chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: having a rashy bump/whitish bumps where he was jabbed; Over the last few weeks he's had palpitations; a little bit of discomfort in his arm; red rashy bump; its itchy; some whitish bumps where he was jabbed.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration on 07Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date in 2021, the patient experienced having a rashy bump/whitish bumps where he was jabbed, over the last few weeks he's had palpitations, a little bit of discomfort in his arm, red rashy bump, its itchy, some whitish bumps where he was jabbed. Therapeutic measures were taken as a result of having a rashy bump/whitish bumps where he was jabbed, a little bit of discomfort in his arm, red rashy bump, its itchy, some whitish bumps where he was jabbed. It was reported that after taking the second dose of Pfizer vaccine patient experienced a rashy bump and kind of having a reaction. The doctor said it was a possible reaction due to the preservatives used in the lot number. The doctor thought it would go away in a couple months. Patient heard that there was some kind of fat in the vaccine and wondered if the vaccination provider may have thought she pushed it all it but pulled back some and maybe didn't get it all in the muscle. Reported that patient thought it was natural to have a little bit of discomfort in his arm but several weeks after he realized he was developing a red rashy bump, some whitish bumps where he was jabbed. He thought it was strange. He usually puts on moisturizer and thought it would help he used antibiotic cream and started to get concerned. Its been maybe 5 weeks since the Covid vaccine and he still has the bump and all that, its itchy at times. Patient asked if there have been other reports of palpitations or tachycardia as a reaction to the vaccine or preservative. Patient did not specify having tachycardia, only asked that as part of his question. The outcome of event (some whitish bumps where he was jabbed.) was not recovered; the outcomes of events (having a rashy bump/whitish bumps where he was jabbed, Over the last few weeks he's had palpitations, a little bit of discomfort in his arm, red rashy bump, its itchy) were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: Lightheaded; Felt a tightness in her chest; Horrible chest pain; Feeling completely out of it and confused; Feeling completely out of it and confused; Horrible headache; This is a spontaneous report from a contactable consumer or other non-health care professional(patient).  A 25-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8735) via an unspecified route of administration in left arm on 12May2021 at 15:15 (at the age at vaccination of 25-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient's medical history included ongoing migraine headaches, started a year to a year and a half ago, but it was rare if she gets one. She had not had a migraine in a while, not since she gave birth and had that. The patient's concomitant medications were not reported. On 12May2021, the patient experienced horrible headache, lightheaded (at 21:00), horrible chest pain, felt a tightness in her chest and feeling completely out of it and confused. It was reported that on 12May2021 (also reported as yesterday) an hour to an hour and a half later (also reported as between 16:30-17:00), patient experienced horrible headache. It was getting worse and was to the point she was feeling out of it. Around at 12:00 (on 12May2021), she went to take a warm, not cold shower to relax her body and she started feeling really lightheaded, that continued on 13May2021 (also reported as today), it was on and off and was felt about the same and was just there. When she was out of the shower, she went to lay down. She fell asleep for 5 minutes or so and felt a tightness in her chest. It got to the point, she would sleep 1 to 1 and a half to 2 hours. It continued on and off. It first she thought she was having an anxiety attack, if it matters, it made her feel she was out of it because it was with light headedness and stuff like that. Patient also experienced horrible chest pain, feeling completely out of it and confused. That came with the chest pain and light headedness. She had an episode 20 minutes or so before the call. It started on 12May2021 (reported as yesterday). She laid on the couch and propped herself up. She thought it would help a little bit, but it did not, and she went to lay in her bed. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse events did not require emergency room or physician office visit. Prior vaccination within 4 weeks was noted as no. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Lightheaded; Felt a tightness in her chest; Horrible chest pain; Feeling completely out of it and confused; Feeling completely out of it and confused; Horrible headache; This is a spontaneous report from a contactable consumer or other non-health care professional(patient).  