chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate, Heart rate increased, Laboratory test, Lymph node pain
Clinical narrative: Lymph node in groin area caused problems I don't know if it was swollen but it was painful. It started slow but it was really bad; Lymph node in groin area caused problems I don't know if it was swollen but it was painful. It started slow but it was really bad; I was walking and I had a hard time making it into the house; fast heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6200) as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure abnormal" (unspecified if ongoing), notes: was on blood pressure medication. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "Lymph node in groin area caused problems I don't know if it was swollen but it was painful. It started slow but it was really bad"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I was walking and I had a hard time making it into the house"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, gait disturbance, heart rate increased.  Additional Information: The problems in the lymph node in the patient's groin area started about 4 days  after vaccination and she didn't realize that it was connected with the Covid injection. The patient was asking how much worst or how much is that with the second shot and if it is that strong as the first one or stronger. The patient was on blood pressure medication and she lost 25 pounds and they took her off the medication because it was doing no harm and it was not doing good. The patient did not know the medication as she have been off of this over a year.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node in groin area caused problems I don't know if it was swollen but it was painful. It started slow but it was really bad; Lymph node in groin area caused problems I don't know if it was swollen but it was painful. It started slow but it was really bad; I was walking and I had a hard time making it into the house; fast heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6200) as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure abnormal" (unspecified if ongoing), notes: was on blood pressure medication. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "Lymph node in groin area caused problems I don't know if it was swollen but it was painful. It started slow but it was really bad"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I was walking and I had a hard time making it into the house"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, gait disturbance, heart rate increased.  Additional Information: The problems in the lymph node in the patient's groin area started about 4 days  after vaccination and she didn't realize that it was connected with the Covid injection. The patient was asking how much worst or how much is that with the second shot and if it is that strong as the first one or stronger. The patient was on blood pressure medication and she lost 25 pounds and they took her off the medication because it was doing no harm and it was not doing good. The patient did not know the medication as she have been off of this over a year.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 11:00 (Lot number: EL9266) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (not ongoing); "High blood pressure" (not ongoing); "COVID-19", start date: 24Aug2020 (unspecified if ongoing); "tinnitus", start date: 2014 (unspecified if ongoing), notes: He had tinnitus 7 years ago, Over the past 7 years, he has experienced ear ringing off and on; "vegan", start date: 2017 (unspecified if ongoing); "allergies" (ongoing); "heart health" (ongoing); "vitamin supplementation" (ongoing). Concomitant medication(s) included: VIT D (ongoing); COQ-10 taken for cardiovascular event prophylaxis (ongoing); CLARITIN [LORATADINE] taken for hypersensitivity (ongoing). The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "unknown", described as "Ear ringing".  Additional information: Patient was also taking an unspecified turmeric supplement 2 tablets a day by mouth and multivitamins 1 tablet by mouth daily for vitamin supplementation. He mentioned that he hasn't been vaccinated in years. Last vaccine he received was about 7 years ago, the one he got was the one for stepping on a rusty nail which hurt. It was also reported that he got the Pfizer vaccine 19 days ago 12Feb2021 and about a week (5-7 days) after receiving the vaccine, he developed ear ringing. He reported the ear ringing was nothing crazy or severe. He checked his blood pressure a few times and it was fine. Patient stated that he knew blood pressure can be a symptom. He also stated that if he was busy doing things, the ear ringing was unnoticed, but he did hear and feel it when he was quiet or going to bed. If he stops doing something, he can hear it. He mentioned he had tinnitus 7 years ago. Patient also mentioned he tested positive for COVID 24Aug2020 and he did not have ear ringing as a symptom. Over the past 7 years, he had experienced ear ringing off and on. He had not been to the doctor because it hasn't been an issue. Event also did not result to emergency room visit.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Poor venous access
Clinical narrative: had routine blood drawn for a routine check-up , they couldn't get it in the arm that I had my shot in, tried different arm and they really had a hard time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: POOR VENOUS ACCESS (non-serious), outcome "unknown", described as "had routine blood drawn for a routine check-up , they couldn't get it in the arm that I had my shot in, tried different arm and they really had a hard time ". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264532 Same reporter, product, and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Poor venous access
