chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Heart palpitations; Tachycardia; shortness of breath; numbness in arms and body more on left side; eyelids very tired and droopy; chest pain; nausea; vomiting; diarrhoea; abdominal pain; cold sweats; drastic body temperature change; bottom lip swelling; headaches; lightheaded; cold hands and cold feet; flushing warmth in face; tingling sensation in hands and feet; increased blood pressure; Blood pressure decreased; foggy brain; memory lapses; blurry vision; This is a spontaneous report from a contactable other healthcare professional. A 28-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jan2021 17:45 (at the age of 28-years-old) (Batch/Lot Number: EL9262) as dose 2, single for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications included docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), multivitamin, vitamin d3 and vitamin c (ascorbic acid). Start and stop dates of all concomitant medications were not reported. There were no known allergies. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jan2021 17:45 (Batch/Lot Number: EL1283) for covid-19 immunisation. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. On 29Jan2021 19:30, the patient experienced heart palpitations, tachycardia, shortness of breath, numbness in arms and body more on left side, eyelids very tired and droopy, chest pain, nausea, vomiting, diarrhoea, abdominal pain, cold sweats, drastic body temperature change, bottom lip swelling, headaches, lightheaded, cold hands and cold feet, flushing warmth in face, tingling sensation in hands and feet, increased blood pressure, blood pressure decreased, foggy brain, memory lapses and blurry vision. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Laboratory tests on an unspecified date included: blood pressure was increased, blood pressure was decreased, body temperature showed drastic body temperature change and on 20Feb2021 sars-cov-1 test was negative (nasal swab). The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: 2 hours after the shot I started having heart palpitations; pins and needles feeling in the back of my heart and down my neck; This is a spontaneous report from a contactable consumer (patient) or other non healthcare professional.   A 55 year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199, Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 12:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Breast Cancer remission from an unknown date and unknown if ongoing Breast Cancer remission. Concomitant medication(s) included tocopherol (VITAMIN E [TOCOPHEROL]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug hypersensitivity. patient did not had covid prior or post to the vaccination. patient did nor received any other vaccine four weeks prior to vaccination. On 03Mar2021 14:30 2 hours after the first dose she started having heart palpitations, pins and needles feeling in the back of my heart and down the neck. Adverse Event resulted in patient visited emergency room, department or urgent care. The patient received treatment with Benadryl via an IV. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Neuralgia
Clinical narrative: right hand unworkable; Nerve pain in opposite arm, near wrist; Sudden onset of electrical-like pain near the right wrist; This is a spontaneous report from a contactable consumer. A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:15 (age at vaccination 50 years) as dose 1, single for covid-19 immunisation. Medical history included lyme disease from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.  On 18Feb2021 22:00 the patient experienced right hand unworkable, nerve pain in opposite arm, near wrist, sudden onset of electrical-like pain near the right wrist. Patient did not receive any treatment for reported event. The outcome of event was not recovered. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received unknown dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. No patient identifiers were provided but the reporter had firsthand knowledge of the patient and was reporting on a specific patient. Reporter stated a patient that had the covid-19 vaccine and experienced heart palpitations, caller stated that patient did not have the vaccine at their clinic, caller stated they called the patient about the paperwork from Pfizer and now they received another letter. The outcome of the event was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Pain, Palpitations, Swelling face