A 25-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8735) via an unspecified route of administration in left arm on 12May2021 at 15:15 (at the age at vaccination of 25-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient's medical history included ongoing migraine headaches, started a year to a year and a half ago, but it was rare if she gets one. She had not had a migraine in a while, not since she gave birth and had that. The patient's concomitant medications were not reported. On 12May2021, the patient experienced horrible headache, lightheaded (at 21:00), horrible chest pain, felt a tightness in her chest and feeling completely out of it and confused. It was reported that on 12May2021 (also reported as yesterday) an hour to an hour and a half later (also reported as between 16:30-17:00), patient experienced horrible headache. It was getting worse and was to the point she was feeling out of it. Around at 12:00 (on 12May2021), she went to take a warm, not cold shower to relax her body and she started feeling really lightheaded, that continued on 13May2021 (also reported as today), it was on and off and was felt about the same and was just there. When she was out of the shower, she went to lay down. She fell asleep for 5 minutes or so and felt a tightness in her chest. It got to the point, she would sleep 1 to 1 and a half to 2 hours. It continued on and off. It first she thought she was having an anxiety attack, if it matters, it made her feel she was out of it because it was with light headedness and stuff like that. Patient also experienced horrible chest pain, feeling completely out of it and confused. That came with the chest pain and light headedness. She had an episode 20 minutes or so before the call. It started on 12May2021 (reported as yesterday). She laid on the couch and propped herself up. She thought it would help a little bit, but it did not, and she went to lay in her bed. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse events did not require emergency room or physician office visit. Prior vaccination within 4 weeks was noted as no. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: itchy rash; Red rash inside left elbow/Red itchy rash would appear intermittently inside left elbow.; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 20Apr2021 (at the age of 23-year-old) as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 (at the age of 23-year-old) as dose 1, single for covid-19 immunization in a Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history included congenital heart disease and 22Q deletion variant. The patient's concomitant medication included daily vitamins. The patient had not received any other vaccine within 4 weeks prior to vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 31Mar2021, the patient had experienced red rash inside left elbow and on 21Apr2021, the patient had red itchy rash which appeared intermittently inside left elbow. The patient had not received any treatment for the events. The outcome of events was recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: joint pain; She has chills; headache; arm soreness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm on 10May2021 12:10 at the age of 32-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient experienced arm soreness, muscle pain and headache. On 13May2021, the patient experienced joint pain and chills. The clinical course was reported as follows: She received her first dose of the Covid vaccine about noon on Monday, 10May2021. On the first day, she had arm soreness. On the second day, her arm soreness was gone. She has started getting joint pain. She has chills, a temperature of 98.6, and she definitely has a headache. The muscle pain and arm soreness began two to three hours after the injection. It was reported that the joint pain and temperature of 98.6 started an hour ago. Clarifies that whenever she says joint pain, she also means muscle pain. Began one hour ago. Chills began one hour ago. Her temperature has also been 98.2ish. She definitely has a headache began on day one, 10May2021, about two or three hours after the injection. It started again, an hour ago today. It was 72 hours after she received the first dose of the Covid vaccine. She was asking if this was normal. She wanted to report these side effects. She was trying to figure out if other people have had these side effects. The patient underwent lab tests and procedures which included body temperature: 98.6 on 13May2021 and body temperature: 98.2 on an unspecified date. Reporter seriousness for Arm soreness, Joint pain, Chills and headache was unspecified. The outcome of event, arm soreness was recovered on 11May2021 while other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: joint pain; She has chills; headache; arm soreness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm on 10May2021 12:10 at the age of 32-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient experienced arm soreness, muscle pain and headache. On 13May2021, the patient experienced joint pain and chills. The clinical course was reported as follows: She received her first dose of the Covid vaccine about noon on Monday, 10May2021. On the first day, she had arm soreness. On the second day, her arm soreness was