Clinical narrative: neither one of us ever had issues drawing blood out of our veins till ever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: POOR VENOUS ACCESS (non-serious), outcome "unknown", described as "neither one of us ever had issues drawing blood out of our veins till ever". Additional information: The reporter and the patient received the first and second shot of BNT162B2. The reporter and the patient have routine blood drawn for a routine check up and neither one of them ever had issues drawing blood out of their veins until they got the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264488 Same reporter/product/event, different patient
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: usually has very bad pain in shoulders because she has no cartilage/she had a whole month and a half with no pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 22Jan2021 (Lot number: EN6200) at the age of 83 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart trouble" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "Severe glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "usually has very bad pain in shoulders because she has no cartilage/she had a whole month and a half with no pain".  Additional information: The patient wanted to talk about her experience with the vaccine. The patient stated that it was awesome, she had no side effect, no pain, and everything went perfect. She was thankful for the COVID vaccine. The patient informed that she had no pain or anything and usually has a very bad pain in shoulders because she has no cartilage. The patient informed that she had no pain in her shoulders from the time between her first to second COVID vaccine and wanted to know if Pfizer can develop a medication for arthritis. The kids of the patient told her that she can move her arms (excruciating to lift her arms because of no cartilage). The patient was thankful because she had a whole month and a half with no pain. The patient wanted tot to get another COVID vaccine just to help her arthritis and for the relief of her shoulder.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Nausea
Clinical narrative: Light headedness and slight nausea; not severe; Light headedness and slight nausea; not severe; Uncomfortable; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (Lot number: EN6202) at the age of 86 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "surgery on her ankle on her leg" (unspecified if ongoing); "cancerous condition she had in a breast" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 01Mar2021, outcome "recovered" (Mar2021) and all described as "Light headedness and slight nausea; not severe"; DISCOMFORT (non-serious) with onset 01Mar2021, outcome "recovered" (Mar2021), described as "Uncomfortable". Therapeutic measures were not taken as a result of dizziness, nausea, discomfort.  Additional information: The patient stated she was taking a lot of medication. She had high blood pressure, she was taking an anti-hormonal drug for a cancerous condition she had in a breast and she was taking a blood thinner. She was also taking a multivitamin. The patient started to experience the events about 4 hours into or maybe 6 hours or more after vaccination because it was almost evening. The patient did not have treatment for the events but said she ate something and that seemed to help. The patient was due for the second dose on 22Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minor aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "minor aches". Additional information: This is the first of the two people in the family reported for minor aches after the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264597 Same reporter, drug and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: two other people in family had the Pfizer vaccine and only had minor aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome unknown, described as two other people in family had the Pfizer vaccine and only had minor aches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264596 same reporter, product and event; different patient
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  A 90 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 13:00 (Lot number: EN6205) at the age of 90 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 08Feb2021, when the patient was 89 years old, for covid-19 immunisation, reaction(s): "had a sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Dysgeusia, Pain in extremity
Clinical narrative: Chills; Very high anxiety; I felt like I taste something; Low energy; Sore arm; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 19Feb2021 (Lot number: EN9581) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cortisone, reactions: "tremors and shakes", notes: Almost for a whole year and "agoraphobic"; Iodine dye for kidney test, reaction: "Hard time breathing". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ANXIETY (non-serious), outcome "unknown", described as "Very high anxiety"; DYSGEUSIA (non-serious), outcome "unknown", described as "I felt like I taste something"; ASTHENIA (non-serious), outcome "unknown", described as "Low energy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".   Additional information: The patient stated to be going for my second shot, but the concern was the first shot and the side effects. The patient reported to had the chills and very high anxiety. The patient even felt like when had my shot, little bit after, felt like patient taste something and anyhow and low energy and this sore arm. The patient stated that the concern was though when had a cortisone shot, patient had the tremors and shakes. The patient would have that almost for a whole year that patient become agoraphobic, it got so bad, but patient was able to manage. The patient was able to get out and do what has to be done but the other one was patient had a Iodine dye, kidney test and of course that was injectable and had a hard time breathing. The patient was concern for the second shot. The patient was querying if patient would have to be worried because patient did have those two different episodes. The patient further stated, that the concern is when patient got anxiety with this first shot, it brought (also reported as broke) all back to how patient felt when patient had cortisone shot although patient didn't shake. Patient did get anxiety.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Hot all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "Hot all over". Therapeutic measures were taken as a result of feeling hot.  Additional information: Aspirin was taken as treatment of the event hot all over.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Myalgia
