chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity
Clinical narrative: taken Ibuprofen and done everything, she is ready to do something that call handler was not able to clarify, and  fight, and it is now cramping up; arm is really numb; arm is painful; This is a spontaneous report from a non-contactable consumer or other non-Health-care professional (Patient herself).   A female patient of an unspecified age received BNT162B2 (BNT162B2 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 was not reported.  The patients concomitant medications includes ibuprofen for Pain in arm on an unspecified date. Patient says she got the Pfizer shot on the 29th, and her arm is numb, it was really painful, she has taken Ibuprofen and done everything, she was ready to do something that call handler was not able to clarify, and fight, and it is now cramping up, so she was seeking recommendations on an unspecified date in Mar2021. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blister, Burning sensation, Feeling abnormal, Hypertension
Clinical narrative: having a bad reaction/ He is really miserable; red blotches/Got red blotches in arm; little blisters; Burning and sore; they are very uncomfortable; Burning and sore; they are very uncomfortable; Blood pressure high; Upset stomach; Throwing up; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced having a bad reaction/ he is really miserable, red blotches/got red blotches in arm, little blisters, burning and sore; they are very uncomfortable, blood pressure high, upset stomach, throwing up on an un-specified date. Additional context reported as Patient wife said my husband had his 2nd Covid shot on the 22Mar2021, my husband is having a bad reaction. He got red blotches down in his arm, it's a little blister on it, he did have red blotches. He got it and he is having really right now; he is really miserable. They are burning and sore, they are very uncomfortable, he got his blood pressure got high (high blood pressure). The patient received treatment for the adverse events. The clinical outcome of the events was unknown. Therapeutic measures were taken as a result of having a bad reaction/ he is really miserable, red blotches/got red blotches in arm, little blisters, burning and sore; they are very uncomfortable, blood pressure high, upset stomach, throwing up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash macular, Vomiting
Clinical narrative: having a bad reaction/ He is really miserable; red blotches/Got red blotches in arm; little blisters; Burning and sore; they are very uncomfortable; Burning and sore; they are very uncomfortable; Blood pressure high; Upset stomach; Throwing up; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced having a bad reaction/ he is really miserable, red blotches/got red blotches in arm, little blisters, burning and sore; they are very uncomfortable, blood pressure high, upset stomach, throwing up on an un-specified date. Additional context reported as Patient wife said my husband had his 2nd Covid shot on the 22Mar2021, my husband is having a bad reaction. He got red blotches down in his arm, it's a little blister on it, he did have red blotches. He got it and he is having really right now; he is really miserable. They are burning and sore, they are very uncomfortable, he got his blood pressure got high (high blood pressure). The patient received treatment for the adverse events. The clinical outcome of the events was unknown. Therapeutic measures were taken as a result of having a bad reaction/ he is really miserable, red blotches/got red blotches in arm, little blisters, burning and sore; they are very uncomfortable, blood pressure high, upset stomach, throwing up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Weak; Dizzy; Nauseous; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported for a female patient.  A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 (52-year-old at the time of vaccination) as Dose 1, single for covid-19 immunisation. Medical history included acquired absence of kidney, asthma, allergic rhinitis, disorder of brain, hypertension, hyperglycemia pruritus vulvae, type 2 diabetes mellitus unknown if ongoing. The patient pregnancy at the time of event  was reported as N/A. Concomitant medication(s) included axitinib (INLYTA, Batch/Lot number was not reported; Expiration Date: 31Jul2023), 5 mg, twice a day for mal neoplasm of rt kidney except renal pelvis 1 tab by mouth from 29Jan2021 to an unspecified date. rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported; medroxyprogesterone (MEDROXYPROGESTERONE) taken for contraception, start and stop date were not reported; diphenhydramine hydrochloride (BANOPHEN) taken for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; potassium chloride (KLOR-CON) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL SUCCINATE) taken for an unspecified indication, start and stop date were not reported; diltiazem (DILTIAZEM) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (MONTELUKAST SODIUM) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported; lidocaine hydrochloride (LIDOCAINE VISCOUS) taken for an unspecified indication, start and stop date were not reported; prochlorperazine (PROCHLORPERAZINE) taken for an unspecified indication, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin (AMOXICILLIN) and penicillin (PENICILLIN NOS) experienced allergy. On an unspecified date on Mar2021, the patient experienced nausea, weak and dizzy. The patient reported that she mentioned she took 1st dose of covid vaccine last weekend and notes she feels weak, dizzy and nauseous. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Malaise, Oropharyngeal pain, Secretion discharge, Sinus headache