gone. She has started getting joint pain. She has chills, a temperature of 98.6, and she definitely has a headache. The muscle pain and arm soreness began two to three hours after the injection. It was reported that the joint pain and temperature of 98.6 started an hour ago. Clarifies that whenever she says joint pain, she also means muscle pain. Began one hour ago. Chills began one hour ago. Her temperature has also been 98.2ish. She definitely has a headache began on day one, 10May2021, about two or three hours after the injection. It started again, an hour ago today. It was 72 hours after she received the first dose of the Covid vaccine. She was asking if this was normal. She wanted to report these side effects. She was trying to figure out if other people have had these side effects. The patient underwent lab tests and procedures which included body temperature: 98.6 on 13May2021 and body temperature: 98.2 on an unspecified date. Reporter seriousness for Arm soreness, Joint pain, Chills and headache was unspecified. The outcome of event, arm soreness was recovered on 11May2021 while other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Inflammation, Injury, Limb injury
Clinical narrative: bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I had a shoulder injury which is not sore and hurting on that side; tendon and had nerve damage; pain and sore in the injury to my shoulder and my hand; pain and sore in the injury to my shoulder and my hand; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included arthritis on an unknown date unknown if ongoing. The concomitant medications were not reported. On an unspecified date, after first dose of vaccine, all of sudden the last day or two the patient experienced bruise on the hand side tip of her finger and it is tingling and hurting, she have had a couple of injuries on that side of my body and the all seem to be inflamed, she had a shoulder injury which is not sore and hurting, the injury she had to her hand and arm was a cat bite that went through the tendon and had nerve damage to that area It has since healed pretty well but it feels like it may be inflamed and I haven't reinjured it, pain and sore in the injury to her shoulder and her hand was nothing severe but she was just surprised to wake up and have the pain and a bruised mark on the pad of that fingertip and it was tingling and hurting, pain in this arm was little sore. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I had a shoulder injury which is not sore and hurting on that side; tendon and had nerve damage; pain and sore in the injury to my shoulder and my hand; pain and sore in the injury to my shoulder and my hand; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included arthritis on an unknown date unknown if ongoing. The concomitant medications were not reported. On an unspecified date, after first dose of vaccine, all of sudden the last day or two the patient experienced bruise on the hand side tip of her finger and it is tingling and hurting, she have had a couple of injuries on that side of my body and the all seem to be inflamed, she had a shoulder injury which is not sore and hurting, the injury she had to her hand and arm was a cat bite that went through the tendon and had nerve damage to that area It has since healed pretty well but it feels like it may be inflamed and I haven't reinjured it, pain and sore in the injury to her shoulder and her hand was nothing severe but she was just surprised to wake up and have the pain and a bruised mark on the pad of that fingertip and it was tingling and hurting, pain in this arm was little sore. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Electrocardiogram, Pain, Paraesthesia
Clinical narrative: He developed on the right chest, a circular rash that was painful to touch; A burning/pins and needles sensation after the vaccine on his left chest area/Abnormal sensation increased; A burning/pins and needles sensation after the vaccine on his left chest area; This is spontaneous report from a contactable Health care professional. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number: Not reported Expiration Date: Unknown ) via an unspecified route of administration, administered in Right Arm on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history concomitant medications were not reported. On an unspecified date, it was reported that two days after his first dose, the patient developed a circular rash on the right side of his chest, it proceeded to spread bigger, and was painful to the touch.  The rash later presented the same way on the left side of his chest, also very painful to the touch. The patient is due for his second dose tomorrow.  The caller would like to know if we have reports of a rash like this occurring, and if this is a contraindication to vaccination. A 20 y/o pt. received the Pfizer COVID-19 vaccine first dose and experienced pain a burning/pins and needles sensation after the vaccine on his left chest area. He received the vaccine on his right arm. She wants to provide updated information that there was no report of a rash or discoloration of the skin, as was reported in the crosslinked INT. The caller wanted to let Pfizer know that this was incorrect. She states the area of abnormal sensation increased, he went to the ER, had an EKG done (which resulted as normal) and was prescribed Valtrex. The sensation slowly improved. 