chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity
Clinical narrative: stabbing pains in the lymph nodes and foot; stabbing pains in the lymph nodes and foot; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient historical vaccine included BNT162B2  via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stabbing pains in the lymph nodes and foot on an unspecified date. The outcome of the evens was unknown.  Additional Context: The caller had both shots, she got the second done a couple of weeks ago. After the vaccine, the caller had stabbing pains in the lymph nodes and foot. The caller had those other symptoms before with the first dose.The caller has had bad side effects from other vaccines before.  Information about lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mesenteric vein thrombosis, SARS-CoV-2 test
Clinical narrative: SMV thrombosis; This is a spontaneous report from a contactable healthcare professional (patient). This 48-years-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, in right arm, on 04Feb2021 at 09:45 (lot EL9269), at 48 years of age, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on 14Jan2021 at 09:45 (at 48 years of age), lot: EL3248 intramuscular, in right arm. Medical history included GERD, hiatal hernia and Hasimotos dx. Prior to vaccination, the patient was not diagnosed with COVID-19. Past drug history included clarithromycin (BIAXIN). Concomitant medication included esompeprazole (NEXIUM). On 01Mar2021 the patient experienced GI/epigastric pain, back pain, abdominal pain. She was diagnosed SMV thrombosis. The events required Emergency room/department or urgent care, Doctor or other healthcare professional office/clinic visit, hospitalization for 3 days and treatment with heparin. The events were reported as serious also as life-threatening and per disability. The events were resolving at the time of report. On 07Apr2021 the patient underwent COVID-19 test with negative result.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mesenteric vein thrombosis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral swelling, SARS-CoV-2 antibody test
Clinical narrative: tingling; numbness; Feels little lumps and bumps in her arm; dull pain in the upper arm. Is probably the worst around the elbow and goes all the way down into the hand and thumb,; This is spontaneous report received from a contactable Nurse (Patient). A 58-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot Number: EN6204), via an unspecified route of administration on 10Mar2021 at 12:00 (at the age of 58-year-old) as 2nd dose, single dose in left arm for COVID-19 immunization at hospital. The patient's medical history included COVID-19 from Dec2020, as she actually got COVID virus over Christmas. Concomitant medications were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot Number: EN6200), via an unspecified route of administration on 17Feb2021, as single dose in left upper arm for COVID-19 immunization. The patient's historical vaccine included flu vaccine in October, which was the last vaccine she received. On an unspecified date in Mar2021, within a week or two, the patient experienced symptoms that mimicked radiculopathy, where you have a nerve situation that moves down the arm into the fingers, causing tingling and numbness, in the thumb. Patient thought it was maybe thoracic outlet syndrome. Patient experienced dull pain in the upper arm, probably the worst around the elbow and goes all the way down into the hand and thumb and has tingling and numbness. Tingling and numbness continued for a while, tingling comes and goes, but numbness was constant. Dull pain worsened when she was not using her arms, which was strange for radiculopathy. Typically, movement would make it worse. When her arm was still, while watching television or during her sleep, it woke her up. But was almost better while cleaning the house. Patient could feel the declination and was getting worse than before. Patient visited Physician's office, saw surgical physician, and told him about dull pain, tingling and numbness. He ordered a CT scan and some X-rays. Patient assumed a possibility of clot, not deep vein thrombosis or anything. Patient felt like little lumps and bumps in her arm and does not know if it was because of age or what was going on. Treatment medication included Tylenol and ice. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive, on an unspecifies date. The clinical outcome of the event dull pain in the upper arm, probably the worst around the elbow and goes all the way down into the hand and thumb, was not resolved. The clinical outcome of all other events was unknown.  Follow-up attempts needed. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: received a vaccine that wasn't diluted; received a vaccine that wasn't diluted; This is a spontaneous report from a contactable other health care professional (on behalf of Pharmacist) via a Pfizer sponsored program.   