Clinical narrative: knot to her right eyebrow, that is almost a little off center, above her nasal passage even with her eyebrow,; burning in both elbows; very bad pain, it hurts, she felts it; heart started thumping very hard and fast; Headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 08Mar2021 at 15:15 (at the age of 62-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history included asthma diagnosed probably three years ago and was prescribed with an inhaler that she hasn't used in a week and a nebulizer that she hasn't used in 3 months. Patient previously took Zyrtec and Mucinex almost every day, for cedar fever, but she has not taken this prior to the Pfizer shot. Patient did not have any other recent vaccinations or started any new concomitant medications. On 08Mar2021 at 15:20, 5 minutes after the shot, the patient experienced side effects which began with a headache. Patient still has the headache. On 08Mar2021 at 21:00, 5 hours and 45 minutes after the first dose, the patient's heart started thumping very hard and fast, which lasted until about 03:00AM at 09Mar2021 morning. Her heart was pumped so hard that she felt like her heart was at her fingertips. Patient felt better as of 05:00 AM at 09Mar2021. On 09Mar2021, morning at about 09:00AM, the patient got a knot to her right eyebrow, that was almost a little off center. It was above her nasal passage even with her eye brow, and it doesn't hurt like she was hit with a baseball. It was not a hive, but was swollen and felt a bump on her head. On 09Mar2021 at about 03:00AM, the patient woke up and had very bad pain and burning in both elbows that subsided when she was up and moving her arms, which she has never had before. Patient received no treatment, until probably at 08:00AM on 09Mar2021. Then she finally took Tylenol (Lot number: LHA041 and expiration date: May2021) 325mg two at once. Patient didn't want to take too many Tylenol because people told her it takes away from working of vaccine. Patient was going to take two more Tylenol and put an ice pack on her eyeball because it was hurting so much. The clinical outcome of the events heart started thumping very hard and fast; and pain was resolving. The clinical outcome of all other events was not resolved.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer. This 44-year-male consumer reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: EN9581), via unspecified route in Left Arm on 24Feb2021 04:00, as single dose for COVID-19 immunization ((age at time of vaccination 44 years). The patient medical history included Sinus arrhythmia. The patient concomitant medications included Omeprazole. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. On 25Feb2021 the patient started having heart palpitations. Just one or two in the evening on day 1. Much more on day 2. Then randomly for a few days. More regular on day 8. Today is a mixed bag. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: chest palpitations; This is a spontaneous report from a contactable reporter. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer (Patient's wife) reported for a 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in left arm on 26Feb2021 at 13:00 (at the age of 73 years) as dose 1, single for covid-19 immunisation. No details regarding products, patient history and investigation assessment. Declined to provide concomitant medications. The vaccination received at pharmacy/drug store type facility. The patient took Covid-19 vaccine for Covid protection. On 26Feb2021, the patient got chest palpitations but his were much more milder compare to his wife and only lasted a few hours (lasted for 4-5 hours). It was reported that he had palpitations and his went away and didn't come back on same day. Reporter and her husband didn't talk about the palpitations. It was mentioned later that night. Event did not require emergency room or physician office visit. The outcome of the event was recovered on 26Feb2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021252324 same reporter/drug/AE, different patient
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Palpitations
Clinical narrative: Heart Palpitations; headaches; severe body aches; tiredness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6203, Expiration date not reported), via an unspecified route of administration, administered in the right arm, on 03Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunisation at Health Clinic. Medical history included supra ventricular tachycardia's heart, epstein barr, obesity, high bp, hypothyroid, stomach issues with indigestion from an unknown date and unknown if ongoing. The patient received other unspecified medications with 2 weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9269, Expiration date not reported), via an unspecified route of administration, administered in the right arm, on 10Feb2021 at 11:30 (at the age of 62-year-old), as single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced allergy. No other vaccine received within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 (reported as: 2 days after 2nd dose), the patient experienced heart palpitations, headaches, severe body aches and tiredness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The outcome of all events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EN6208 and expiry date: not reported), via an unspecified route of administration in left arm on 10Mar2021 at 11:00 (at the age of 25-year-old) as Dose 1, Single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took sulpha drug and experienced allergy. On 10Mar2021 at 12:00, patient experienced heart palpitations. Patient did not receive any treatment in response to the event. Outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Myalgia
