chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rheumatoid arthritis
Clinical narrative: high indicators for Rheumatoid Arthritis; This is a spontaneous report from a non-contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 (at the age of 44years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: ER8733) on 05Mar2021 12:00 PM (at the age of 44years) via an unspecified route of administration (right arm) for Covid-19 immunization and developed severe pain in right shoulder approximately 7 days after 1st vaccine, went to ER and diagnosed with bursitis; also developed joint pain in hands, knuckles, toe joints in both feet, ankle joint pain in both feet. The patient is not pregnant at the time of vaccination. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the joint pain in hands, knuckles, toe joints in both feet, ankle joint pain in both feet that developed 1-2 weeks after 1st vaccine has progressed and joint pain worsened over the next weeks. It was further reported that the shoulder joints began with pain. The patient had blood work done last week (unspecified date in 2021) and she have high indicators for rheumatoid arthritis. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with unspecified medications. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  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 appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dyspepsia, Headache, Nausea
Clinical narrative: vomiting; headache; stomachache; heartburn-like sensation; diarrhea; generalized pain across the body; Nausea; This is a spontaneous report from a contactable consumer (patient's Mother). A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on 09Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. They are scheduled to get the second dose in 2 weeks. On unknown date the patient experienced, Caller mentions that she and her daughter got the first dose of the Pfizer covid vaccine past Friday (8 days ago) and since then they had vomiting, headache, stomachache and heartburn-like sensation, diarrhea and generalized pain across the body. Diarrhea started today for her and for her daughter yesterday, as well for the heartburn-like sensation. She would like to know if the heartburn-like sensation is normal and that is what worries them most. The outcome of the event was unknown.  Case AER#2021422771 is for caller self (Mother) and split into AER#2021428556 for daughter.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422771 same reporter/SD/AE, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: vomiting; headache; stomachache; heartburn-like sensation; diarrhea; generalized pain across the body; Nausea; This is a spontaneous report from a contactable consumer (patient's Mother). A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on 09Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. They are scheduled to get the second dose in 2 weeks. On unknown date the patient experienced, Caller mentions that she and her daughter got the first dose of the Pfizer covid vaccine past Friday (8 days ago) and since then they had vomiting, headache, stomachache and heartburn-like sensation, diarrhea and generalized pain across the body. Diarrhea started today for her and for her daughter yesterday, as well for the heartburn-like sensation. She would like to know if the heartburn-like sensation is normal and that is what worries them most. The outcome of the event was unknown.  Case AER#2021422771 is for caller self (Mother) and split into AER#2021428556 for daughter.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422771 same reporter/SD/AE, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Erythema, Pain in extremity, Tinnitus
Clinical narrative: loss of hearing in my hearing impaired ear; sore arm; tinnitus; slight redness; This is a spontaneous report from a contactable consumer reporting for herself. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EW0153) via an unspecified route of administration in left arm on 15Apr2021 04:15PM for COVID-19 immunization. The patient took first dose of BNT162b2 (Lot number ER8730) on 25Mar2021 03:00PM in left arm. Relevant medical history included previous cancer history and two stem cell transplants. The patient had no known allergies. Concomitant medications included metoprolol, pravastatin, levothyroxine and cetirizine hydrochloride (ZYRTEC). On 16Mar2021 at 09:30PM the patient experienced loss of hearing in her hearing impaired ear, sore arm, tinnitus and slight redness. Clinical course was described as follows. Standard sore arm and slight redness, but the day after the second vaccine sudden onset tinnitus and loss of hearing in my hearing impaired ear. The patient noticed recent increase in tinnitus that may have started after the first vaccine, but this was very sudden after the second vaccine. Much better but tinnitus was ongoing. No treatment was given for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction in lips and tong became numb and a funny taste in mouth then hart time breathing; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 02Apr2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had an allergic reaction in lips and tong became numb and a funny taste in mouth then hart time breathing. Patient spent 6 hours in the ER at hospital. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unknown date, after receiving vaccination, the patient experienced anaphylactic reaction. The outcome of the event was unknown.  