A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EW0167; Expiration Date: Aug2021, NDC: 59267100001), via an unspecified route of administration, administered in Arm Left on 01Jun2021 (at the age of 58-years-old) as a single dose for covid-19 immunisation. Patient had no medical history and concomitant medications were not reported was not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EW0171, Expiration Date: Aug2021, NDC: 59267100001) via an unspecified route of administration, administered in Arm Left on 11May2021 at 0.3 ml as a single dose for covid-19 immunisation. On 01Jun2021, (reported as happened an hour ago) the patient received a vaccine that wasn't diluted. Reporter wanted to know the side effects that would happen to the customer who received the vaccine that wasn't diluted. The seriousness of the events was reported as medically significant. The outcome of the events was unknown.  Follow-up attempts needed. Additional information has been requested. ; Sender's Comments: Based on known drug safety profile there is reasonable possibility of causal association between the reported events and the suspect drug.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep vein thrombosis from groin to knee; This is a spontaneous report from a contactable consumer (patient). This 58-years-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 04May2021 at 14:00 (lot EW0171), at the age of 58 years, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on 09Apr2021 at 15:00 (at 58 years of age), lot: EP7533, in left arm. Medical history included COVID-19. Past drug history included allergy to lamotrigine (LAMITRIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 21May2021 the patient deep vein thrombosis from groin to knee. The event required ER visit, Doctor or other healthcare professional office/clinic visit, hospitalization for 6 days and was reported as serious also as life-threatening condition. Treatment received included removed blood clot and blood thinners administration. The event was resolving at the time of report. Since the vaccination, the patient had not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: Headache; left arm sore from injection; Got a little tired; Crappy; This is a spontaneous report from Pfizer sponsored program Xelsource. A contactable consumer (patient) reported that, A 49-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733, Expiry Date: 30Jun2021), via unspecified route of administration on 30Mar2021 (at the age of 49 Years) as a 2nd dose single for COVID-19 immunization (did not want Covid, as reported). Patient had medical history diagnosed in 2004 with Rheumatoid arthritis, Upper Respiratory infections both on unspecified dates and huge bruises on her legs, everything black and blue in Jan2014 which was resolved. Patient reported that, her rheumatoid arthritis and having to work a 60 hour week causes her to be tired. For Rheumatoid Arthritis, Patient had a temporary stop on Methotrexate (Tablet) in 2008-2010 due to being in remission which has started in 2004 (Unknown dosage oral once a week), which she took for a 9 month window (Dosage permanently discontinued), adverse event improved as a result of it. and resulted in the Upper Respiratory infections (on unknown date) and Enbrel in 2004 (Unknown dosage injection weekly) which caused, huge bruises on her legs, everything black and blue (on unknown date) which has been permanently discontinued in 2004. Patient switched from Enbrel to Humira in 2004-2005 and she recovered completely from being switched. Patient also reported that, she permanently stopped on Methotrexate injections a couple of years before (NDC, lot number and expiration: Unknown). Reporter seriousness for stopped to taking Methotrexate and Enbrel and all the historical events were Unspecified. Patient's concomitant medication included, Xeljanz XR 11mg for Rheumatoid arthritis and informed it has been working really well for her and has had no flare ups. He did not received any other product. Patient had first dose of historical vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206, Expiry date: 30Jun2021), via an unspecified route of administration on left arm on 08Mar2021 (at the age of 49 Years) as a 1st dose single for COVID-19 immunization. After 1st dose of vaccine on 08Mar2021patient experienced, headache which was recovered on 09 Mar2021 and left arm sore from injection recovered on 11Mar2021. Patient Stated that on 30Mar2021, she took the Covid vaccine and got a little tired and it caused her to be in the bed for a little while and crappy and after a day or so she was fine. She also experienced headache and left arm sore from the injection on the same day (30Mar2021). Patient had Blood test, stated that she gets bloodwork often (dates and results unspecified). Patient received Over the counter Tylenol as a treatment for events. Outcome of the left arm sore from injection was recovered on 02Apr2021 and rest of the events were resolved on 31Mar2021.  No follow-up attempts are required; information about lot/batch number already obtained.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain, Pain in extremity