Clinical narrative: looks like a balloon on her elbow; She has light muscle pain in the left arm on the same arm that you received the vaccine in; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm on 10Mar2021 scheduled at 11:00 and got it 3 hours later (70-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, blood pressure, spine stimulator and cholesterol from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for an unspecified indication, Olmesartan taken for blood pressure, Ezetimibe taken for an unspecified indication start and stop date were not reported. Historical vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in Arm on 09Feb2021 (Batch/Lot Number: EN6210) as DOSE 1, SINGLE for covid-19 immunisation. Patient reported side effect to # earlier today. She received her first Pfizer Covid vaccine dose on 8Feb2021 and her second dose on 10Mar202. After the first dose she did not experience any side effects but after her second dose she experienced pain in her left arm (injection arm) and 3 hours ago today (12Mar2021) she stated, I suddenly see something on my elbow which looks like a soft tennis ball - reddish/pink - not painful, it looks like it is filled with water. Patient stated that the balloon on her elbow was about two inches in diameter and it looks like a little ball. The patient put ice on it hoping it would go away. The patient noticed it 2.5 hours before calling Pfizer. On 10 Mar2021, she had light muscle pain in the left arm on the same arm that received the vaccine in, wanted to know if this was normal. She was worried about this side effect and wants to know what to do. She was scheduled for a hip replacement on 15Mar2021 and was worried she would not be able to get the surgery if they see she had this bump on her elbow. She stated she had her thyroid removed in 2014 and takes levothyroxine. She mentioned that her husband had cold like symptoms after getting the vaccine. The clinical outcome of the event She has light muscle pain in the left arm on the same arm that you received the vaccine in was recovering and looks like a balloon on her elbow was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Heart rate went up/Fast heart beat with palpations; Heart rate went up/Fast heart beat with palpations; sudden rush of heat in chest; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.;Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 at 16:00 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure from an unknown date. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Allergies to medications, food, or other products reported as no. Concomitant medication(s) included metoprolol (METOPROLOL) taken for hypertension, magnesium oxide (MAGNESIUM OXIDE), amlodipine (AMLODINE [AMLODIPINE]), valsartan (VALSARTAN) and hydrochlorothiazide (HTZ) received within 2 weeks of vaccination. The patient experienced heart rate went up/fast heart beat with palpations and sudden rush of heat in chest on 19Feb2021 at 16:00. Facility where the most recent COVID-19 vaccine administered was other. It was reported that, almost 3 weeks now but when patient first took the vaccine patient had rush of warp to you know patient upper body (incomplete sentence), patient heart rate went up significantly and actually patient still having problems with that, with heart rate so, they have called patient for that second vaccine but patient was skeptical about taking it because of the reaction that it did, so in expert opinion should patient take the second dose. Outcome of event patient do not know because, patient do have high blood pressure (Clarified as medical history) too, so patient guess it is same. (Patient was unsure, hence not outcome was left unchecked). No treatment received for the events. The patient underwent lab tests and procedures which included heart rate: increased on 19Feb2021. The outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma exercise induced, Autopsy, Chest pain, Dyspnoea, Pulmonary thrombosis
Clinical narrative: blood clot in her lungs; shortness of breath; chest pain; exertion when walking; This is a spontaneous report from a contactable consumer, based on information received by Pfizer  (manufacturer control number: (Not provided)), for bnt162b2 (CO-MIRNATY). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 03Mar2021 (age at vaccination 51years old) as single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing, malaise from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced blood clot in her lungs on Mar2021, shortness of breath, chest pain on an unspecified, exertion when walking on an unspecified date. The patient had a very large bilateral blood clot in her lungs. She underwent urgent thrombectomy procedure shortly after admission and recovered. Most, but not all, of the clot was successfully re-moved. The doctor told her that she was very lucky to be alive as they usually only see blood clots that big on autopsy. It was imagined they would have performed a SARS-CoV test, but I am not sure of the results. I will try to find out more. Her symptoms were shortness of breath, chest