Clinical narrative: Sinus infection; sore throat; ears that felt full; mucus drainage; pressure headache around the eyes and forehead; generally not feeling good; This is a spontaneous report from a contactable consumer (patient) via from a Pfizer sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Mar2021, patient began to have sinus infection, manifested by having a sore throat, ears that felt full, mucus drainage, pressure headache around the eyes and forehead, and generally not feeling good. Patient took antibiotics called Cefdinir 300mg twice a day for these symptoms. She reported that, 2nd vaccination was scheduled for tomorrow 01Apr2021. Patient wanted to know whether it is alright to push through her 2nd vaccination because she took antibiotics for her sinus infection. Therapeutic measures were taken as a result of events. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; sore throat; ears that felt full; mucus drainage; pressure headache around the eyes and forehead; generally not feeling good; This is a spontaneous report from a contactable consumer (patient) via from a Pfizer sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Mar2021, patient began to have sinus infection, manifested by having a sore throat, ears that felt full, mucus drainage, pressure headache around the eyes and forehead, and generally not feeling good. Patient took antibiotics called Cefdinir 300mg twice a day for these symptoms. She reported that, 2nd vaccination was scheduled for tomorrow 01Apr2021. Patient wanted to know whether it is alright to push through her 2nd vaccination because she took antibiotics for her sinus infection. Therapeutic measures were taken as a result of events. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Heart rate increased, Investigation
Clinical narrative: Dizzy; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration in left arm on 10Mar2021, as dose 1, single for COVID-19 immunization (age at vaccination: 67 years) and LISINOPRIL (LISINOPRIL, route of administration, lot number and expiry date was not reported) on an unspecified date for high blood pressure (hypertension) once a day (it is 20/12.5). Medical history included high blood pressure. Concomitant medications were not reported. The patient experienced dizzy and rapid heartbeat on an unspecified date in 2021. The patient stated the concern that she took this 1st vaccine like 3 weeks ago and scheduled to get another one Thursday 01Apr2021. She was wondering that one point she had like dizzy, rapid heartbeat. She did not know that she used to take the blood pressure medicine when you do it, she takes it in the morning, but then she took it the other day, she did not know if it was the blood pressure medicine or not. Two or three days after she get the rapid heartbeat and dizziness. She got the dizziness when she first got it, so all of those typical symptoms and she wanted to know if it was the typical symptom. Therapeutic measures were taken as a result of event dizzy. The patient stated that she did lab test recently may be in January, but she did not know, and her doctor has all the information. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Tenderness
Clinical narrative: Patient states after she got the Pfizer Covid vaccine first dose, she felt some tenderness in her hands; She has been very tired; Sleeping more from it; This is a spontaneous report from a contactable physician. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (46-year-old) as a single dose for COVID-19 immunisation. Medical history included long qt syndrome (reported as I45.81). It was unknown if the patient had known allergies to medications, food or other products. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included diclofenamide (KEVEYIS) taken for unspecified indication, from an unknown date and unknown if ongoing. It was unknown if the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in Mar2021 after first dose of vaccination, the patient stated, she felt some tenderness in her hands and she had been very tired and sleeping more from it. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was unknown since the vaccination, if the patient had been tested for COVID-19. It was unknown if therapeutic measures were taken as a result of the reported events. The clinical outcome of the events she felt some tenderness in her hands, she had been very tired and sleeping more from it was unknown at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: her arm just about fell off/could not lift her right arm/still hurts; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Lot number was not reported) at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported, after she retired, she took the Pneumonia Vaccine and her arm just about fell off.  Within an hour, she could not lift her right arm. It still hurts to this day. It has been at least 9-10 years. Outcome of the event was unknown.  No follow-up attempts are needed; information on the batch/lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: suspect drug was recoded to generic pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) since it was unspecified if it was Pfizer/non-Pfizer product. Case upgraded to valid.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Fillers were nodular and hard; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injec-tion, Batch/Lot number: not reported)), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. botulinum toxin type a (BOTOX), route of administration, start and stop date, batch/lot number and dose were not reported for an un-specified indication. The patient medical history was not reported. The concomitant medication(s) include voluma in cheek on 25Jun2020 of last year no fillers since that date, volbella in different area V15LA80728 EXP Sep2020 treatment was in June 2020 did not use fillers when AE happened patient saw last week. The patient experienced fillers were nodular and hard. botox has voluma in cheek (25Jun2020 of last year no fillers since that date) last week was supposed to have another procedure that is when nodukar was seen and said she had vaccine 2 weeks told her Pfizer they did not do Botox no info on that last week Mar2021no labs no meds no previous surgerys Voluma lot VB20B00020 Expiration Jun2021 did volbella in different area V15LA80728 EXP Sep2020 treatment was in June 2020 did not use fillers when AE happened patient saw last week coming in for botox she had filler in the check when she came in it was very nodular and hard had covid vaccine 2weeks prior.The action taken in response to the event(s) for botulinum toxin type a was un-known. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Headache, Neuralgia, Pain in extremity
Clinical narrative: exacerbation of MS nerve pain; exacerbation of MS nerve pain; Headache; fever; chills; injection site pain; arm soreness; itching; rash; This is a spontaneous report from a non-contactable consumer (patient).  A 37-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (at the age of 37-year-old), as Dose 2, Single for COVID-19 immunization. Medical history included multiple sclerosis (ms) on an unknown date. Concomitant medication included gabapentin and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: EN6205), dose1 at arm left on 12Mar2021,16:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19, Prior to vaccination and since the vaccination. No allergies to medications, food, or other products. On 03Apr2021 10:30, the patient experienced exacerbation of MS nerve pain, headache, fever, chills, injection site pain, arm soreness, itching, rash. The events were not treated. The outcome of all the events was Recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Vaccination site pain
Clinical narrative: exacerbation of MS nerve pain; exacerbation of MS nerve pain; Headache; fever; chills; injection site pain; arm soreness; itching; rash; This is a spontaneous report from a non-contactable consumer (patient).  A 37-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (at the age of 37-year-old), as Dose 2, Single for COVID-19 immunization. Medical history included multiple sclerosis (ms) on an unknown date. Concomitant medication included gabapentin and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: EN6205), dose1 at arm left on 12Mar2021,16:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19, Prior to vaccination and since the vaccination. No allergies to medications, food, or other products. On 03Apr2021 10:30, the patient experienced exacerbation of MS nerve pain, headache, fever, chills, injection site pain, arm soreness, itching, rash. The events were not treated. The outcome of all the events was Recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Weight decreased
