chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; This is a spontaneous report from a contactable consumer(patient).  A 79-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 intramuscular on 18Feb2021 10:00 (At the age of 79-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER BION-TECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 intra-muscular on 27Jan2021 15:30(At the age of 79-year-old) as dose 1, single for COVID-19 immunization. The patient experienced swelling on an unspecified date in 2021. It was reported that prior vaccinations and relevant tests was None. The AEs required visit to Physician office. Therapeutic measures were taken as a result of swelling with ACE inhibitor. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: felt itchy; nausea; headache; body aches from head to toe; felt so exhausted; chills; fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified age as dose 1, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. It was reported that The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains had not yet been determined. On 25February, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It was important to had a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine did not protect against. While we had not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we was taking multiple steps to be ready in case a strain becomes resistant to the vaccine.The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine was not approved. Thepatient received both doses of the Pfizer COVID-19 vaccine. After receiving both shots, the patient felt itchy.The nurse told him it was normal. When the patient received the first shot, one hour after the patient experienced nausea and headache. Towards the end of night, the patient was having body aches from head to toe and tired. The patient also had chills with fever. The patient kept taking Tylenol that's why him temperature was 99. The patient did not even wake up or move. The patient felt so exhausted and did not even get out of bed.The patient received the second dose on Tuesday and had the same symptoms, but his chills lasted longer. The patient still did not feel great today and still had pain in the arm. Today the patient was able to get out of med. This morning the patient had sweats and felt cold.The patient still feel nauseas and had a headache.The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: felt itchy; nausea; headache; body aches from head to toe; felt so exhausted; chills; fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified age as dose 1, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. It was reported that The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains had not yet been determined. On 25February, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It was important to had a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine did not protect against. While we had not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we was taking multiple steps to be ready in case a strain becomes resistant to the vaccine.The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine was not approved. Thepatient received both doses of the Pfizer COVID-19 vaccine. After receiving both shots, the patient felt itchy.The nurse told him it was normal. When the patient received the first shot, one hour after the patient experienced nausea and headache. Towards the end of night, the patient was having body aches from head to toe and tired. The patient also had chills with fever. The patient kept taking Tylenol that's why him temperature was 99. The patient did not even wake up or move. The patient felt so exhausted and did not even get out of bed.The patient received the second dose on Tuesday and had the same symptoms, but his chills lasted longer. The patient still did not feel great today and still had pain in the arm. Today the patient was able to get out of med. This morning the patient had sweats and felt cold.The patient still feel nauseas and had a headache.The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Apr 16, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. After she received the first dose of the Pfizer COVID-19 vaccine, the next Tuesday she started having muscle and joint pain. After 2 weeks, she has had joint pain ever since. The pain is not going away. She would like to know when will it end. The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pyrexia
Clinical narrative: low grade fevers; Their second dose of the vaccine is due tomorrow 04May2021 and they were told that they will be receiving the second dose on a different facility and have to reschedule; This is a spontaneous report from a Pfizer sponsored program and a contactable consumer (wife), who reported for her husband.  A 62-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was Not reported) via an unspecified route of administration on 13Apr2021 as a DOSE 1, SINGLE dose for COVID-19 immunization.Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low grade fevers and Their second dose of the vaccine is due tomorrow 04May2021 and they were told that they will be receiving the second dose on a different facility and have to reschedule. They both received their second Pfizer Covid vaccines on 05May2021 and on 06May2021 he reports they have low grade fevers. The reporter together with his wife, got their first dose of the vaccine 3 weeks ago (13Apr2021). Their second dose of the vaccine is due tomorrow 04May2021 and they were told that they will be receiving the second dose on a different facility and have to reschedule. He also wanted to know if it would matter if they can take it after their due date or if it will affect the vaccine. He had no questions at this time. The outcome of the events was unknown.  No unaddressed medical questions were referred or forwarded to Medical Information.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait disturbance, Headache, Nausea