pain, and exertion when walking. reporter was not sure if she is on any cc meds or what anticoagulant therapy she was placed on. If I can find out the name of the treating physician. I will pass that along as well so your company can contact them directly. The patient was scheduled to remain in the hospital for the next 3-4 days. The patient was hospitalized for blood clot in her lungs from unspecified date in Mar2021 and patient was discharged from the hospital on 18Mar2021. The patient underwent lab tests and procedures which included autopsy: blood clots on Mar2021 blood clots that big on, sars-cov-1 test: unknown on Mar2021 and not sure of the results, thrombectomy: blood clots on Mar2021 clot was successfully removed. The clinical outcome of the event blood clot in her lungs was recovered in March2021 and other events was unknown. Therapeutic measures were taken as a result of blood clot in her lungs.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Thrombectomy
Clinical narrative: blood clot in her lungs; shortness of breath; chest pain; exertion when walking; This is a spontaneous report from a contactable consumer, based on information received by Pfizer  (manufacturer control number: (Not provided)), for bnt162b2 (CO-MIRNATY). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 03Mar2021 (age at vaccination 51years old) as single dose for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing, malaise from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced blood clot in her lungs on Mar2021, shortness of breath, chest pain on an unspecified, exertion when walking on an unspecified date. The patient had a very large bilateral blood clot in her lungs. She underwent urgent thrombectomy procedure shortly after admission and recovered. Most, but not all, of the clot was successfully re-moved. The doctor told her that she was very lucky to be alive as they usually only see blood clots that big on autopsy. It was imagined they would have performed a SARS-CoV test, but I am not sure of the results. I will try to find out more. Her symptoms were shortness of breath, chest pain, and exertion when walking. reporter was not sure if she is on any cc meds or what anticoagulant therapy she was placed on. If I can find out the name of the treating physician. I will pass that along as well so your company can contact them directly. The patient was scheduled to remain in the hospital for the next 3-4 days. The patient was hospitalized for blood clot in her lungs from unspecified date in Mar2021 and patient was discharged from the hospital on 18Mar2021. The patient underwent lab tests and procedures which included autopsy: blood clots on Mar2021 blood clots that big on, sars-cov-1 test: unknown on Mar2021 and not sure of the results, thrombectomy: blood clots on Mar2021 clot was successfully removed. The clinical outcome of the event blood clot in her lungs was recovered in March2021 and other events was unknown. Therapeutic measures were taken as a result of blood clot in her lungs.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Palpitations
Clinical narrative: Caller says he is not taking the next dose; Heart racing; This is a spontaneous report from a contactable consumer (patient himself). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left (at age of 62-years-old) on 15Mar2021 11:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included olmesartan taken for blood pressure measurement, clopidogrel taken for blood viscosity increased, acetylsalicylic acid (ASPIRIN (E.C.)) taken for blood viscosity increased, start and stop date were not reported. Patient's Medical History (including any illness at time of vaccination) was not reported. Patient did not have family History. Patient did not have prior Vaccinations (within 4 weeks). There was no any history of all previous immunization with the Pfizer vaccine considered as suspect was reported. It was reported that, the consumer calling regarding the Pfizer COVID 19 shot. He got the shot yesterday and last night it had his heart racing and he did not think he can get the next shot. Clarified he received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021 at 11:45 AM in the left arm. On same day at the night when he laid down at 10:00 PM he noticed his heart racing and it lasted at least three hours. He didn't go to sleep until about 04:00 AM. Stated that, he asked the nurse at the vaccination clinic since he has a stent would it be okay, and she said yes but he didn't look at the paper because it said you could have heart racing. Reports today he was fine and has recovered but added he did not know if it will race again when he lays down. Confirmed that, he was scheduled to receive the next dose on 06Apr2021. The adverse events did not require emrgency room visit or physician office visit. There was not any relevant test. The outcome of heart racing was resolved on 16Mar2021 while it was unknown for event caller says he is not taking the next dose.