Clinical narrative: Loss of appetite; weight loss; weariness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Er5218), via an unspecified route of administration, administered in left arm on 25Jan2021 (at the age of 78-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history includes asthma, hip replacement, arthritis and high cholesterol from an unknown dare and unknown if ongoing. The patient previously took clindamycin and experienced known drug allergies. Concomitant medications included ibuprofen 400 mg (MOTRIN [IBUPROFEN]), simvastatin 20 mg (SIMVASTATIN) and vitamin D NOS (VITAMIN D NOS) all were from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021, the patient experienced loss of appetite, weight loss and weariness. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events and the treating medication was ferrous sulfate 325 mg twice daily. The clinical outcome of the events loss of appetite, weight loss and weariness were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: 3 days after the shot I woke up in the morning and the left side of my face was all swollen.; This is a spontaneous report from a contactable consumer. A 44-years-old non-pregnant female patient received bnt162b2 (BNT162B2,Formulation:Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:15 (at the age of 44-year-old) as Dose 1, Single for covid-19 immunization. Medical history included allergy. It was reported that patient was not received any vaccine in four weeks and had other medications in two weeks. The patient had not covid prior vaccination nor tested post vaccination. On 27Mar2021 (at 06:00), the patient experienced 3 days after the shot i woke up in the morning and the left side of my face was all swollen. The patient received steroids and  antibiotics in a shot and pills as treatment for the events. On an unspecified date in Apr2021,the patient had recovered from the event.   No follow-up attempts were needed. No further information was expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Pain, Pyrexia
Clinical narrative: I was hit hard by chills; Fever; Extreme shivering; Hot flashes; I was achy; I was achy with a pounding headache; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: ER8729 and expiry date was not reported), via an unspecified route of administration in the left arm, on 02Apr2021 at 10:00 (at the age of 34-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included known allergies to penicillin and sulfas from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EN6208 and expiry date was not reported), via an unspecified route of administration in the left arm, on an unspecified date in Mar2021 (at the age of 34-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced tingly, felt overcaffeinated, was extremely thirsty. On 02Apr2021 at 20:00 PM, after about 10 hours of vaccination, the patient was hit hard by chills, fever, extreme shivering and hot flashes. The patient was achy with a pounding headache. Symptoms dissipated after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the events were recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Blood pressure measurement, Fatigue, Pain, Pain in extremity, Scan
Clinical narrative: fatigue, tiredness; achy; sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) based on information received by Pfizer (manufacturer control number: EC-2020-085416), for bnt162b2. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via intramuscular on 26Mar2021 (Batch/Lot number was not reported) as dose 2, single, first dose via intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; lenvatinib mesilate (LENVIMA), oral from 12Dec2020 (Batch/Lot number was not reported) and ongoing, at 18 mg for renal cell carcinoma; everolimus (EVEROLIMUS), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 5 mg daily for renal cell carcinoma. Medical history included ongoing blood pressure measurement (per patient this was present prior to start of therapy and is unchanged since starting Lenvima), MD aware, diarrhoea from an unknown date and unknown if ongoing uncontrollable diarrhea, dehydration from an unknown date and unknown if ongoing period of dehydration. The patient's concomitant medications were not reported. The patient experienced fatigue, tiredness, achy, sore arm on an unspecified date. It was reported that, patient reported that a couple of weeks ago there was a "handful of days" that patient was experiencing "uncontrollable diarrhea" which led to a period of dehydration. Patient stated that he stopped Lenvima for two days and the aforementioned side effects resolved. MD not aware. Patient reported that after start of therapy he had both his Covid-19 vaccines and stated after the vaccines he experienced fatigue, tiredness and was achy (these symptoms have resolved). As per patient, he was currently experiencing a sore arm, but he had his second COVID-19 vaccine on 03/26/2021 and the soreness was starting to improve. Unknown if MD aware. Patient stated scans done on an unspecified date in March 2021 showed "remarkable" results with the Lenvima improving his cancer. MD aware. The patient underwent lab tests and procedures which included blood pressure measurement: high. The action taken in response to the events for lenvatinib mesilate was dose not changed. The outcome of the events fatigue, tiredness, achy was reported as recovered on an unspecified date and outcome of event sore arm was reported as resolving.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Dysphonia, Feeling abnormal