2 days after stopping the Valtrex, he developed the abnormal sensation on the other side of his chest (right side). She wants to know if it is ok for him to get the second dose. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unknown date 2021.Therapeutic measures were taken as a result of adverse event and treatment included Valtrex. Outcome of all events was recovered on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported). A 60-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 31, 2021, single dose, for COVID-19 immunization. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Medical history included arthritis and pain. He had pain and arthritis in both his legs, ankles and knees since before the vaccination. The patient's concomitant medications not reported. A few days ago, 6 weeks after his 2nd dose, patient experienced exacerbated pain in both his legs, ankles and knees; but it became way worse after he received the vaccine. He always has aches and pains throughout his body (normally). He believes his weight isn't helping and his age caught up on him. Outcome of the event: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lip haemorrhage, Tongue haemorrhage, Vascular rupture
Clinical narrative: didn't bite her tongue but her blood vessels burst/didn't bite her lip, but a blood vessel burst in her lip; the blood was gushing and gushing; A blood vessel burst in her lip. It kept bleeding; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12May2021 (yesterday) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included dimeticone (CHAPSTICK) taken for an unspecified indication, start and stop date were not reported. The patient reported that she got the 2nd shot of the Pfizer Covid Vaccine yesterday. On 13May2021, she did not bite her tongue, but her blood vessels burst this morning, the blood was gushing and gushing. She never had this before not even nosebleeds. This morning, she didn't bite her lip or anything, but a blood vessel burst in her lip; It kept bleeding. It stopped a few hours, but later started again. There was a lot of blood she wanted to go to Medical Information, was asking what information they have on that and was her blood vessels inside our gonna burst. She questioned will she die? and stated that that she does not have any bleeding disorders. She took treatment with Tylenol, she did apply Chapstick and was asking if this was okay. Outcome of events was not recovered/not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Malaise, Oral discomfort, Oral pruritus
Clinical narrative: The itchiness started in her left eye and it went down to her left mouth; the daughter had a mouth reaction. The itchiness started in her left eye and it went down to her left mouth. It was described as "not the best feeling".; had a reaction in her mouth; she is not feeling the greatest/ not the best feeling; This is a spontaneous report from a contactable reporter, patient's mother.  A 33-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 13May2021 (age at vaccination 33-years-old), as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter and the patient had their COVID shots on 13May2021, but the reason the reporter was calling was because her adult daughter and herself went to get the first dosage of the COVID vaccine and everything went fine but while they were waiting after about 5 minutes her daughter had a mouth reaction that was like an itchy feeling on the left side of her mouth and she was not feeling the greatest. She was just sitting still right now. But it started at her left eye and went to the center of her mouth and they talked to the person that was giving the vaccination and they claimed that her daughter was having some kind of a minor reaction because it was something new that was going into her body and the body may respond in different ways. They thought eventually it may go away and they came home. The reporter wanted to know if that adverse event has been reported. The itchiness started in her left eye and it went down to her left mouth and had a mouth reaction, was described as not the best feeling on 13May2021. The outcome of all the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Rhinorrhoea