Clinical narrative: everything is shift on left side of my body and I am feeling this pretty much since I would say the second day of the Vaccine but pain has been more afterwards; feel the pain going from my shoulder, the top of my shoulder towards my neck it gets around my collar area; pain I would say shoulder cup area in the back and on the mid back area where that shoulder was going; pain, I would say around my shoulder cup area, I would say the cup area, sometimes its there, sometimes like the pain was running down my from shoulder cup area down my arm towards my wrist/felt it in my left hip; sore arm/I am feeling pain in my thigh area and in the back of my thigh/have feel the pain in the top of my hand and just to the back of my hand from around my finger bone area to the middle left; This is a spontaneous report via Pfizer-sponsored program from a contactable consumer (patient). A 30-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot Number: EW0185), intramuscularly on 22May2021 16:30 as 1st dose, single dose in left arm (on left shoulder as reported) for COVID-19 immunisation at pharmacy. Patient didn't receive any other vaccinations within 4weeks. Medical history included ongoing blood pressure measurement (takes Amlodipine 5mg to control blood pressure). Concomitant medications included amlodipine at 5 mg taken for blood pressure. It was reported that when I got the vaccine I had the normal side effect which was the sore arm which, I received like 12 hours later and it lasted for 25 hours but its been, I had the vaccine administered on 22nd and since then pretty much I have been having pain, I would say around my shoulder cup area, I would say the cup area, sometimes its there, sometimes like the pain was running down my from shoulder cup area down my arm towards my wrist. And sometimes I have feel the pain in the top of my hand and just to the back of my hand from around my finger bone area to the middle left and if I say feel the pain going from my shoulder, the top of my shoulder towards my neck it gets around my collar area. Then sometimes I am feeling pain I would say shoulder cup area in the back and on the mid back area where that shoulder was going. I would say I am feeling pain in my thigh area and in the back of my thigh, worried about my knee and the back of my thigh. Sometimes I feel it down and I also felt it in my left hip all on 22May2021. So everything was shift on left side of my body and I am feeling this pretty much since I would say the second day of the Vaccine but pain has been more afterwards." Therapeutic measures were taken for the adverse events was Tylenol. The outcome of the events was unknown.  Information about batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Laziness, Pain, Psychiatric symptom
Clinical narrative: I'm feeling like lazy; Body ache; Headache; but I do not feel confident going to work like that; 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, Formulation: Solution for injection, Batch/Lot number and expiry dates were not reported), via an unspecified route of administration, on 28May2021 as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Patient stated that I already got my second one and that was on last Friday (28May2021), so five days ago so I am doing okay just yesterday (31May2021) I am feeling like lazy and like body ache, headache and all the body ache is gone but I still had the headache a little bit and it comes back like once or twice a day. The patient had been taking Tylenol (treatment) for the events Laziness, Body ache and headache and that helped and, but I do not feel confident going to work like that. Outcome of the events headache was not recovered; body pain was recovered on an unknown date in 2021; and for other events it was unknown.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anion gap, Blood chloride, Lymphocyte count, Ovarian cyst
Clinical narrative: She had abdominal pain and was diagnosed with an ovarian cyst; She had abdominal pain and was diagnosed with an ovarian cyst; This is a spontaneous report from a contactable registered nurse (patient's mother). A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration date: Unknown), via an unspecified route, administered in Left arm on 18May2021 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. No concomitant medications were reported for the patient. The initial information was not related to any study or programme.On 30May2021, the patient had experienced abdominal pain and was diagnosed with an ovarian cyst. The reporter had called to her doctor. There was no survey provided due to Physician waited for reporter. The reporter stated that, the doctor does not think it was related to the Pfizer vaccine and recommends that she get the second dose. The reporter explained that there were no reports of Ovarian cysts in Pfizer date or CDC information obtained and was referred to HCP. Offered to email this document for review. The reporter stated that her daughter had not been seen by the doctor provided at this time and stated they were out of town, so she was seen at an Emergency room. The reporter stated that, her daughter's pain was better, but she was assuming the cyst was still there. The reporter stated that her daughter's lab work was also a little off, stated her Lymphocyte count was low, was 15.6 and should have been 28-48. The reporter stated that patient's Chloride was 1.09 and her Anion was 4, so a little low. Exact levels were unknown. No investigational assessment was provided for Ovarian cyst. Product Details: NDC, Lot and Expiration unknown at the time of report. The reporter does not have the patient's vaccine record card on hand at the time of the report. The reporter wanted to know if this could be related to the vaccine. The reporter wanted to know if she should delay second dose because of ovarian cyst and then how long do we have to repeat. The outcome of the event ovarian cyst was not recovered and the outcome of another event was recovering.  