Clinical narrative: awful; hoarseness; This is a spontaneous report received from a contactable consumer (patient), based on information received by Pfizer. (manufacturer control number: EC-2021-090533) for BNT162B2.   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization; lenvatinib mesylate (LENVIMA, lot number: not reported) via an unspecified route of administration on 26Mar2021 at 20 mg and pembrolizumab (KEYTRUDA) via an unspecified route of administration on an unspecified date at an unspecified dose both for an unspecified indication. Medical history included C54.1 endometrial cancer. Concomitant medications were not reported. Patient previously took fluoxetine. She stated that she got her first COVID shot (unsure which one) and her first Keytruda infusion as well. She felt "awful" for a day or two after all three were on board but feels much better today. Patient also reported hoarseness. Outcome of events was unknown.   Lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac stress test, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; Dizzy; didn't feel good; has problems with his heart; lungs he has problems; Tiredness; arm soreness; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6207, Expiry Date: UNKNOWN), via an unspecified route of administration, administered in left arm on 17Mar2021 03:00 as dose 1, single (at the age of 53-years-old) for COVID-19 immunization. Medical history included lung carcinoma cell type unspecified stage IV from Mar2018 as Verbatim: Lung cancer stage IV, cancer surgery from 31May2018 to an unknown date Verbatim: lung cancer surgery, neoplasm as have a small tumor on his bladder the size of a BB, prostate(Prostate infection). Concomitant medication(s) included alfuzosin hydrochloride (10mg once a day by mouth), taken for prostate infection from 12Feb2021. On an unspecified date of Mar2021 the patient experienced tiredness and arm soreness. On an unspecified date the patient experienced shortness of breath, dizzy, didn't feel good, has problems with his heart. Reporter stated after his first shot the first couple days he had soreness and was tired, and now he has other different things going on. He says he ws not gonna get second shot, he doesn't need any more health problems, he just wants to make sure this is what is causing those. Now they think he has problems with his heart, he is also having more problems breathing than he was before with the cancer, which he has had 3 years. He says he never had these problems before he got the shot. Reporter stated a week after that, those wore off, and he felt kinda dizzy, he didn't feel good, he had shortness of breath. The patient underwent lab tests and procedures which included stress test (Cardiac stress test): fine on 05Mar2021 did a stress test on 05Mar, and it was fine. Other Medical Conditions mentioned as he might have a small tumor on his bladder the size of a BB, and now they think he has heart problems also. Investigations mentioned as his stress test came back fine, but his heart and lungs he has problems now he doesn't know if it is related to the vaccine but that is why he doesn't want to get a second dose. Reporter stated he started a medication for his prostate a month and a half ago, but he didn't have any side effects before getting the Pfizer COVID-19 vaccine. The outcome of event tiredness and arm soreness was recovered on an unspecified date. The outcome of rest all events was unknown  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Malaise, Pain in extremity
Clinical narrative: Shortness of breath; Dizzy; didn't feel good; has problems with his heart; lungs he has problems; Tiredness; arm soreness; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6207, Expiry Date: UNKNOWN), via an unspecified route of administration, administered in left arm on 17Mar2021 03:00 as dose 1, single (at the age of 53-years-old) for COVID-19 immunization. Medical history included lung carcinoma cell type unspecified stage IV from Mar2018 as Verbatim: Lung cancer stage IV, cancer surgery from 31May2018 to an unknown date Verbatim: lung cancer surgery, neoplasm as have a small tumor on his bladder the size of a BB, prostate(Prostate infection). Concomitant medication(s) included alfuzosin hydrochloride (10mg once a day by mouth), taken for prostate infection from 12Feb2021. On an unspecified date of Mar2021 the patient experienced tiredness and arm soreness. On an unspecified date the patient experienced shortness of breath, dizzy, didn't feel good, has problems with his heart. Reporter stated after his first shot the first couple days he had soreness and was tired, and now he has other different things going on. He says he ws not gonna get second shot, he doesn't need any more health problems, he just wants to make sure this is what is causing those. Now they think he has problems with his heart, he is also having more problems breathing than he was before with the cancer, which he has had 3 years. He says he never had these problems before he got the shot. Reporter