chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blue toe syndrome, Cardiovascular disorder, Pain in extremity, Peripheral coldness
Clinical narrative: Right toes turned solid purple/blue 2 hours after shot.; No clot but blood flow restricted.; Feet always feel cold and ache; Feet always feel cold and ache/Toes hurt to walk on.; This is a spontaneous report from a contactable consumer.  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Aug2021 17:00 (Batch/Lot Number: FA7485) (at the age of 39-years-old ) as single dose for covid-19 immunisation.  The patient had received the first dose of vaccine on 22Jul2021 12:00 AM in Left arm (Lot number  EN0180). Medical history was none.  The patient was not pregnant.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant drugs included vitamins. Two hours after shot on 12Aug2021 at 19:00 the patient experienced right toes turned solid purple/blue. Went to ER. No clot but blood flow restricted. Symptoms continued to come back 10 days after. Feet always felt cold and ache. Toes hurt to walk on. It was reported that the events resulted in Emergency room/department or urgent care, disability or permanent damage. . Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Pressure headache; Chills; Had 99 degrees temperature on Saturday (21Aug2021)/On Sunday (22Aug2021), caller's temperature was at 101+ degrees/Today (23Aug2021), her temperature was still at around 101 degrees; Arm was hurting a little; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pressure headache on 23Aug2021, chills on 22Aug2021, arm was hurting a little on Aug2021, had 99 degrees temperature on Saturday (21aug2021)/on Sunday (22aug2021), caller's temperature was at 101+ degrees/today (23aug2021), her temperature was still at around 101 degrees on 21Aug2021. The patient underwent lab tests and procedures which included body temperature: 99 degrees on 21Aug2021, body temperature: 101+ degrees on 22Aug2021, body temperature: around 101 degrees on 23Aug2021. The outcome of the event pyrexia was not recovered, the outcome of the events headache, chills, pain in extremity was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Movement disorder, Pain in extremity, Pyrexia
Clinical narrative: feeling off; icky" although he "could still move around; fever; sore arm; This is a spontaneous report from a non-contactable consumer (patient). This 32-year-old male consumer received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 19Aug2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021 patient experienced sore arm, on 21Aug2021 feeling, icky" although he "could still move around, fever of recovering. The patient underwent lab tests and procedures which included pyrexia: 102-104 fahrenheit on 21Aug2021 with one of those ear thermometers. Therapeutic measures were taken as a result of fever took Tylenol extra strength and Advil liquid gels which helped to knock his fever down. Caller said he has heard rumors that symptoms are only "suppose to last two days" and so asked how long these symptoms will last? response received saying that fever and sore arm were both reported side effects. Informed caller that "In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter", emphasizing that a specific time frame is not noted for specific side effects. Encouraged caller to reach to his doctor for any symptoms that are prolonged or are worrisome to him for medical evaluation. The outcome for all events was unknown except fever it was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Paraesthesia oral, Vision blurred
Clinical narrative: Discomfort; a little tingling in my mouth on my side, on my right side, tingling on my lips; little blurriness on my right eye; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Aug2021 (Lot Number: FC3180) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 17Jul2021 (lot number: FA6780) as dose 1, single for covid-19 immunisation. The patient took the vaccine about two hours ago and was ok but about may be 40 minutes ago from the time of reporting, the patient had just a some discomfort and a little tingling in the mouth on the side, on the right side, tingling on the lips and a little blurriness on the right eye. The patient did not know if this bear off or should the patient give it some time or should go somewhere. The patient stated this was the second shot and that was the concern. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Skin mass
Clinical narrative: bumps feel hot an itchy like a mosquito bite; he noticed bumps in his legs; itchy like a mosquito bite; This is a spontaneous report from a contactable consumer. This is the 2nd case out of 2 cases. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Aug2021 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. On 21Aug2021 the patient experienced bumps feel hot an itchy like a mosquito bite, he noticed bumps in his legs, itchy like a mosquito bite. Reporter stated, noticed 6 bumps on his legs, wrist and it started itching more, bumps feel hot and itchy like a mosquito bite. Reporters husband (consumer) received his Pfizer Covid-19 vaccine first shot yesterday around the same time and his side effects were between 12:30 to 2:00 am last night, he noticed bumps in his legs when he went to the restaurant it started itching and when he went to bed, he started itching more and noticed 6 bumps on his legs and wrist, bumps feel hot an itchy like a mosquito bite. She gave answer to his questions. The patient did not receive any treatment for reported events. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Illness, Nasopharyngitis