Clinical narrative: Muscle pain in my leg; Did not sleep last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 22Feb2021 (Lot number: EM6200) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (first dose), for COVID-19 immunisation.  The following information was reported: MYALGIA (non-serious), outcome "not recovered", described as "Muscle pain in my leg"; INSOMNIA (non-serious), outcome "unknown", described as "Did not sleep last night". The events "muscle pain in my leg" and "did not sleep last night" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, insomnia.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 09Feb2021 (Lot number: EN9581, Expiration Date: May2021) at the age of 70 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "thyroid disorder" (unspecified if ongoing); "thyroidectomy", start date: 2013 (unspecified if ongoing), notes: about 8 years ago. Concomitant medication included: SYNTHROID taken for thyroid hormone replacement therapy. Vaccination history included: Flu shot (she took a paracetamol [TYLENOL] before her flu shot), administration date: Sep2020, for immunisation, reaction: "none". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The patient stated that the event was over in 2 days. She had no family medical history relevant to the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Expected arm is going to hurt like after first dose where she couldn't elevate her arm.; terrible headache; Felt weird.; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Feb2021 (Lot number: EL9264) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "an accident three to four years ago on her left arm" (unspecified if ongoing), notes: three to four years ago.; "achy and felt the pain" (unspecified if ongoing), notes: three to four years ago.; "it is like the flu" (unspecified if ongoing), notes: three to four years ago.; "She has a plate in the left arm" (unspecified if ongoing), notes: three to four years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Expected arm is going to hurt like after first dose where she couldn't elevate her arm."; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "terrible headache"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Felt weird.". The events "expected arm is going to hurt like after first dose where she couldn't elevate her arm.", "terrible headache" and "felt weird." were evaluated at the physician office visit. Additional Information: The patient had an accident three to four years ago on her left arm. She was left-handed. Pain there was horrible form the beginning. From her accident she doesn't take therapy or nothing. She was ok. She stated it was like the flu. She started getting achy and felt the pain. From the accident everything was ok. She was feeling it all over her body. She has a plate in the left arm. The patient has no additional vaccines administered on the same date of vaccine. The patient has not received any vaccine within 4 weeks prior to vaccination. The patient has no family medical history. The patient expected arm was going to hurt like after first dose where she couldn't elevate her arm. She had terrible (headache) off and on since first COVID Vaccine and felt weird. The events required a visit to physician's office. She did not visit emergency room. The patient received second dose COVID vaccine on 01Mar2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264901 same patient/reporter/drug, different AE in separated time
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Headache, Migraine, Vision blurred
Clinical narrative: Blurred vision; Extreme headache; Extreme migraine; This is a spontaneous report received from contactable reporter (consumer).  A 84 year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 84 years as single dose for covid-19 immunization. Relevant medical history included: "high cholesterol" (ongoing); "high blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose; Lot number unknown), administration date: 03Feb2021, when the patient was 84 years old, single for covid-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 02Mar2021, outcome "recovering", described as "Blurred vision"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovering", described as "Extreme headache"; MIGRAINE (non-serious) with onset 02Mar2021, outcome "recovering", described as "Extreme migraine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated, after the second shot she's been experiencing an extreme headache, with blurred vision and she had the shot on (02Mar2021) Wednesday so we are on day three. and I didn't know, I have not seen, when I had access to the internet, that as one of the side effects and  just wanted to know if this is and it is been reported in time frame of the symptom and when it should resolved?".  The reporter stated that she had blood work done 2 weeks before (unspecified date in Feb2021) for cholesterol and blood pressure, basic blood work, everything was normal; cholesterol was in the acceptable range. The reporter stated about the event that is getting better but is still persisting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hyperhidrosis, Illness, Lethargy
