chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Paraesthesia
Clinical narrative: Feeling like pens/needles are in your hand and toes; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for a female patient (reporter's colleague)   A female patient of an unspecified age received bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 19May2021 as single dose for COVID-19 immunisation. Medical history included patients that are immunosuppressed that are on biologics (as reported). concomitant medications were not reported. Per the reporter (Nurse), they see patients that are immunosuppressed that are on biologics. They have received the Pfizer COVID-19 Vaccine. Per reporter the individuals came back negative for immunity on the spike test. The reporter reported that all the patients taking imbruvica 450 mg tablets (un-specified indication) also came back negative on antibody testing, enquired whether the patient showing no antibodies were still immune, asked if booster given for negative immunity or what course would you take to get the immunity at a higher level. Response was given from The CDC for the use of Covid-19 vaccines stating that the need for and timing of booster doses for mRNA Covid-19 vaccines has not been established. No additional doses are recommended at this time.  The reporter asked if there have been reports of feeling like pens and needles are in your hand and toes after receiving the Pfizer  COVID-19  Vaccine. She then voiced that she was asking for one of the nurses. She reported the nurse received the Pfizer  COVID-19 Vaccine on 19May2021. Her symptoms started on 24May2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Hypoaesthesia
Clinical narrative: numbness on left side of face; sharp pain from back left side of ear; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient reported that she received her first dose of covid vaccine on an unspecified date and 30 minutes after receiving the covid vaccine, she started experiencing numbness on left side of face and sharp pain from back left side of ear. She wanted to know if this side effect had been reported. The patient refused to provide age. The patient was responded from reference fact sheet, section (WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?) Revised: 10May2021 and replied from attachment. The outcome of the events was unknown.  Additional information about Batch no/ Lot no. has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Dizziness, Dyspnoea, Ear pain, Headache
Clinical narrative: numbness on left side of face; sharp pain from back left side of ear; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient reported that she received her first dose of covid vaccine on an unspecified date and 30 minutes after receiving the covid vaccine, she started experiencing numbness on left side of face and sharp pain from back left side of ear. She wanted to know if this side effect had been reported. The patient refused to provide age. The patient was responded from reference fact sheet, section (WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?) Revised: 10May2021 and replied from attachment. The outcome of the events was unknown.  Additional information about Batch no/ Lot no. has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Grip strength decreased, Pain, Pain in extremity
Clinical narrative: aches and pain in the left side of body that went away; aches and pain in the right side of body; pain in right and left side joints,elbow,knee,wrist,shoulder; right arm and forearm pain; its effecting my gripping power; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 19May2021 as, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in May2021, 1week after vaccination the patient experienced aches and pain in the left side of body that went away. From the second week patient experienced right side of body pain in joints at the wrist, shoulder, elbow joints, now it's started in her right knee. She states right side is very different symptoms, it is problematic, but improving, she don't think it's going away anytime soon. Patient stated If her body has not returned to normal, it's also in the forearm, its effecting her gripping power and she was concerned about getting the second shot before this resolves. it's gonna take a while, she hoped to delay the second dose to the 4th week. She stated it was weird because her body was split in two, on left side one week and then the right side started and it was so different, it seems to be all in her right arm until today it started in knee. She felt vaccine was working and her body reacting to the first dose, don't want to make things worse, just curious about the switching side, starting in one side and then going to the other, it was isolated on one side and then switched to the other side. The side it started on was not the side she got the shot.  