stated a week after that, those wore off, and he felt kinda dizzy, he didn't feel good, he had shortness of breath. The patient underwent lab tests and procedures which included stress test (Cardiac stress test): fine on 05Mar2021 did a stress test on 05Mar, and it was fine. Other Medical Conditions mentioned as he might have a small tumor on his bladder the size of a BB, and now they think he has heart problems also. Investigations mentioned as his stress test came back fine, but his heart and lungs he has problems now he doesn't know if it is related to the vaccine but that is why he doesn't want to get a second dose. Reporter stated he started a medication for his prostate a month and a half ago, but he didn't have any side effects before getting the Pfizer COVID-19 vaccine. The outcome of event tiredness and arm soreness was recovered on an unspecified date. The outcome of rest all events was unknown  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness
Clinical narrative: dizzy; chills; joint pain; This is a spontaneous report from a Contactable Consumer. This consumer reporter This consumer reporter for a Unknown male: The Unknown male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced chills, joint pain, and was feeling dizzy. The consumer asked if these were normal side effects of the vaccine. The event outcome was unknown. The consumer asked if patient could take motrin for pain.  No follow-up attempts were possible; Information about lot/batch number could not be obtained
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: redness and a rash on the left arm; redness and a rash on the left arm; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EN6206), dose1, single at Arm Left on 10Mar2021 08:00 and 2nd dose (BNT162B2, Solution for injection, lot number ER8730) on 31Mar2021 08:00 in left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included famotidine and ethinylestradiol, norethisterone acetate (LOESTRIN). Prior to vaccination, the patient was not diagnosed with COVID-19. After 1st dose, patient developed redness and a rash on the left arm that was injected 10 days after vaccine (onset date 18Mar2021 08:00 PM) and it lasted 1 day. After 2nd vaccine, patient developed redness and a rash on the left arm that was injected 1 day after vaccine and it lasted 4 days. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event Since the vaccination, the patient had not been tested for COVID-19. At the time of report, outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Pain, Palpitations
Clinical narrative: My face got tight; Got very hot; Sharp pain down spine; Hard to breath; Racing heart lasting about 3-4 minutes; pain throughout the body; teeth chattering chills (over 2 hours); This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration in the left arm on 04Mar2021 at 11:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis on an unknown date. The patient did not have any allergies to food, medications or other products. Concomitant medications included glatiramer acetate (COPAXONE) at a dose of 40 mg from an unknown date for an unknown indication, other items not listed due 2 space. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 19:30 the patient experienced face got tight, got very hot, sharp pain down spine, hard to breath, racing heart lasting about 3-4 minutes, pain throughout the body and teeth chattering chills (over 2 hours). The events were right after giving copaxone shot (over 24 hours from COVID). The patient did contact MS doctor but they felt it was a blood vessel. No therapeutic measures were taken as a result of reported events. 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 face got tight, got very hot, sharp pain down spine, hard to breath, racing heart lasting about 3-4 minutes, pain throughout the body and teeth chattering chills (over 2 hours) was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Reduced facial expression, Spinal pain
Clinical narrative: My face got tight; Got very hot; Sharp pain down spine; Hard to breath; Racing heart lasting about 3-4 minutes; pain throughout the body; teeth chattering chills (over 2 hours); This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration in the left arm on 04Mar2021 at 11:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis on an unknown date. The patient did not have any allergies to food, medications or other products. Concomitant medications included glatiramer acetate (COPAXONE) at a dose of 40 mg from an unknown date for an unknown indication, other items not listed due 2 space. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 19:30 the patient experienced face got tight, got very hot, sharp pain down spine, hard to breath, racing heart lasting about 3-4 minutes, pain throughout the body and teeth chattering chills (over 2 hours). The events were right after giving copaxone shot (over 24 hours from COVID). The patient did contact MS doctor but they felt it was a blood vessel. No therapeutic measures were taken as a result of reported events. 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 face got tight, got very hot, sharp pain down spine, hard to breath, racing heart lasting about 3-4 minutes, pain throughout the body and teeth chattering chills (over 2 hours) was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pyrexia, Rash, Urticaria