Follow-up (02Jun2021): This is a follow-up spontaneous report from a contactable nurse: Added report details, event onset date, lab data and reporter comments. Narrative was updated accordingly.  Information on the lot/batch number have been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle ache; Tiredness; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), via an unspecified route of administration in left arm on 26May2021 at 09:00 as a single dose for COVID-19 immunization at pharmacy. The patient's medical history was not reported. Concomitant medication included ongoing naproxen sodium (ALEVE ARTHRITIS) at 220 mg, twice a day for minor headaches. The patient did not receive any additional vaccines administered on same day. The patient did not receive any vaccinations with 4 weeks prior to the fist dose administration. The patient did not experience any adverse events prior vaccination. It was reported that she experienced chills, fever, headache, muscle aches, tiredness. patient stated she woke up last night at 10:30 with chills, literally shivering until she realized possibly what was going on, says she then knew it was a fever on 01Jun2021. patient stated she took Tylenol to help see if it would subside some. She started to develop a headache on 01Jun2021, slept on and off throughout the night on. patient says this morning when she woke up and felt ok, her head hurt kind of hurt a little bit, and she was really tired on 02Jun2021. patient stated she began developing chills and was just kind of sleeping off and on all day, says she has a slight headache and has not taken any medicine since 5am, says she wanted to see what's going to happen. The chills have gotten a little better. Today, she just started to develop muscle aches also on 02Jun2021 08:00. Fever began around 10:30 and she doesn't feel she has a fever anymore. Headache began around midnight and it's better, it's tolerable. Last night, her headache was to the point, she had to force herself to sleep just because she knew she needed the sleep. Muscle aches began around 8am when she got up this morning. She confirms the aches are better, it feels fine to get up and walk, but they are still noticeably there. Tiredness was kind of off and on, says she wakes up from sleeping, then dozes back off. patient states she slept from 5am until 8am really good, and then by 9am she was ready to doze. She took a nap between 10 to 11am and has been up since. The tiredness comes in waves. The patient was not hospitalized. The patient did not underwent any laboratory test. The outcome of the event fever was unknown, fatigue was not resolved and all other events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Illness
Clinical narrative: His covid tested was positive; Fever; Chills; Headache; Body aches; A cough; Feeling really sick; This is a spontaneous report from a contactable pharmacist (parent) via medical information team. A 20-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15May2021 (age at vaccination 20-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17May2021, patient had fever, chills, headache, body aches and a cough. patient had fever and chills for I believe she said about 5 days. So she took him to the doctor and he ended up being positive for COVID. He was also "feeling really sick on 17May2021 but hesitated to get tested" for Covid-19, for fear of "being hospitalized. The son had the side effects for 6 days and "got tested for Covid on Thursday, 20May2021, his covid tested was positive." patient has completed his isolation period at home and has "been fine for 4 days." "Because he was Covid -19 positive, how long should he wait for his 2nd dose?" The outcome of events was unknown.  Information about lot/batch number has been requested
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: His covid tested was positive; Fever; Chills; Headache; Body aches; A cough; Feeling really sick; This is a spontaneous report from a contactable pharmacist (parent) via medical information team. A 20-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 15May2021 (age at vaccination 20-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17May2021, patient had fever, chills, headache, body aches and a cough. patient had fever and chills for I believe she said about 5 days. So she took him to the doctor and he ended up being positive for COVID. He was also "feeling really sick on 17May2021 but hesitated to get tested" for Covid-19, for fear of "being hospitalized. The son had the side effects for 6 days and "got tested for Covid on Thursday, 20May2021, his covid tested was positive." patient has completed his isolation period at home and has "been fine for 4 days." "Because he was Covid -19 positive, how long should he wait for his 2nd dose?" The outcome of events was unknown.  Information about lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: he has diarrhea from food he ate; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to reschedule an appointment for second dose, because patient had diarrhea on an unspecified date and can't make it to his appointment. The patient had diarrhea from food he ate. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dehydration, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: fever; she is not able to hold herself up to walk; ringing in her ears/buzzing in her ears; pain in her lower back has become stronger/pain in the lower back worsened; severe headache; she can't even stand; she can't walk; little bit of pain in her lower back; very tired; really thirsty; my lips felt like I had become dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: EW0191) via an unspecified route of administration in arm right on 27May2021 15:00 (at the age of 46-year-old), as a single dose for COVID-19 immunization. Patient medical history included fever. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 06May2021 (at the age of 46-year-old) as a single dose for COVID-19 immunization. It was reported as patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 27May2021 at 15:00. The next day she went to work but two hours later she had a severe headache, fever and some pain in her lower back. The next day she was fine but since yesterday the pain in the lower back worsened. Today she woke up with such pain that she can't walk, she can't even stand, she feel like she have a fever and a ringing in my ears. The day after the vaccine, she felt very thirsty, her lips felt like she had become dehydrated. She is also very tired. On 01Jun2021 it was reported as the pain in her lower back has become stronger, on 02Jun2021 it was reported as she is not able to hold herself up to walk today. She is feeling feverish and has ringing in her ears and buzzing in her ears. She also stated that the next day after receiving the vaccine she was really thirsty and feels like she's dehydrated. She took Ibuprofen. Her right arm didn't ache but she had the other symptoms. She had to get the COVID 19 vaccine because she works with a lot of people. She had to get the vaccine for work. She reports she has no other medical conditions and she only takes Ibuprofen if she has discomfort. She works as she normally does. These symptoms she had with the second dose are normal symptoms. She was told to treat her symptoms in her house. She has the symptoms listed above and pain in her lower back on the left side but now she can't support herself to walk. On the day after she received the COVID 19 vaccine she was thirsty and she felt tired and she feels buzzing in her ears. Outcome of events headache, Fever, really thirsty, Dehydration, Difficulty in standing, Unable to walk was unknown and not recovered for other events.  Follow-up attempts are possible; Additional information is been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Pyrexia, Thirst, Tinnitus
Clinical narrative: fever; she is not able to hold herself up to walk; ringing in her ears/buzzing in her ears; pain in her lower back has become stronger/pain in the lower back worsened; severe headache; she can't even stand; she can't walk; little bit of pain in her lower back; very tired; really thirsty; my lips felt like I had become dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: EW0191) via an unspecified route of administration in arm right on 27May2021 15:00 (at the age of 46-year-old), as a single dose for COVID-19 immunization. Patient medical history included fever. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 06May2021 (at the age of 46-year-old) as a single dose for COVID-19 immunization. It was reported as patient stated that she received the second dose of the Pfizer Covid-19 vaccine on 27May2021 at 15:00. The next day she went to work but two hours later she had a severe headache, fever and some pain in her lower back. The next day she was fine but since yesterday the pain in the lower back worsened. Today she woke up with such pain that she can't walk, she can't even stand, she feel like she have a fever and a ringing in my ears. The day after the vaccine, she felt very thirsty, her lips felt like she had become dehydrated. She is also very tired. On 01Jun2021 it was reported as the pain in her lower back has become stronger, on 02Jun2021 it was reported as she is not able to hold herself up to walk today. She is feeling feverish and has ringing in her ears and buzzing in her ears. She also stated that the next day after receiving the vaccine she was really thirsty and feels like she's dehydrated. She took Ibuprofen. Her right arm didn't ache but she had the other symptoms. She had to get the COVID 19 vaccine because she works with a lot of people. She had to get the vaccine for work. She reports she has no other medical conditions and she only takes Ibuprofen if she has discomfort. She works as she normally does. These symptoms she had with the second dose are normal symptoms. She was told to treat her symptoms in her house. She has the symptoms listed above and pain in her lower back on the left side but now she can't support herself to walk. On the day after she received the COVID 19 vaccine she was thirsty and she felt tired and she feels buzzing in her ears. Outcome of events headache, Fever, really thirsty, Dehydration, Difficulty in standing, Unable to walk was unknown and not recovered for other events.  Follow-up attempts are possible; Additional information is been requested.