Clinical narrative: He could barely walk for the first two days; Extreme fatigue; Swelling; Dizziness; Arm pain at vaccine site; Fingertips pain; Headache up the back; Nauseous; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller reports that he received second dose Tuesday of vaccine. Caller reports that he could barely walk for the first two days, he has experienced swelling, extreme fatigue, dizziness, arm pain at vaccine site, finger tips pain, headache up the back and nauseous. Caller reports that he is still suffering side effects today and would like to know how long they will last. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site pain
Clinical narrative: He could barely walk for the first two days; Extreme fatigue; Swelling; Dizziness; Arm pain at vaccine site; Fingertips pain; Headache up the back; Nauseous; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller reports that he received second dose Tuesday of vaccine. Caller reports that he could barely walk for the first two days, he has experienced swelling, extreme fatigue, dizziness, arm pain at vaccine site, finger tips pain, headache up the back and nauseous. Caller reports that he is still suffering side effects today and would like to know how long they will last. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Muscle spasms, Nasal congestion, Nasopharyngitis
Clinical narrative: Symptoms of cold; nasal congestion; little bit of itchiness in throat; Feeling sleepy; dry cough; Diarrhea; Sore throat was because of repeated sneezing; Sore throat was because of repeated sneezing; Little tiny cramps in some part of my body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in arm left on 28Apr2021 (age at vaccination 62 years) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. Other Products was reported as no. She stated that she just wanted to report that, what was supposed to be considered abnormal symptoms to the vaccine, Pfizer vaccine, so after 48 hours of getting the vaccine on 30Apr2021, she started with a symptoms of cold, which were nasal congestion, feeling sleepy and some diarrhea. She stated today on 30Apr2021 she got a new symptoms that was a sore throat but it was just for few hours and she thought that sore throat was because of repeated sneezing because she didn't feel any pain in her throat or mouth. She further stated it was 1st shot, she also felt like little tiny cramps in some part of her body, now she did not feel bad and this has been since friday last week and she feel some symptoms and little bit of itchiness in throat, its dry cough, all cold symptoms she did not experience all this symptoms until 48hrs after the vaccine all events experienced on 30Apr2021. Seriousness of the events was non serious. The patient did not receive any treatment for the adverse events. The outcome of the event nasal congestion was not recovered and all other events was unknown.  No follow up attempts are needed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sneezing, Somnolence, Throat irritation
Clinical narrative: Symptoms of cold; nasal congestion; little bit of itchiness in throat; Feeling sleepy; dry cough; Diarrhea; Sore throat was because of repeated sneezing; Sore throat was because of repeated sneezing; Little tiny cramps in some part of my body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 62-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in arm left on 28Apr2021 (age at vaccination 62 years) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. Other Products was reported as no. She stated that she just wanted to report that, what was supposed to be considered abnormal symptoms to the vaccine, Pfizer vaccine, so after 48 hours of getting the vaccine on 30Apr2021, she started with a symptoms of cold, which were nasal congestion, feeling sleepy and some diarrhea. She stated today on 30Apr2021 she got a new symptoms that was a sore throat but it was just for few hours and she thought that sore throat was because of repeated sneezing because she didn't feel any pain in her throat or mouth. She further stated it was 1st shot, she also felt like little tiny cramps in some part of her body, now she did not feel bad and this has been since friday last week and she feel some symptoms and little bit of itchiness in throat, its dry cough, all cold symptoms she did not experience all this symptoms until 48hrs after the vaccine all events experienced on 30Apr2021. Seriousness of the events was non serious. The patient did not receive any treatment for the adverse events. The outcome of the event nasal congestion was not recovered and all other events was unknown.  No follow up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Headache, Illness
Clinical narrative: didn't feel well for 24 hours; GI issues; Fever; Chills; Night sweats; Headache; loss of appetite; he was sick as a dog after second dose of the vaccine; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friends' niece) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 01May2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date of 2021 as DOSE 1, SINGLE for covid-19 immunization. Reporter stated she has a friend that reported that they didn't feel well for 24 hours after getting the second dose of the Pfizer COVID-19 vaccine on May2021. She initially says that she was guessing that he got the vaccine yesterday, then clarifies that it was Saturday morning, so May 1st. She stated her friend said he was sick as a dog after second dose of the vaccine, and was just starting to feel better, and was now having GI issues. Reporter stated he also told her he had fever, chills, night sweats, headache, loss of appetitive, and GI issues on an unspecified date on May2021 and that her friend also said he had a niece who also received the second dose of the vaccine the same day, and he said she experienced the same things he did. The outcome of the event were unknown.  No follow-up attempts are possible;information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pyrexia