Clinical narrative: fever; red eyes like conjunctivitis; rash on her body, rash on both arms; hives from her head to toe; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 2, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, started 8 days after 2nd dose, the patient experienced fever, red eyes like conjunctivitis, rash on her body, rash on both arms and hives from her head to toe. It was reported that rash lasted several days and fever lasted 1 week. The outcome of all the events was reported as unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Tongue pruritus
Clinical narrative: tongue started feeling itchy; asthma was triggered; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 at approximately 8:45am (at the age of 65-Year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included allergies to Penicillin and Shrimp. The patient's concomitant medications were not reported. The patient previously took avelox and lisinopril and experienced allergy. On 06Apr2021, patient reported that she didn't have a reaction until about 9:45 am but about an hour after her tongue started feeling itchy and asthma was triggered. She took 25mg Benadryl at 9:10, but when it started to wear off this afternoon, tongue started itching again, she took another Benadryl at 4:45pm. She further enquired can this be a reaction to the vaccine. If so, how long was it expected to last and how can she treat her reaction. Therapeutic measures were taken as a result of tongue started feeling itchy and asthma was triggered. At the time of this report, the outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: feverish; slight headache; left arm where the injection was given, felt hot and very sore (felt like heat was radiating); left arm where the injection was given, felt hot and very sore (felt like heat was radiating); 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), via an unspecified route of administration, administered in the left arm on 02Apr2021 (at the age of 62 years old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included AFIB (atrial fibrillation) from Dec2018 to an unknown date, mitral valve replacement, known allergies to milk, lactose allergy, and allergies. The patient was not pregnant at the time of the events. Concomitant medications included metoprolol tartrate taken for an unspecified indication, start and stop date were not reported, rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN) taken for hypersensitivity, start and stop date were not reported; and acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 on 09Mar2021 for COVID-19 immunisation and experienced metal taste in mouth, soreness at injection, tired, and on the outside of my left arm a pain shot down my arm all the way down my pinky finger.  On 02Apr2021, the patient experienced left arm where the injection was given, felt hot and very sore (felt like heat was radiating). On 03Apr2021, the patient experienced feverish and slight headache. No treatment was received for the events. The outcome of the event vaccination site pain was not recovered, and outcome of other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, Pruritus, Respiratory rate
Clinical narrative: itching/head, back, arms and feet itching; Hives or rash present; This is a spontaneous report from a non-contactable other HCP (Nurse). A 74-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0150), via an unspecified route of administration on an unspecified date at 17:14 as dose 2, single (Age at vaccination: Unknown) for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) on an unspecified date for covid-19 immunization. Medical history included asthma, tachycardia, hypertension, diabetes mellitus. Concomitant medications includes Vitamins. Patient Allergies (food/drugs/etc.) includes Penicillin, Acrylic allergy. Patient denies Illness at time of vaccination or up to 1-month prior. On an unspecified date the patient experienced itching/head, back, arms and feet itching and hives or rash present. The patient underwent lab tests and procedures which included BP (blood pressure measurement): 131/74, HR (heart rate): 67, O2 SAT (oxygen saturation): transmit too long, RESP (respiratory rate): 18. Therapeutic measures were taken as a result of itching/head, back, arms and feet itching, hives or rash present which includes Diphenhydramine (Dose: 25mg; Route: PO). Stated relief of itching at 17:50 (10 mins after taking PO Diphenhydramine). No CPR indicated. The outcome of event itching/head, back, arms and feet itching was recovering while outcome of event hives or rash present was unknown. No follow-up attempts are possible; no further information expected.