Clinical narrative: complaints of cold; sore throat; coughing up dark brown phlegm; extreme headache; nausea; feels weak; feels really sick; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 as dose 1, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that after vaccine, she was fine for two to three days. But, after 2-3 days of vaccination, on an unspecified date in Aug2021, patient started having complaints of cold, sore throat, coughing up dark brown phlegm, extreme headache, nausea, feels weak, and feels really sick and was very tired. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Productive cough
Clinical narrative: complaints of cold; sore throat; coughing up dark brown phlegm; extreme headache; nausea; feels weak; feels really sick; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 as dose 1, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was reported that after vaccine, she was fine for two to three days. But, after 2-3 days of vaccination, on an unspecified date in Aug2021, patient started having complaints of cold, sore throat, coughing up dark brown phlegm, extreme headache, nausea, feels weak, and feels really sick and was very tired. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive to COVID 19 on both an antigen and PCR test; Tested positive to COVID 19 on both an antigen and PCR test; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration in Jun2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient received her 2nd dose of BNT162B2 in mid Jun2021 and she tested positive on both an antigen and PCR test on 17Aug2021 while traveling in Ireland. The patient was asymptomatic. She had a previous PCR test in Jul2021 that was negative. The outcome of the event was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain, Somnolence
Clinical narrative: feel sleepy; headache; body ache; feels weakness; This is a spontaneous report received from a contactable consumer(patient). A male patient received BNT162B2 (COMIRNATY- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 16Aug2021 night, at dose1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine made by Pfizer on Monday night of last week, 12 hours later on 17Aug2021 he began to feel sleepy, headache and body ache, today he still had a headache and felt weakness, the patient wants to know if this is normal. He has been taking serum (PENDING CLARIFICATION). The outcome of the events for feel sleepy and body ache were unknown while for headache and body ache were not recovered at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: he had diabetes; This is a spontaneous report from a Pfizer-sponsored Regulatory Authority Support. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on unspecified date at unknown DOSE 1, SINGLE for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date at unknown DOSE 2, SINGLE for COVID-19 immunization. No medical history reported. No concomitant medications. He stated that he was confused in regards with Pfizer's general plan. He pointed to the 3rd dose/booster if they could get it because they were informed that after 12 months getting the 2nd dose they will be receiving the 3rd dose but up to now they didn't receive it. (Withheld) is aggravated already in regards to what happened and he stated that he wants to go to the media to inform people about Pfizers general plan because he had diabetes and his wife had a polycystic condition. While talking to the representative she stated that she thinks she can not help it since he was in the original trial and we were in the clinical trial. The outcome of Event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia
Clinical narrative: first dose of the vaccine on 02Aug2021 and her second dose on 17Aug2021; she can't sleep; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for herself) communicated to Pfizer sponsored Program. A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 17Aug2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 02Aug2021, as single for covid-19 immunisation. On an unspecified date in Aug2021, the patient cannot sleep. Patient stated she received her first dose of the vaccine on 02Aug2021 and her second dose on 17Aug2021 and wanted to know if that was ok. She stated she received the first vaccine then went back and got her second at 2 weeks and one day and she was not sure how this happened because (withheld) did not say a word that she was there early. She stated she cannot sleep and should she be freaked out. This case was reported as non-Serious. The patient outcome of the event she cannot sleep was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Vaccination site pain