Clinical narrative: didn't feel well for 24 hours; GI issues; Fever; Chills; Night sweats; Headache; loss of appetite; he was sick as a dog after second dose of the vaccine; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friends' niece) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 01May2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date of 2021 as DOSE 1, SINGLE for covid-19 immunization. Reporter stated she has a friend that reported that they didn't feel well for 24 hours after getting the second dose of the Pfizer COVID-19 vaccine on May2021. She initially says that she was guessing that he got the vaccine yesterday, then clarifies that it was Saturday morning, so May 1st. She stated her friend said he was sick as a dog after second dose of the vaccine, and was just starting to feel better, and was now having GI issues. Reporter stated he also told her he had fever, chills, night sweats, headache, loss of appetitive, and GI issues on an unspecified date on May2021 and that her friend also said he had a niece who also received the second dose of the vaccine the same day, and he said she experienced the same things he did. The outcome of the event were unknown.  No follow-up attempts are possible;information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Felt tired; Headache; My temperature running high; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Stated that, when probed for the concern, the patient had got the 1st Vaccine last Tuesday on an unspecified date and felt a little tired for the first 2 days but like noticed yesterday and today on an unspecified date, the patient had been having headache, just really fatigue and the patient went to get hair cut today and they screened the temperature and they told, the patient was running a bit high. Stated that, was this, it's been about 5 days, the patient was just wondered whether it was normal side effect or was there something the patient should be concerned about like getting tested. When paraphrased the concern, the consumer stated as yes and the consumer was informed about the Role of Drug Safety and Medical Information Department. When probed further question, the consumer stated that, actually the consumer did not had 10 minutes time to spare, no. Stated that, as the consumer was not willing to proceed the call, product details (LOT#, expiration date, NDC# and UPC#), pharmacy details and treatment could not be probed over the call. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pyrexia
Clinical narrative: fever; Chills; more neck pain than normal; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 26-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:30 (at the age of 26-years-old) as single dose for COVID-19 immunisation. Medical history included polycystic ovaries from 2016 and ongoing Verbatim: Polycystic ovarian syndrome, pyrexia (Her Mom had a hard time with the vaccine, had a fever both times but didn't have the arm thing), anaemia, headache, neck pain, vitamin d deficiency, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. ferritin taken for anaemia, start and stop date were not reported. colecalciferol (D3 VITAMIN) taken for vitamin d deficiency, start and stop date were not reported. loratadine taken for hypersensitivity from Apr2021 to an unspecified stop date; ibuprofen taken for headache, neck pain, start and stop date were not reported. Flu Vaccine a couple of years ago where she felt pretty bad, 2018. As a child she had flu vaccines(2018), but parents were weird and so she did not get as many of them. On 17Mar2021 after the first shot, she noticed more neck pain than normal but it went away quickly, she had fever and chills. Therapeutic measures were taken as a result of more neck pain than normal , fever, chills .Patient received treatment with Tylenol initially the day she had fever and chills, Ibuprofen for Chronic Neck Pain a couple of times. Patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 09Apr2021 12:30 at 26 years old (Lot number: EW0153) as single dose on left arm for covid-19 immunisation. The outcome of more neck pain than normal was recovered on an unspecified date in Mar2021 and outcome of fever and chills was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101.2; sore arm; headache; body aches; This is a spontaneous report from a contactable consumer. This consumer (patient's spouse) reported for a 37-year-old male patient that:  A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 37-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever of 101.2, sore arm, headache and body aches. The patient underwent lab tests and procedures which included body temperature: 101.2 on an unknown date. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: high temperature; body aches; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Pfizer Sponsored Program.  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 on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient received second dose of COVID vaccine 24 hours ago and experiencing high temperature, body aches and headache. She was wondering when she can take something for it. The outcome of the event was unknown.  No follow-up attempts were possible. Information about batch number cannot be obtained; no further information was expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypersensitivity, Tachycardia