Clinical narrative: his allergies "fired up" today; Runny Nose; Watery Eyes; This is a spontaneous report from a Pfizer sponsored program COVAX US support (CEP:159558) by a contactable consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8736, Expiry Date: unknown), via an unspecified route of administration in left arm on 12May2021 at 14:00 (at the age of 26-years-old) as dose 1, single for COVID-19 immunization at public health department. The patient's medical history included allergies from an unknown to ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Family medical history relevant to events was none. Concomitant medication was not reported. Additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccinations within 4 weeks and events following prior vaccinations were none. The patient received his Pfizer covid vaccine yesterday and his allergies fired up today (13May2021). On 13May2021, the patient experienced runny nose and watery eyes; however, during this season, he usually gets that. He already has allergies this time of year, it was nothing new. Caller confirms that the runny nose and watery eyes started after receiving the COVID vaccine. Any events did not require a visit to emergency room and physician office. Relevant tests were none. The clinical outcome of events runny nose' and watery eyes' was not recovered, while the outcome of the remaining vent was unknown.  No follow-up attempts are needed. No further information was expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported.  A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included ovarian cancer stage iii from an, surgery from Sep2020 to an unknown date, hypertension, blood cholesterol, depression takes a mild antidepressant Venlafaxine 37.5mg twice per day, blood pressure measurement from 1979 to an unknown date. Concomitant medication(s) included metoprolol; simvastatin; venlafaxine taken for depression. The patient previously took lynparza for ovarian cancer stage iii. Consumer said that her main concern is that she is currently taking a cancer management treatment, Lynparza. She said she has been on this medication prior to receiving the vaccine. She said it takes away some of her immune system, and wants to know how it could affect the vaccines efficacy or if she has to stay isolated. Caller states she had a big surgery in Sep2020 and they wanted her to wait to heal from that before starting the Lynparza and she began taking it on 04Nov2020. The patient experienced sore arm on Feb2021. Outcome of the event was unknown. Description of Product Complaint: Vaccine Supplemental Form completed in additional context. Caller on the line who had the 1st dose of the Pfizer COVID vaccine on 11Feb2021 and the 2nd dose on 04Mar2021; states the caller is taking three medications and the medication is Lynparza and she is taking four tablets of Lynparza as a cancer maintenance pill; Caller asks if taking the Lynparza would lessen the Pfizer Vaccine immunization protection. States for the Pfizer COVID vaccine, the 1st dose lot is EL9266 and the 2nd dose has lot EN6205 and her patient card has no expiry date or NDC written on it. States she has been on other medicaitons for a while and takes a blood pressure medication Metoprolol 50mg, takes Simvastatin for cholesterol 40mg once per day by mouth, takes a mild antidepressant Venlafaxine 37.5mg twice per day; states she was on other blood pressure medications since 1979 and she was on and off of them since then and some of the blood pressure medications she was on just kind of quit working and it was many years ago and she has no names, dosages or lots, expiry dates or NDC numbers to provide. Caller states she sees her HCP on the 3rd next month and was seeing him once per month and how sees the HCP every 5 weeks. States her HCP said there is not enough information yet and he did not know if the Lymparza which lowers the immune system somewhat could have an affect on the Pfizer COVID vaccine. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Joint swelling, Lymphadenitis, Lymphadenopathy, Rash
Clinical narrative: Rash; Lymph nodes were swollen; Swelling on her face, ankle; Swelling on her face, ankle; Lymphatic bumps all over her clavicle, elbow, thigh, knee; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, lymph nodes were swollen, swelling on her face, ankle and lymphatic bumps all over her clavicle, elbow, thigh, knee. Patient asking how long will the vaccine last in regards to efficacy of a single dose. Patient stated her doctor told her she should wait for her 2nd dose because she broke out in a rash, her lymph nodes were swollen, she had swelling on her face, ankle, and below her elbow she had a rash there. They recommended her to wait for 2nd dose. Patient stated she had lymphatic bumps all over her clavicle, elbow, thigh, knee. An ultrasound was done and the HCP stated it was lymphatic. Patient stated the bumps were 3-4 inch bumps like huge soft plums. Patient asking if anybody has reported lymphatic bumps and swelling 3 to 4 inches. Patient stated she read something about T-cells that will have the memory to fight off Covid. T-cells will recognize the Covid virus and will have a memory on it and will be able to fight it. Patient is asking what does your study say about T-cells about recognizing and being able to fight it again. Patient also wondering if Pfizer is in the works of making a booster shot. Has Pfizer provided a statement on the need for a booster dose (3rd dose). Is Pfizer investigating the need for a booster dose. Patient stated her doctor told her to wait for her second dose and it's been almost over 42 days. Patient is wondering if she needs to restart. Verbatim and Event Description: swap from FC- Patient stated she got her 1st dose of the vaccine and she was tested for anti-bodies. She broke out with bumps under her elbow, swelling on her face, her lymph nodes. Patient wants to know how long does this vaccine last after the anti-bodies fade away. Her doctor told her to wait to get the 2nd dose. She wanted to know if just the one dose will protect her. The patient underwent lab tests and procedures which included antibody test was unknown and ultrasound was abnormal (lymphatic) on an unspecified date. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Ultrasound testes