Information on the lot/batch number has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the event anaphylactic reaction and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: he had a temperature; achy; wiped out/exhausted; This is a spontaneous report from a contactable Nurse via a  Program. A 65-years-old male received first 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 an unknown date as a single dose for COVID-19 immunization; axitinib (INLYTA), orally from an unspecified date (Batch/Lot number was not reported; Expiration Date: 31Dec2022) to an unspecified date, at 3 mg, 2x/day (3 Tablets Orally) for Mal Neoplasm of Unspecified Kidney Except Renal Pelvis, secondary Malignant Neoplasm Of Brain. Medical history included chronic kidney disease, hypertension, heart failure, hypothyroidism, major depressive disorder (single episode). The patient had no known allergies. Concomitant medications included pembrolizumab (KEYTRUDA) taken for an unspecified indication, start and stop date were not reported. The patients wife reported that the patient had a triple wammy because they started him on keytruda and inlyta again and had the covid vaccine 1 week ago. He had been in bed ever since. He had a temperature one day and he is run down and achy and wiped out. He was on inlyta for 10 months, but they took him off because they did not want him in the hospital. It was hard to say what was normal they had to lower his dose because he was weak and he has been trying to sleep but his arm was bothering him, he was exhausted. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021430895
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Influenza like illness, Suspected COVID-19
Clinical narrative: flu/covid like symptoms; Covid like symptoms; loss of taste and smell; loss of taste and smell; 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), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu/covid like symptoms in Apr2021 after vaccination. He indicated they have taken nasal decongestant and have loss of taste and smell in Apr2021. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer program. A contactable consumer (patient herself) of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient and husband had their second dose appointment scheduled for 21Apr2021, would like to cancel appointments as both tested positive for covid. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: allergic hives all over body; This is a spontaneous report from a contactable consumer via Pfizer representative. A 17-year-old patient of an unspecified gender received the 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 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was healthy and on an unspecified date, the patient experienced allergic hives all over body 4 days after 2nd dose of COVID-19 vaccine and went to the emergency room (ER). Day five after vaccination and hives have not resolved. Treatment prescribed by ER  doctor (MD) was Benadryl. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 25Mar2021 and was due to get the second dose tomorrow, 15Apr2021. She would not be able to make tomorrow's appointment because she was feeling unwell (2021). She would like to reschedule her second dose to up to two weeks from now as advised to her. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a male patient (husband) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient have their second dose appointment scheduled for 21Apr2021, and would like to cancel appointments as both tested positive for COVID. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Limb mass
Clinical narrative: got a lump in her above ankle; she got sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got sick and got a lump in her above ankle on an unspecified date. Escalating because the caller got sick after her 1st dose. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first dose of the vaccine last 25Mar2021. However, he tested positive for Covid-19 on an unspecified date and will finish his isolation on Friday. The patient called in to ask if he can still get his second dose due on 17Apr2021. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pyrexia
Clinical narrative: temperature increased to 100 degree; nausea; dizziness; This is a spontaneous report from a Pfizer sponsored program,  from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in Mar2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient's first dose was in Mar2021 (reported as "3 weeks ago"), patient mentioned that after she got the vaccine her temperature increased to 100 degree, had nausea and dizziness. Patient's second dose was due on 21Apr2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: 1st dose more likely to induce autoimmune reaction based on timeline; This is a spontaneous report from a contactable physician. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration, administered on the left deltoid on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing hypertension, ongoing coronary artery diseases, ongoing hyperlipedmia, ongoing prostate cancer and GERD. Concomitant medications included omeprazole, losartan potassium (LOZAR), simvastatin (ZOCOR), apixaban, baclofen (LIORESAL), diazepam (VALIUM), melatonin, tolterodine tartrate, mirtazapine (REMERON), cholecalciferol, sildenafil citrate, omeprazole (PRILOSEC [OMEPRAZOLE]), losartan potassium (COZAAR), simvastatin, baclofen, mirtazapine and tamsulosin. It was reported that the 1st dose more likely to induce autoimmune reaction based on timeline on an unspecified date. The patient was hospitalized due to the event. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded.  The case will be reassessed if 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; low fever; pain in injected arm; fatigue; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced post COVID-19 vaccine symptoms of body aches, low fever, pain in injected arm, fatigue on an unknown date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She has been experiencing fatigue since then; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue since then on an unspecified date in 2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site warmth