Clinical narrative: rapid heartbeat; blood pressure rising; she did take the first shot and her allergies were not as bad; This is a spontaneous report from a contactable consumer (patient herself).  An 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0153, Expiry date was not reported), via an unspecified route, administered in left arm on 20Apr2021 at 11:00 (Age at vaccination 85-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The vaccination facility type was pharmacy or drug store. Medical history included asthma (asthma was bad this year since the beginning of Jan2021) to an unknown date and arthritis from an unknown date and unknown if ongoing. Concomitant medications included prednisone ongoing, been taking for maybe 4 or 5 years for asthma and arthritis, formoterol fumarate (SYMBICORT) taken for asthma, start and stop date were not reported. The patient experienced rapid heartbeat, blood pressure rising on 20Apr2021, and she did take the first shot and her allergies were not as bad on an unspecified date in Apr2021. It was reported that she did take the first shot and her allergies were not as bad. The asthma did not get bad because of the vaccine. The asthma had been bad this year since the beginning of January. Patient stated that the symptom she experienced was a rapid heartbeat. She had a thing that she puts her finger in and her heart rate went over 100 and it was about 110. Her blood pressure was rising on 20Apr2021 and so she took an extra half of blood pressure medication, and she took a medication called Librium that she takes for her nerves, 2 pills that were 5mg each and so her heart racing only lasted an hour in a half and she laid down and it subsided. Rapid heartbeat started about an hour after she got home and once it went away which it lasted about hour in a half and was annoying and scary, but it finally went away after she laid down and took medicine. she felt was relevant to the blood pressure that was rising and rapid heartbeat she experienced after receiving the COVID 19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received treatment for rapid heartbeat and blood pressure rising. The clinical outcome of the event she did take the first shot and her allergies were not as bad was unknown and rest of the events was resolved on 20Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Got the second shot and she has been experiencing fever from like twelve days; This is a spontaneous report from a non-contactable consumer (patient's parent). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Lot number was not reported, Expiry date was unknown)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported, Expiry date was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient got the second shot, and she has been experiencing fever from like twelve days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Chills; little bit nausea; Fever like 105 degree; This is a spontaneous report from a non contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: ER8736), via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: ER8732), via an unspecified route of administration on 13Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had some of the side effects not like severe but like body aches, chills, little bit nausea and fever like 105 degree on an unspecified date. Consumer further stated that just wanted to know how long will these last and when are they supposed to be start getting better, that was only consumer want to ask. Consumer don't know if it was supposed to last for a day or couple of days or it will go away. The patient underwent lab tests and procedures which included pyrexia: 105 degrees centigrade on unspecified date. At the time of this report, the outcome of events was not recovered.  No follow-up attempts needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal oedema, Oropharyngeal discomfort, Rhinorrhoea
Clinical narrative: running nose; Cough; throat is bothering her; Headache; Small bumps inside nose; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 56-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: WPSTT) via an unspecified route of administration on 27Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 30Apr2021 the patient experienced running nose, cough, throat is bothering her, headache and small bumps inside nose.  The events outcome was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: body aches; Fever of 102; chills; left arm pain at injection site; This is a spontaneous report from a contactable consumer, the patient.  A 74-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: ER8736), via an unspecified route of administration, in arm left on 06May2021 at 11:45 as dose 2, single (age at vaccination 74 years) for covid-19 immunisation. Medical history included PSVT, osteoporosis, prediabetes and was allergic to contrast dye, shellfish, paramenobenzoic acid (PAPA). The patient did not have covid prior vaccination. No other vaccine was administered in four weeks. Concomitant medication(s) included verapamil and vitamins since an unknown date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0151), via an unspecified route of administration, in arm left on 13Apr2021 at 12:30 as dose 1, single (age at vaccination 74 years) for covid-19 immunisation and experienced fever of 99, headache, body aches, left arm pain at injection site. After the second dose, on 07May2021 at 18:30 the patient experienced fever of 102, chills, body aches, left arm pain at injection site. The patient underwent lab tests which included body temperature: 102 Fahrenheit on 07May2021. No therapeutic treatment was taken for the events. The patient was not tested post covid vaccination. The outcome of the events was recovered.  No follow-up attempts are possible, no further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Lymphadenopathy, Pain, Pruritus