It's like some one drew a line down the middle of the body, and one week was on one side and then the next week the other side. Patient enquired whether will it be effective if she delays second dose to the fourth week". The outcome of the event aches and pain in the left side of body was recovered on unspecified date of May2021. The outcome of the event aches and pain in the right side of body, arthralgia, pain in extremity, grip strength decreased was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: felt like he got stronger because he had also taken the flu shot and it kept him up a little bit; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730), via an unspecified route of administration, in Arm Right on 04May2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose on 04May2021 and was scheduled for the second dose on 27May2021. He missed the second dose on 27May2021. The patient felt like he got stronger because he had also taken the flu shot and it kept him up a little bit on 27May2021. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: painful area on bottom of second and third toe on left foot has disappeared; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer colleague (patient's daughter). An 80-years-old female patient received BNT162B2 (PFIZER, formulation: solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 80-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient previously received first dose of BNT162B2 for COVID-19 immunisation. Medical history included Something on the bottom of her left foot/like something hard that bothered her and it would hurt when she walks. Something that was like itching on second and third toe underneath. There were no concomitant medications. On an unknown date, the patient's painful area on bottom of second and third toe on left foot has disappeared. It was reported that, she just told her she had the two doses of the Pfizer Covid vaccine as well, she said that used to have something on the bottom of her left foot, something that was like itching on second and third toe underneath, like something hard that bothered her and it would hurt when she walks and since her mother had the two doses of the vaccine, states it is gone. Her mother washes feet every day with very warm water and noticed it was gone. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump under armpit; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program . A 16-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 15May2021 10:46 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. Patient's Medical History (including any illness at time of vaccination) was none. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior Vaccinations (within 4 weeks). And had no AE(s) following prior vaccinations. Family Medical History Relevant to AE(s) was unknown. About a week after first dose (May2021) of Covid-19 vaccine administered on 15May2021, the patient developed the lump under her armpit. AE(s) did not require a visit to Emergency Room/ Physician Office. The patient wanted to know the treatment for this lump. The reporter did not know if the lump under the patient's armpit had improved, persisted, or worsened. Reporter assessed the event as non-serious. There were no Investigation assessment and no relevant tests. Outcome of the event was unknown. The reporter assessed the relatedness of drug to reaction(s)/event(s) by Global Introspection method as Related.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pyrexia
Clinical narrative: get two bumps under each arm pit but they went away a couple days late; fever; This is a spontaneous report from a contactable consumer (patient herself).  A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247; Expiry date: unknown) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunization. Medical history included mammary duct ectasia from 1999 to an unknown date. Patient had not received any other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 01Feb2021 for COVID-19 immunization. The patient's concomitant medications were not reported. Caller stated that she was calling to report not an adverse event, just the opposite, wanted to report an additional benefit to the Pfizer COVID vaccine, caller was a Pfizer employee, stated she also wanted to report that after she had her oldest daughter in 1999 she had a clogged breast duct under her right arm pit, and there has been a bump that comes and goes with her period under her right arm pit since then, saw a doctor many years ago and did so many tests, CT and ultrasounds, they were not concerned. Caller stated she had the first dose of the Pfizer COVID vaccine on 01Feb2021, then second dose was on 22Feb2021, stated she was not really paying any attention. She saw that article and then looking at her past three periods the bump did not bother her, it had not been an issue since the doses of the vaccine. Caller stated after the second dose, on Feb2021 she did experience a fever the whole next day, states she did initially get two bumps under each arm pit but they went away a couple days later, exact dates was unknown. Reporter seriousness for bump under right arm pit has disappeared and not bothered her was unspecified. The outcome of events was recovered on Feb2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: loss of balance; Staggering; This is a spontaneous report from Pfizer-sponsored program. This is a report from contactable consumer or other non health professional (patient). A 80-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Right on 31Mar2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased from 2009, ongoing macular degeneration, ongoing osteoporosis and high cholesterol. Concomitant medication(s) included ongoing calcium (CALCIUM) taken for osteoporosis and has been taking longer than 2016. Stated she takes calcium 1500 mg daily and the calcium was 600 mg and she takes 2.5 tablets; ongoing levothyroxine (LEVOTHYROXINE) taken at dose of 50 mg once a day for an unspecified indication from an unspecified start date; ongoing lovastatin (LOVASTATIN) taken at dose of 40 mg at bedtime for blood cholesterol increase from 2011; ongoing vitamin d3 (VITAMIN D3, Batch/Lot Number: EP6955) 500 units daily, for an unspecified indication from 2016; ongoing Areds 2 Eye Vitamin at dose of 2 every day,  she has been taking 8 years. Stated she was told she has macular degeneration then told she does not. Stated she was prescribed this in error and had just continued to take it. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number : EN62(or 7)05) via an unspecified route of administration, administered in Arm left on 10Mar2021 at 09:00 or 10:00  as 1st dose, single dose for covid-19 immunisation. Family Medical History Relevant medical history to AE none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. On an unspecified date the patient experienced loss of balance. She was unsure of exact date that it began. Stated she wasn't sure at first and was staggering and has to hold onto rails when she goes up steps. Stated it's all day. Stated she hadn't reported it because she thought it would clear up. she stated it had improved, but was still continuing. Caller added she was a very active person so she just didn't associate it with anything other than her age, when it first started she just felt like it was her age, then she calculated that it started soon after the shot, and confirms it was after the second shot. The outcome for the event Loss of balance was recovering and Staggering was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Chest X-ray, Pain
Clinical narrative: she felt hurt so bad; dose 1: stomach hurt; dose 1: abdomen hurt; This is a spontaneous report from a contactable consumer (patient herself). A 57-years-old female patient received BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8731/Batch number was not reported; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in arm left on 19Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing (Investigation assessment, yes) and overweight from an unknown date and unknown if ongoing (she is a little overweight, but obesity is not a medical condition). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Th patient family medical history relevant to events includes none (but her mom and dad passed away when she was little). History of all previous immunization with the Pfizer vaccine considered as suspect includes none. It was reported that patient was calling to report to side effects. She doesn't know if they are really side effects. The patient experienced she felt hurt so bad on an unspecified date and dose 1: stomach hurt, dose 1: abdomen hurt on 22Apr2021. The consumer stated After the first dose she spoke to her doctor because her stomach and abdomen hurt every day. Stomach hurt: It lasted about one and a half weeks, around 30Apr2021. Caller clarifies it still feels heavy. She says she still can feel it, but it's not pain. It's expanded and it's coming down. It's not comfortable. Abdomen hurt: It's not the whole day, within a day it comes and goes, sometimes lasts about an hour, it's not comfortable. She does not feel the abdomen hurting today. It lasted until the end of the month, and from the first dose, it's completely over. She states she has heart dis-functioning problems before receiving the shot and her body is slowed. When she was due for her second dose she said she really didn't want to get it because she felt hurt so bad and the doctor said to get the shot to be on the safe side. She also states her coworker, her partner, was coughing a lot before he received the covid vaccine. She states they live together. She believe that the shot may help to prevent her from getting covid 19. The patient underwent lab tests and procedures which included chest x-ray: normal on 30May2021 (however caller states that doctor told her she has too much fluid in her body). The outcome of the event dose 1: abdomen hurt was resolved on an unspecified date in Apr2021 and remaining events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Chest X-ray, Dyspnoea
Clinical narrative: could not catch her breath if she moved; face swelled, too, it was hard to go down everyday; there is too much fluid in her body; she believes it's swelling; stomach hurt; abdomen hurt; bloating/swell of stomach; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179, Expiration date: 31Aug2021), via an unspecified route of administration on 10May2021 between 07:00-10:00 (at the age of 57-year-old), as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included heart dis-functioning, body was slowed and a little overweight. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiration date: 31Jul2021), via an unspecified route of administration on 19Apr2021 between 07:00-10:00 (at the age of 57-year-old), as single dose in left upper arm for COVID-19 immunization and experienced stomach hurt and abdomen hurt. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 morning, after the second shot, the patient experienced stomach hurt, abdomen hurt and bloating/swell of stomach. Patient reported that her stomach was bloated and felt she could not catch her breath if she moved, for which the patient went to the emergency room on 30May2021 and got released on 31May2021. Doctor told her that there was too much fluid in her body. After second shot, patient's face swelled, too, it was hard to go down every day. Her stomach got extended like a balloon. Patient believed it was swelling. When patient was due for her second dose, she really didn't want to get it, because she felt hurt so bad and the doctor advised her to get the shot to be on the safe side. The patient underwent lab tests and procedures which included chest X-ray: normal on 30May2021. The clinical outcome of the events stomach hurt, abdomen hurt, bloating/swell of stomach was not resolved and clinical outcome of all other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Swelling, Swelling face
Clinical narrative: could not catch her breath if she moved; face swelled, too, it was hard to go down everyday; there is too much fluid in her body; she believes it's swelling; stomach hurt; abdomen hurt; bloating/swell of stomach; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179, Expiration date: 31Aug2021), via an unspecified route of administration on 10May2021 between 07:00-10:00 (at the age of 57-year-old), as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included heart dis-functioning, body was slowed and a little overweight. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiration date: 31Jul2021), via an unspecified route of administration on 19Apr2021 between 07:00-10:00 (at the age of 57-year-old), as single dose in left upper arm for COVID-19 immunization and experienced stomach hurt and abdomen hurt. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 morning, after the second shot, the patient experienced stomach hurt, abdomen hurt and bloating/swell of stomach. Patient reported that her stomach was bloated and felt she could not catch her breath if she moved, for which the patient went to the emergency room on 30May2021 and got released on 31May2021. Doctor told her that there was too much fluid in her body. After second shot, patient's face swelled, too, it was hard to go down every day. Her stomach got extended like a balloon. Patient believed it was swelling. When patient was due for her second dose, she really didn't want to get it, because she felt hurt so bad and the doctor advised her to get the shot to be on the safe side. The patient underwent lab tests and procedures which included chest X-ray: normal on 30May2021. The clinical outcome of the events stomach hurt, abdomen hurt, bloating/swell of stomach was not resolved and clinical outcome of all other events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Heaviness in his chest; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 66-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration in left deltoid as 2nd dose, single dose on 10Apr2021 at 15:30 (Lot number- ER8730) and as 1st dose, single dose (Lot number: EL 3302) on 19Mar2021 at 15:30 for COVID-19 immunization at pharmacy/drug store. Medical history was not reported. Concomitant medication included calcium, ergocalciferol (VIT D). Patient did not receive any other vaccination within four weeks prior to the first administration date of the suspect vaccine. Patient stated with the 1st vaccine he had heaviness in his chest and that went away and when he had his 2nd vaccine it came back it. It was reported that with the 1st vaccine the heaviness in his chest started 1-2 days after and he thinks it started to ease up a few days before he got the 2nd vaccine but it did not go totally away and he would like to report it. Patient stated with the 2nd vaccine the heaviness in his chest started 1-2 days later and improved and is now totally gone. Patient does not recall when it stopped, it gradually went away. Not required to visit emergency room and physician office. The patient was taking Covid 19 vaccine because of his age and people telling him he should get it. The outcome of the event was recovered.   Information on Lot/Batch number is available; Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Nausea, Pain in extremity
Clinical narrative: injection site was painful and uncomfortable; fatigue/feeling of tiredness; nausea; chills; hot; pain in his arm of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old elderly male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot:Unknown),via an unspecified route of administration on 11May2021 as second dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine was bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration as 1st Dose, Single Dose for COVID-19 immunization Within 6-7 hours, on 11May2021,the patient experienced fatigue, nausea, chills, hot, feeling of tiredness, pain in his arm of injection ,injection site was painful and uncomfortable. The events resolved within 48 to 72 hours except for the arm pain which was still persisting. The outcome for the event pain in extremity was not recovered/not resolved, vaccination site pain was unknown and rest of the events was recovered/resolved.