Clinical narrative: experienced fever for 3-4 days; have a bump that is warm to touch at the injection site; have a bump that is warm to touch at the injection site; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 14apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever for 3-4 days, have a bump that is warm to touch at the injection site. she wanted to know if she should take the second dose or not. The event assessed as non-serious with outcome unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid PCR test 15Apr2021 after being fully vaccinated/Positive; covid PCR test 15Apr2021 after being fully vaccinated/Positive; is pregnant: Yes; This is a spontaneous report from a contactable physician. A 34-years-old pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 intramuscular on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history was none. No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. The patient was pregnant at the time of vaccination. Her last menstrual date was 03Jul2020 and delivered on (date). Gestational period was 33 (as reported). On 15Apr2021, after being fully vaccinated, the patient had post vaccination covid test which showed positive result. covid test type post vaccination was Nasal Swab, covid test name post vaccination was NAAT LumiraDX: This RT-PCR assay targets ORF1a. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of the events was recovered.  Information about the Lot/batch number has been requested.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be ruled out.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vaccination site bruising, Vision blurred
Clinical narrative: she feels like she is another world and has to lay down frequently; she feels like she is another world and has to lay down frequently; She has been experiencing intermittent dizziness; she feels like everything is a blur; injection arm is "black and blue."; This is a spontaneous report from a contactable consumer (patient) reported that a 91-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has been experiencing intermittent dizziness, she feels like everything is a blur, she feels like she is another world and has to lay down frequently, vaccination site bruising on an unspecified date. Her injection arm is "black and blue." She wants to know if this is normal after the vaccine, she states she is going to an eye doctor appointment tomorrow 20Mar2021. No PQC involved. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Joint swelling, Lip swelling, Lymphadenopathy
Clinical narrative: find out if his side effects are normal or if he maybe has a "blood clot."; the shoulder and neck on the side where he received his injection are swollen and painful; the shoulder and neck on the side where he received his injection are swollen and painful; the shoulder and neck on the side where he received his injection are swollen and painful; the shoulder and neck on the side where he received his injection are swollen and painful; across his collar bone is painful; my lips, nodes and top of my right my trap area is swollen; my lips, nodes and top of my right my trap area is swollen; I was told you might swollen on arm where shot went it or under your armpit not on top on my neck; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 (lot number and expiry date not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient stated that he received his second dose of the Pfizer COVID-19 vaccine on Saturday 17Apr2021. He stated that he called Pfizer yesterday, Sunday 18Apr2021 and reported his side effects, but was not able to have his questions answered. He was calling back to find out if his side effects were normal or if he maybe had a "blood clot." The patient stated that the shoulder and neck on the side where he received his injection were swollen and painful. The patient stated that across his collar bone was painful. He stated that the swelling and pain had improved slightly since yesterday. He stated that other than these side effects he feels great. He added, "I just got my second shot yesterday. No symptoms showed up except my lips nodes and top of my, right my trap area is swollen. So I want to make sure, is that normal? Because I was told you might swollen on arm where shot went it or under your armpit not on top on my neck." Clinical outcome of blood clot was unknown, while for the other events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Swelling, Thrombosis, Vaccination site swelling
Clinical narrative: find out if his side effects are normal or if he maybe has a "blood clot."; the shoulder and neck on the side where he received his injection are swollen and painful; the shoulder and neck on the side where he received his injection are swollen and painful; the shoulder and neck on the side where he received his injection are swollen and painful; the shoulder and neck on the side where he received his injection are swollen and painful; across his collar bone is painful; my lips, nodes and top of my right my trap area is swollen; my lips, nodes and top of my right my trap area is swollen; I was told you might swollen on arm where shot went it or under your armpit not on top on my neck; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Apr2021 (lot number and expiry date not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient stated that he received his second dose of the Pfizer COVID-19 vaccine on Saturday 17Apr2021. He stated that he called Pfizer yesterday, Sunday 18Apr2021 and reported his side effects, but was not able to have his questions answered. He was calling back to find out if his side effects were normal or if he maybe had a "blood clot." The patient stated that the shoulder and neck on the side where he received his injection were swollen and painful. The patient stated that across his collar bone was painful. He stated that the swelling and pain had improved slightly since yesterday. He stated that other than these side effects he feels great. He added, "I just got my second shot yesterday. No symptoms showed up except my lips nodes and top of my, right my trap area is swollen. So I want to make sure, is that normal? Because I was told you might swollen on arm where shot went it or under your armpit not on top on my neck." Clinical outcome of blood clot was unknown, while for the other events was recovering.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence
Clinical narrative: She's been having a "severe case of gas and bloating"; She's been having a "severe case of gas and bloating"; This is a spontaneous report receivec from a contactable consumer (patient). This 54-years-old female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided) via an unspecified route of administration on 16Apr2021 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medication were not reported. In Apr2021, patient had severe case of gas and bloating. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Myocardial infarction
Clinical narrative: had a NSTMI/heart attack; stomach virus; This is a spontaneous report from a contactable consumer (patient's parent). A 23-year-old male patient (son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via on an unspecified date (batch/lot number was not reported) and second dose via on 08Apr2021 (batch/lot number was not reported); both via an unspecified route of administration as single dose for covid-19 immunization. Medical history included covid in Aug2020 and never consumed a drug, cigarette or alcoholic beverage. The patient's concomitant medications were not reported. The parent reported that the patient that received his second dose of bnt162b2 on 08Apr2021 had a NSTMI on 12Apr2021 after having had covid in Aug2020, and a recent stomach virus on 10Apr2021 (the 2 days prior to his heart attack). The parent did not for 1 minute blame Pfizer for the patient's heart attack however the timing of things created the perfect storm for perfectly healthy, never consumed a drug, cigarette or alcoholic beverage in his life clean-living son. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient, self-reported). This 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On 17Apr2021, Saturday, the patient tested positive for COVID-19. On unknown date in Apr2021, a week ago, the patient tested negative. On 19Apr2021, The patient scheduled to receive the second dose of the vaccine today.The patient wants to know if she should reschedule or proceed with her second dose today. The patient underwent lab tests and procedures which included tested for COVID-19 was positive on 17Apr2021, Saturday. Outcome of the events were unknown.  Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula, Rash erythematous, Swelling, Swelling face, Throat irritation
Clinical narrative: her throat started severely burning/throat irritation; the inside of her cheeks had a patchy red rash that was fire red in color; her uvula became swollen and bright red; face is still swollen; neck is still swollen; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient 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 15Apr2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitantly patient was taking Benadryl 50 mg every 4 hours. It was reported that after administration of first dose of vaccination on 15Apr2021 patient had an allergic reaction afterwards. Patient had throat irritation, rash erythematous, enlarged uvula, swelling face, swelling. Patient reported that her throat started severely burning, the inside of her cheeks had a patchy red rash that was fire red in color, and her uvula became swollen and bright red instantly after receiving the vaccine. Reportedly, few hours later her face and neck began to swell as well. It was reported that burning in her throat started to subside on Saturday night, but she still experienced burning here and there, uvula, face, and neck was still swollen. Patient consulted with a physician after the vaccine in which she states they were unable to see much of the swelling. They advised her to take 50 mg of Benadryl every 4 hours for the day. Patient reports that the symptoms ended up getting worse and she has a long allergy list and is unable to try new medications. Patient stated that the vaccine was the only thing new introduced to her body and this was very scary because her symptoms occur and then follow with more intense reactions and is unsure that she will get the second dose due to the reaction she was experiencing. Patient asked if this would be considered an allergic reaction and reason to not receive the second dose. No PQC was present. At the time of reporting, the outcome of the events was unknown.  E-transmitting AE information to agent due to caller stating that she reported her reaction to agent before she was transferred.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Loss of consciousness
Clinical narrative: Blacked out; This is a spontaneous report from a contactable consumer (who is also the patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Mar2021 10:30 (lot number: ER8730); then the second dose via an unspecified route of administration, administered in the right arm, on 16Apr2021 10:30, both as single dose, for COVID-19 immunisation. Medical history included colon cancer from 2016 (5 years ago). The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies. There were no concomitant medications (no other medications in two weeks. The patient did not receive other vaccines in four weeks. On 26Mar2021 at 10:30, almost immediately after the first vaccination, the patient blacked out twice. On 16Apr2021, after the second vaccination, the patient blacked out four or more times. The event resulted to emergency room visit. The patient underwent EKG and blood work on an unspecified date with unknown results. The patient recovered from the event on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Drug ineffective, Hypersensitivity, Pain in extremity
