chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphatic disorder
Clinical narrative: Problems with her lymph glands under her arm; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced problems with her lymph glands under her arm. It was reported that reporter had a medical background and a friend of reporter have received her first dose of the Pfizer vaccine anyway reporter trying to help her make a decision because she went to her oncologist and she is having problems with her lymph glands under her arm and the doctor would not tell her to get the second vaccine, the second dose. And she was wondering if she should or if it was going to cause her more problems. And reporter also stated that will they be able to advise her whether she should take the vaccine or not. The outcome of the event was unknown.   Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: her daughter had it worse; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, NDC number was not provided) dose number unknown via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Investigation assessment was not provided. On an unspecified date the patient experienced her daughter had it worse. Reporter reported that she had her first Pfizer COVID-19 vaccine shot and was ready to get her second shot, but she got the COVID. She said that she had her appointment for on the second then on the first she tested positive. Caller said something about her husband and daughter two days later and a week after. Unable to clarify with caller due to poor sound quality and caller speaking over call handler. She said her question is can she get the second dose of the vaccine still and how soon she can get it. She said her husband is 84 and she was 70 and they had very mild symptoms, so she thought the vaccine helped them, which her daughter had it worse. Caller said she had been on the phone three hours now and she was tired. She said she was afraid to provide further information on this call since she did not know if it was Pfizer. Address: Caller began to provide address then declined to clarify street name, documented as provided. Caller declined to complete a report. No further details captured, reported, or documented at this time. The clinical outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: has knot in his arm; lump; his is actually on the outside on his arm; This is a spontaneous report from a contactable consumer or other non hcp (patient s wife). This is the first case out of two cases.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 05Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has knot in his arm, lump, his was actually on the outside on his arm on an unspecified date. Reporter stated, patient had our shot of the Pfizer vaccine (Clarified as Covid vaccine) on 05Feb2021 and so his arm was sore for day and a half and her husbands was not, but now he had knot in his arm, was that common to have a lump there. Yes, it was on the arm and I have been looking all information and patient know something that happen with arm pit but his was actually on the outside on his arm where he had the shot little bit below where he had the shot. The outcome of the event was not resolved at the time of this report.  Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Piloerection
Clinical narrative: I have had chills that does not seem to go away without a fever. Just random chills like goosebumps; I have had chills that does not seem to go away without a fever. Just random chills like goosebumps; Just random chills like goosebumps. After my first vaccine i got a weird cold sensation throughout my left arm and it happened again last night; This is a spontaneous report from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL1284), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 17:00 as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 05Feb2021 (lot Number: EL3249) as dose 2, single (at the age of 22-years-old) for covid-19 immunization. Medical history reported as none. The patient concomitant medications were not reported. The patient had chills that did not seem to go away without a fever. Just random chills like goosebumps. After her first vaccine she got a weird cold sensation throughout her left arm and it happened again last night. The patient did not receive any treatment for events. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient visited the doctor or other healthcare professional office/clinic for the events. The patient did not have COVID prior the vaccination and did not test post vaccination. There were no allergies. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Extreme fatigue; heavy arm; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 39-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: Tl8982), via an unspecified route of administration, administered in left arm on 26Jan2021 18:00 (at the age of 39-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously experienced known allergies: Amoxicillin. The patient experienced extreme fatigue and heavy arm on 27Jan2021. The patient received no treatment for the event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of all the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I felt quite dizzy for 1 hour after getting the vaccine dose. I stayed at (Pharmacy name) and waited to drive home. DIzziness subsided at the 1-hour mark and I drove home then.; This is a spontaneous report from a contactable Other health care professional (patient herself). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 29Jan2021 15:15 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 42 years). The patient's medical history included just hypothyroid, low progesterone and ADHD(Attention deficit hyperactivity disorder). The patient previously took Bactrim sulfa and experienced drug allergy. Concomitant medications included Levothyroxine sodium 25mcg, Progesterone (PROGESTIN) and Methylphenidate hydrochloride (CONCERTA 27mg). It was stated that she was not pregnant at the time of vaccination. She did not receive any other vaccine in four weeks prior COVID vaccination. She was not diagnosed with COVID prior vaccination and not test with COVID post vaccination. On 29Jan2021 15:15, the patient reported that she felt quite dizzy for 1 hour after getting the vaccine dose. She stayed at and waited to drive home. Dizziness subsided at the 1-hour mark and she drove home then. The outcome of the event was resolved on 29Jan2021.