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A 43-years-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0140), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:45 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included migraine headaches. The patient had no known allergies. The patient's concomitant medication included botulinum toxin type a (BOTOX), sertraline hydrochloride (ZOLOFT), zolmitriptan (ZOMIG), montelukast sodium (SINGULAIR), magnesium and ribof. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination and post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), dose 1 via an unspecified route of administration, administered in Arm Left on 30Dec2020 11:45 (at the age of 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 02Feb2021 at 04:00 PM, the patient experienced heart palpitations that started after the second injection and have not subsided. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive the treatment for the adverse event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart racing; hard time breathing; This is a spontaneous report from a contactable consumer(patient). A 91-year-old female patient received BNT162B2  (FIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. Medical history included blood cholesterol, lung disorder and thyroid disorder from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing she has atrial fibrillation predating treatment with the Pfizer COVID 19 vaccine. Concomitant medication(s) included prednisone taken for lung disorder and lovastatin taken for blood cholesterol from an unspecified start date and ongoing. On 15Mar2021 at 02:00, The patient experienced heart racing, hard time breathing. she was having terrible side effects from her second shot. She can't stand it. Her heart was  racing. Clarified she received the first dose of the Pfizer COVID 19 vaccine three weeks ago from this past Saturday. And then received the second dose of the Pfizer COVID 19 vaccine on this past Saturday. Adds she was alright Sunday but then at 02:00AM she woke up with her heart racing and having a hard time breathing. Mentions she had atrial fibrillation predating treatment with the Pfizer COVID 19 vaccine. She took some pills this morning that she had for atrial fibrillation to slow her heart rate down but last time she checked it was still 150 beats per minute. The medication she took to slow her heart down were Metoprolol 25mg, caller does not see NDC, lot or expiration date on product dispensed in a pharmacy vial from (pharmacy name). This morning she took one half then took another one half and another one half trying to bring it down. Caller is breathless when she tries to speak and confirms she is not feeling well. States she waited two hours to ask what to do? Strongly advised caller to contact her HCP or go to the emergency room for her symptoms. The outcome of the events were not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Neutrophil count decreased, Paraesthesia, Vaccination site mass, Vaccination site pain
Clinical narrative: big bump on the injection site; scalp area has tingling sensation; white blood cells and neutrophils are low/white blood cells was low; white blood cells and neutrophils are low/absolute neutrophils was low; big knot at injection site and sore to touch; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via intramuscular, administered in Arm Left on 14Mar2021 16:00 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203), via intramuscular, administered in Arm Left on 21Feb2021 around 17:00 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. Medical history included uterine leiomyosarcoma from Jun2020 and ongoing, ongoing seasonal allergy, ongoing food allergy diagnosed within past 5 years with seed allergies like soy and sesame, chemotherapy from Jul2020 to Oct2020 From Jul to Oct 2020, she had a different round of chemo. She finished that chemo in October. Concomitant medications included adriamycin [doxorubicin] taken for an unspecified indication from 26Feb2021 and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had flu shot back in Nov2020, she did not had a problem with it and never had a problem with the flu shot. On 18Mar2021, the patient experienced big bump on the injection site, scalp area has tingling sensation. On an unspecified date in Mar2021, patient experienced white blood cells and neutrophils are low, big knot at injection site and sore to touch. The patient underwent lab tests and procedures which included blood test: low on 16Mar2021 her was white blood cells was low and her  absolute neutrophils was low, basically not there, blood test: improved on 17Mar2021 improved, going in the right direction. The events did not result in emergency room/physician office visit. The outcome of the events white blood cells and neutrophils are low were recovering while the outcome of other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: big bump on the injection site; scalp area has tingling sensation; white blood cells and neutrophils are low/white blood cells was low; white blood cells and neutrophils are low/absolute neutrophils was low; big knot at injection site and sore to touch; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via intramuscular, administered in