Clinical narrative: chills; sweating; very bad cold; very weak; lethargic; not feeling well; wasn't feeling good; sick; Little pain in my arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EL9267) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (Lot number: EL9263 as dose 1, single), administration date: 25Jan2021, when the patient was 86 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Little pain in my arms"; CHILLS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "sweating"; NASOPHARYNGITIS (non-serious) with onset 26Feb2021, outcome "unknown", described as "very bad cold"; ASTHENIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "very weak"; LETHARGY (non-serious) with onset 26Feb2021, outcome "unknown", described as "lethargic"; MALAISE (non-serious) with onset 26Feb2021, outcome "unknown", described as "not feeling well; wasn't feeling good"; ILLNESS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "sick". The events "little pain in my arms", "chills", "sweating", "very bad cold", "very weak", "lethargic", "not feeling well; wasn't feeling good" and "sick" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient took the first dose and she was fine. It was reported that patient was fine, she had a little pain in her arms and it went away in about two days. Four days after the vaccination, patient came down with chills, no fever, then sweating and it was like a very bad cold and very weak and lethargic and just not feeling well, 4 days after patient was still sick. The patient went to an urgent visit. It was reported that it was not worsened but she was still sick, have chills and sweating. Patient called her doctor and asked if she should come in today and he said it's a reaction to the vaccine just take paracetamol (TYLENOL).   No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: chills; sweating; very bad cold; very weak; lethargic; not feeling well; wasn't feeling good; sick; Little pain in my arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Lot number: EL9267) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: Bnt162b2 (Lot number: EL9263 as dose 1, single), administration date: 25Jan2021, when the patient was 86 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Little pain in my arms"; CHILLS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "chills"; HYPERHIDROSIS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "sweating"; NASOPHARYNGITIS (non-serious) with onset 26Feb2021, outcome "unknown", described as "very bad cold"; ASTHENIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "very weak"; LETHARGY (non-serious) with onset 26Feb2021, outcome "unknown", described as "lethargic"; MALAISE (non-serious) with onset 26Feb2021, outcome "unknown", described as "not feeling well; wasn't feeling good"; ILLNESS (non-serious) with onset 26Feb2021, outcome "not recovered", described as "sick". The events "little pain in my arms", "chills", "sweating", "very bad cold", "very weak", "lethargic", "not feeling well; wasn't feeling good" and "sick" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient took the first dose and she was fine. It was reported that patient was fine, she had a little pain in her arms and it went away in about two days. Four days after the vaccination, patient came down with chills, no fever, then sweating and it was like a very bad cold and very weak and lethargic and just not feeling well, 4 days after patient was still sick. The patient went to an urgent visit. It was reported that it was not worsened but she was still sick, have chills and sweating. Patient called her doctor and asked if she should come in today and he said it's a reaction to the vaccine just take paracetamol (TYLENOL).   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: patient's mother was asked if they were doing any trials for women that are nursing because she got her 1st and 2nd shot recently; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the parent (mother). A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transmammary (Batch/Lot number: unknown) as dose 2, single and transmammary (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "patient's mother was asked if they were doing any trials for women that are nursing because she got her 1st and 2nd shot recently".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021265330 mother case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Jaw disorder, Sensation of blood flow
Clinical narrative: Started feeling a little bit bad like the blood had rushed to head; Started feeling a little bit bad like the blood had rushed to head; Wondering if a side effect; cheeks part on the bottom of jaw where teeth behind the gummies had little balls; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 10:15 (Batch/Lot number: unknown) at the age of 79 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), SENSATION OF BLOOD FLOW (non-serious) all with onset 05Mar2021, outcome "unknown" and all described as "Started feeling a little bit bad like the blood had rushed to head"; JAW DISORDER (non-serious) with onset 05Mar2021, outcome "unknown", described as "Wondering if a side effect; cheeks part on the bottom of jaw where teeth behind the gummies had little balls". Therapeutic measures were not taken as a result of feeling abnormal, sensation of blood flow, jaw disorder. Additional Information: The reporter went in the morning at 10:15am to get the COVID-19 vaccine for the patient (grandmother). The patient went to get the COVID Vaccine and waited there as she needed to and didn't have any reaction. However, when the patient came home, she started feeling a little bit bad like she felt like the blood had rushed to her head and then she went to sit down and she drink some water and rested for a bit and then she ate some food and then went to sleep. However, when she woke up on the parts where the cheeks part on the bottom of the jaw on the part where the teeth are like behind the gummies she felt like she had balls like little balls. They were concerned because they were wondering if that was a side effect of the Covid Vaccine. The reporter stated, "Yes, the balls were in her mouth like behind the cheeks where the gum is behind it that was about." The reporter stated they were not sure about all the name of her concomitant medications. There were no treatment for the problems.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021266103 same reporter, suspect product, different patient, event and dose