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Slight headache; pain at injection site; fatigue; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6203), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 at 12:00 PM as DOSE 1, SINGLE (at the age of 33-years-old) for COVID-19 immunisation. The patient's medical history included Known allergies: Penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. On 19Feb2021 at 15:00 hours, the patient experienced slight headache, pain at injection site, and fatigue. The patient received no treatment for the events. The patient had received no other vaccine in four weeks and no other medications in two weeks. The patient did not have COVID prior to vaccination, did not get COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Tiredness; Mild headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 17Feb2021 at 14:30 (age at vaccination was 72-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. No medical history was reported. No known allergies. The concomitant medications were not reported. On 17Feb2021 at 16:30 , the patient experienced tiredness, mild headache and sore arm. No treatment was received. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Vaccination site pain
Clinical narrative: Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); Pain at injection site within a hew hours with general muscle aches. Aches continued next day, especially pain in left hip (possibly unrelated); This is a spontaneous report from a contactable consumer (patient).  A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, in Left arm on 23Feb2021 10:50 AM (at the age 55-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, in Left arm on an unspecified date 10:30 AM as dose 1, single for COVID-19 immunization. The patient concomitant medications included sertraline hcl (ZOLOFT), losartan, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), multivitamin, Tumeric (received within two weeks of vaccination). The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 23Feb2021 1:00 PM, the patient had experienced pain at injection site within hew hours with general muscle aches, aches continued next day, especially pain in left hip (possibly unrelated). Patient had not received any treatment for the events reported. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Flatulence
Clinical narrative: Significant gas; mostly flatulence; some burping; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown) via an unspecified route of administration in arm right on 15Feb2021 11:00 (Age at vaccination: 52-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing , gluten sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included eszopiclone (LUNESTA) taken for an unspecified indication, start and stop date were not reported; alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported; lorazepam (LORAZEPAM) taken for an unspecified indication, start and stop date were not reported. On 15Feb2021 05:00 PM, patient experienced significant gas, mostly flatulence, some burping. Facility type vaccine was other. Other vaccine in four weeks was none. No treatment received for Adverse event. COVID was present prior vaccination. No COVID tested post vaccination. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm is swollen; This is a spontaneous report from Pfizer sponsored program. A consumer reported that a female patient (daughter) of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his daughter got her shot, arm was swollen on unspecified date. Outcome of the event was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes more than 8 days after injection.; This is a spontaneous report from a contactable consumer (patient). An adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 as dose 2, single for COVID-19 immunization, at workplace clinic. The patient medical history included known allergies: Penicillin. Other medical history was not provided. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 27Jan2021 as dose 1, single for COVID-19 immunization. The patient received no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 18Feb2021, the patient experienced swollen lymph nodes more than 8 days after injection. The event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: swollen lymph nodes; dizziness; nausea; fever; This is a spontaneous report from a contactable consumer (Patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient stated that four or five days later, she had some glands that swelled behind her ear and on her head. She also had fever, and nausea and she had to go to the doctor. Patient stated that the doctor injected her with two very strong antibiotics. She stated that it continued, and two days later, she went to see the same doctor again, because she was getting more glands, and the doctor sent her to the emergency room. At hospital, the staff did a CT, and they told her that she had some swollen nodules (swollen lymph nodes), and they changed her antibiotics. Patient reported that they are still swollen, they are less, but she is also still dizzy and nauseous (medically significant). Patient is wondering if this could be a side effect of the vaccine. Patient states that she was due on Monday for her second dose, and she was wondering about if she should still get it. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No further information is expected
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lethargy, Pain of skin, Tinnitus
Clinical narrative: her left ear that is ringing; her skin hurt to the touch; weird static noise/ tinnitus, in her left ear; flu-like symptoms; chilled; her skin hurt to the touch; lethargic; This is a spontaneous report from a contactable consumer (Patient herself). A 71-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 71-year-old) as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number: EL8982), via an unspecified route of administration, administered in Arm Right on 15Jan2021 as single dose for covid-19 immunisation. Medical history included factor V leiden carrier from 2015 and ongoing. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken for factor V leiden carrier from 2015 and ongoing. Patient received no other vaccines on the day of her COVID vaccine. Caller stated that with her second dose, on the day of her second dose, 05Feb2021, maybe two hours after getting the second dose, she had this really weird static noise in her left ear, that she was hoping would go away, but it did not. Caller stated that same evening, she had flu-like symptoms, no fever but was chilled, and her skin hurt to the touch, and she was lethargic, the caller didn't get out of bed for a day and a half. Caller reported that the static in her ear started before she had the flu-like symptoms, but by Sunday, she was fine. Caller stated that she was hoping the static in her ear would go away, but it has not. Caller stated that the sound will sometimes disappear but then come back, but most of the time the sound was there. Caller stated that she thinks loud noises set it off. Caller was wondering if there have been any other people who have reported tinnitus after the vaccine. The outcome of the event weird static noise/ tinnitus, in her left ear was not recovered while the outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Thinking abnormal, Vomiting