Clinical narrative: Rash; Lymph nodes were swollen; Swelling on her face, ankle; Swelling on her face, ankle; Lymphatic bumps all over her clavicle, elbow, thigh, knee; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, lymph nodes were swollen, swelling on her face, ankle and lymphatic bumps all over her clavicle, elbow, thigh, knee. Patient asking how long will the vaccine last in regards to efficacy of a single dose. Patient stated her doctor told her she should wait for her 2nd dose because she broke out in a rash, her lymph nodes were swollen, she had swelling on her face, ankle, and below her elbow she had a rash there. They recommended her to wait for 2nd dose. Patient stated she had lymphatic bumps all over her clavicle, elbow, thigh, knee. An ultrasound was done and the HCP stated it was lymphatic. Patient stated the bumps were 3-4 inch bumps like huge soft plums. Patient asking if anybody has reported lymphatic bumps and swelling 3 to 4 inches. Patient stated she read something about T-cells that will have the memory to fight off Covid. T-cells will recognize the Covid virus and will have a memory on it and will be able to fight it. Patient is asking what does your study say about T-cells about recognizing and being able to fight it again. Patient also wondering if Pfizer is in the works of making a booster shot. Has Pfizer provided a statement on the need for a booster dose (3rd dose). Is Pfizer investigating the need for a booster dose. Patient stated her doctor told her to wait for her second dose and it's been almost over 42 days. Patient is wondering if she needs to restart. Verbatim and Event Description: swap from FC- Patient stated she got her 1st dose of the vaccine and she was tested for anti-bodies. She broke out with bumps under her elbow, swelling on her face, her lymph nodes. Patient wants to know how long does this vaccine last after the anti-bodies fade away. Her doctor told her to wait to get the 2nd dose. She wanted to know if just the one dose will protect her. The patient underwent lab tests and procedures which included antibody test was unknown and ultrasound was abnormal (lymphatic) on an unspecified date. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Arm Pain; There is small bumps and now there is like larger rash all over my face and scalp/rash on the face; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself) via medical information team. A 21-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 07May2021 (at the age of 21-years-old) as dose 1, single for COVID-19 immunization. Medical history included Birth control like a Contraceptives from an unknown date and ongoing. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for contraception, start and stop date were not reported. On 10May2021 the patient got vaccine on Friday, and she notice symptoms when she woke up on Monday, she doesn't know it was 36 hours or more than that she guess like two and half day after that she got it Friday afternoon. the symptoms are persisting and actually got worse because first there is small bumps and now there is like larger rash all over my face and scalp and on unspecified date patient experienced arm pain. Patient just called to report the symptom that she had and called because she was not sure if she should get the second dose or if she should take a different vaccine. Therapeutic measures were taken which includes Ibuprofen for arm pain. The outcome of event there is small bumps and now there is like larger rash all over my face and scalp/rash on the face was not recovered and the outcome of arm pain was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Felt soreness in her shoulder; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164; Expiry date was not reported) via an unspecified route, administered in Arm Left on 21Apr2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 21Apr2021 after her first shot the patient just felt soreness in her shoulder and so she took Tylenol and that was fine. She only had soreness in her shoulder with the first dose and she treated it with Tylenol a couple of times and it eased off. Outcome of the event was recovered on 22Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: made me sick; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-091505), for BNT162B2. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral from Feb2021 (Batch/Lot Number: 1391900; Expiration Date: 30Apr2024) to an unspecified date, at 10 mg, daily (5day pk) for uterine cancer. Medical history included hysterectomy; lung neoplasm malignant. The patient had no known allergies. Concomitant medications included ondansetron 4 mg tablet; pembrolizumab (KEYTRUDA), 100 MG/4ML VIAL; ibuprofen (MOTRIN CHILDREN) 200 mg capsule; paracetamol (TYLENOL) 325 mg tablet; promethazine hcl 12.5 mg tablet; paracetamol, tramadol hydrochloride (TRAMADOL HCL AND ACETAMINOPHEN); rosuvastatin 10 mg tablet; lisinopril 10 mg tablet; esomeprazole magnesium; levothyroxine 100 mcg capsule. The patient had a reaction to her 2nd COVID-19 VACCINE made me sick on an unspecified date. The action taken in response to the events for LENVIMA was unknown. The outcome of event was unknown.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Nodule, Pain in extremity
