that Thursday evening, he sweated, and it was very bad to the point where he had to change his sheets. He specified that this occurred for 3 days and stopped. He also reported that on the following Monday and Tuesday, he realized that while walking short distances he had no energy. He pursued describing his appetite was small or little and said that he could not eat much of what his wife cooked for dinner last night. He explained he drank liquids and Gatorade to remain hydrated. He also mentioned he was missing out on his outings, specifying that he was supposed to play golf. He asked if his experience was reported as a side effect of the COVID-19 vaccine and wanted to know that can he take the vitamins. He also mentioned that it will be difficult to consult his PCP. The patient got this vaccination last Thursday evening. Thursday, Friday, Saturday, Sunday, he had heavy sweats. Monday and Tuesday so far this week, sweats did go away, but every time he try to exert himself, he had no energy. The patient also reported that, had already had the sweats. He sweat so much that the bed, He had to change the sheets on the bed for 3 days. The sweat was gone. It was like anytime that exerts himself, he felt like he starts to sweat again. If he gets up and walk to his car in the parking lot and come back, he gets out of breath. On Thursday, Friday, Saturday and Sunday he had severe sweats. Ever since the day he had severe sweats. On Wednesday in the following week, and he was very sluggish and was still getting cold and hot. The patient reported that, he had nightly sweats and his bed was wet for three days. He also reported that, he did not had fever. He was not in a rush, and no rashes and It was just sweats, no energy. On an unspecified date, the sweat (asthenia) was resolved, and another events outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Night sweats, Sluggishness
Clinical narrative: appetite [as] small/little; he couldn't eat much; If I get up and walk to my car in the parking lot and come back, I am out of breath; Very sluggish; Night sweats; getting cold and hot; while walking short distances [he] had no energy/Anytime I exert myself, I have no energy, I feel like I start to sweat again; sweated/Heavy sweats; sweat so much that I had to change the sheets on the bed; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: and Expiration Date not reported) via an unspecified route of administration on Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of the COVID-19 vaccine last Thursday afternoon. He said during that Thursday evening, he sweated, and it was very bad to the point where he had to change his sheets. He specified that this occurred for 3 days and stopped. He also reported that on the following Monday and Tuesday, he realized that while walking short distances he had no energy. He pursued describing his appetite was small or little and said that he could not eat much of what his wife cooked for dinner last night. He explained he drank liquids and Gatorade to remain hydrated. He also mentioned he was missing out on his outings, specifying that he was supposed to play golf. He asked if his experience was reported as a side effect of the COVID-19 vaccine and wanted to know that can he take the vitamins. He also mentioned that it will be difficult to consult his PCP. The patient got this vaccination last Thursday evening. Thursday, Friday, Saturday, Sunday, he had heavy sweats. Monday and Tuesday so far this week, sweats did go away, but every time he try to exert himself, he had no energy. The patient also reported that, had already had the sweats. He sweat so much that the bed, He had to change the sheets on the bed for 3 days. The sweat was gone. It was like anytime that exerts himself, he felt like he starts to sweat again. If he gets up and walk to his car in the parking lot and come back, he gets out of breath. On Thursday, Friday, Saturday and Sunday he had severe sweats. Ever since the day he had severe sweats. On Wednesday in the following week, and he was very sluggish and was still getting cold and hot. The patient reported that, he had nightly sweats and his bed was wet for three days. He also reported that, he did not had fever. He was not in a rush, and no rashes and It was just sweats, no energy. On an unspecified date, the sweat (asthenia) was resolved, and another events outcome was unknown.  Follow-up attempts are completed. No further information is expected.