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: experiences swollen and sore arm; experiences swollen and sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol" (unspecified if ongoing); "blood thinner" (unspecified if ongoing); "potassium" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "experiences swollen and sore arm".  Additional information: It was reported that patient was taking concomitant medications for blood thinner, potassium and cholesterol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fatigue, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: flu-like symptoms; Headache; swollen glands; pain in breast; pain near kidneys; nausea; vomiting; tiredness; This is a spontaneous report received from a contactable reporter (Pharmacist).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: VITAMIN D3. Vaccination history included: Bnt162b2 (swelling and redness for 9 days), when the patient was 68 years old, for Covid-19 immunisation, reactions: "redness", "swelling".  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "flu-like symptoms"; HEADACHE (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "swollen glands"; BREAST PAIN (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "pain in breast"; RENAL PAIN (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "pain near kidneys"; NAUSEA (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "vomiting"; FATIGUE (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of influenza like illness, headache, lymphadenopathy, breast pain, renal pain, nausea, vomiting, fatigue.  Additional Information: The patient did not receive other vaccine within four weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244753 Same reporter, patient, and product; Different dose and events
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Renal pain, Vomiting
Clinical narrative: flu-like symptoms; Headache; swollen glands; pain in breast; pain near kidneys; nausea; vomiting; tiredness; This is a spontaneous report received from a contactable reporter (Pharmacist).  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: VITAMIN D3. Vaccination history included: Bnt162b2 (swelling and redness for 9 days), when the patient was 68 years old, for Covid-19 immunisation, reactions: "redness", "swelling".  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "flu-like symptoms"; HEADACHE (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "swollen glands"; BREAST PAIN (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "pain in breast"; RENAL PAIN (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "pain near kidneys"; NAUSEA (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "vomiting"; FATIGUE (non-serious) with onset 04Mar2021 20:30, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of influenza like illness, headache, lymphadenopathy, breast pain, renal pain, nausea, vomiting, fatigue.  Additional Information: The patient did not receive other vaccine within four weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244753 Same reporter, patient, and product; Different dose and events
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: had a reaction to his 1st Covid dose with ringing in the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "had a reaction to his 1st Covid dose with ringing in the ears".  Additional information: The patient informed that the ringing was really loud and he does not want it with dose 2. The patient wanted to know if he can skip dose 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: feels like he has a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feels like he has a cold". Additional information: It was reported that the patient was scheduled for second dose on 04Mar2021 and he missed the second dose. He was inquiring if he can get the vaccine so far apart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness in the arm".  Additional information: This report was received from a Pfizer-sponsored program.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: her arm sores; her back really hurts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "arthritis on her back" (unspecified if ongoing); "dental surgery" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; HYDROCODONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "her arm sores"; BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "her back really hurts.". Additional information: The patient has been using paracetamol (TYLENOL) and hydrocodone for 2 weeks. The patient wanted to know if she could use paracetamol as she read that it could interfere with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Myalgia
Clinical narrative: joint problem; muscle soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPATHY (non-serious) with onset 2021, outcome "unknown", described as "joint problem"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle soreness".  Additional information: The patient was wondering if she will still get the second shot of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.