Clinical narrative: Arm is little bit sore where I got the shot; pain in my arm where they give me the shot and it was sore; I noticed like a lump, not at the injection site where I got the shot. It is more like on my collar bone area, my shoulder collar bone area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3181), via an unspecified route of administration in right arm, on 23Aug2021 (at the age of 42-year old) as dose 1, single for COVID-19 immunisation. Medical history included High Blood Pressure from an unknown date. Concomitant medication included enalapril maleate (ENALPRIN) taken for hypertension. On 23Aug2021, after vaccination, he experienced little bit sore where he got the shot, in his right arm and also he noticed something like a lump, not at the injection site where he got the shot. It was more likely on his shoulder collar bone area. No treatment was given in response to the events. The patient was not sure if the events was related to the shot. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller wanted to file lawsuit against Pfizer for getting covid but had received the covid vaccine; Caller wanted to file lawsuit against Pfizer for getting covid but had received the covid vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient got COVID. It was reported that the patient wanted to file lawsuit against Pfizer for getting COVID but had received the COVID vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. Outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Memory impairment
Clinical narrative: I am facing problem with fatigue and memory few things/ The next thing was the memory problem. Started about a month ago and they are increasing.; I am facing problem with fatigue and memory few things/ The fatigue gradually increase after the second shot. Starting, About the three month ago and it continued since then till now; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ENG201, expiration date was not reported), via an unspecified route of administration, in left shoulder, on 03Mar2021 (at the age of 73-years-old), at dose 2, single for covid-19 immunization. Medical history included multiple sclerosis from 40 years and trigeminal neuralgia. Concomitant medications included ocrelizumab (OCREVUS) for multiple sclerosis; carbamazepine for trigeminal neuralgia; fampridine (DALFAMPRIDINE); finasteride; terazosin; levothyroxine; atorvastatin; colecalciferol (VITAMIN D); cyanocobalamin (VIT B12); duloxetine; metoprolol succinate; calcium citrate; acetylsalicylic acid (ASPIRINE) (low dose aspirin); thiamine (VITAMIN B1); krill oil (OMEGA 3 KRILL); biotin; botulinum toxin type a (BOTOX); lisinopril; Montelukast; iron; folic acid; hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), multi - vitamin gummies.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJO686, expiration date was not reported), via an unspecified route of administration, in left shoulder, on 10Feb2021 (at the age of 73-years-old), at dose 1, single for covid-19 immunization.  The patient experienced problem with fatigue and memory few things; the fatigue gradually increased from three months (May2021) after the second shot of vaccination and it continued since the time of report. The memory problem started about a month ago (Jul2021) and they are increasing at the time of report. The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: My granddaughters other grandmother went bald from it; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was reported that, reporter granddaughters other grandmother went bald from it, and a friend whose hair fell out the back, and another friend who goes to the beauty shop, and the beautician said people are complaining left and right about their hair. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I have a friend whose hair fell out the back; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (her friend) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) 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. The patient experienced "I have a friend whose hair fell out the back" on an unspecified date. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: He woke up today with a massive headache; I have a headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient experienced massive headache on 22Aug2021, 3 days after the first dose of vaccination. Patient stated it was said to take Tylenol only if there is headache. Patient enquired whether he could take Excedrin for a headache. The event was treated with Tylenol. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: red rashes over my arms, in my elbows, in my face; red rashes on arms, face and elbows, and her arms and face were also itching badly; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation and experienced arm was just a little stiff. The patient got the vaccine and in Aug2021 was having these red rashes on arms, face and elbows, and her arms and face were also itching badly. She wanted to get an idea how long this rash will last. The arm was a little swollen and sore, and felt warm to the touch, but at the time of reporting it seemed that the swelling was down, arm was cool, but the rash. The outcome of feeling of warmth was recovered in Aug2021, outcome of swelling was recovering, and outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic ovarian cyst, Menstruation irregular
Clinical narrative: Irregular menstrual cycle, right hemorrhagic ovarian cyst; Irregular menstrual cycle, right hemorrhagic ovarian cyst; This is a spontaneous report from a contactable Other HCP (patient).  A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Apr2021 15:30 (Batch/Lot Number: Er8731) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation.  Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination.  There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced irregular menstrual cycle and right hemorrhagic ovarian cyst on 05May2021.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken and included prescription of birth control for ovarian cyst. Facility type vaccine: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Back injury