Clinical narrative: covid test and came out positive; covid test and came out positive; allergy symptoms; she started feeling a little bad having pain in his hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunization. The patient's previously received first dose of bnt162b2 (lot number and expiry date were not provided), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at night, the patient experienced she started feeling a little bad having pain in his hands, dizziness and allergy symptoms. On 14Apr2021, she took the COVID test and came out positive. Now, the patient had a lot of pain in her hands and legs and dizziness. She also infected a 4-month-old baby even when she wears face mask. Therapeutic measures as a result of allergic symptoms included Claritin. The reporter classified the events as non-serious. Outcome of the events was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid test and came out positive; covid test and came out positive; allergy symptoms; she started feeling a little bad having pain in his hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunization. The patient's previously received first dose of bnt162b2 (lot number and expiry date were not provided), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at night, the patient experienced she started feeling a little bad having pain in his hands, dizziness and allergy symptoms. On 14Apr2021, she took the COVID test and came out positive. Now, the patient had a lot of pain in her hands and legs and dizziness. She also infected a 4-month-old baby even when she wears face mask. Therapeutic measures as a result of allergic symptoms included Claritin. The reporter classified the events as non-serious. Outcome of the events was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient wants to know if she should take the second dose of the Pfizer COVID-19 vaccine after the side effects that she developed, she received the first dose of the Pfizer COVID-19 vaccine on March 26th and was supposed to get the second dose on April 16th but she chose not to get it as she developed vertigo 6 days after the first dose and the side effect is continuous since the past couple of weeks, she mentioned that she has allergies towards some medications and she tends to develop dizziness as an allergy symptom and she does not want to develop a reaction that she might not be able to handle, this concerns her moving forward with the second dose of the vaccine. On 06 April 2021 she received response saying, Nausea is reported as a side effect of the medication, no reports of vertigo, dizziness is described as part of a possible severe allergic reaction to the vaccine. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. According to information of the CDC these reactions could be normal signs that your body is building protection and should go away in a few days. Patient wants to know the efficacy of the Pfizer COVID-19 vaccine after a single dose and also wants to know if a booster for the other COVID-19 variants (i.e a third dose) will be needed in 6 months. Responded as there is limited data of the efficacy of the vaccine after a single dose, efficacy data started to get collected 7 days after the second dose with a 95% efficacy rate. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. Patient wants to know what is the longest time that she could wait to receive the second dose of the COVID-19 vaccine. Responded as a second dose 6 weeks or 42 days after the first dose is still considered valid. The recommendation is to take the second dose as close as possible to the 3week time period. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a Pfizer-sponsored program, via Pfizer Epsilon Escalation team from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced chest pain on an unspecified date with outcome of not recovered.  The patient had chest pain since got a First vaccine on 07Mar2021, 2nd vaccine on 28Mar2021, chest pain not going away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Productive cough, SARS-CoV-2 test, Sinus disorder
Clinical narrative: phlegm; sinuses; I got my 1st dose on Mar20th. Two weeks later I tested positive for Covid; I got my 1st dose on Mar20th. Two weeks later I tested positive for Covid; This is a spontaneous report from contactable consumer (patient) from a Pfizer-sponsored program. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP6955 and expiry: unknown), via an unspecified route of administration, in the right arm, on 20Mar2021 (at the age of 52-years-old) as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 02Apr2021, two weeks later patient tested positive for Covid. On unknown date patient experienced phlegm and sinuses. Treatment received was decongestant as loratadine (CLARITIN D) or guaifenesin pseudoephedrine hydrochloride (MUCINEX D) for phlegm and sinuses. Patient wants to know when and if she can get 2nd dose. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: also mentioned that he is feeling a little hot after getting the first dose and asking if he can Tylenol.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included regular medications like blood thinner and calcium. The patient was feeling a little hot after getting the first dose on 14Apr2021 and asking if he can Tylenol. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 19 year old daughter who received the 1st dose of Pfizer COVID vaccine and contracted COVID 5 days later; This is a spontaneous report from a contactable Physician via a medical information team.  A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via unspecified route of administration on unspecified date at single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Physician mentioned that her sister from another country who was also a Physician emailed Pfizer last week to inquire about her 19-year-old daughter who received the first dose of Pfizer COVID vaccine and contracted COVID-19 5 days later on an unspecified date. She says that she was scheduled to receive her second dose 90 days later due to this. She was asking if it was pertinent to wait those 90 days. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing on his ears; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Apr2021, patient experienced ringing on his ears and is still persistent up to now. Asking if that is common side effect or if it will go away eventually. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.