Clinical narrative: had her first Pfizer COVID-19 vaccine and her arm was a little sore - new and resolved,; CT scan at the end of February that the showed that the "saw improvement with the nodules" - new, is a "little slow" -new; This is a spontaneous report from a contactable consumer based on information received by Pfize (manufacturer control number HK-Fosun-2021FOS000486), license party for bnt162b2 (COMIRNATY). A 63-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral from 11Dec2020 (Batch/Lot Number: 1330511) and ongoing, at 14 mg, 1x/day, oral from 11Dec2020 (Batch/Lot Number: 1265576) and ongoing, at 14 mg, 1x/day for malignant neoplasm of endometrium. Medical history included malignant neoplasm of endometrium. Concomitant medications were not reported. Description of the event: Patient reported she had her first Pfizer COVID-19 vaccine and her arm was a little sore - new and resolved, CT scan at the end of February that the showed that the "saw improvement with the nodules"' - new, is a "little slow"-new. Description of the event: Patient reported 'the doctor told me to take 10 mg daily to help with being so tired and it seems to be helping'- New. 'my right foot has pain" - New, "my blood pressure is well controlled now'- Resolved, 'I had my 2nd Covid vaccine and my arm was sore and I felt achy for a day' - New, Resolved (patient gave verbal consent to be contacted by the manufacturer). Outcome: Unknown. Was the event considered a drug interaction: No. The patient underwent lab tests and procedures which included blood pressure measurement: well controlled on an unspecified date, computerised tomogram: improvement with the nodules on an unspecified date Feb2021. Patient received treatment for the adverse events. The action taken in response to the events for lenvatinib mesilate was dose not changed. Outcome of the event her arm was a little sore was resolved and saw improvement with the nodules" - new, is a "little slow"-new was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Seasonal allergy, Throat irritation
Clinical narrative: allergy symptoms due to first dose; throat irritation; like allergic reaction to pollen; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 22Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergy symptoms due to first dose, throat irritation and like allergic reaction to pollen on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021544988 same reporter/vaccine different patient/AE
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Rash, Urticaria, Vaccination site rash
Clinical narrative: Itching; Yes, the 1st shot I receive a small rash on my head yet same side on the arm that it was given on left side.; Yes, the 1st shot I receive a small rash on my head yet same side on the arm that it was given on left side.; little hive on her hip; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that,  A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in arm left on 21Mar2021 as dose 1, single for covid 19 immunisation, (age at the vaccination 72 years old) and patient took ascorbic acid, lycopene, omega-3 fatty acids, tocopherol (EVION [ASCORBIC ACID;LYCOPENE;OMEGA-3 FATTY ACIDS;TOCOPHEROL]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart, insulin aspart protamine (NOVOLOG MIX) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTON) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported; insulin detemir (LEVEMIR) taken for diabetes mellitus, start and stop date were not reported. It was reported that she received the first one in March 2021 and noticed a little hive on her hip, on the left side, the same side she received the needle. On an unspecified date in Mar2021, the patient experienced, little hive on her hip on the left side, the same side she received the needle and Yes, the 1st shot she receive a small rash on my head yet same side on the arm that it was given on left side, and on an unknown date patient experienced itching. When probed for the laboratory test, the patient stated, "she had laboratory test last week, she had at my doctor's office." The patient stated, she took, she did tried putting some cream on it some put it down cream (Captured as suspect) but that really didn't helped, made it worth and then she had Benadryl by mouth, she took Xyzal by mouth, she took Xyzal last night, she thought that would help she was mean itching, Evion Cream, Benadryl tablet 5mg, Xyzal tablet, 5mg. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.