Arm Left on 14Mar2021 16:00 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203), via intramuscular, administered in Arm Left on 21Feb2021 around 17:00 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. Medical history included uterine leiomyosarcoma from Jun2020 and ongoing, ongoing seasonal allergy, ongoing food allergy diagnosed within past 5 years with seed allergies like soy and sesame, chemotherapy from Jul2020 to Oct2020 From Jul to Oct 2020, she had a different round of chemo. She finished that chemo in October. Concomitant medications included adriamycin [doxorubicin] taken for an unspecified indication from 26Feb2021 and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had flu shot back in Nov2020, she did not had a problem with it and never had a problem with the flu shot. On 18Mar2021, the patient experienced big bump on the injection site, scalp area has tingling sensation. On an unspecified date in Mar2021, patient experienced white blood cells and neutrophils are low, big knot at injection site and sore to touch. The patient underwent lab tests and procedures which included blood test: low on 16Mar2021 her was white blood cells was low and her  absolute neutrophils was low, basically not there, blood test: improved on 17Mar2021 improved, going in the right direction. The events did not result in emergency room/physician office visit. The outcome of the events white blood cells and neutrophils are low were recovering while the outcome of other events were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling
Clinical narrative: Fatigue  Large bump at injection site after 7 days
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea (with stomach cramps preceding it) at 9:00 PM on 7/30/2021 and again at approximately 4:05 AM on 7/31/2021
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Paraesthesia
Clinical narrative: On 3/16/21: Sore left arm; body tingling (hard to describe); tired; This is a spontaneous report from a contactable consumer. This 45-year-old Female consumer (patient) reported for herself patient received second dose of BNT162B2 (Pfizer, Formulation: Solution for injection, Lot number: EL3247, Expiry date: unknown), via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 AM as dose 2, single for COVID-19 immunization. Patient historical vaccine included received second dose of BNT162B2 (Pfizer, Formulation: Solution for injection, Lot number: EL3247, Expiry date: unknown), via an unspecified route of administration in the left arm on 23Feb2021at 10:00 AM as dose 1, single for COVID-19 immunization. Patient medical history included pre-diabetes, glucose tolerance impaired. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient had no known allergies. patient was not tested for Covid post vaccination. Patient had not covid prior vaccination. On 16Mar2021 at 11:45 AM patient experienced sore left arm, body tingling (hard to describe), tired. Patient did not receive any treatment during or after event. The outcome of the event was recovered in Mar 2021.  Follow-up (22Mar2021) This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included that.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Fatigue, Hypoaesthesia
Clinical narrative: Arm injected in swelled from shoulder to fingers, tingling, numbness.; Intense joint aches and extreme fatigue; Arm injected in swelled from shoulder to fingers, tingling, numbness.; Arm injected in swelled from shoulder to fingers, tingling, numbness.; Lightheaded and short of breath all within 30 minutes.; Lightheaded and short of breath all within 30 minutes.; After an hour an a half a fever spiked; Intense joint aches and extreme fatigue.; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported)  via an unspecified route of administration on 26Mar2021 at 09:30 (at the age of 26-years-old, Non-pregnant) as dose 1, single for covid-19 immunisation. Medical history was none. The patient had no known allergies. There were no concomitant medications. Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Mar2021 at 10:00, the patient experienced arm injected in swelled from shoulder to fingers, tingling, numbness, intense joint aches and extreme fatigue, lightheaded and short of breath all within 30 minutes, after an hour and a half a fever spiked. Treatment was provided with Tylenol and antihistamine. Facility where the most recent COVID-19 vaccine was administered was a hospital. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovered on an unspecified day in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Arm injected in swelled from shoulder to fingers, tingling, numbness.; Intense joint aches and extreme fatigue; Arm injected in swelled from shoulder to fingers, tingling, numbness.; Arm injected in swelled from shoulder to fingers, tingling, numbness.; Lightheaded and short of breath all within 30 minutes.; Lightheaded and short of breath all within 30 minutes.; After an hour an a half a fever spiked; Intense joint aches and extreme fatigue.; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported)  via an unspecified route of administration on 26Mar2021 at 09:30 (at the age of 26-years-old, Non-pregnant) as dose 1, single for covid-19 immunisation. Medical history was none. The patient had no known allergies. There were no concomitant medications. Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. On 26Mar2021 at 10:00, the patient experienced arm injected in swelled from shoulder to fingers, tingling, numbness, intense joint aches and extreme fatigue, lightheaded and short of breath all within 30 minutes, after an hour and a half a fever spiked. Treatment was provided with Tylenol and antihistamine. Facility where the most recent COVID-19 vaccine was administered was a hospital. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovered on an unspecified day in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report from a contactable pharmacist reported on behalf of female nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced heart palpitations. While caller is reporting on her experience with the Pfizer COVID 19 vaccine, she says one of the nurses in the hospital said she had heart palpitations after it, she doesn't know if she can give out anything, they may want to contact them but those people may not want to get involved they just said that in conversation and she just thought it was strange that 3 people had the same problem, well one just said she had palpitations. She is not able to go through a report about those people, she does not even know which vaccine she is assuming it was Moderna or Pfizer, but she does not know she was just saying in general. She knew they would probably just call it hear say because she did not have the whole list of stuff. She does not know any information about the people, nor does she have and NDC lot expiration for the COVID 19 vaccine they received, she is not able to go through a report about their experience. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345867 same reporter/drug, different patient and event
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dizziness, Feeding disorder
Clinical narrative: Fever 100.2; extreme nausea; Dizzy; severe chills; muscle aches; chest pain; headache; vomiting every 4 hours; Have not been able to eat anything but crackers; This is a spontaneous report from a contactable consumer, the patient.   A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 08:30 (at the age of 22-years-old), as dose 2, single for COVID-19 immunisation. Medical history included asthma and patient was allergic to an unspecified substance (one known). Concomitant medication within 2 weeks of vaccination included Sertraline hydrochloride (Zoloft 50 MG manufacturer unknown), trazodone (50 MG, manufacturer unknown) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202 and expiration date was not reported), via an unspecified route of administration in the left leg (vaccine administered at inappropriate site) on 08Mar2021 at 14:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. On 29Mar2021 at 17:00, the patient had fever (100.2), extreme nausea, dizzy along with severe chills, muscle aches, chest pain and headache. On the same day, the patient had not been able to eat anything but crackers since lunch after the vaccination and had vomiting which began at midnight after the dose and ending around 11:00. Therapeutic measure taken as a result of the events experienced included ADVIL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, extreme nausea, vomiting, had not been able to eat anything, dizzy along with severe chills, muscle aches, chest pain and headache was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever 100.2; extreme nausea; Dizzy; severe chills; muscle aches; chest pain; headache; vomiting every 4 hours; Have not been able to eat anything but crackers; This is a spontaneous report from a contactable consumer, the patient.   A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 08:30 (at the age of 22-years-old), as dose 2, single for COVID-19 immunisation. Medical history included asthma and patient was allergic to an unspecified substance (one known). Concomitant medication within 2 weeks of vaccination included Sertraline hydrochloride (Zoloft 50 MG manufacturer unknown), trazodone (50 MG, manufacturer unknown) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202 and expiration date was not reported), via an unspecified route of administration in the left leg (vaccine administered at inappropriate site) on 08Mar2021 at 14:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. On 29Mar2021 at 17:00, the patient had fever (100.2), extreme nausea, dizzy along with severe chills, muscle aches, chest pain and headache. On the same day, the patient had not been able to eat anything but crackers since lunch after the vaccination and had vomiting which began at midnight after the dose and ending around 11:00. Therapeutic measure taken as a result of the events experienced included ADVIL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, extreme nausea, vomiting, had not been able to eat anything, dizzy along with severe chills, muscle aches, chest pain and headache was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.