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was painful and uncomfortable; fatigue/feeling of tiredness; nausea; chills; hot; pain in his arm of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old elderly male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot:Unknown),via an unspecified route of administration on 11May2021 as second dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine was bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration as 1st Dose, Single Dose for COVID-19 immunization Within 6-7 hours, on 11May2021,the patient experienced fatigue, nausea, chills, hot, feeling of tiredness, pain in his arm of injection ,injection site was painful and uncomfortable. The events resolved within 48 to 72 hours except for the arm pain which was still persisting. The outcome for the event pain in extremity was not recovered/not resolved, vaccination site pain was unknown and rest of the events was recovered/resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Increased appetite, Positron emission tomogram, Therapeutic response unexpected
Clinical narrative: Lymphoma tumor has disappeared; appetite has increased; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization.Medical history included lymphoma from an unknown date.The patient's concomitant medications were not reported.The patient experienced lymphoma tumor had disappeared. also reported increased appetite.Caller stated she was calling to report not an adverse event, just the opposite, wanted to report an additional benefit to the Pfizer Covid vaccine, stated she was sent this article from her sister, stated the email said the article came out on 14May2021. Article said a lady was diagnosed with lymphoma in the end of 2019, that because of the Covid pandemic last year she did not go to the hospital, stated this year after the 2 injections of the Pfizer Covid vaccine, the location of the tumor it decreased and then it completely disappeared. Caller said the article stated she went to doctor for a PET scan and the tumor was gone and her appetite increased. Caller had no patient . The patient underwent lab tests and procedures which included positron emission tomogram: the tumor was gone. NDC Lot and Expiration Date unknown. Exact dates unknown. Outcome of both events was unknown.  No further information known for report.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Woke up feeling a bit nauseous/ Experiencing nausea "on and off"; This is a spontaneous report received from a contactable consumer. A 14-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 01Jun2021 15:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient woke up feeling a bit nauseous. experiencing nausea "on and off" throughout the morning on 02Jun2021. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Foreign body reaction, Vaccination site erythema, Vaccination site nodule
Clinical narrative: Nodules (implant site nodule) in the perioral area; mild redness (Implant site erythema) and elevation; The physician believed it was more a Foreign body reaction (Foreign body reaction); This is a spontaneous report from a non-contactable consumer (patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in 2021 as unknown single dose for covid-19 immunisation and hyaluronic acid (RESTYLANE) Defyne, via an unspecified route of administration from 02Dec2020 (Batch/Lot number was not reported). The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021 the patient experienced NODULES (Implant site nodule) in the perioral area from Defyne. There was mild Redness (Implant site erythema) and elevation, and the HCP could feel fairly large subcutaneous nodules, which were not fluctuant or tender. the physician believed it was more a foreign Body type reaction (foreign body reaction) than a biofilm or an infection. Action taken for hyaluronic acid was unknown. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Tinnitus
Clinical narrative: Intermittent dizziness; Tinnitus and pressure in her right ear; Tinnitus and pressure in her right ear; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, consumer was prepared for this because patient who happens to be a nurse has had some intermittent dizziness. The tinnitus and pressure in her right ear are what's concerning her because she was a musician. She contacted her doctor and had a tele-visit/video visit with the doctor on 30May2021. When she had an appointment with her doctor on 30May2021 the doctor did not know what to tell her really; if these effects were anticipated to subside with time; patient questioned if she should go back for the second shot of Pfizer COVID Vaccine which she won't do if the events do not improve. The doctor told her it could happen again or not at all, that there was no way to know until she got the second shot of Pfizer COVID Vaccine. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Pain
Clinical narrative: ear infection; achy body; This is a spontaneous report received from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient stated she had an ear infection when she received her shot with an achy body and all that. The outcome of the events was unknown.  Information on batch/Lot number requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eye disorder, Eye swelling, Pigmentation disorder