Clinical narrative: nausea; vomiting; thought she was going to die,; This is a spontaneous report from a contactable other healthcare professional via Pfizer-sponsored program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included antibody therapy from Oct2020 to an unknown date. Concomitant medications were not reported. On an unspecified date, after first dose, patient had nausea, vomiting and thought she was going to die. The patient had her second dose scheduled for 24Feb2021. Patient wants to see if it was ok to receive second dose. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: 8 hrs after vaccine #2  terrible headache. felt like chisel was hitting head above brow bone.; Injections site extremely sore; Intermittent chills; headache& sore arm; This is a spontaneous report from a non-contactable consumer.   A 71-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration (at the age of 71 years) as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for covid-19 immunization. The patient relevant medical history includes high blood pressure. Patient had no known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient concomitant medications were not reported. It was reported that 8 hours after vaccine 2 patient had experienced terrible headache, felt like chisel was hitting head above brow bone, Injections site extremely sore. Headache and sore arm slowly subsided after 24 hrs. Intermittent chills also occurred while experiencing headache. By day 3 felt. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were recovered.   No follow-up attempts are possible. No further information is provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Light fever; Soreness at injection site; Swelling and pain in lymphnodes; Swelling and pain in lymphnodes; This is a spontaneous report from a contactable other hcp. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number: EN6201, expiry date: unknown) dose 2 intramuscular, administered in Arm Left on 23Feb2021 08:30 AM as DOSE 2 SINGLE, for covid-19 immunization (age at vaccination:44-Year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number: EL9264, expiry date: unknown) on 02Feb2021 08:30 AM intramuscularly in left arm as DOSE 1 single, for covid-19 immunization. On 25Feb2021 10:00 AM the patient experienced headache, light fever (pyrexia), soreness at injection site (vaccination site pain), swelling and pain in lymph nodes (lymphadenopathy) and swelling and pain in lymph nodes (lymph node pain). The patient had not received any treatment for the events.The outcome of all events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: two of her doctors said they felt very sick after receiving the second vaccine.; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-healthcare professional.  A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter reported that two of her doctors said that they felt very sick after receiving the second vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Stomatitis
Clinical narrative: Sores in mouth; dry throat; This is a spontaneous report from a non-contactable consumer (Patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021, as dose number unknown, single for COVID-19 immunisation at hospital. The patient medical history, concomitant medications were not reported and had no allergies. The patient did not receive other Vaccine in four weeks. On 16Feb2021, 14 days after vaccination, the patient had sores in mouth and experienced dry throat. The patient was not Covid prior vaccination and was not tested Covid post vaccination. The patient did not receive any treatment for the events. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Platelet disorder
Clinical narrative: bruises in her mouth and on her stomach; Suspect platelet disorder; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 23Feb2021 at 18:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. Medical history included overweight, antibiotic and latex allergy, implant done for her tooth, gastrointestinal upset (She is having an implant done for her tooth and was put on an antibiotic. She only took it for one day because she started to have gastrointestinal upset) and arthritis in both feet (Recently she has had two people die in her family. She attributes it to being upset. Recently she has arthritis in both feet that popped up out of nowhere. It is more in the left foot. She saw a Podiatrist and the orthotics are helping already), all from an unknown date. There were no concomitant medications. The patient previously took iodine and steroids and experienced allergies. The patient experienced bruises in her mouth and on her stomach on 25Feb2021 at 08:30. The clinical course was as follows: Patient wanted to know if bruises in her mouth and stomach area are side effects of the PFIZER-BIONTECH COVID-19 vaccine - She had the 1st dose last 23Feb2021 then symptoms came out today 25Feb2021. She got the shot on the twenty third at 6:30pm. She didn't have any kind of reaction at all, but this morning it's been a day and a half. She has bruises in her mouth and on her stomach. She looked it up and sees all the platelet problems. She is concerned about that. Is what she is experiencing a side effect? It says there have only been 36 people that have platelet issue. The bruise on her mouth is getting darker and bigger. It is on the corner of the lip going into the mouth. It is the edge of her lip. It is more of a purple color now. She has not had anything at this time, but she thinks she may go to get a blood test. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Pyrexia