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: non tender, 1-2 inch node supraclavicular; This is a spontaneous report from a Pfizer sponsored program support. A contactable Physician reported that a 17-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via unspecified route of administration in left arm on 26May2021 (Batch/Lot number: not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient's concomitant medication was not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via unspecified route of administration on unspecified date (Batch/Lot number: not reported) as single dose for COVID-19 immunisation. On unspecified date the patient experienced a non-tender, 1-2-inch node supraclavicular, not painful. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER same reporter, product and AE, different patient
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea
Clinical narrative: Pt. has some diarrhea occasionally; This is a spontaneous report from a Pfizer Sponsored Program Optum Xeljanz Program. This contactable consumer (Other Health Professional) reported that a 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number and expiration date: Unknown), via an unspecified route of administration on an unknown date as unknown dose, single dose for COVID-19 immunization and started receiving tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, Lot number and expiration date: Unknown), at 11 mg via an unspecified route of administration from 01Mar2021 and unknown date for an unknown indication. Medical history and concomitant medications were not reported. Patient reported that doctor instructed her to take one week off from the medication before the COVID Vaccine, and one week after she gets the COVID-19 vaccine. Patient had some diarrhea occasionally, but Imodium helped. The outcome of event was unknown.  Information about the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria, Vaccination site lymphadenopathy
Clinical narrative: I broke out in hives all over my legs. Since day 5 until today which is day 13; Lymphadenopathy under my left arm which was the vaccination site; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 45-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0177 and expiration dates were not reported), via an unspecified route of administration, in arm left on 20May2021 at 16:00 (age at vaccination 45-year-old) as 1ST dose, single for COVID-19 immunization. Facility type vaccine: facility. The patient did not receive any other vaccine in four weeks. The patient unknown whether tested covid prior vaccination and COVID tested post vaccination. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). On 22May2021 at 12:00 the patient experienced broke out in hives all over her legs. Since day 5 until today which is day 13, lymphadenopathy under left arm which was the vaccination site. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in both of his arms; Numbness and tingling in both of his arms; This is a spontaneous report from a contactable pharmacist through Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date (two to three days after receiving the first dose of the vaccine), patient experienced numbness and tingling in both of his arms. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Pharmacist wanted to know if there had been reports like this. The outcome of both the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: This patient had done the same thing, only he ended up taking pneumonia and dying with it; This is a spontaneous report from a contactable consumer or other non hcp. This is a split case report which was conservatively captured as per the statement 'This patient had done the same thing'. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date. It was reported that, when reporter saw her medical doctor, the day before reporting the event, who was very concerned because she had a recent patient that was about the same age as the reporter, he was 75 years old. The patient had done the same thing, only he ended up taking pneumonia and dying with it. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal on an unknown date.  Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: This patient had done the same thing, only he ended up taking pneumonia and dying with it
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Ear discomfort, Tinnitus
Clinical narrative: concerning; increase in her preexisting tinnitus/tinnitus almost doubled in both ears, but her right ear is worse; pressure on the right ear/and feeling like there's pressure in her right ear/feels like right ear is a little blocked or has a little pressure; slight  intermittent- dizziness with  light  headedness / had a very light sensation of lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 59-years-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, administered in arm left on 22May2021 11:45 as single dose for covid-19 immunisation. Medical history included ongoing tinnitus (had pre-existing baseline tinnitus for many years prior to having the Pfizer Covid Vaccine). Patient just takes basic vitamins. The patient was taking vaccine just from peer pressure to be able to go back to work in person. The patient experienced increase in her pre-existing tinnitus which almost doubled in