Clinical narrative: Bumps and dark spots under the eyes; Bumps and dark spots under the eyes; Swelling under the eyes; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in 2021 (2-3 months ago) as an unknown, single dose for COVID-19 immunization, hyaluronic acid (RESTYLANE, Formulation: Unknown), via an unspecified route of administration from 03Apr2021 at an unspecified dose and frequency for an unknown indication. The patient's medical history and concomitant medications were not reported. Patient received Pfizer COVID vaccines 2-3 months ago. Patient injected with Restylane Silk on 03Apr2021 under eyes. Reported swelling under the eyes same day (03Apr2021). On 04Apr2021 reported bumps and dark spots under eyes. Massage only. The action taken in response to the events for hyaluronic acid was unknown. The outcome of the events was not resolved.  Follow-up needed, Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid; This is a spontaneous report from a non-contactable consumer reported for a female patient.   A female patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: unknown), via an unspecified route of administration on 11May2021, as first dose single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any concomitant medications. On 14May2021, the patient was diagnosed with covid. It was reported that the patient was scheduled for her second dose on an unspecified date. The patient later stated that she received the Pfizer vaccine, not the Moderna vaccine (mRNA-1273). The event was reported as non-serious. The outcome of the event was unknown. The reporter was asking whether the patient should get her second dose or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: having a problem since I got the vaccine with keeping my balance; I kept loosing my balance; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), dose 2 via an unspecified route of administration on 02Mar2021, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included bnt162b2 dose 1 bnt162b2 for covid-19 immunisation. The patient had a problem since got the vaccine with keeping patient balance. When patient had the second shot, March 02nd which was exactly three months from today and it had not gone away. It started about an hour after when patient got the second shot patient kept loosing my balance now it seems like it was getting worse. The outcome of the events was not recovered.  Follow up attempts are needed, Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise, Vomiting
Clinical narrative: Allergic reaction; threw up in the first 5 minute; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A male patient (reporter's son) of an unspecified age (13 unspecified units) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, so patient got his first vaccination here in (withheld) and he threw up within the first 5 minute on an unspecified date in 2021 and the doctor that administered it said he had an allergic reaction on an unspecified date in 2021 so reporter just she was concerned and want to know what to watch for or if anything like this happened to another young child you know between 12 and she guess 15. Just you know see what if there was any concern here that's a normal thing or you know. The patient was not feeling well on an unspecified date in 2021. When confirmed the vaccine as Pfizer COVID 19 Vaccine, reporter stated, yes, it was, and he was 13. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photophobia
Clinical narrative: I felt the nausea; everything was so bright you know, I had the same effect but mine went away; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration on 15May2021 at 04:00 PM, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received list of any other medications within 2 weeks of vaccination. She stated that she stayed at hospital like half hours for her daughter because the doctor said to stay there and then she felt the nausea, and everything was so bright on an unspecified date, in May2021 and she had the same effect but went away. She stated that she did not have too many reactions. The patient did not receive any allergy medication Prior to vaccination and was not diagnosed with COVID-19. The patient was not tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient was resolved from the events.  Information on the Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Sciatica
Clinical narrative: some aches/aching all over; aching all over and in her back; Sciatica pain; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old female patient received both first dose and 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 unspecified date in Mar2021 single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. In 2021, caller reports she received two doses of Pfizer covid vaccine in March and had some aches. Then three weeks later she is experiencing aching all over and in her back. She stated that she has always had Sciatica pain. She was taking Tylenol. She recently saw her HCP but was feeling good then, she will make an appointment to see HCP about current aching. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm muscle pain/forearm pain; sore arm muscle pain; This is a spontaneous report from a contactable pharmacist (patient). A 66-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0167, Expiry Date, UPC, NDC number of Pfizer BioNTech COVID-19 Vaccine: Unknown), via an unspecified route of administration, administered in upper left arm on 13May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history included as was in hit and run car accident a while ago few 5 years ago and so I have pain in my face my trigeminal nerve associated with that but I am taking medication for that. Concomitant medication included oxycodone at 10 mg taken for an unspecified indication, start and stop date were not reported. At pharmacy where COVID-19 vaccine was administered. The patient stated as, the patient had first Pfizer vaccine three weeks ago and patient supposed to get second one tomorrow, but patient have been having for the last 3 weeks really, on 15May2021, sore arm muscle pain / forearm pain, pain prohibits him from lifting glass or door knob and thought it would just meant to go away but it hasn't gotten any less so patient wondering if patient should get the second one and what to do you know I don't. Due date of second shot was confirmed as 03Jun2021. The patient think doesn't have it in any other part of his body and haven't injured himself or fallen or knocked it against the door knob or it's patient forearm where he experiencing extreme muscle pain for the last 3 weeks. The patient took Ibuprofen or Aleve but, don't know sometimes patient stomach was sensitive to that but patient tried to take Ibuprofen, one day it didn't seem to do or do much but maybe he should take in successive days I don't know the events were just persisting it's not getting better or worse. Outcome of the events not recovered.   Follow-up actions are needed. Further information is requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: My hip joints are so bad since I got the shot I can barely walk; its's so painful in my joint; Pain all the time; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received an unspecified dose of BNT162B2 via an unspecified route of administration on 17Mar2021 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On unspecified date, the patient not been able to walk without much pain since got Pfizer COVID vaccine and have been telling to the doctor and they have been telling to patient, they don't wanna report it and the patient's joints are so bad since got the shot, the patient can barely walk and in so much pain all the time. The patient was not success with go away and it's been since march it has not gone away. The patient stated that will sue and want to talk to the person in charge not the Pharmacist. The patient further stated, "I want to report the side effects, I'm not the only one that is having joint problem, I live in an older community and other people are having the same side effects (further clarification unknown), mine are so painful I can even hardly walk its's so painful in my joint. Everyday it's horrible and I thought it will go away. My last COVID shot was 17March and this is 02June now and my problem has not gone away is getting worse and I need help. I would like you guys to pay for it, you gave it to me." The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: Woke up this morning with top lip swollen; woke up this morning with fingertips swollen; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) via Pfizer sponsored prgram. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 03Jun2021, the patient woke up in morning with top lip swollen, with fingertips swollen. The patient was due for his second dose Pfizer Covid 19 Vaccine on 03Jun2021 (today). Patient wanted to know if he should get the second dose Pfizer Covid Vaccine today, 03Jun2021 or not. Reporter seriousness was unspecified. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: have facial tingling on right side of face form cheek bone to jaw bone; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, shortly after dose, the patient started to have facial tingling on right side of face from cheek bone to jaw bone. Tingling was still intermittently ongoing. The patient would like to know if this something that has been experienced or reported by others and would also like to know if he should get second dose of vaccine or not. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus worsened; This is a spontaneous report from contactable consumer (patient). A female patient of an unspecified age received received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were not reported. Patient stated that She had tinnitus, and after the shot her tinnitus got worse. She was wondering if the Covid vaccine affects the neurological system. She had an appointment to get her second dose of the vaccine and is not sure if she should get it. She wanted to know if she doesn't get the second dose how it will effect the first dose. It was reported that She probably won't answer the phone unless it comes up as a contact. She was getting bombarded by telemarketers. If Pfizer wanted to call they could send a text with a number that she can call. She really doesn't like to get too much mail. She lives on a busy street and is trying to eliminate how much mail she gets. She declined to give her mailing address. She has put this off. She thought that maybe it would fade away, but it's not. If she has to be in some sort of study because of this she would probably cooperate. She asked if the second dose of the vaccine is the same as the first dose. She needs to make a decision quick because her appointment for the second dose is in 30 minutes. She would rather be transferred to Medical Information now. Patient was unwilling to complete the report The outcome of the event was not recovered.