Clinical narrative: 29 hours after injection, minor fever; 23 hours after injection, extreme exhaustion; All muscles felt week; general tired feeling.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 23Feb2021 at 01:45 PM (age at vaccination was 47 Years) as DOSE 1, SINGLE for COVID-19 immunisation at workplace clinic. Medical history included Covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. No allergies reported. Concomitant medications includes vitamin d3, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) and probiotics; taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid tested post vaccination. 23 hours after injection, on 24Aug2021 at 12:45 PM, the patient was experienced extreme exhaustion set in. All muscles felt week. On 24Aug2021 at 06:45 PM, 29 hours after injection, minor fever. 40 hours after injection, exhaustion and fever were resolved and the patient just had a general tired feeling on an unspecified date in Feb2021. The report was non-serious. The patient was not received any treatment for adverse event. Outcome of the event tiredness was unknown and remaining events were recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: tendonitis on the arm; This is a spontaneous report received from a contactable consumer (patient), from Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medication included cyanocobalamin (B12-SHOTS) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, after vaccination, the patient experienced tendonitis on the arm. Therapeutic measures were taken as result of event included, patient's doctor prescribed a steroid shot. It was reported that, the patient received the 1st dose a week ago (at the time of report). She was asking if it was ok to proceed with the 2nd dose of the vaccine. Patient was about to receive 3 of the B12 shots. Once in a month for 3 months. She already had the 1 of 3 of the B12. The patient will have these shots in between the vaccine. Patient was asking if she should wait to have B12 before or after the vaccine. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Lacrimation increased
Clinical narrative: This is a spontaneous report from a contactable consumer. A female consumer of an unspecified age reported for herself, who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EM9810, expiry date: 30Jun2021) via an unspecified route of administration on 05Feb2021, as SINGLE dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination on Feb2021, patient stated that next day or so or may be that same day on 05Feb2021 she had developed onset of sniffles, a little running of nose and watering of the eyes. On the second day, on 06Feb2021, she got some chest congestion and cough. She coughed every now and then but not terribly. She took cold tablets for probably about 6-7 days until they ran out. She was taking the second bottle of cough syrup which was almost finished, but still coughs every now and then. She wondered since it seems to her, she got those events after the Pfizer COVID-19 Vaccine, and she was supposed to get the second dose of Pfizer COVID-19 Vaccine tomorrow but had a doubt whether she should or should not get the second dose as scheduled relative to these events. The outcome of the events sniffles/ runny nose and cough were not recovered; chest congestion was improved (recovering) but it was almost gone but not completely and she no longer had watery eyes, recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Headache, Illness
Clinical narrative: chest pain; severe headache; muscle pain; she has felt real, real sick,; she does not feel well; She has so much pain; joint pain; back pain; chest pain unbearable/generally lots of pain/headaches were so bad; This is a spontaneous report from a contactable nurse (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 09Feb2021 (age at vaccination was 71 years) as dose 1, single for COVID-19 immunisation. The patient has a history of bad reactions to other vaccines, Graves' disease, rheumatic fever and multiple allergic reactions to multiple stuff; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient received the first dose of the vaccine 09Feb2021 and patient didn't feel well and was not doing so well. On an unspecified date the patient had so much pain, specifically severe headache almost every day, muscle pain, joint pain, back pain, chest pain, and generally lots of pain. The headaches were so bad that she can't even talk and she finds the chest pain unbearable. The patient has felt real, real sick, since getting her vaccine on 09Feb2021. The patient finds that it was not a regular kind of pain and was unusual because it started gradual. The patient did not do anything and that this came in after the vaccine. The patient second shot was in a few days, 02Mar2021, so patient was asking if she should still take the second dose. The patient doesn't feel like she wants to go because she does not feel well. The patient knows many of her friends that tolerated the vaccine pretty well, and the patient knew that patient could have some reaction to it, but the patient was on the third week of symptoms now. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain
Clinical narrative: chest pain; severe headache; muscle pain; she has felt real, real sick,; she does not feel well; She has so much pain; joint pain; back pain; chest pain unbearable/generally lots of pain/headaches were so bad; This is a spontaneous report from a contactable nurse (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 09Feb2021 (age at vaccination was 71 years) as dose 1, single for COVID-19 immunisation. The patient has a history of bad reactions to other vaccines, Graves' disease, rheumatic fever and multiple allergic reactions to multiple stuff; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient received the first dose of the vaccine 09Feb2021 and patient didn't feel well and was not doing so well. On an unspecified date the patient had so much pain, specifically severe headache almost every day, muscle pain, joint pain, back pain, chest pain, and generally lots of pain. The headaches were so bad that she can't even talk and she finds the chest pain unbearable. The patient has felt real, real sick, since getting her vaccine on 09Feb2021. The patient finds that it was not a regular kind of pain and was unusual because it started gradual. The patient did not do anything and that this came in after the vaccine. The patient second shot was in a few days, 02Mar2021, so patient was asking if she should still take the second dose. The patient doesn't feel like she wants to go because she does not feel well. The patient knows many of her friends that tolerated the vaccine pretty well, and the patient knew that patient could have some reaction to it, but the patient was on the third week of symptoms now. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild soreness at injection site which lasted for 2 days; This is a spontaneous report from a contactable Other HCP. A 28-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262) dose 1 via an unspecified route of administration, administered in Arm Left on 24Jan2021 11:00 (at the age of 28 years old) at dose 1, single for covid-19 immunisation. Medical history included ongoing rhinitis allergic and uterine leiomyoma from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took feraheme and experienced drug hypersensitivity. The patient received other medications within 2 weeks of vaccination. On 24Jan2021, the patient experienced mild soreness at injection site which lasted for 2 days. The patient was did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered on an unspecified date 2021.   Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling
Clinical narrative: She had heart palpitations; The opposite arm was swollen up; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in left arm on 17Feb2021 (at the age of 65-years-old) as single dose for COVID-19 immunization. The patient's medical history included palpitations and she takes medicine for it. The patient's concomitant medications were not reported. The patient previously experienced known allergies to lot of medicines and things. On 19Feb2021, the patient experienced swollen up in the opposite arm when she woke up. The patient also experienced heart palpitations the last night. The patient noticed the opposite arm was swollen this morning. The patient was trying to figure out why it was feeling so tight and she got out of the shower and she was lotioning up and she noticed it and said oh that was why. The patient said the injection was given in the left arm but this was the right arm that was swollen. The right arm and it was swollen in the fold of the arm like where the crease was between arm and elbow. The patient said it was swollen in the bend of her elbow and was ongoing. The outcome of the opposite arm was swollen up was not recovered. The outcome of heart palpitations was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Myalgia, Sleep disorder
Clinical narrative: The next morning 19Feb2021 she said she woke up around 2am; gassy; had muscle pain like nots throughout her body; This is a spontaneous report from a contactable consumer (patient's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER COVID VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Feb2021 at 17:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the next morning 19Feb2021 she said she woke up around 2 AM, was gassy, and had muscle pain like nots throughout her body. The events lasted for two hours and ended up going away. The patient recovered from the events on 19Feb2021 at 04:00.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain
Clinical narrative: This is a spontaneous report from contactable other HCP via Pfizer Sales Representative. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single for COVID-19 immunization. After the 2nd dose, the patient did not feel well the day after receiving the 2nd dose. She experienced minor body aches and chills on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Post dose 2 headache lasting a week; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, post dose 2, the patient experienced headache, lasting a week. Outcome of the event was resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: Chills; Diarrhea; Cramping and pain in my stomach terrible; Cramping and pain in my stomach terrible; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified gender and age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On the 5th day after vaccination the patient experienced little chill before but had diarrhea and cramping and pain in stomach terrible. The outcome of the events were unknown.  Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: had chills and body aches; had chills and body aches; This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This Other HCP reported for a patient that:  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the first dose the patient had chills and body aches that lasted for about 1 day. The clinical outcome of events were recovered on unspecified date.  Information about lot/ batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Mild pain at injection site; Itchiness at injection site; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. A contactable consumer of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as SINGLE dose for covid-19 immunization. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as SINGLE dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was a neighbour of the reporter, who developed mild pain and itchiness at injection site after second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Mild swelling, redness and itchyness At injection site.; Mild swelling, redness and itchyness At injection site.; Mild swelling, redness and itchyness At injection site.; This is a spontaneous report from a contactable reporter. This reporter reported for a female consumer.  An 82-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EMn00n, Expiration date: unknown), via intramuscular, administered in right arm on 15Feb2021 07:15 (at the age of 82-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via unspecified route, administered on 25Jan2021 07:30 AM (at the age of 82-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Congestive heart failure and Adhesive tape allergy with unknown onset and unknown ongoing and concomitant medications include Apixaban (ELIQUIS), Furosemide (LASIX SPECIAL) and Metformin. On 19Feb2021 04:00 PM, 04 days after the vaccination, the patient experienced mild swelling, redness and itchiness at injection site. Patient took no other vaccine in four weeks; patient was not diagnosed with covid prior vaccination. Patient was not tested with covid post vaccination. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.