Clinical narrative: Began having normal body aches; Armpits were a little bit swollen; A bit itchy in his chest area; A few hives and a little redness on his chest; A few hives and a little redness on his chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0173, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 04May2021 at 13:45 hours as dose 2, single (at the age of 21- years) for COVID-19 immunization. Patient had no medical history and had received no concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient had no family medical history relevant to adverse event. The patient had not received any additional vaccines on same date of the Pfizer suspect. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0158, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 13Apr2021 at 13:45 hours as dose 1, single (at the age of 21-years) for COVID-19 immunization and experienced heat rashes or sun rash and itching. On 05May2021, patient began having normal body aches, noted his armpits were a little bit swollen and was a bit itchy in his chest area and noticed a few hives and a little redness on his chest, could be his anxiety getting the best of him right now, but he wants to know if it was okay to take Benadryl or if he needs to take more serious action but patient verified later in the call that he had not received any treatment for all the events. The outcome of all the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Began having normal body aches; Armpits were a little bit swollen; A bit itchy in his chest area; A few hives and a little redness on his chest; A few hives and a little redness on his chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0173, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 04May2021 at 13:45 hours as dose 2, single (at the age of 21- years) for COVID-19 immunization. Patient had no medical history and had received no concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient had no family medical history relevant to adverse event. The patient had not received any additional vaccines on same date of the Pfizer suspect. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0158, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 13Apr2021 at 13:45 hours as dose 1, single (at the age of 21-years) for COVID-19 immunization and experienced heat rashes or sun rash and itching. On 05May2021, patient began having normal body aches, noted his armpits were a little bit swollen and was a bit itchy in his chest area and noticed a few hives and a little redness on his chest, could be his anxiety getting the best of him right now, but he wants to know if it was okay to take Benadryl or if he needs to take more serious action but patient verified later in the call that he had not received any treatment for all the events. The outcome of all the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Investigation, Laboratory test, Pyrexia
Clinical narrative: little chilly; little fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8727, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left upper arm (left shoulder) on 16Apr2021 as dose 1, single (at the age of 76-years-old) for COVID-19 immunization. The patient's medical history included bad back (has been having problems 15 years or longer), high blood pressure (has had for 20-something years), gastro stomach problems (has had for 15 years, probably 10 to 15 years), COVID-19 from Jan2021 and unknown if ongoing, clot in her lung from unknown date to unknown date, chills since starting her blood thinner from Jan2021 to unknown date, anxiety, pain and allergies from unknown date to unknown if ongoing. Patient had no family medical history relevant to adverse event. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had that antibody, she had antibodies before she realized she had COVID-19. Concomitant medication included cetirizine taken for allergies, apixaban (Eliquis) as blood thinners, lisinopril taken for blood pressure high, famotidine for the stomach, amlodipine besilate taken for blood pressure high, vitamin D and vitamin C for an unspecified indication. Patient also had anxiety and pain medications, but she did not take them prior to the vaccines. Patient also has acetaminophen-hydrocodone but did not use in the two weeks prior to the vaccines. On 16Apr2021, after the first shot patient was okay, but at night, patient was just little chilly but not had a cold and had a little fever, but, like she said, she does not feel bad.  Patient does not feel weak or tired or anything.  She does take blood thinners, too. Patient stated that fever and chills did not stick around. On an unspecified date of 2021 (last week from 06May2021), patient did have some lab work results were unknown. The only thing the doctor did was give her a chest, nuclear. Patient confirmed that as chest, nuclear. The doctor said the clot was gone. The doctor did not see it, that was why they did a nuclear test and they injected nuclear fluid into her arm so it could go to her lungs to let them know if anything was still there, patient developed the blood clot when she got COVID. Patient had no physician office and emergency room visit for the events. The outcome of both the events was recovered on an unspecified date of 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: High fever; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's mother) via medical information team. A 22-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 04May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Reporter stated that she got an email stating that there was a recall on sterile solution/water. Her daughter and she got the second dose of the Pfizer covid vaccine yesterday (04May2021). Reporter wanted to know was that what they put in the vaccine. On 04May2021, her daughter had a high fever, chills and nausea. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Sore arm (site of injection); sore arm (site of injection) across the chest (towards the left arm); has prominent lymph nodes at the armpit; This is a spontaneous report from a contactable consumer or other non healthcare professional (Patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route, administered in Arm Left on 15Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm (site of injection), across the chest (towards the left arm) and has prominent lymph nodes at the armpit. The patient was asking if you did not take a 2nd dose of Covid-19 vaccine, can she take it more than 3 weeks and would it still be effective. Then, she also wanted to know if the 1st dose of the Covid-19 vaccine was enough and can protect her to Covid-19. Moreover, the 1st dose was taken last 15Apr2021 and her 2nd dose was originally scheduled today (06May2021) but due to the symptoms that she was experiencing, the 2nd dose was moved on 19May2021. The medical questions were addressed by this program forwarded/referred to Medical Information. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: felt itchy; nausea; headache; body aches from head to toe; tired/I felt so exhausted; chills; fever; have pain in the arm.; I had sweats and felt cold; I had sweats and felt cold; couldn't even wake up or move/I couldn't even get out of bed; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection , Lot number was not reported), dose 2 via an unspecified route of administration in May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. The patient reported felt itchy, nausea, headache, body aches from head to toe,chills, fever, have pain in the arm , tired/I felt so exhausted, i had sweats and felt cold , couldn't even wake up or move/i couldn't even get out of bed in May2021. It was further stated by the patient that "I received both doses of the Pfizer COVID-19 vaccine. After receiving both shots, I felt itchy. The nurse told me it was normal. When I received the first shot, one hour after I experienced nausea and headache. Towards the end of night, I was having body aches from head to toe and tired. I also had chills with fever. I kept taking Tylenol that's why my temperature was 99. I couldn't even wake up or move. I felt so exhausted. I couldn't even get out of bed. I received the second dose on Tuesday. I have the same symptoms, but my chills lasted longer. I still don't feel great today. I still have pain in the arm. Today I was able to get out of med. This morning I had sweats and felt cold. I still feel nauseas and have a headache". Therapeutic measures were taken as a result of felt itchy, nausea, headache, body aches from head to toe, tired, chills, fever, have pain in the arm, i felt so exhausted, couldn't even wake up or move/i couldn't even get out of bed. Treatment for I had sweats and felt cold was not reported. Patient was asking about booster dose 3.Relevant laboratory tests included body temperature was 99 in May2021. The outcome of the events nausea and headache was not yet recovered. The outcome of the rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Movement disorder, Nausea, Pain, Pain in extremity
Clinical narrative: felt itchy; nausea; headache; body aches from head to toe; tired/I felt so exhausted; chills; fever; have pain in the arm.; I had sweats and felt cold; I had sweats and felt cold; couldn't even wake up or move/I couldn't even get out of bed; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection , Lot number was not reported), dose 2 via an unspecified route of administration in May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. The patient reported felt itchy, nausea, headache, body aches from head to toe,chills, fever, have pain in the arm , tired/I felt so exhausted, i had sweats and felt cold , couldn't even wake up or move/i couldn't even get out of bed in May2021. It was further stated by the patient that "I received both doses of the Pfizer COVID-19 vaccine. After receiving both shots, I felt itchy. The nurse told me it was normal. When I received the first shot, one hour after I experienced nausea and headache. Towards the end of night, I was having body aches from head to toe and tired. I also had chills with fever. I kept taking Tylenol that's why my temperature was 99. I couldn't even wake up or move. I felt so exhausted. I couldn't even get out of bed. I received the second dose on Tuesday. I have the same symptoms, but my chills lasted longer. I still don't feel great today. I still have pain in the arm. Today I was able to get out of med. This morning I had sweats and felt cold. I still feel nauseas and have a headache". Therapeutic measures were taken as a result of felt itchy, nausea, headache, body aches from head to toe, tired, chills, fever, have pain in the arm, i felt so exhausted, couldn't even wake up or move/i couldn't even get out of bed. Treatment for I had sweats and felt cold was not reported. Patient was asking about booster dose 3.Relevant laboratory tests included body temperature was 99 in May2021. The outcome of the events nausea and headache was not yet recovered. The outcome of the rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.