both ears, feeling like there was pressure on the right ear which she has never felt before and felt like right ear was a little blocked or had a little pressure causing ear discomfort but her right ear was worse leading to condition aggravated. Patient experienced almost dizziness about once a day since she was administered the Pfizer Covid Vaccine with light headedness and had a very light sensation of light headedness on an unspecified date. The tinnitus and pressure in her right ear were what's concerning her. She asked if there was anything that could be done about these events, if these were common with the vaccine; if there was information on expected duration of these events. Caller would like to know if she decides to not take the second dose of the vaccine given the side effects she experienced above, what level of protection does she have with only one dose of the vaccine? Patient contacted her doctor and had a tele-visit/video visit with the doctor on 30May2021. When patient 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 increase in her preexisting tinnitus, pressure on the right ear, tinnitus almost doubled in both ears, but her right ear is worse was not recovered, the outcome of the other events was unknown.  Follow up attempts needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Insomnia, Pain in extremity
Clinical narrative: my hand now are hurting like I have arthritis or something/causes the hurt and they just ache my wrist and my hands like hurt so bad like/ hands felt so bad; They were numb, my toes went numb; my toes went numb and that was for few days; I can't even hardly sleep at night.; my hands causes the hurt, they just ache my wrist and my hands like hurt so bad like; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 26May2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient hands were hurting like a patient had arthritis or something. Patient wonder that was the side effect of the vaccine, toes were not numb anymore, they were numb, toes went numb, patient did not had diabetes, any neuropathy or anything like that, toes went numb and that was for few days and gone, after like 2 days patient hands cause the hurt and they just ache, wrist and hands like hurt so bad like, patient did not even hardly sleep at night, patient can barely sleep. Hands felt so bad. Patient never had a problem with any sort off arthritis or anything like. The outcome event toes went numb was recovered and for other it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 43-year-old female patient received second dose of 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 13May2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously received first dose of 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 as a single dose for COVID-19 immunization. Reporter states the patient's isn't on any medication so there's no potential interactions. No prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer suspect. It was reported that the reporter would like to document that one of her patients had an adverse event happen after receiving the Pfizer COVID vaccine. Reporter states because she doesn't feel comfortable reporting all the information, but she would provide the potential side effect from the vaccine. Reporter states the patient had the second Pfizer vaccine on 13May2021 and on 24May2021, this month, she was diagnosed with bell's palsy. Caller states so far, the patient has no improvement, the symptoms are persisting. No investigation assessment. Reporter stated the patient went to urgent care. Patient would be coming to see the reporter, the patient's physician, in a few days. The adverse events require a visit to physician office visit. The adverse events did not require a visit to emergency room. The event was considered as serious (disability) by the physician. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Bells Palsy cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Joint swelling, SARS-CoV-2 test
Clinical narrative: hips are swollen; significant aches and pain in her hips after the first dose/worsened after the 2nd dose; have to rest and painful to walk; My shoulder was hurting started in my joints; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 17Mar2021 as second dose, single for COVID-19 immunisation. The patient's medical history included underlying condition of lower back pain since unspecified years ago. She also suffered from COVID-19 from 21Dec2020 to 11Jan2021 (for 3 weeks).  The patient's concomitant medications were not reported. She had antibodies but did not know how long they would last. The patient experienced aggravated swelling and pain in her hips after the second dose on an unspecified date post vaccination. It was painful to walk, and she had to sit down a lot and rest in between. She had joints pain as additional new event after second vaccination. She had joint pain in her shoulders which she noticed when she was lifting weights. She went to a Pain specialist doctor and was prescribed Tramadol (unspecified dosage and formulation). She took the pain away only for a day but that was it. The outcome of the events was reported as unknown at the time of report.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021642671 Same reporter / drug, different patient