Clinical narrative: she injured her back; This is a spontaneous report from a Pfizer-sponsored Regulatory Authority Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164) dose 1 via an unspecified route of administration on 30Jul2021 as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were was not reported. On 15Aug2021, she injured her back and she was under different medication such as steroid (Intent: treatment), now she is supposed to get her second dose on 18Aug2021 however that needs to be canceled because she is still under medication (treatment) she was schedule for the second dose on 25Aug2021, this coming Wednesday however she thinks she is still unable to make it Wednesday. She was still worried about her condition (Clarification unknown). She was on a lot of medications she does not know if she could be on these medicines when she got the vaccine she was taking 'Mobic' (Not clarified) now which is anti-inflammatory, she thinks and steroid 'Dosepak', she finished steroid 'Dosepak' today, she needed to move it (second dose) ahead a little bit because of the medication. She was seeking for advice. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Fluid retention, Pain in extremity, Peripheral swelling
Clinical narrative: low grade fever last night of 99.1; felt like balloons, retaining water/weird feeling; That night her legs were really sore and last night her legs were in a lot of pain; both legs being swollen; large indentations like she was retaining water and they were pretty bad last night and her legs felt like balloons; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3183), via an unspecified route on 21Aug2021 (at the age of 38-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included COVID-19 on Feb2020, immunocompromised and had Major Surgery (half of her kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice) kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice on 18May2021. The patient concomitant medications included HPV VACCINE Injection on 20Aug2021 for unspecified indication. On 21Aug2021, the patient experienced night her legs were really sore and last night her legs were in a lot of pain. They felt like balloons, retaining water and this morning when she checked her socks she had sock lines- she took a bath and still had the sock lines. They are major indentations. It only happens at night when she's at rest. She also had a low grade fever last night of 99.1. The sock lines really hurt, annoyingly and in both legs. Last night after it was more painful and this morning when she was retaining water she figured she would call and see if this was a normal side effect. Patient stated that she know soreness is a normal side effect but the fact she got sock lines and her legs were like balloons and she felt like she needed those things you get after surgery that they put on your legs and her legs are painful. Patient had a weird feeling. Patient was assured that HPV Vaccine the day before the Covid Vaccine would not interfere with Covid Vaccine. Patient stated that she took pictures of her sock lines on her legs and showed her friend who told her she should call Pfizer. She states the symptoms only seem to occur when her legs are at rest at night. Says they are sore the next morning, but that it goes away. Patient did not visited to Emergency Room/ Physician Office. The outcome of the events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever last night of 99.1; felt like balloons, retaining water/weird feeling; That night her legs were really sore and last night her legs were in a lot of pain; both legs being swollen; large indentations like she was retaining water and they were pretty bad last night and her legs felt like balloons; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3183), via an unspecified route on 21Aug2021 (at the age of 38-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included COVID-19 on Feb2020, immunocompromised and had Major Surgery (half of her kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice) kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice on 18May2021. The patient concomitant medications included HPV VACCINE Injection on 20Aug2021 for unspecified indication. On 21Aug2021, the patient experienced night her legs were really sore and last night her legs were in a lot of pain. They felt like balloons, retaining water and this morning when she checked her socks she had sock lines- she took a bath and still had the sock lines. They are major indentations. It only happens at night when she's at rest. She also had a low grade fever last night of 99.1. The sock lines really hurt, annoyingly and in both legs. Last night after it was more painful and this morning when she was retaining water she figured she would call and see if this was a normal side effect. Patient stated that she know soreness is a normal side effect but the fact she got sock lines and her legs were like balloons and she felt like she needed those things you get after surgery that they put on your legs and her legs are painful. Patient had a weird feeling. Patient was assured that HPV Vaccine the day before the Covid Vaccine would not interfere with Covid Vaccine. Patient stated that she took pictures of her sock lines on her legs and showed her friend who told her she should call Pfizer. She states the symptoms only seem to occur when her legs are at rest at night. Says they are sore the next morning, but that it goes away. Patient did not visited to Emergency Room/ Physician Office. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm (on the side of the injection down to her wrist) still hurts from it; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date in Jun2021 at the age of 58-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date in May2021 at the age of 58-years-old as dose 1, single for covid-19 immunisation. It was reported that she received first shot of pfizer covid vaccine in May2021 and 2nd shot in Jun2021. Stated that since receiving her second shot on an unspecified date in Jun2021, her arm (on the side of the injection down to her wrist) still hurts from it. when she wakes up she can hardly move it. Adds before receiving the vaccine, she had no issues with her arm. She asked, why would her arm still hurt? The reporter asked, why should she have to pay for costs associated with side effects of the vaccine. The case was reported as non-serious. The outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test false positive
Clinical narrative: positive for covid virus; positive for covid virus; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program COVAX US support. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was positive for covid virus. The patient on an unknown date underwent sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myocarditis
Clinical narrative: About 6 days after vaccination, started having shortness of breath and irregular heartbeat, Diagnosis with mild myocarditis; Pregnancy at time of Vaccination:Yes/gestational period:25 weeks; This is a spontaneous report from a contactable Nurse (Patient). This Nurse reported information for mother (herself). This is a maternal report.  A 33-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 10Aug2021 at the age of 33 years (Lot number and Expiry date was not reported) as dose 1, single for covid-19 immunization.  Medical history included Polycystic ovary syndrome (PCOS) and Hashimoto's. The patient did not have covid prior and post vaccination. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. The patient experienced pregnancy at time of vaccination:yes/gestational period:25 weeks on 10Aug2021, about 6 days after vaccination (discrepantly reported), started having shortness of breath and irregular heartbeat and went to cardiologist and diagnosed with mild myocarditis on 18Aug2021. The mother was due to deliver on 19Nov2021. It was reported, the event myocarditis resulted in the Doctor or Other health care professional office/ clinic visit, Emergency room/department or urgent care. It was reported, beta blocker was received as treatment for the event. The outcome for the event was Not recovered/Not resolved.   The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association and known drug safety profile a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported event of Myocarditis. The case will be reassessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient developed COVID-19 symptoms and subsequently tested positive by PCR test.; Patient developed COVID-19 symptoms and subsequently tested positive by PCR test.; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an intramuscular route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. It was unknown, if patient received any vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient medical history and concomitant medications were not reported. It was reported that patient developed covid-19 symptoms and subsequently tested positive by pcr test. on 21Aug2021. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 21Aug2021. It was unknown if patient received any treatment. The clinical outcome for the event was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Flushing, Illness, Limb discomfort
Clinical narrative: fever; body aches; didn't feel well; felt that his ankles were on fire. It went up above his knees to his legs; flushing; runny nose; sore throat; really sick for the next 2 days; moved up to his calf area, still burning; burning really hard again, all the way up above his knees; felt that his ankles were on fire. It went up above his knees to his legs/moved up to his calf area, above his socks; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 2, single for covid-19 immunization.  The patient medical history included blood cholesterol abnormal (reported as cholesterol). Patient concomitant medications were not reported.  Patient was really sick for the next 2 days after the first dose of vaccine, he had fever and body aches that were really bad. Reporter stated that ever since then, patient was not feeling well. Reporter state that this morning the patient got up and he went into work and he called his wife about 08: 20, he had been at work about an hour and he asked if she changed anything with the laundry as he felt the feeling he felt years ago from his Cholesterol meds that caused flushing. He felt like his ankles were on fire. Wife told him they haven't changed any laundry stuff, soaps or anything. He felt like somebody had poured gasoline on his ankles, he thought something was wrong with his socks. He called the caller about an hour later and said it had moved up to his calf area, above his socks, it was still burning but not near as bad. He then called about half an hour ago and he said it's burning really hard again and it's all the way up above his knees. He was not feeling good, had runny nose and sore throat. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal discomfort, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever; body aches; didn't feel well; felt that his ankles were on fire. It went up above his knees to his legs; flushing; runny nose; sore throat; really sick for the next 2 days; moved up to his calf area, still burning; burning really hard again, all the way up above his knees; felt that his ankles were on fire. It went up above his knees to his legs/moved up to his calf area, above his socks; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 2, single for covid-19 immunization.  The patient medical history included blood cholesterol abnormal (reported as cholesterol). Patient concomitant medications were not reported.  Patient was really sick for the next 2 days after the first dose of vaccine, he had fever and body aches that were really bad. Reporter stated that ever since then, patient was not feeling well. Reporter state that this morning the patient got up and he went into work and he called his wife about 08: 20, he had been at work about an hour and he asked if she changed anything with the laundry as he felt the feeling he felt years ago from his Cholesterol meds that caused flushing. He felt like his ankles were on fire. Wife told him they haven't changed any laundry stuff, soaps or anything. He felt like somebody had poured gasoline on his ankles, he thought something was wrong with his socks. He called the caller about an hour later and said it had moved up to his calf area, above his socks, it was still burning but not near as bad. He then called about half an hour ago and he said it's burning really hard again and it's all the way up above his knees. He was not feeling good, had runny nose and sore throat. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: fever; body aches; didn't feel well; felt that his ankles were on fire. It went up above his knees to his legs; flushing; runny nose; sore throat; really sick for the next 2 days; moved up to his calf area, still burning; burning really hard again, all the way up above his knees; felt that his ankles were on fire. It went up above his knees to his legs/moved up to his calf area, above his socks; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 2, single for covid-19 immunization.  The patient medical history included blood cholesterol abnormal (reported as cholesterol). Patient concomitant medications were not reported.  Patient was really sick for the next 2 days after the first dose of vaccine, he had fever and body aches that were really bad. Reporter stated that ever since then, patient was not feeling well. Reporter state that this morning the patient got up and he went into work and he called his wife about 08: 20, he had been at work about an hour and he asked if she changed anything with the laundry as he felt the feeling he felt years ago from his Cholesterol meds that caused flushing. He felt like his ankles were on fire. Wife told him they haven't changed any laundry stuff, soaps or anything. He felt like somebody had poured gasoline on his ankles, he thought something was wrong with his socks. He called the caller about an hour later and said it had moved up to his calf area, above his socks, it was still burning but not near as bad. He then called about half an hour ago and he said it's burning really hard again and it's all the way up above his knees. He was not feeling good, had runny nose and sore throat. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tenderness
Clinical narrative: headache on her left side, it is sore to the touch; headache on her left side, it is sore to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FD8448) via an unspecified route of administration, administered in Arm Left on 19Aug2021 (at the age of 58 years old) as dose 1, single for COVID-19 immunisation. Medical history included heart beats real fast (she has palpitations but it has not been diagnosed. sometimes she will be thinking too hard and gets anxious, and her heart beats really fast). There were no concomitant medication. The patient previously took lipitor for blood cholesterol (the only medication she takes was cholesterol and its from Pfizer. She clarifies she was taking Lipitor. She explains about 2 weeks ago, she stopped taking it because her cholesterol was under control). Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Adverse event following prior vaccinations was none (never had any reaction to any medication). The patient experienced headache on her left side, it is sore to the touch on 19Aug2021. Reported as, she took her first dose of the Pfizer COVID-19 vaccine on 19Aug2021 and has been having a headache on her left side, it was sore to the touch, like if someone were to hit him on the head with something. She mentions she scheduled an appointment with her doctor for the first of November. Patient confirms the headache began late in the evening on Thursday, 19Aug2021. She states sometimes there is a sharp pain, like zoop zoop. Most of the pain is on her left side, but sometimes she feels it in her forehead. Outcome of the events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report form a non-contactable consumer (co-worker). A female patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after the shot, the patient had a stroke, assessed as medically significant. At the time of the report the event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.